WorldWideScience

Sample records for plastics drug manufacturing

  1. 21 CFR 178.3010 - Adjuvant substances used in the manufacture of foamed plastics.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Adjuvant substances used in the manufacture of... substances used in the manufacture of foamed plastics. The following substances may be safely used as adjuvants in the manufacture of foamed plastics intended for use in contact with food, subject to any...

  2. Synaptic plasticity in drug reward circuitry.

    Science.gov (United States)

    Winder, Danny G; Egli, Regula E; Schramm, Nicole L; Matthews, Robert T

    2002-11-01

    Drug addiction is a major public health issue worldwide. The persistence of drug craving coupled with the known recruitment of learning and memory centers in the brain has led investigators to hypothesize that the alterations in glutamatergic synaptic efficacy brought on by synaptic plasticity may play key roles in the addiction process. Here we review the present literature, examining the properties of synaptic plasticity within drug reward circuitry, and the effects that drugs of abuse have on these forms of plasticity. Interestingly, multiple forms of synaptic plasticity can be induced at glutamatergic synapses within the dorsal striatum, its ventral extension the nucleus accumbens, and the ventral tegmental area, and at least some of these forms of plasticity are regulated by behaviorally meaningful administration of cocaine and/or amphetamine. Thus, the present data suggest that regulation of synaptic plasticity in reward circuits is a tractable candidate mechanism underlying aspects of addiction.

  3. Essential Aspects in Assessing the Safety Impact of Interactions between a Drug Product and Its Associated Manufacturing System.

    Science.gov (United States)

    Jenke, Dennis

    2012-01-01

    An emerging trend in the biotechnology industry is the utilization of plastic components in manufacturing systems for the production of an active pharmaceutical ingredient (API) or a finished drug product (FDP). If the API, the FDP, or any solution used to generate them (for example, process streams such as media, buffers, and the like) come in contact with a plastic at any time during the manufacturing process, there is the potential that substances leached from the plastic may accumulate in the API or FDP, affecting safety and/or efficacy. In this article the author develops a terminology that addresses process streams associated with the manufacturing process. Additionally, the article outlines the safety assessment process for manufacturing systems, specifically addressing the topics of risk management and the role of compendial testing. Finally, the proper use of vendor-supplied extractables information is considered. Manufacturing suites used to produce biopharmaceuticals can include components that are made out of plastics. Thus it is possible that substances could leach out of the plastics and into manufacturing solutions, and it is further possible that such leachables could accumulate in the pharmaceutical product. In this article, the author develops a terminology that addresses process streams associated with the manufacturing process. Additionally, the author proposes a process by which the impact on product safety of such leached substances can be assessed.

  4. 21 CFR 310.509 - Parenteral drug products in plastic containers.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Parenteral drug products in plastic containers... Parenteral drug products in plastic containers. (a) Any parenteral drug product packaged in a plastic... parenteral drug product for intravenous use in humans that is packaged in a plastic immediate container on or...

  5. Current manufacturing processes of drug-eluting sutures.

    Science.gov (United States)

    Champeau, Mathilde; Thomassin, Jean-Michel; Tassaing, Thierry; Jérôme, Christine

    2017-11-01

    Drug-eluting sutures represent the next generation of surgical sutures since they fulfill their mechanical functions but also deliver the drug in their vicinity after implantation. These implants are produced by a variety of manufacturing processes. Drug-eluting sutures represent the next generation of surgical sutures since they fulfill their mechanical functions but also deliver the drug in their vicinity after implantation. These implants are produced by a variety of manufacturing processes. Two general approaches can be followed: (i) the ones that add the API into the material during the manufacturing process of the suture and (ii) the ones that load the API to an already manufactured suture. Areas covered: This review provides an overview of the current manufacturing processes for drug-eluting suture production and discusses their benefits and drawbacks depending on the type of drugs. The mechanical properties and the drug delivery profile of drug-eluting sutures are highlighted since these implants must fulfill both criteria. Expert opinion: For limited drug contents, melt extrusion and electrospinning are the emerging processes since the drug is added during the suture manufacture process. Advantageously, the drug release profile can be tuned by controlling the processing parameters specific to each process and the composition of the drug-containing polymer. If high drug content is targeted, the coating or grafting of a drug layer on a pre-manufactured suture allows for preservation of the tensile strength requirements of the suture.

  6. Manufacture of wood/plastic composites by radiation

    International Nuclear Information System (INIS)

    Iwamoto, Takeo

    1976-01-01

    The manufacture and use of wood/plastic composite (WPC) as an example of wood matrix and wood sawdust/plastic composites (SDP) as an example of plastic matrix are reviewed. The raw material for WPC are mostly vinyl monomers, particularly methyl methacrylate and styrene. The reaction in WPC polymerization is radical polymerization. Researches on the radiation sources mostly resulted in gamma-ray. Electron beam can be applied only to thin products. The future use of WPC may be for furnitures, sporting goods, decorative parts and the like. Vital study on the reduction of manufacturing costs is required, for example, the improvement of reaction and the adoption of continuous process must be considered. The raw materials for SDP are wood sawdust, vinyl monomer (mostly methyl methacrylate) and resins. Electron beam accelerators are the most preferable radiation source because of its high efficiency and safe operation. SDP shows good forming property. The most preferable use of SDP is as interior materials for prefabricated houses, for example, opening frames for bath rooms. Some combination of the technologies of wood engineering, chemical engineering and radiation engineering must be established to develop and maintain the demands. The present radiation sources are forced to grow to large scale industrially, but the establishment of radiation source technology which can be enlarged stepwise is important to keep pace with the development. (Iwakiri, K.)

  7. [Structural plasticity associated with drugs addiction].

    Science.gov (United States)

    Zhu, Jie; Cao, Guo-fen; Dang, Yong-hui; Chen, Teng

    2011-12-01

    An essential feature of drug addiction is that an individual continues to use drug despite the threat of severely adverse physical or psychosocial consequences. Persistent changes in behavior and psychological function that occur as a function of drugs of abuse are thought to be due to the reorganization of synaptic connections (structural plasticity) in relevant brain circuits (especially the brains reward circuits). In this paper we summarized evidence that, indeed, exposure to amphetamine, cocaine, nicotine or morphine produced persistent changes in the structure of dendrites and dendritic spines on cells in relevant brain regions. We also approached the potential molecular mechanisms of these changes. It is suggested that structural plasticity associated with exposure to drugs of abuse reflects a reorganization of patterns of synaptic connectivity in these neural systems, a reorganization that alters their operation, thus contributing to some of the persistent sequela associated with drug use-including addiction.

  8. Supply chain integration: A qualitative exploration of perspectives from plastic manufacturers in Gauteng

    OpenAIRE

    Yvonne Vermeulen; Wesley Niemann; Theuns Kotzé

    2016-01-01

    Background: Supply chain integration was identified as a tool to assist an organisation to survive in a competitive marketplace. It was unclear how plastic manufacturers in Gauteng perceived supply chain integration efforts between themselves and their suppliers. Objectives: This study’s main purpose was to investigate the nature and extent of supply chain integration between 10 plastic manufacturers in Gauteng and their suppliers. The focus was on these manufacturers’ commitment to and p...

  9. Process combinations for the manufacturing of metal-plastic hybrid parts

    International Nuclear Information System (INIS)

    Drossel, W-G; Lies, C; Albert, A; Haase, R; Müller, R; Scholz, P

    2016-01-01

    The usage of innovative lightweight materials and processing technologies gains importance in manifold industrial scopes. Especially for moving parts and mobility products the weight is decisively. The aerospace and automotive industries use light and high-strength materials to reduce weight and energy consumption and thereby improve the performance of their products. Composites with reinforced plastics are of particular importance. They offer a low density in combination with high specific stiffness and strength. A pure material substitution through reinforced plastics is still not economical. The approach of using hybrid metal-plastic structures with the principle of “using the right material at the right place” is a promising solution for the economical realization of lightweight structures with a high achievement potential. The article shows four innovative manufacturing possibilities for the realization of metal-plastic-hybrid parts. (paper)

  10. 21 CFR 201.122 - Drugs for processing, repacking, or manufacturing.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Drugs for processing, repacking, or manufacturing... for processing, repacking, or manufacturing. A drug in a bulk package, except tablets, capsules, or... manufacturing, processing, or repacking”; and if in substantially all dosage forms in which it may be dispensed...

  11. Supply chain integration: A qualitative exploration of perspectives from plastic manufacturers in Gauteng

    Directory of Open Access Journals (Sweden)

    Yvonne Vermeulen

    2016-05-01

    Full Text Available Background: Supply chain integration was identified as a tool to assist an organisation to survive in a competitive marketplace. It was unclear how plastic manufacturers in Gauteng perceived supply chain integration efforts between themselves and their suppliers. Objectives: This study’s main purpose was to investigate the nature and extent of supply chain integration between 10 plastic manufacturers in Gauteng and their suppliers. The focus was on these manufacturers’ commitment to and perceptions of supplier integration efforts. Method: The study was conducted with plastic manufacturing organisations in Gauteng, over a period of 2 months. A total of 10 participants were engaged through semi-structured interviews. Results: The main findings of the study revealed that commitment and trust were found to be the antecedents of supplier integration and closer collaboration, while customer price pressure and limited available resources served as motivating factors for integration efforts. Conclusion: It is recommended that organisations must revisit integration efforts when new markets are penetrated and top management support must be revisited using a strategic framework. Keywords: Supply chain integration; supply chain commitment; organisational integration; performance; visibility; supplier integration; customer integration; qualitative study; semi-structured interview; basic research.

  12. Potential of Continuous Manufacturing for Liposomal Drug Products.

    Science.gov (United States)

    Worsham, Robert D; Thomas, Vaughan; Farid, Suzanne S

    2018-05-21

    Over the last several years, continuous manufacturing of pharmaceuticals has evolved from bulk APIs and solid oral dosages into the more complex realm of biologics. The development of continuous downstream processing techniques has allowed biologics manufacturing to realize the benefits (e.g. improved economics, more consistent quality) that come with continuous processing. If relevant processing techniques and principles are selected, the opportunity arises to develop continuous manufacturing designs for additional pharmaceutical products including liposomal drug formulations. Liposome manufacturing has some inherent aspects that make it favorable for a continuous process. Other aspects such as formulation refinement, materials of construction, and aseptic processing need development, but present an achievable challenge. This paper reviews the current state of continuous manufacturing technology applicable to liposomal drug product manufacturing and an assessment of the challenges and potential of this application. This article is protected by copyright. All rights reserved.

  13. Drug development and manufacturing

    Science.gov (United States)

    Warner, Benjamin P.; McCleskey, T. Mark; Burrell, Anthony K.

    2015-10-13

    X-ray fluorescence (XRF) spectrometry has been used for detecting binding events and measuring binding selectivities between chemicals and receptors. XRF may also be used for estimating the therapeutic index of a chemical, for estimating the binding selectivity of a chemical versus chemical analogs, for measuring post-translational modifications of proteins, and for drug manufacturing.

  14. Effect of drug precursors and chemicals relevant to clandestine laboratory investigation on plastic bags used for collection and storage.

    Science.gov (United States)

    Michelot, Harmonie; Fu, Shanlin; Stuart, Barbara; Shimmon, Ronald; Raymond, Tony; Crandell, Tony; Roux, Claude

    2017-04-01

    In the area of clandestine laboratory investigations, plastic bags are used to collect and store evidence, such as solvents, precursors, and other compounds usually employed for the manufacturing of drugs (although liquids may be stored in glass containers within the bags first). In this study, three different types of plastic bags were provided by the NSW Police Force and investigated for their suitability for evidence collection: two different types of low-density polyethylene (LDPE) bags and one type of polyvinyl chloride (PVC) bag. Three different experiments were carried out: (1) storing relevant chemicals in the bags for up to three months; (2) exposing the bags including their content to accelerated conditions using a weatherometer, and (3) simulating an expected real case scenario. This study indicates that drugs and related chemicals stored in plastic bags may lead to a change in the composition of the chemical and an alteration or degradation of the plastic bag. All experiments led to the same conclusion: the polyvinyl chloride bags appeared to be the most affected. LDPE bags seem to be more appropriate for routine use, although it has been established they are not suitable for the collection of liquids (unless pre-packaged in, for instance, a glass container). Copyright © 2017 Elsevier B.V. All rights reserved.

  15. In Situ Manufacturing of Plastics and Composites to Support H&R Exploration, Phase II

    Data.gov (United States)

    National Aeronautics and Space Administration — Makel Engineering and BAE Systems propose to develop processes to manufacture plastics and composites for radiation shielding based on In Situ Resources Utilization...

  16. National supply-chain survey of drug manufacturer back orders.

    Science.gov (United States)

    Wellman, G S

    2001-07-01

    The impact of manufacturer back orders on the supply chain for pharmaceuticals in the institutional setting was studied. A questionnaire was distributed during May and June 2000 to 600 institutional pharmacies affiliated with a major national drug and supply group purchasing organization. The instrument included questions on basic institutional demographics, perceptions about the frequency of manufacturer back orders for pharmaceuticals, the quality of communication with manufacturers and wholesalers about back orders, the two most significant back orders that had occurred in the 12 months preceding the survey, and the reasons for and impact of back orders. A total of 170 usable surveys were returned (net response rate, 28.3%). Reported manufacturer back orders included an array of drug classes, including blood products, antimicrobials, antiarrhythmics, benzodiazepine antagonists, thrombolytics, corticosteroids, and antihypertensives. Respondents perceived significant back orders as increasing in frequency. Communication by manufacturers and wholesalers about back orders was reported to be relatively poor. A raw-material shortage was the most common reason given by manufacturers for back orders (36.5%), followed by a regulatory issue (23.2%). In most cases (92%), medical staff members had to be contacted, indicating an interruption in the normal drug distribution process. In over a third of instances, respondents stated that the back order resulted in less optimal therapy. A survey found that manufacturer back orders for pharmaceuticals were increasing in frequency and that information flow within the supply chain was insufficient to meet the needs of end users.

  17. 21 CFR 212.2 - What is current good manufacturing practice for PET drugs?

    Science.gov (United States)

    2010-04-01

    ..., holding, or distribution of PET drugs intended for human use. Current good manufacturing practice is... 21 Food and Drugs 4 2010-04-01 2010-04-01 false What is current good manufacturing practice for... HUMAN SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION...

  18. Stockpiling anti-viral drugs for a pandemic: the role of Manufacturer Reserve Programs.

    Science.gov (United States)

    Harrington, Joseph E; Hsu, Edbert B

    2010-05-01

    To promote stockpiling of anti-viral drugs by non-government organizations such as hospitals, drug manufacturers have introduced Manufacturer Reserve Programs which, for an annual fee, provide the right to buy in the event of a severe outbreak of influenza. We show that these programs enhance drug manufacturer profits but could either increase or decrease the amount of pre-pandemic stockpiling of anti-viral drugs.

  19. Comparative Analysis of Properties and Microstructure of the Plastically Deformed Alloy Inconel®718, Manufactured by Plastic Working and Direct Metal Laser Sintering

    Directory of Open Access Journals (Sweden)

    Żaba K.

    2016-03-01

    Full Text Available Nickel superalloys as Inconel® are materials widely used in the aerospace industry among others for diffusers, combustion chamber, shells of gas generators and other. In most cases, manufacturing process of those parts are used metal strips, produced by conventional plastic processing techniques, and thus by hot or cold rolling. An alternative technology allowing for manufacturing components for jet engines is the technique of 3D printing (additive manufacturing, and most of all Direct Metal Laser Sintering, which is one of the latest achievement in field of additive technologies.

  20. HVAC Modeling for Cost of Ownership Assessment in Biotechnology & Drugs Manufacturing

    OpenAIRE

    Broomes, Peter; Dornfeld, David A

    2003-01-01

    Heating, ventilation, and air conditioning (HVAC) systems used in the clean room environment of biotechnology and drug development and manufacturing, are extremely energy and water intensive and represent a significant operating cost for these facilities [1]. HVAC systems are also the primary source of environmental emissions for the majority of companies operating within the biotechnology and drugs sector. While the processes used in drug manufacture have negligible environmental impact...

  1. Pharmacy on demand: New technologies to enable miniaturized and mobile drug manufacturing.

    Science.gov (United States)

    Lewin, John J; Choi, Eugene J; Ling, Geoffrey

    2016-01-15

    Developmental pharmaceutical manufacturing systems and techniques designed to overcome the shortcomings of traditional batch processing methods are described. Conventional pharmaceutical manufacturing processes do not adequately address the needs of military and civilian patient populations and healthcare providers. Recent advances within the Defense Advanced Research Projects Agency (DARPA) Battlefield Medicine program suggest that miniaturized, flexible platforms for end-to-end manufacturing of pharmaceuticals are possible. Advances in continuous-flow synthesis, chemistry, biological engineering, and downstream processing, coupled with online analytics, automation, and enhanced process control measures, pave the way for disruptive innovation to improve the pharmaceutical supply chain and drug manufacturing base. These new technologies, along with current and ongoing advances in regulatory science, have the future potential to (1) permit "on demand" drug manufacturing on the battlefield and in other austere environments, (2) enhance the level of preparedness for chemical, biological, radiological, and nuclear threats, (3) enhance health authorities' ability to respond to natural disasters and other catastrophic events, (4) minimize shortages of drugs, (5) address gaps in the orphan drug market, (6) support and enable the continued drive toward precision medicine, and (7) enhance access to needed medications in underserved areas across the globe. Modular platforms under development by DARPA's Battlefield Medicine program may one day improve the safety, efficiency, and timeliness of drug manufacturing. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

  2. "Current Good Manufacturing Practices" and the Federal Food, Drug and Cosmetic Act

    OpenAIRE

    Goldstein, Beth F.

    1995-01-01

    The Food and Drug Administration (hereinafter, FDA) regulates food, drugs, and cosmetics in order to ensure that these products are safe and truthfully labelled. As part of its responsibilities under the Federal Food, Drug, and Cosmetic Act (hereinafter, Act), the FDA monitors the manufacturing practices of companies involved in the production of food, drugs, and medical devices. The manufacturing practices used by these companies must comply with certain standards, identified in the Act as "...

  3. Durability of wood plastic composites manufactured from recycled plastic

    Directory of Open Access Journals (Sweden)

    Irina Turku

    2018-03-01

    Full Text Available The influence of accelerated weathering, xenon-arc light and freeze-thaw cycling on wood plastic composites extruded from a recycled plastic was studied. The results showed that, in general, weathering had a stronger impact on samples made from plastic waste compared to a sample made from virgin material. After weathering, the mechanical properties, tensile and flexural, were reduced by 2–30%, depending on the plastic source. Wettability of the samples was shown to play a significant role in their stability. Chemical analysis with infrared spectroscopy and surface observation with a scan electron microscope confirmed the mechanical test results. Incorporation of carbon black retained the properties during weathering, reducing the wettability of the sample, diminishing the change of mechanical properties, and improving color stability. Keywords: Environmental science, Mechanical engineering, Materials science

  4. A review on recent technologies for the manufacture of pulmonary drugs.

    Science.gov (United States)

    Hadiwinoto, Gabriela Daisy; Lip Kwok, Philip Chi; Lakerveld, Richard

    2018-01-01

    This review discusses recent developments in the manufacture of inhalable dry powder formulations. Pulmonary drugs have distinct advantages compared with other drug administration routes. However, requirements of drugs properties complicate the manufacture. Control over crystallization to make particles with the desired properties in a single step is often infeasible, which calls for micronization techniques. Although spray drying produces particles in the desired size range, a stable solid state may not be attainable. Supercritical fluids may be used as a solvent or antisolvent, which significantly reduces solvent waste. Future directions include application areas such as biopharmaceuticals for dry powder inhalers and new processing strategies to improve the control over particle formation such as continuous manufacturing with in-line process analytical technologies.

  5. Chemistry, manufacturing and controls in passive transdermal drug delivery systems.

    Science.gov (United States)

    Goswami, Tarun; Audett, Jay

    2015-01-01

    Transdermal drug delivery systems (TDDS) are used for the delivery of the drugs through the skin into the systemic circulation by applying them to the intact skin. The development of TDDS is a complex and multidisciplinary affair which involves identification of suitable drug, excipients and various other components. There have been numerous problems reported with respect to TDDS quality and performance. These problems can be reduced by appropriately addressing chemistry, manufacturing and controls requirements, which would thereby result in development of robust TDDS product and processes. This article provides recommendations on the chemistry, manufacturing and controls focusing on the unique technical aspects of TDDS.

  6. Snap-lock bags with red band: A study of manufacturing characteristics, thermal and chemical properties.

    Science.gov (United States)

    Sim, Yvonne Hui Ying; Koh, Alaric C W; Lim, Shing Min; Yew, Sok Yee

    2015-10-01

    Drug packaging is commonly submitted to the Forensic Chemistry and Physics Laboratory of the Health Sciences Authority, Singapore, for examination. The drugs seized are often packaged in plastic bags. These bags are examined for linkages to provide law enforcement with useful associations between the traffickers and drug abusers. The plastic bags submitted may include snap-lock bags, some with a red band located above the snap-lock closure and some without. Current techniques for examination involve looking at the physical characteristics (dimensions, thickness and polarising patterns) and manufacturing marks of these bags. In cases where manufacturing marks on the main body of the bags are poor or absent, the manufacturing characteristics present on the red band can be examined. A study involving approximately 1000 bags was conducted to better understand the variations in the manufacturing characteristics of the red band. This understanding is crucial in helping to determine associations/eliminations between bags. Two instrumental techniques, namely differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FT-IR) were explored to evaluate the effectiveness of examining the chemical composition to discriminate the bags. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  7. 77 FR 69634 - International Conference on Harmonisation; Guidance on Q11 Development and Manufacture of Drug...

    Science.gov (United States)

    2012-11-20

    ...] International Conference on Harmonisation; Guidance on Q11 Development and Manufacture of Drug Substances... Administration (FDA) is announcing the availability of a guidance entitled ``Q11 Development and Manufacture of... guidance is intended to apply only to the manufacture of drug substance, not the manufacture of finished...

  8. 78 FR 65904 - Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products

    Science.gov (United States)

    2013-11-04

    ... Manufacturing of Certain Drug or Biological Products AGENCY: Food and Drug Administration, HHS. ACTION: Proposed.... The Fabrazyme shortage resulted from contamination at the manufacturing [[Page 65910

  9. 21 CFR 510.7 - Consignees of new animal drugs for use in the manufacture of animal feed.

    Science.gov (United States)

    2010-04-01

    ... manufacture of animal feed. 510.7 Section 510.7 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... Provisions § 510.7 Consignees of new animal drugs for use in the manufacture of animal feed. (a) A new animal drug intended for use in the manufacture of animal feed shall be deemed to be unsafe unless at the time...

  10. DESIGNERS’ KNOWLEDGE IN PLASTICS

    DEFF Research Database (Denmark)

    Eriksen, Kaare

    2013-01-01

    The Industrial designers’ knowledge in plastics materials and manufacturing principles of polymer products is very important for the innovative strength of the industry, according to a group of Danish plastics manufacturers, design students and practicing industrial designers. These three groups ...

  11. Manufacturing of golf club using wood-plastic combination produced by γ-irradiation

    International Nuclear Information System (INIS)

    Yamagami, Masayuki; Tsujii, Yukio; Ohnishi, Tokuhiro; Miyoshi, Hirofumi; Chubachi, Mitsuo; Takada, Hisatoshi.

    1992-01-01

    Wood-plastic combination (WPC) was produced by γ-irradiation of persimmon impregnated with acrylonitrile and styrene. The hardness and strength of WPC obtained were higher than those of an unmodified wood. Thus, it was found that the WPC is suited for a head of golf club, because the Shore hardness value of WPC is 36% greater than that of unmodified wood. An impregnation method of monomers with some pigments could produce colored WPC without diminishing natural grain. Head of golf club could be manufactured from colored WPC in practice. (auhtor)

  12. Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule.

    Science.gov (United States)

    2008-07-15

    The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.

  13. [Trial manufacture of a plunger shield for a disposable plastic syringe].

    Science.gov (United States)

    Murakami, Shigeki; Emoto, Takashi; Mori, Hiroshige; Fujita, Katsuhisa; Kubo, Naoki

    2008-08-20

    A syringe-type radiopharmaceutical being supplied by a manufacturer has a syringe shield and a plunger shield, whereas an in-hospital labeling radiopharmaceutical is administered by a disposable plastic syringe without the plunger shield. In cooperation with Nihon Medi-Physics Co. Ltd., we have produced a new experimental plunger shield for the disposable plastic syringe. In order to evaluate this shielding effect, we compared the leaked radiation doses of our plunger shield with those of the syringe-type radiopharmaceutical (Medi shield type). Our plunger shield has a lead plate of 21 mm in diameter and 3 mm thick. This shield is equipped with the plunger-end of a disposal plastic syringe. We sealed 99mTc solution into a plastic syringe (Terumo Co.) of 5 ml with our plunger shield and Medi shield type of 2 ml. We measured leaked radiation doses around syringes using fluorescent glass dosimeters (Dose Ace). The number of measure points was 18. The measured doses were converted to 70 microm dose equivalent at 740 MBq of radioactivity. The results of our plunger shield and the Medi shield type were as follows: 4-13 microSv/h and 3-14 microSv/h at shielding areas, 3-545 microSv/h and 6-97 microSv/h at non-shielding areas, 42-116 microSv/h and 88-165 microSv/h in the vicinity of the syringe shield, and 1071 microSv/h and 1243 microSv/h at the front of the needle. For dose rates of shielding areas around the syringe, the shielding effects were approximately the same as those of the Medi shield type. In conclusion, our plunger shield may be useful for reducing finger exposure during the injection of an in-hospital labeled radiopharmaceutical.

  14. Home Manufacture of Drugs: An Online Investigation and a Toxicological Reality Check of Online Discussions on Drug Chemistry.

    Science.gov (United States)

    Hearne, Evelyn; Alves, Emanuele Amorim; Van Hout, Marie Claire; Grund, Jean-Paul C

    2017-01-01

    Emerging trends in market dynamics and the use of new psychoactive substances are both a public health concern and a complex regulatory issue. One novel area of investigation is the availability of homemade opioids, amphetamines and dissociatives, and the potential fueling of interest in clandestine home manufacture of drugs via the Internet. We illustrate here how online communal folk pharmacology of homemade drugs on drug website forums may actually inform home manufacture practices or contribute to the reduction of harms associated with this practice. Discrepancies between online information around purification and making homemade drugs safer, and the synthesis of the same substances in a proper laboratory environment, exist. Moderation and shutdown of synthesis queries and discussions online are grounded in drug websites adhering to harm-reduction principles by facilitating discussions around purification of homemade drugs only. Drug discussion forums should consider reevaluating their policies on chemistry discussions in aiming to reach people who cannot or will not refrain from cooking their own drugs with credible information that may contribute to reductions in the harms associated with this practice.

  15. Drug-printing by flexographic printing technology--a new manufacturing process for orodispersible films.

    Science.gov (United States)

    Janssen, Eva Maria; Schliephacke, Ralf; Breitenbach, Armin; Breitkreutz, Jörg

    2013-01-30

    Orodispersible films (ODFs) are intended to disintegrate within seconds when placed onto the tongue. The common way of manufacturing is the solvent casting method. Flexographic printing on drug-free ODFs is introduced as a highly flexible and cost-effective alternative manufacturing method in this study. Rasagiline mesylate and tadalafil were used as model drugs. Printing of rasagiline solutions and tadalafil suspensions was feasible. Up to four printing cycles were performed. The possibility to employ several printing cycles enables a continuous, highly flexible manufacturing process, for example for individualised medicine. The obtained ODFs were characterised regarding their mechanical properties, their disintegration time, API crystallinity and homogeneity. Rasagiline mesylate did not recrystallise after the printing process. Relevant film properties were not affected by printing. Results were comparable to the results of ODFs manufactured with the common solvent casting technique, but the APIs are less stressed through mixing, solvent evaporation and heat. Further, loss of material due to cutting jumbo and daughter rolls can be reduced. Therefore, a versatile new manufacturing technology particularly for processing high-potent low-dose or heat sensitive drugs is introduced in this study. Copyright © 2012 Elsevier B.V. All rights reserved.

  16. Recycling of plastic waste: Presence of phthalates in plastics from households and industry.

    Science.gov (United States)

    Pivnenko, K; Eriksen, M K; Martín-Fernández, J A; Eriksson, E; Astrup, T F

    2016-08-01

    Plastics recycling has the potential to substitute virgin plastics partially as a source of raw materials in plastic product manufacturing. Plastic as a material may contain a variety of chemicals, some potentially hazardous. Phthalates, for instance, are a group of chemicals produced in large volumes and are commonly used as plasticisers in plastics manufacturing. Potential impacts on human health require restricted use in selected applications and a need for the closer monitoring of potential sources of human exposure. Although the presence of phthalates in a variety of plastics has been recognised, the influence of plastic recycling on phthalate content has been hypothesised but not well documented. In the present work we analysed selected phthalates (DMP, DEP, DPP, DiBP, DBP, BBzP, DEHP, DCHP and DnOP) in samples of waste plastics as well as recycled and virgin plastics. DBP, DiBP and DEHP had the highest frequency of detection in the samples analysed, with 360μg/g, 460μg/g and 2700μg/g as the maximum measured concentrations, respectively. Among other, statistical analysis of the analytical results suggested that phthalates were potentially added in the later stages of plastic product manufacturing (labelling, gluing, etc.) and were not removed following recycling of household waste plastics. Furthermore, DEHP was identified as a potential indicator for phthalate contamination of plastics. Close monitoring of plastics intended for phthalates-sensitive applications is recommended if recycled plastics are to be used as raw material in production. Copyright © 2016 Elsevier Ltd. All rights reserved.

  17. [Three types of brand name loyalty strategies set up by drug manufacturers].

    Science.gov (United States)

    PréMont, Marie-Claude; Gagnon, Marc-André

    2014-11-01

    The recent restructuring of the pharmaceutical industry has led to three new types of promotional strategies to build patient loyalty to brand name drugs: loyalty through rebates, patient support, and compassion programs. Loyalty through rebates seeks to keep patients on a brand name drug and prevent their switch to the generic equivalent. Loyalty through patient support provides aftersales services to help and support patients (by phone or home visits) in order to improve adherence to their treatments. Finally, compassion programs offer patients access to drugs still awaiting regulatory approval or reimbursement by insurers. When and if the approval process is successful, the manufacturer puts an end to the compassion program and benefits from a significant cohort of patients already taking a very expensive drug for which reimbursement is assured. The impact of these programs on public policies and patients' rights raises numerous concerns, among which the direct access to patients and their health information by drug manufacturers and upward pressure on costs for drug insurance plans.

  18. A Miniaturized Extruder to Prototype Amorphous Solid Dispersions: Selection of Plasticizers for Hot Melt Extrusion.

    Science.gov (United States)

    Lauer, Matthias E; Maurer, Reto; Paepe, Anne T De; Stillhart, Cordula; Jacob, Laurence; James, Rajesh; Kojima, Yuki; Rietmann, Rene; Kissling, Tom; van den Ende, Joost A; Schwarz, Sabine; Grassmann, Olaf; Page, Susanne

    2018-05-19

    Hot-melt extrusion is an option to fabricate amorphous solid dispersions and to enhance oral bioavailability of poorly soluble compounds. The selection of suitable polymer carriers and processing aids determines the dissolution, homogeneity and stability performance of this solid dosage form. A miniaturized extrusion device (MinEx) was developed and Hypromellose acetate succinate type L (HPMCAS-L) based extrudates containing the model drugs neurokinin-1 (NK1) and cholesterylester transfer protein (CETP) were manufactured, plasticizers were added and their impact on dissolution and solid-state properties were assessed. Similar mixtures were manufactured with a lab-scale extruder, for face to face comparison. The properties of MinEx extrudates widely translated to those manufactured with a lab-scale extruder. Plasticizers, Polyethyleneglycol 4000 (PEG4000) and Poloxamer 188, were homogenously distributed but decreased the storage stability of the extrudates. Stearic acid was found condensed in ultrathin nanoplatelets which did not impact the storage stability of the system. Depending on their distribution and physicochemical properties, plasticizers can modulate storage stability and dissolution performance of extrudates. MinEx is a valuable prototyping-screening method and enables rational selection of plasticizers in a time and material sparing manner. In eight out of eight cases the properties of the extrudates translated to products manufactured in lab-scale extrusion trials.

  19. Reduction of non-specific adsorption of drugs to plastic containers used in bioassays or analyses.

    Science.gov (United States)

    Fukazawa, Tominaga; Yamazaki, Yuri; Miyamoto, Yohei

    2010-01-01

    Non-specific adsorption (NSA) of drugs to plastic or glass containers used in clinical use is well known, but methods for reducing NSA have been rarely reported. We assessed the NSA to various containers and then investigated methods to reduce NSA. Probe drugs (methotrexate, warfarin, chloroquine, propranolol, verapamil, digoxin and paclitaxel) dissolved in water were incubated in conventional or low-adsorption containers for 4h at 4 degrees C and the NSA was determined by HPLC. They were also dissolved in aqueous methanol or acetonitrile and the NSA to a conventional polypropylene microplate was determined. Finally, tissue culture microplates were coated with silane coupling agents and the effects of the coatings were evaluated. Hydrophobic drugs (paclitaxel, verapamil and digoxin) were highly adsorbed to conventional plastic microplates, but in addition to hydrophobic drugs, positively charged drugs were well adsorbed to the tissue culture microplate. Low-adsorption microplates could reduce NSA below 15%, but positively charged or neutral hydrophobic drugs showed relatively higher adsorption. Acetonitrile showed stronger NSA inhibition than that of methanol, but the peak shapes of methotrexate and chloroquine were broadened and split. Among the silane coupling agents, GPTMS suppressed the NSA below 10%. Also, AATMS resembled the NSA pattern of GPTMS, but it increased the adsorption of methotrexate to 29%. On conventional plastic microplates, NSA is mainly driven by hydrophobic interactions, but on tissue culture microplates and low-adsorption microplates, in addition to hydrophobic interactions, ionic interactions play a role in the NSA. Therefore, to reduce the NSA to plastic containers, both hydrophobic and ionic interactions should be reduced using amphiphilic organic solvents or neutral and hydrophilic coatings. 2010 Elsevier Inc. All rights reserved.

  20. Prescription for fairness: a new approach to tort liability of brand-name and generic drug manufacturers.

    Science.gov (United States)

    Rostron, Allen

    2011-02-01

    Over the past two decades, courts have consistently ruled that the manufacturer of a brand-name prescription drug cannot be liable for injuries suffered by those taking generic imitations of its product. This meant that a patient injured by a generic drug could have no remedy at all because in many instances the generic drug manufacturer would escape liability on the ground that it did not produce any information on which the patient's doctor relied. It was a perplexing dilemma. The generic drug manufacturer made the product that the plaintiff received, the brand-name manufacturer produced all of the information the patient's doctor saw, and neither manufacturer could be held liable even if each acted negligently. The California Court of Appeal recently issued a stunning decision in which it concluded that a brand-name drug manufacturer could be liable to a plaintiff who took a generic version of its product. The reaction to the decision has been overwhelmingly negative. Commentators have condemned the decision as one of the worst rulings made by any court in recent years. Judges around the country have dismissed it as a misguided aberration from the otherwise strong judicial consensus on the issue. Although the decision has been the subject of scathing criticism, this Article argues that the California court's ruling actually represents the first time that a court has properly examined this issue. In addition, the Article points out some weaknesses in the California court's reasoning and proposes a novel general framework for analyzing the liability of brand-name and generic drug manufacturers.

  1. Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products. Final rule.

    Science.gov (United States)

    2015-07-08

    The Food and Drug Administration (FDA or the Agency) is amending its regulations to implement certain drug shortages provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). The rule requires all applicants of covered approved drugs or biological products--including certain applicants of blood or blood components for transfusion and all manufacturers of covered drugs marketed without an approved application--to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (or a significant disruption in supply for blood or blood components) of the product in the United States.

  2. Plastic condoms.

    Science.gov (United States)

    1968-01-01

    Only simple equipment, simple technology and low initial capital investment are needed in their manufacture. The condoms can be made by people who were previously unskilled or only semi-skilled workers. Plastic condoms differ from those made of latex rubber in that the nature of the plastic film allows unlimited shelf-life. Also, the plastic has a higher degree of lubricity than latex rubber; if there is a demand for extra lubrication in a particular market, this can be provided. Because the plastic is inert, these condoms need not be packaged in hermetically sealed containers. All these attributes make it possible to put these condoms on the distributors' shelves in developing countries competitively with rubber condoms. The shape of the plastic condom is based on that of the lamb caecum, which has long been used as luxury-type condom. The plastic condom is made from plastic film (ethylene ethyl acrilate) of 0.001 inch (0.0254 mm.) thickness. In addition, a rubber ring is provided and sealed into the base of the condom for retention during coitus. The advantage of the plastic condom design and the equipment on which it is made is that production can be carried out either in labour-intensive economy or with varying degrees of mechanization and automation. The uniform, finished condom if made using previously untrained workers. Training of workers can be done in a matter of hours on the two machines which are needed to produce and test the condoms. The plastic film is provided on a double wound roll, and condom blanks are prepared by means of a heat-sealing die on the stamping machine. The rubber rings are united to the condom blanks on an assembly machine, which consists of a mandrel and heat-sealing equipment to seal the rubber ring to the base of the condom. Built into the assembly machine is a simple air-testing apparatus that can detect the smallest pinhole flaw in a condom. The manufacturing process is completed by unravelling the condom from the assembly

  3. 10 CFR 32.72 - Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing...

    Science.gov (United States)

    2010-01-01

    ... radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling... constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial...

  4. Advanced surface chemical analysis of continuously manufactured drug loaded composite pellets.

    Science.gov (United States)

    Hossain, Akter; Nandi, Uttom; Fule, Ritesh; Nokhodchi, Ali; Maniruzzaman, Mohammed

    2017-04-15

    The aim of the present study was to develop and characterise polymeric composite pellets by means of continuous melt extrusion techniques. Powder blends of a steroid hormone (SH) as a model drug and either ethyl cellulose (EC N10 and EC P7 grades) or hydroxypropyl methylcellulose (HPMC AS grade) as polymeric carrier were extruded using a Pharma 11mm twin screw extruder in a continuous mode of operation to manufacture extruded composite pellets of 1mm length. Molecular modelling study using commercial Gaussian 09 software outlined a possible drug-polymer interaction in the molecular level to develop solid dispersions of the drug in the pellets. Solid-state analysis conducted via a differential scanning calorimetry (DSC), hot stage microscopy (HSM) and X-ray powder diffraction (XRPD) analyses revealed the amorphous state of the drug in the polymer matrices. Surface analysis using SEM/energy dispersive X-ray (EDX) of the produced pellets arguably showed a homogenous distribution of the C and O atoms in the pellet matrices. Moreover, advanced chemical surface analysis conducted via atomic force microscopy (AFM) showed a homogenous phase system having the drug molecule dispersed onto the amorphous matrices while Raman mapping confirmed the homogenous single-phase drug distribution in the manufactured composite pellets. Such composite pellets are expected to deliver multidisciplinary applications in drug delivery and medical sciences by e.g. modifying drug solubility/dissolutions or stabilizing the unstable drug (e.g. hormone, protein) in the composite network. Copyright © 2016. Published by Elsevier Inc.

  5. Northwest Manufacturing Initiative

    Science.gov (United States)

    2014-07-31

    biodegradable wipes, and bags. The gStyle clothing line consists of various types of stylish clothes for babies. All gDiapers are plastic free...offers recycling services for industrial plastics and non-serviceable containers. Industrial plastics include pails, buckets, pallets, plastic film, and...manufacturer, now recycle used soda bottles, unusable second quality fabrics and worn out garments into polyester fibers to produce many of their clothes

  6. A feasible injection molding technique for the manufacturing of large diameter aspheric plastic lenses

    Science.gov (United States)

    Shieh, Jen-Yu; Wang, Luke K.; Ke, Shih-Ying

    2010-07-01

    A computer aided engineering (CAE) tool-assisted technique, using Moldex3D and aspheric analysis utility (AAU) software in a polycarbonate injection molding design, is proposed to manufacture large diameter aspheric plastic lenses. An experiment is conducted to verify the applicability/feasibility of the proposed technique. Using the preceding two software tools, these crucial process parameters associated with the surface profile errors and birefringence of a molded lens can be attainable. The strategy adopted here is to use the actual quantity of shrinkage after an injection molding trial of an aspherical plastic lens as a reference to perform the core shaping job while keeping the coefficients of aspheric surface, radius, and conic constant unchanged. The design philosophy is characterized by using the CAE tool as a guideline to pursue the best symmetry condition, followed by injection molding trials, to accelerate a product’s developmental time. The advantages are less design complexity and shorter developmental time for a product.

  7. The theory of constraints applied in a manufacture CAD-CAM system in the industry Metalworking-plastic

    Directory of Open Access Journals (Sweden)

    Luis Juiña

    2017-06-01

    Full Text Available In the following project, the theory of constraints was applied in order to implement a manufacture CAD-CAM system into the metal mechanic industry processes of polymers injection and blown of polymers. The research showed that the manufacture of the mold with the engraving took 223,17 hours. In the workflow for the manufacture of the mold, a restriction was found in the outsource service of CNC. It took 120 hours of the whole process and represent the 51,47 % the total time of tooling manufacturing. There is also a constraint found in the design time. It was 60 hours that corresponds to 26,88 % of the overall time. In order to reduce the time, a modern system of design in 3D and CAM was established to improve the model process of design and manufacture. A simulation by computational resource was applied to the plastic. The design was changed from 2D to 3D. The implementation was focused in the design. A software was installed to improve the speed of modeling methods with reliable information. In the manufacture of molds, a new CNC machine was acquired with three simultaneous axes to eliminate the outsource service. By acquiring the design system, the working time was diminished in 79% and regarding to the CNC process, the working time was improved in 88%.

  8. Musculoskeletal disorders among workers in plastic manufacturing plants.

    Science.gov (United States)

    Fernandes, Rita de Cássia Pereira; Assunção, Ada Avila; Silvany Neto, Annibal Muniz; Carvalho, Fernando Martins

    2010-03-01

    Epidemiological studies have indicated an association between musculoskeletal disorders (MSDs) and physical work demands. Psychosocial work demands have also been identified as possible risk factors, but findings have been inconsistent. To evaluate factors associated with upper back, neck and upper limb MSD among workers from 14 plastic manufacturing companies located in the city of Salvador, Brazil. A cross-sectional study design was used to survey a stratified proportional random sample of 577 workers. Data were collected by questionnaire interviews. Factor analysis was carried out on 11 physical demands variables. Psychosocial work demands were measured by demand, control and social support questions. The role of socio-demographic factors, lifestyle and household tasks was also examined. Multiple logistic regression was used to identify factors related to upper back, neck and upper limb MSDs. Results from multiple logistic regression showed that distal upper limb MSDs were related to manual handling, work repetitiveness, psychosocial demands, job dissatisfaction, and gender. Neck, shoulder or upper back MSDs were related to manual handling, work repetitiveness, psychosocial demands, job dissatisfaction, and physical unfitness. Reducing the prevalence of musculoskeletal disorders requires: improving the work environment, reducing biomechanical risk factors, and replanning work organization. Programs must also be aware of gender specificities related to MSDs.

  9. Plastic waste as a resource. Strategies for reduction and utilization of plastic waste

    OpenAIRE

    Pasqual i Camprubí, Gemma

    2010-01-01

    Plastic materials have experienced a spectacular rate of growth in recent decades, consequently, production of plastics, and likewise their consumption, has increased markedly since 1950. Moreover, they are lightweight and durable, as well as can be moulded into a variety of products that can be manufactured in many different types of plastic and in a wide range of applications. Inevitably, continually increasing amounts of used plastic are originating daily, resulting in a plastic waste prob...

  10. Plastics and environment

    International Nuclear Information System (INIS)

    Avenas, P.

    1996-01-01

    Synthetic organic polymers, such as plastics, PVC, polyamides etc are considered less ecological than natural materials such as wood. Other artificial materials such as metals, glass or biodegradable plastics have also a better image than petroleum products. This short paper demonstrates that the manufacturing or the transport of every material uses energy and that the complete energy balance sheet of a plastic bottle, for instance, is more favourable than the one of a glass bottle. Plastic materials are also easily valorized and recycled and part of the energy spent during manufacturing can be recovered during incineration for district heating. During the life-cycle of such a synthetic material, the same petroleum quantity can be used twice which leads to less negative effects on the environment. Finally, the paper focusses on the problem of biodegradable materials which are not degradable when buried under several meters of wastes and which are a nuisance to recycling. (J.S.)

  11. Manufacturability of Wood Plastic Composite Sheets on the Basis of the Post-Processing Cooling Curve

    Directory of Open Access Journals (Sweden)

    Sami Matthews

    2015-10-01

    Full Text Available Extruded wood-plastic composites (WPCs are increasingly regarded as promising materials for future manufacturing industries. It is necessary to select and tune the post-processing methods to be able to utilize these materials fully. In this development, temperature-related material properties and the cooling rate are important indicators. This paper presents the results of natural cooling in a factory environment fit into a cooling curve function with temperature zones for forming, cutting, and packaging overlaid using a WPC material. This information is then used in the evaluation of manufacturability and productivity in terms of cost effectiveness and technical quality by comparing the curve to actual production time data derived from a prototype post-process forming line. Based on this information, speed limits for extrusion are presented. This paper also briefly analyzes techniques for controlling material cooling to counter the heat loss before post-processing.

  12. Recycling of plastic waste: Presence of phthalates in plastics from households and industry

    DEFF Research Database (Denmark)

    Pivnenko, Kostyantyn; Eriksen, Marie Kampmann; Martín-Fernández, J. A.

    2016-01-01

    recognised, the influence of plastic recycling on phthalate content has been hypothesised but not well documented. In the present work we analysed selected phthalates (DMP, DEP, DPP, DiBP, DBP, BBzP, DEHP, DCHP and DnOP) in samples of waste plastics as well as recycled and virgin plastics. DBP, DiBP and DEHP...... product manufacturing (labelling, gluing, etc.) and were not removed following recycling of household waste plastics. Furthermore, DEHP was identified as a potential indicator for phthalate contamination of plastics. Close monitoring of plastics intended for phthalates-sensitive applications...

  13. Recycling of plastic waste: Presence of phthalates in plastics from households and industry

    DEFF Research Database (Denmark)

    Pivnenko, Kostyantyn; Eriksen, Marie Kampmann; Martín-Fernández, J. A.

    2016-01-01

    Plastics recycling has the potential to substitute virgin plastics partially as a source of raw materials in plastic product manufacturing. Plastic as a material may contain a variety of chemicals, some potentially hazardous. Phthalates, for instance, are a group of chemicals produced in large...... recognised, the influence of plastic recycling on phthalate content has been hypothesised but not well documented. In the present work we analysed selected phthalates (DMP, DEP, DPP, DiBP, DBP, BBzP, DEHP, DCHP and DnOP) in samples of waste plastics as well as recycled and virgin plastics. DBP, DiBP and DEHP...

  14. Characterization and Conditions of the Internationalization Process of Companies in the Plastic Products Manufacturing Subsector in Bogota

    Directory of Open Access Journals (Sweden)

    Jackson Paul Pereira Silva

    2016-04-01

    Full Text Available This paper proposes a qualitative research by conducting surveys in 30 companies from the plastic products manufacturing subsector, based on theories of internationalization. It aims to find the main determinants of internationalization of these companies, while characterizing and analyzing evidence by contrasting practice and theory, in order to explain how the dynamics in the sector and its current state are and to propose recommendations for greater competitiveness and efficiency in foreign trade.

  15. Structural plasticity in mesencephalic dopaminergic neurons produced by drugs of abuse: critical role of BDNF and dopamine.

    Directory of Open Access Journals (Sweden)

    Ginetta eCollo

    2014-11-01

    Full Text Available Mesencephalic dopaminergic neurons were suggested to be a critical physiopathology substrate for addiction disorders. Among neuroadaptive processes to addictive drugs, structural plasticity has attracted attention. While structural plasticity occurs at both pre- and post-synaptic levels in the mesolimbic dopaminergic system, the present review focuses only on dopaminergic neurons. Exposures to addictive drugs determine two opposite structural responses, hypothrophic plasticity produced by opioids and cannabinoids (in particular during the early withdrawal phase and hypertrophic plasticity, mostly driven by psychostimulants and nicotine. In vitro and in vivo studies indentified BDNF and extracellular dopamine as two critical factors in determining structural plasticity, the two molecules sharing similar intracellular pathways involved in cell soma and dendrite growth, the MEK-ERK1/2 and the PI3K-Akt-mTOR, via preferential activation of TrkB and dopamine D3 receptors, respectively. At present information regarding specific structural changes associated to the various stages of the addiction cycle is incomplete. Encouraging neuroimaging data in humans indirectly support the preclinical evidence of hypotrophic and hypertrophic effects, suggesting a possible differential engagement of dopamine neurons in parallel and partially converging circuits controlling motivation, stress and emotions.

  16. Achieving continuous manufacturing: technologies and approaches for synthesis, workup, and isolation of drug substance. May 20-21, 2014 Continuous Manufacturing Symposium.

    Science.gov (United States)

    Baxendale, Ian R; Braatz, Richard D; Hodnett, Benjamin K; Jensen, Klavs F; Johnson, Martin D; Sharratt, Paul; Sherlock, Jon-Paul; Florence, Alastair J

    2015-03-01

    This whitepaper highlights current challenges and opportunities associated with continuous synthesis, workup, and crystallization of active pharmaceutical ingredients (drug substances). We describe the technologies and requirements at each stage and emphasize the different considerations for developing continuous processes compared with batch. In addition to the specific sequence of operations required to deliver the necessary chemical and physical transformations for continuous drug substance manufacture, consideration is also given to how adoption of continuous technologies may impact different manufacturing stages in development from discovery, process development, through scale-up and into full scale production. The impact of continuous manufacture on drug substance quality and the associated challenges for control and for process safety are also emphasized. In addition to the technology and operational considerations necessary for the adoption of continuous manufacturing (CM), this whitepaper also addresses the cultural, as well as skills and training, challenges that will need to be met by support from organizations in order to accommodate the new work flows. Specific action items for industry leaders are: Develop flow chemistry toolboxes, exploiting the advantages of flow processing and including highly selective chemistries that allow use of simple and effective continuous workup technologies. Availability of modular or plug and play type equipment especially for workup to assist in straightforward deployment in the laboratory. As with learning from other industries, standardization is highly desirable and will require cooperation across industry and academia to develop and implement. Implement and exploit process analytical technologies (PAT) for real-time dynamic control of continuous processes. Develop modeling and simulation techniques to support continuous process development and control. Progress is required in multiphase systems such as

  17. Sustainable reverse logistics for household plastic waste

    NARCIS (Netherlands)

    Bing, X.

    2014-01-01

    Summary of the thesis titled “Sustainable Reverse Logistics for Household Plastic Waste”

    PhD Candidate: Xiaoyun Bing

    Recycled plastic can be used in the manufacturing of plastic products to reduce the use of virgin plastics material. The cost of recycled plastics is usually lower

  18. Environmental sustainability: plastic's evolving role in the automotive life cycle

    International Nuclear Information System (INIS)

    Jekel, L.; Tam, E.K.L.

    2002-01-01

    One method of assessing the sustainability of manufactured products involves performing a life cycle analysis for a product and comparing it to alternative ones, or else examining if individual stages of the product can be modified. LCA applications are being used more extensively, especially in the automotive and related industries. Automotive plastics in particular are being scrutinized with much greater care. Plastic components have replaced metal ones in vehicle manufacturing to improve vehicle fuel efficiency and aesthetics. However, at the end of a vehicle's life, recycling rates for plastic are negligible when compared to those of steel. In order to gain the full environmental benefits of using plastic as a vehicle material, plastics must be recycled at the end of a vehicle's life, especially given their increasing use. While a variety of processes have been developed for the recycling of automotive plastics, the challenges of sorting, processing, and finally recycling a heterogeneous mixture of used plastics have yet to be effectively solved. A preliminary life cycle assessment of a plastic automotive fascia demonstrates the usefulness of this eco-balance technique in evaluating potential improvements to manufacturing and end-of-life processes. Improving the manufacturing process may reduce environmental burdens to a larger extent than just recycling the plastic. (author)

  19. Estimating Drug Costs: How do Manufacturer Net Prices Compare with Other Common US Price References?

    Science.gov (United States)

    Mattingly, T Joseph; Levy, Joseph F; Slejko, Julia F; Onwudiwe, Nneka C; Perfetto, Eleanor M

    2018-05-12

    Drug costs are frequently estimated in economic analyses using wholesale acquisition cost (WAC), but what is the best approach to develop these estimates? Pharmaceutical manufacturers recently released transparency reports disclosing net price increases after accounting for rebates and other discounts. Our objective was to determine whether manufacturer net prices (MNPs) could approximate the discounted prices observed by the U.S. Department of Veterans Affairs (VA). We compared the annual, average price discounts voluntarily reported by three pharmaceutical manufacturers with the VA price for specific products from each company. The top 10 drugs by total sales reported from company tax filings for 2016 were included. The discount observed by the VA was determined from each drug's list price, reported as WAC, in 2016. Descriptive statistics were calculated for the VA discount observed and a weighted price index was calculated using the lowest price to the VA (Weighted VA Index), which was compared with the manufacturer index. The discounted price as a percentage of the WAC ranged from 9 to 74%. All three indexes estimated by the average discount to the VA were at or below the manufacturer indexes (42 vs. 50% for Eli Lilly, 56 vs. 65% for Johnson & Johnson, and 59 vs. 59% for Merck). Manufacturer-reported average net prices may provide a close approximation of the average discounted price granted to the VA, suggesting they may be a useful proxy for the true pharmacy benefits manager (PBM) or payer cost. However, individual discounts for products have wide variation, making a standard discount adjustment across multiple products less acceptable.

  20. Co-recycling of acrylonitrile-butadiene-styrene waste plastic and nonmetal particles from waste printed circuit boards to manufacture reproduction composites.

    Science.gov (United States)

    Sun, Zhixing; Shen, Zhigang; Zhang, Xiaojing; Ma, Shulin

    2015-01-01

    This study investigated the feasibility of using acrylonitrile-butadiene-styrene (ABS) waste plastic and nonmetal particles from waste printed circuit boards (WPCB) to manufacture reproduction composites (RC), with the aim of co-recycling these two waste resources. The composites were prepared in a twin-crew extruder and investigated by means of mechanical testing, in situ flexural observation, thermogravimatric analysis, and dimensional stability evaluation. The results showed that the presence of nonmetal particles significantly improved the mechanical properties and the physical performance of the RC. A loading of 30 wt% nonmetal particles could achieve a flexural strength of 72.6 MPa, a flexural modulus of 3.57 GPa, and an impact strength of 15.5 kJ/m2. Moreover, it was found that the application of maleic anhydride-grafted ABS as compatilizer could effectively promote the interfacial adhesion between the ABS plastic and the nonmetal particles. This research provides a novel method to reuse waste ABS and WPCB nonmetals for manufacturing high value-added product, which represents a promising way for waste recycling and resolving the environmental problem.

  1. Manufacture of plastic parts by radiation molding

    International Nuclear Information System (INIS)

    Leszyk, G.M.; Morrison, E.D.; Williams, R.F. Jr.

    1977-01-01

    Thin plastic parts which can have precise tolerances and can be of complex shape are prepared by casting a viscous radiation-curable composition onto a support, such as a moving web of polymeric material, in the shape of the desired part and then irradiating, for example with ultraviolet radiation or high energy electrons, to cause curing of the composition to a solid plastic. The radiation-curable composition is formulated with viscosity and flow characteristics it to be cast in the exact shape of the part desired yet retain this shape during curing while supported only by the surface on which it has been cast. Plastic parts made by this method can be formed entirely of the radiation-curable composition by casting onto a web having a release surface from which the part can be stripped subsequent to curing or can be formed partially from a web material and partially from the radiation-curable composition by casting onto a web to which the composition will bond and subsequently cutting the web into discrete portions which include the cured composition

  2. Extruding plastic scintillator at Fermilab

    International Nuclear Information System (INIS)

    Pla-Dalmau, Anna; Bross, Alain D.; Rykalin, Viktor V.

    2003-01-01

    An understanding of the costs involved in the production of plastic scintillators and the development of a less expensive material have become necessary with the prospects of building very large plastic scintillation detectors. Several factors contribute to the high cost of plastic scintillating sheets, but the principal reason is the labor-intensive nature of the manufacturing process. In order to significantly lower the costs, the current casting procedures had to be abandoned. Since polystyrene is widely used in the consumer industry, the logical path was to investigate the extrusion of commercial-grade polystyrene pellets with dopants to yield high quality plastic scintillator. This concept was tested and high quality extruded plastic scintillator was produced. The D0 and MINOS experiments are already using extruded scintillator strips in their detectors. An extrusion line has recently been installed at Fermilab in collaboration with NICADD (Northern Illinois Center for Accelerator and Detector Development). This new facility will serve to further develop and improve extruded plastic scintillator. This paper will discuss the characteristics of extruded plastic scintillator and its raw materials, the different manufacturing techniques and the current R andD program at Fermilab

  3. 78 FR 41069 - Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug...

    Science.gov (United States)

    2013-07-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-D-0743] Medical Device Reporting for Manufacturers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and...

  4. Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls. Final rule.

    Science.gov (United States)

    2012-03-20

    The Food and Drug Administration (FDA) is amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. FDA is also permitting the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. This action is intended to protect consumers from labeling errors more likely to cause adverse health consequences, while eliminating the regulatory burden of applying the rule to labeling unlikely to reach or adversely affect consumers. This action is also intended to permit manufacturers to use a broader range of error prevention and labeling control techniques than permitted by current CGMPs.

  5. Assessment of MEKC suitability for residue drug monitoring on pharmaceutical manufacturing equipment

    CSIR Research Space (South Africa)

    Boca, MB

    2008-03-01

    Full Text Available obtained for all compounds. The method could be used as part of a cleaning validation study when assaying trace levels of co-trimoxazole drug, some of its decomposition products and detergent in the swab samples collected from pharmaceutical manufacturing...

  6. Drug adsorption to plastic containers and retention of drugs in cultured cells under in vitro conditions.

    Science.gov (United States)

    Palmgrén, Joni J; Mönkkönen, Jukka; Korjamo, Timo; Hassinen, Anssi; Auriola, Seppo

    2006-11-01

    Loss of drug content during cell culture transport experiment can lead to misinterpretations in permeability analysis. This study analyses drug adsorption to various plastic containers and drug retention in cultured cells under in vitro conditions. The loss of various drugs to polystyrene tubes and well plates was compared to polypropylene and glass tubes both in deionised water and buffer solution. In cellular uptake experiments, administered drugs were obtained from cultured cells by liquid extraction. Samples were collected at various time points and drug concentrations were measured by a new HPLC-MS/MS method. Acidic drugs (hydrochlorothiazide, naproxen, probenicid, and indomethacin) showed little if any sorption to all tested materials in either water or buffer. In the case of basic drugs, substantial loss to polystyrene tubes and well plates was observed. After 4.5 h, the relative amount remaining in aqueous test solution stored in polystyrene tubes was 64.7 +/- 6.8%, 38.4 +/- 9.1%, 31.9 +/- 6.7%, and 23.5 +/- 6.1% for metoprolol, medetomidine, propranolol, and midazolam, respectively. Interestingly, there was no significant loss of drugs dissolved in buffer to any of the tested materials indicating that buffer reduced surficial interaction. The effect of drug concentration to sorption was also tested. Results indicated that the higher the concentration in the test solution the lower the proportional drug loss, suggesting that the polystyrene contained a limited amount of binding sites. Cellular uptake studies showed considerable retention of drugs in cultured cells. The amounts of absorbed drugs in cellular structures were 0.45%, 4.88%, 13.15%, 43.80%, 23.57% and 11.22% for atenolol, metoprolol, medetomidine, propranolol, midazolam, and diazepam, respectively. Overall, these findings will benefit development and validation of further in vitro drug permeation experiments.

  7. Power electronic modules design and manufacture

    CERN Document Server

    Sheng, William W

    2004-01-01

    IntroductionSelection ProcedureMaterialsInsulating Substrate and MetallizationBase PlateBonding MaterialPower Interconnection and TerminalEncapsulantPlastic Case and Cover Manufacturing of Power IGBT ModulesManufacturing Process Process Control/Long-Term ReliabilityManufacturing FacilitiesManufacturing Flow Charts DesignThermal ManagementCircuit PartitioningDesign Guidelines and ConsiderationsThermal Results of Different Samples

  8. Effects of dopamine and glutamate on synaptic plasticity: a computational modeling approach for drug abuse as comorbidity in mood disorders.

    Science.gov (United States)

    Qi, Z; Kikuchi, S; Tretter, F; Voit, E O

    2011-05-01

    Major depressive disorder (MDD) affects about 16% of the general population and is a leading cause of death in the United States and around the world. Aggravating the situation is the fact that "drug use disorders" are highly comorbid in MDD patients, and VICE VERSA. Drug use and MDD share a common component, the dopamine system, which is critical in many motivation and reward processes, as well as in the regulation of stress responses in MDD. A potentiating mechanism in drug use disorders appears to be synaptic plasticity, which is regulated by dopamine transmission. In this article, we describe a computational model of the synaptic plasticity of GABAergic medium spiny neurons in the nucleus accumbens, which is critical in the reward system. The model accounts for effects of both dopamine and glutamate transmission. Model simulations show that GABAergic medium spiny neurons tend to respond to dopamine stimuli with synaptic potentiation and to glutamate signals with synaptic depression. Concurrent dopamine and glutamate signals cause various types of synaptic plasticity, depending on input scenarios. Interestingly, the model shows that a single 0.5 mg/kg dose of amphetamine can cause synaptic potentiation for over 2 h, a phenomenon that makes synaptic plasticity of medium spiny neurons behave quasi as a bistable system. The model also identifies mechanisms that could potentially be critical to correcting modifications of synaptic plasticity caused by drugs in MDD patients. An example is the feedback loop between protein kinase A, phosphodiesterase, and the second messenger cAMP in the postsynapse. Since reward mechanisms activated by psychostimulants could be crucial in establishing addiction comorbidity in patients with MDD, this model might become an aid for identifying and targeting specific modules within the reward system and lead to a better understanding and potential treatment of comorbid drug use disorders in MDD. © Georg Thieme Verlag KG Stuttgart · New

  9. Application of lean manufacturing concepts to drug discovery: rapid analogue library synthesis.

    Science.gov (United States)

    Weller, Harold N; Nirschl, David S; Petrillo, Edward W; Poss, Michael A; Andres, Charles J; Cavallaro, Cullen L; Echols, Martin M; Grant-Young, Katherine A; Houston, John G; Miller, Arthur V; Swann, R Thomas

    2006-01-01

    The application of parallel synthesis to lead optimization programs in drug discovery has been an ongoing challenge since the first reports of library synthesis. A number of approaches to the application of parallel array synthesis to lead optimization have been attempted over the years, ranging from widespread deployment by (and support of) individual medicinal chemists to centralization as a service by an expert core team. This manuscript describes our experience with the latter approach, which was undertaken as part of a larger initiative to optimize drug discovery. In particular, we highlight how concepts taken from the manufacturing sector can be applied to drug discovery and parallel synthesis to improve the timeliness and thus the impact of arrays on drug discovery.

  10. Dual-role plasticizer and dispersant for ceramic layers

    DEFF Research Database (Denmark)

    2016-01-01

    Thus, one aspect of the invention relates to a green ceramic layer comprising a ceramic material, a binder, and a dual-role dispersant and plasticizer, wherein said dual-role dispersant and plasticizer is an organic di- or tri-ester selected from compounds of formula (I), (II), (III) and (IV......). Another aspect of the present invention relates to a slurry for use in the manufacturing of a green ceramic layer comprising a ceramic material, a solvent, a binder, and a dual-role dispersant and plasticizer, wherein said dual role dispersant and plasticizer is an organic di- or tri- ester. Further...... aspects include uses of and methods of manufacturing said green ceramic layers....

  11. Nano-Ceramic Coated Plastics

    Science.gov (United States)

    Cho, Junghyun

    2013-01-01

    Plastic products, due to their durability, safety, and low manufacturing cost, are now rapidly replacing cookware items traditionally made of glass and ceramics. Despite this trend, some still prefer relatively expensive and more fragile ceramic/glassware because plastics can deteriorate over time after exposure to foods, which can generate odors, bad appearance, and/or color change. Nano-ceramic coatings can eliminate these drawbacks while still retaining the advantages of the plastic, since the coating only alters the surface of the plastic. The surface coating adds functionality to the plastics such as self-cleaning and disinfectant capabilities that result from a photocatalytic effect of certain ceramic systems. These ceramic coatings can also provide non-stick surfaces and higher temperature capabilities for the base plastics without resorting to ceramic or glass materials. Titanium dioxide (TiO2) and zinc oxide (ZnO) are the candidates for a nano-ceramic coating to deposit on the plastics or plastic films used in cookware and kitchenware. Both are wide-bandgap semiconductors (3.0 to 3.2 eV for TiO2 and 3.2 to 3.3 eV for ZnO), so they exhibit a photocatalytic property under ultraviolet (UV) light. This will lead to decomposition of organic compounds. Decomposed products can be easily washed off by water, so the use of detergents will be minimal. High-crystalline film with large surface area for the reaction is essential to guarantee good photocatalytic performance of these oxides. Low-temperature processing (nano-ceramic coatings (TiO2, ZnO) on plastic materials (silicone, Teflon, PET, etc.) that can possess both photocatalytic oxide properties and flexible plastic properties. Processing cost is low and it does not require any expensive equipment investment. Processing can be scalable to current manufacturing infrastructure.

  12. Quality Tools and TRIZ Based Quality Improvement Case Study at PT ‘X’ A Plastic Moulding Manufacturing Industry

    Science.gov (United States)

    Wirawan, Christina; Chandra, Fory

    2016-02-01

    Theory of Inventive Problem Solving (TRIZ) is a creative encouraging problem solving method. TRIZ is prepared by Altshuller for product design. Altshuller prepared contradiction matrix and suggestion to solve contradictions usually occur in product design. This paper try to combine TRIZ with quality tools such as Pareto and Fault Tree Analysis (FTA) to solve contradiction in quality improvement problem, neither than product design problem. Pareto used to identify defect priority, FTA used to analysis and identify root cause of defect. When there is contradiction in solving defect causes, TRIZ used to find creative problem solving. As a case study, PT ’X’, a plastic molding manufacturing industry was taken. PT ‘X’ using traditional press machine to produce plastic thread cone. There are 5 defect types that might occur in plastic thread cone production, incomplete form, dirty, mottle, excessive form, rugged. Research about quality improvement effort using DMAIC at PT ‘X’ have been done by Fory Candra. From this research, defect types, priority, root cause from FTA, recommendation from FMEA. In this research, from FTA reviewed, contradictions found among causes troublesome quality improvement efforts. TRIZ used to solve the contradictions and quality improvement effort can be made effectively.

  13. Assessment of prescribing information for generic drugs manufactured in the Middle East and marketed in Saudi Arabia

    International Nuclear Information System (INIS)

    Gebran, N.; Al-Haldari, K.

    2006-01-01

    Little research has assessed the quality of manufacturer provided prescribing information or documented difference in key aspects of drug information among different marketed generic products of the same drug particularly in Middle East and Arabian Gulf. We assessed the quality of written prescribing information for selected generic drugs marketed in Saudi Arabia and manufactured in various countries of Middle East. We assessed the correctness and completeness of information pertaining to indications, dosage cautions/contraindications, side effects and drug interactions in 37 packages inserts for generic products registered in Saudi Arabia and manufactured in the Middle East, including atenolol (6 inserts), fluoxetine (4 inserts), ciprofloxacin (11 inserts), melformin (7 inserts) and omeprazole (9 inserts). We also described deficiencies in quality and quantity of manufacturers provided information that could be misleading to patients and prescribes. We found substantial disagreement in information between generic packages inserts versus the British National Formulary and the package insert of the brand product marketed in Saudi Arabia. A cumulative average of 63.16% of drug information indicators were in agreement with these standard references. Section headings with the least conformity with study references were those related to dosage (57, 28%) and side effects (54+-30%). Our results indicate that national authorities should implement appropriate measures aimed at removing misleading and incorrect information in generic package inserts and incorporating crucial prescribing information that is missing. National authorities in the Middle East and Arabian Gulf should strengthen collaboration and information interchange among each other and with international agencies to maintain common quality standards for delivering information through package inserts. (author)

  14. Particle shedding from peristaltic pump tubing in biopharmaceutical drug product manufacturing.

    Science.gov (United States)

    Saller, Verena; Matilainen, Julia; Grauschopf, Ulla; Bechtold-Peters, Karoline; Mahler, Hanns-Christian; Friess, Wolfgang

    2015-04-01

    In a typical manufacturing setup for biopharmaceutical drug products, the fill and dosing pump is placed after the final sterile filtration unit in order to ensure adequate dispensing accuracy and avoid backpressure peaks. Given the sensitivity of protein molecules, peristaltic pumps are often preferred over piston pumps. However, particles may be shed from the silicone tubing employed. In this study, particle shedding and a potential turbidity increase during peristaltic pumping of water and buffer were investigated using three types of commercially available silicone tubing. In the recirculates, mainly particles of around 200 nm next to a very small fraction of particles in the lower micrometer range were found. Using 3D laser scanning microscopy, surface roughness of the inner tubing surface was found to be a determining factor for particle shedding from silicone tubing. As the propensity toward particle shedding varied between tubing types and also cannot be concluded from manufacturer's specifications, individual testing with the presented methods is recommended during tubing qualification. Choosing low abrasive tubing can help to further minimize the very low particle counts to be expected in pharmaceutical drug products. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

  15. Alternative Manufacturing Concepts for Solid Oral Dosage Forms From Drug Nanosuspensions Using Fluid Dispensing and Forced Drying Technology.

    Science.gov (United States)

    Bonhoeffer, Bastian; Kwade, Arno; Juhnke, Michael

    2018-03-01

    Flexible manufacturing technologies for solid oral dosage forms with a continuous adjustability of the manufactured dose strength are of interest for applications in personalized medicine. This study explored the feasibility of using microvalve technology for the manufacturing of different solid oral dosage form concepts. Hard gelatin capsules filled with excipients, placebo tablets, and polymer films, placed in hard gelatin capsules after drying, were considered as substrates. For each concept, a basic understanding of relevant formulation parameters and their impact on dissolution behavior has been established. Suitable matrix formers, present either on the substrate or directly in the drug nanosuspension, proved to be essential to prevent nanoparticle agglomeration of the drug nanoparticles and to ensure a fast dissolution behavior. Furthermore, convection and radiation drying methods were investigated for the fast drying of drug nanosuspensions dispensed onto polymer films, which were then placed in hard gelatin capsules. Changes in morphology and in drug and matrix former distribution were observed for increasing drying intensity. However, even fast drying times below 1 min could be realized, while maintaining the nanoparticulate drug structure and a good dissolution behavior. Copyright © 2018 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  16. Thermal comfort study of plastics manufacturing industry in converting process

    Directory of Open Access Journals (Sweden)

    Sugiono Sugiono

    2017-09-01

    Full Text Available Thermal comfort is one of ergonomics factors that can create a significant impact to workers performance. For a better thermal comfort, several environment factors (air temperature, wind speed and relative humidity should be considered in this research. The object of the study is a building for converting process of plastics manufacturing industry located in Malang, Indonesia. The maximum air temperature inside the building can reach as high as 36°C. The result of this study shows that heat stress is dominantly caused by heat source from machine and wall building. The computational fluid dynamics (CFD simulation is used to show the air characteristic through inside the building. By using the CFD simulation, some scenarios of solution are successfully presented. Employees thermal comfort was investigated based on predicted mean vote model (PMV and predicted percentage of dissatisfied model (PPD. Existing condition gives PMV in range from 1.83 to 2.82 and PPD in range from 68.9 to 98%. Meanwhile, modification of ventilation and replacing ceiling material from clear glass into reflective clear glass gave significant impact to reduce PMV into range from 1.63 to 2.18 and PPD into range from 58.2 to 84.2%. In sort, new design converting building process has more comfortable for workers.

  17. 75 FR 4973 - Registration Requirements for Importers and Manufacturers of Prescription Drug Products...

    Science.gov (United States)

    2010-02-01

    ... diverted to the clandestine manufacture of a controlled substance. Most of the ephedrine, pseudoephedrine... for-profit. Other: Not-for-profit, government agencies. Abstract: The Domestic Chemical Diversion... may be diverted in the United States for the production of illicit drugs must register with DEA...

  18. 78 FR 22887 - Guidance for Industry on Non-Penicillin Beta-Lactam Drugs: A Current Good Manufacturing Practices...

    Science.gov (United States)

    2013-04-17

    ... for Preventing Cross- Contamination; Availability AGENCY: Food and Drug Administration, HHS. ACTION... require separation of manufacturing facilities to avoid cross-contamination, the only class of products... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-D-0104...

  19. Plastics and health risks.

    Science.gov (United States)

    Halden, Rolf U

    2010-01-01

    By 2010, the worldwide annual production of plastics will surpass 300 million tons. Plastics are indispensable materials in modern society, and many products manufactured from plastics are a boon to public health (e.g., disposable syringes, intravenous bags). However, plastics also pose health risks. Of principal concern are endocrine-disrupting properties, as triggered for example by bisphenol A and di-(2-ethylhexyl) phthalate (DEHP). Opinions on the safety of plastics vary widely, and despite more than five decades of research, scientific consensus on product safety is still elusive. This literature review summarizes information from more than 120 peer-reviewed publications on health effects of plastics and plasticizers in lab animals and humans. It examines problematic exposures of susceptible populations and also briefly summarizes adverse environmental impacts from plastic pollution. Ongoing efforts to steer human society toward resource conservation and sustainable consumption are discussed, including the concept of the 5 Rs--i.e., reduce, reuse, recycle, rethink, restrain--for minimizing pre- and postnatal exposures to potentially harmful components of plastics.

  20. Tool steel quality and surface finishing of plastic molds

    Directory of Open Access Journals (Sweden)

    Rafael Agnelli Mesquita

    2010-01-01

    Full Text Available Plastic industry is today in a constant growth, demanding several products from other segments, which includes the plastic molds, mainly used in the injection molding process. Considering all the requirements of plastic molds, the surface finishing is of special interest, as the injected plastic part is able to reproduce any details (and also defects from the mold surface. Therefore, several aspects on mold finishing are important, mainly related to manufacturing conditions - machining, grinding, polishing and texturing, and also related to the tool steel quality, in relation to microstructure homogeneity and non-metallic inclusions (cleanliness. The present paper is then focused on this interrelationship between steel quality and manufacturing process, which are both related to the final quality of plastic mold surfaces. Examples are discussed in terms of surface finishing of plastic molds and the properties or the microstructure of mold steels.

  1. Synaptic Plasticity in the Bed Nucleus of the Stria Terminalis: Underlying Mechanisms and Potential Ramifications for Reinstatement of Drug- and Alcohol-Seeking Behaviors.

    Science.gov (United States)

    Harris, Nicholas A; Winder, Danny G

    2018-06-13

    The bed nucleus of the stria terminalis (BNST) is a component of the extended amygdala that shows significant changes in activity and plasticity through chronic exposure to drugs and stress. The region is critical for stress- and cue-induced reinstatement of drug-seeking behaviors and is thus a candidate region for the plastic changes that occur in abstinence that prime addicted patients for reinstatement behaviors. Here, we discuss the various forms of long-term potentiation (LTP) and long-term depression (LTD) in the rodent BNST and highlight the way that these changes in excitatory transmission interact with exposure to alcohol and other drugs of abuse, as well as other stressors. In addition, we highlight potential areas for future research in this area, including investigating input- and cell-specific bidirectional changes in activity. As we continue to accrue foundational knowledge in the mechanisms and effects of plasticity in the BNST, molecular targets and treatment strategies that are relevant to reinstatement behaviors will also begin to emerge. Here, we briefly discuss the effects of catecholamine receptor modulators on synaptic plasticity in the BNST due to the role of norepinephrine in LTD and dopamine on the short-term component of LTP as well as the role that signaling at these receptors plays in reinstatement of drug- and alcohol-seeking behaviors. We hope that insights gained on the specific changes in plasticity that occur within the BNST during abstinence from alcohol and other drugs of abuse will provide insight into the biological underpinnings of relapse behavior in human addicts and inform future treatment modalities for addiction that tackle this complex biological problem.

  2. Conformational Plasticity of the Influenza A M2 Transmembrane Helix in Lipid Bilayers Under Varying pH, Drug Binding and Membrane Thickness

    Science.gov (United States)

    Hu, Fanghao; Luo, Wenbin; Cady, Sarah D.; Hong, Mei

    2010-01-01

    Membrane proteins change their conformations to respond to environmental cues, thus conformational plasticity is important for function. The influenza A M2 protein forms an acid-activated proton channel important for the virus lifecycle. Here we have used solid-state NMR spectroscopy to examine the conformational plasticity of membrane-bound transmembrane domain of M2 (M2TM). 13C and 15N chemical shifts indicate coupled conformational changes of several pore-facing residues due to changes in bilayer thickness, drug binding and pH. The structural changes are attributed to the formation of a well-defined helical kink at G34 in the drug-bound state and in thick lipid bilayers, non-ideal backbone conformation of the secondary-gate residue V27 in the presence of drug, and non-ideal conformation of the proton-sensing residue H37 at high pH. The chemical shifts constrained the (ϕ, ψ) torsion angles for three basis states, the equilibrium among which explains the multiple resonances per site in the NMR spectra under different combinations of bilayer thickness, drug binding and pH conditions. Thus, conformational plasticity is important for the proton conduction and inhibition of M2TM. The study illustrates the utility of NMR chemical shifts for probing the structural plasticity and folding of membrane proteins. PMID:20883664

  3. 27 CFR 555.180 - Prohibitions relating to unmarked plastic explosives.

    Science.gov (United States)

    2010-04-01

    ... unmarked plastic explosives. 555.180 Section 555.180 Alcohol, Tobacco Products, and Firearms BUREAU OF... Marking of Plastic Explosives § 555.180 Prohibitions relating to unmarked plastic explosives. (a) No person shall manufacture any plastic explosive that does not contain a detection agent. (b) No person...

  4. Application of Quality by Design (QbD) Principles to Extractables/Leachables Assessment. Establishing a Design Space for Terminally Sterilized Aqueous Drug Products Stored in a Plastic Packaging System.

    Science.gov (United States)

    Jenke, Dennis

    2010-01-01

    The concept of quality by design (QbD) reflects the current global regulatory thinking related to pharmaceutical products. A cornerstone of the QbD paradigm is the concept of a design space, where the design space is a multidimensional combination of input variables and process parameters that have been demonstrated to provide the assurance of product quality. If a design space can be established for a pharmaceutical process or product, then operation within the design space confirms that the product or process output possesses the required quality attributes. This concept of design space can be applied to the safety (leachables) assessment of drug products manufactured and stored in packaging systems. Critical variables in such a design space would include those variables that affect the interaction of the drug product and its packaging, including (a) composition of the drug product, (b) composition of the packaging system, (c) configuration of the packaging system, and (d) the conditions of contact. This paper proposes and justifies such a leachables design space for aqueous drug products packaged in a specific plastic packaging system. Such a design space has the following boundaries:Aqueous drug products with a pH in the range of 2 to 8 and that contain no polarity-impacting agents such as organic solubilizers and stabilizers (addressing variable a). Packaging systems manufactured from materials that meet the system's existing material specifications (addressing variable b). Nominal fill volumes from 50 to 1000 mL (addressing variable c). Products subjected to terminal sterilization and then stored at room temperature for a period of up to 24 months (addressing variable d). The ramification of such a design space is that any drug product that falls within these boundaries is deemed to be compatible with the packaging system, from the perspective of safety, without the requirement of supporting drug product testing. When drug products are packaged in plastic

  5. Detection of drugs and plastic explosives using neutron tomography

    Energy Technology Data Exchange (ETDEWEB)

    Ferreira, F.J.O. [Instituto de Engenharia Nuclear (IEN), Rio de Janeiro, RJ (Brazil)], E-mail: fferreira@ien.gov.br; Crispim, V.R; Silva, A.X. [Universidade Federal do Rio de Janeiro (UFRJ), RJ (Brazil). Coordenacao dos Programas de Pos-graduacao de Engenharia (COPPE). Programa de Engenharia Nuclear], E-mail: ademir@con.ufrj.br, E-mail: verginia@com.ufrj.br

    2007-07-01

    The unique ability of neutrons to image certain elements and isotopes that are either completely undetectable or poorly detected by other Non-Destructive-Assay (NDA) methods makes neutron radiography an important tool for the NDA community. Neutron radiography, like other imaging techniques takes a number of different forms (i.e. / that is film, radioscopic, transfer methods, tomography, etc.) In this work report the Neutron Tomography System developed, which will allow inspections NDA of samples with high efficiency, in terms of minors measure time and the result analysis, and the application for detection of drugs and plastic explosives, which is very important for the combat to the terrorism and drug trafficking. The neutron tomography system developed is third generation. Therefore a rotary table driven by a step motor connected to a computerized motion control system has been installed at the sample position. In parallel to this a suitable electronic imaging device has been designed and can be controlled by a computer in order to synchronize the software the detector and of the rotary table with the aim of an automation of measurements. To obtain 2D tomography image, a system with an electronic imaging system for producing real time neutron radiography. Images are processing digital for cancel random noise effects and to optimize spatial resolution. Finally, using a (ARIEN) algorithm reconstruction of tomography images by finite element maximum entropy. The system was installed adjacent to the exit of the J-9 irradiation channel of the Argonauta Reactor in the Nuclear Engineering Institute (IEN) - which is an organ of the National Nuclear Energy Commission (CNEN - Brazil).The Argonauta reactor operates at 340 watts, being that the characteristics of the neutron beam on the plane of the image: thermal neutron flux 4,46 x10{sup 5} n/cm{sup 2}s. In the tomography assays, several encapsulated samples of paste, rock and cocaine powder and plastic explosives devices

  6. Detection of drugs and plastic explosives using neutron tomography

    International Nuclear Information System (INIS)

    Ferreira, F.J.O.; Crispim, V.R; Silva, A.X.

    2007-01-01

    The unique ability of neutrons to image certain elements and isotopes that are either completely undetectable or poorly detected by other Non-Destructive-Assay (NDA) methods makes neutron radiography an important tool for the NDA community. Neutron radiography, like other imaging techniques takes a number of different forms (i.e. / that is film, radioscopic, transfer methods, tomography, etc.) In this work report the Neutron Tomography System developed, which will allow inspections NDA of samples with high efficiency, in terms of minors measure time and the result analysis, and the application for detection of drugs and plastic explosives, which is very important for the combat to the terrorism and drug trafficking. The neutron tomography system developed is third generation. Therefore a rotary table driven by a step motor connected to a computerized motion control system has been installed at the sample position. In parallel to this a suitable electronic imaging device has been designed and can be controlled by a computer in order to synchronize the software the detector and of the rotary table with the aim of an automation of measurements. To obtain 2D tomography image, a system with an electronic imaging system for producing real time neutron radiography. Images are processing digital for cancel random noise effects and to optimize spatial resolution. Finally, using a (ARIEN) algorithm reconstruction of tomography images by finite element maximum entropy. The system was installed adjacent to the exit of the J-9 irradiation channel of the Argonauta Reactor in the Nuclear Engineering Institute (IEN) - which is an organ of the National Nuclear Energy Commission (CNEN - Brazil).The Argonauta reactor operates at 340 watts, being that the characteristics of the neutron beam on the plane of the image: thermal neutron flux 4,46 x10 5 n/cm 2 s. In the tomography assays, several encapsulated samples of paste, rock and cocaine powder and plastic explosives devices. (author)

  7. Hazardous drug residue on exterior vial surfaces: evaluation of a commercial manufacturing process.

    Science.gov (United States)

    Power, Luci A; Sessink, Paul J M; Gesy, Kathy; Charbonneau, Flay

    2014-04-01

    Hazardous drug residue on the exterior surface of drug vials poses a potential risk for exposure of health care workers involved in handling these products. The purpose of this article is to heighten the awareness of this serious issue and to evaluate a commercial manufacturing process for removing and containing hazardous drug (HD) residue on exterior vial surfaces. Additionally, findings from this study are interpreted, incorporated into the current body of evidence, and discussed by experts in this field. This study includes separate evaluations for the presence or absence of surface drug contamination on the vials of 3 HD products: 5-fluorouracil, cisplatin, and methotrexate. The drug products were packaged in vials using a patented prewashing/decontamination method, application of a polyvinylchloride (PVC) base, and use of clear glass vials. An additional step of encasing the vial in a shrink-wrapped sheath was used for 5-fluorouracil and cisplatin. Of all 5-fluorouracil (110 vials), methotrexate (60 vials), and cisplatin (60 vials) tested, only 2 had detectable amounts of surface residue. One 5-fluorouracil vial was found to have approximately 4 mg of 5-fluorouracil on the surface of the vial. The second contaminated vial was cisplatin, which was discovered to have 131 ng of platinum, equal to 200 ng of cisplatin or 0.2 μL of cisplatin solution, on the vial sheath. Using validated extraction and analytic methods, all but 2 of the 230 tested vials were found to be free of surface drug contamination. Pharmacy leaders need to take an active role in promoting the need for clean HD vials. Manufacturers should be required to provide their clients with data derived from externally validated analytic studies, reporting the level of HD contamination on the exterior of their vial products.

  8. AN ENVIRONMENTAL COMPARISON OF PLASTIC AND PAPER CONSUMER CARRIER BAGS IN SOUTH AFRICA: IMPLICATIONS FOR THE LOCAL MANUFACTURING INDUSTRY

    Directory of Open Access Journals (Sweden)

    J. Sevitz

    2012-01-01

    Full Text Available

    ENGLISH ABSTRACT: The conventional consumer carrier bags have recently received considerable attention in South Africa. The choice of material for these bags, based on environmental preferences in the South African context, could significantly influence the local manufacturing industry. Life Cycle Assessment (LCA, an environmental management tool, has been applied to objectively evaluate and compare the overall environmental impacts of the complete life cycles (from raw material extraction to final disposal of consumer plastic and paper carrier bags in South Africa. Paper bags have a higher carrying capacity compared to plastic bags and different use ratios were subsequently evaluated. Plastic bags have a lower environmental impact for use ratios of up to 2.5 plastic bags to one paper bag. Above this ratio the conclusions are not reliable. Paper bags would need to increase its recycled content significantly to be competitive in terms of environmental impacts. The re-use of thicker plastic, as proposed by the new plastic bag legislation, has the potential to significantly lower the impact of plastic bags.

    AFRIKAANSE OPSOMMING: Die konvensionele gebruikersdrasakke het onlangs aansienlike aandag in Suid Afrika ontvang. Die keuse van materiaal vir hierdie sakke, wat gebaseer is op omgewingsvoorkeure in die Suid-Afrikaanse konteks, kan 'n wesenlike invloed uitoefen op die plaaslike vervaardigingsindustrie. Lewenssiklusanalise (LCA, 'n omgewingsbestuurgereedskap, is aangewend vir 'n objektiewe evaluasie en vergelyking van die algehele omgewingsimpakte van die totale lewenssiklus (vanaf grondstofekstraksie tot finale wegdoening van gebruikersplastiek- en papierdrasakke in Suid-Afrika. Aangesien papiersakke 'n hoër drakapasiteit het in vergelyking met plastieksakke, is verskillende gebruiksverhoudings evalueer. Plastieksakke het 'n laer omgewingsimpak vir gebruiksverhoudings tot en met 2.5 plastieksakke vir elke papiersak. Die gevolgtrekkings

  9. Low cost plastic scintillator by using commercial polystyrene

    International Nuclear Information System (INIS)

    Oktar, O.; Ari, G.; Guenduez, O.; Demirel, H.; Demirbas, A.

    2009-01-01

    Plastic scintillation detectors have been used in nuclear and high energy physics for many decades. Among their benefits are fast response, ease of manufacture and versatility. Their main drawbacks are radiation resistance and cost. Plastic Scintillators can be described as solid materials which contain organic fluorescent compounds dissolved within a polymer matri10. Transparent plastics commonly used for light scintillation are Polystyrene (or PS, poly-vinyl-benzene) and polyvinyl-toluene (or PVT, poly-methyl-styron). In this activity, preliminary studies for low cost plastic scintillator production by using commercial polystyrene pellets and extrusion method were aimed. For this purpose, PS blocks consist of commercial fluorescent dopant were prepared by an extruder in SANAEM. Molds suitable for extruder were designed and manufactured and optimum production parameters such as extrusion temperature profile, extrusion rate and pressure were obtained. Plastic blocks prepared were optically and mechanically tested and its response against various radioactive sources was measured.This study has shown that plastic scintillators imported can be produced in SANAEM domestically and be used for detection of radioactive materials within the country or border gates.

  10. GABAA receptor drugs and neuronal plasticity in reward and aversion: focus on the ventral tegmental area

    Directory of Open Access Journals (Sweden)

    Elena eVashchinkina

    2014-11-01

    Full Text Available GABAA receptors are the main fast inhibitory neurotransmitter receptors in the mammalian brain, and targets for many clinically important drugs widely used in the treatment of anxiety disorders, insomnia and in anesthesia. Nonetheless, there are significant risks associated with the long-term use of these drugs particularly related to development of tolerance and addiction. Addictive mechanisms of GABAA receptor drugs are poorly known, but recent findings suggest that those drugs may induce aberrant neuroadaptations in the brain reward circuitry. Recently, benzodiazepines, acting on synaptic GABAA receptors, and modulators of extrasynaptic GABAA receptors (THIP and neurosteroids have been found to induce plasticity in the ventral tegmental area (VTA dopamine neurons and their main target projections. Furthermore, depending whether synaptic or extrasynaptic GABAA receptor populations are activated, the behavioral outcome of repeated administration seems to correlate with rewarding or aversive behavioral responses, respectively. The VTA dopamine neurons project to forebrain centers such as the nucleus accumbens and medial prefrontal cortex, and receive afferent projections from these brain regions and especially from the extended amygdala and lateral habenula, forming the major part of the reward and aversion circuitry. Both synaptic and extrasynaptic GABAA drugs inhibit the VTA GABAergic interneurons, thus activating the VTA DA neurons by disinhibition and this way inducing glutamatergic synaptic plasticity. However, the GABAA drugs failed to alter synaptic spine numbers as studied from Golgi-Cox-stained VTA dendrites. Since the GABAergic drugs are known to depress the brain metabolism and gene expression, their likely way of inducing neuroplasticity in mature neurons is by disinhibiting the principal neurons, which remains to be rigorously tested for a number of clinically important anxiolytics, sedatives and anesthetics in different parts of

  11. Plastics recycling: challenges and opportunities.

    Science.gov (United States)

    Hopewell, Jefferson; Dvorak, Robert; Kosior, Edward

    2009-07-27

    Plastics are inexpensive, lightweight and durable materials, which can readily be moulded into a variety of products that find use in a wide range of applications. As a consequence, the production of plastics has increased markedly over the last 60 years. However, current levels of their usage and disposal generate several environmental problems. Around 4 per cent of world oil and gas production, a non-renewable resource, is used as feedstock for plastics and a further 3-4% is expended to provide energy for their manufacture. A major portion of plastic produced each year is used to make disposable items of packaging or other short-lived products that are discarded within a year of manufacture. These two observations alone indicate that our current use of plastics is not sustainable. In addition, because of the durability of the polymers involved, substantial quantities of discarded end-of-life plastics are accumulating as debris in landfills and in natural habitats worldwide. Recycling is one of the most important actions currently available to reduce these impacts and represents one of the most dynamic areas in the plastics industry today. Recycling provides opportunities to reduce oil usage, carbon dioxide emissions and the quantities of waste requiring disposal. Here, we briefly set recycling into context against other waste-reduction strategies, namely reduction in material use through downgauging or product reuse, the use of alternative biodegradable materials and energy recovery as fuel. While plastics have been recycled since the 1970s, the quantities that are recycled vary geographically, according to plastic type and application. Recycling of packaging materials has seen rapid expansion over the last decades in a number of countries. Advances in technologies and systems for the collection, sorting and reprocessing of recyclable plastics are creating new opportunities for recycling, and with the combined actions of the public, industry and governments it

  12. Plastics recycling: challenges and opportunities

    Science.gov (United States)

    Hopewell, Jefferson; Dvorak, Robert; Kosior, Edward

    2009-01-01

    Plastics are inexpensive, lightweight and durable materials, which can readily be moulded into a variety of products that find use in a wide range of applications. As a consequence, the production of plastics has increased markedly over the last 60 years. However, current levels of their usage and disposal generate several environmental problems. Around 4 per cent of world oil and gas production, a non-renewable resource, is used as feedstock for plastics and a further 3–4% is expended to provide energy for their manufacture. A major portion of plastic produced each year is used to make disposable items of packaging or other short-lived products that are discarded within a year of manufacture. These two observations alone indicate that our current use of plastics is not sustainable. In addition, because of the durability of the polymers involved, substantial quantities of discarded end-of-life plastics are accumulating as debris in landfills and in natural habitats worldwide. Recycling is one of the most important actions currently available to reduce these impacts and represents one of the most dynamic areas in the plastics industry today. Recycling provides opportunities to reduce oil usage, carbon dioxide emissions and the quantities of waste requiring disposal. Here, we briefly set recycling into context against other waste-reduction strategies, namely reduction in material use through downgauging or product reuse, the use of alternative biodegradable materials and energy recovery as fuel. While plastics have been recycled since the 1970s, the quantities that are recycled vary geographically, according to plastic type and application. Recycling of packaging materials has seen rapid expansion over the last decades in a number of countries. Advances in technologies and systems for the collection, sorting and reprocessing of recyclable plastics are creating new opportunities for recycling, and with the combined actions of the public, industry and governments it

  13. 3D Printer-Manufacturing of Complex Geometry Elements

    Science.gov (United States)

    Ciubară, A.; Burlea, Ș L.; Axinte, M.; Cimpoeșu, R.; Chicet, D. L.; Manole, V.; Burlea, G.; Cimpoeșu, N.

    2018-06-01

    In the last 5-10 years the process of 3D printing has an incredible advanced in all the fields with a tremendous number of applications. Plastic materials exhibit highly beneficial mechanical properties while delivering complex designs impossible to achieve using conventional manufacturing. In this article the printing process (filling degree, time, complications and details finesse) of few plastic elements with complicated geometry and fine details was analyzed and comment. 3D printing offers many of the thermoplastics and industrial materials found in conventional manufacturing. The advantages and disadvantages of 3D printing for plastic parts are discussed. Time of production for an element with complex geometry, from the design to final cut, was evaluated.

  14. Waste product profile: Plastic film and bags

    Energy Technology Data Exchange (ETDEWEB)

    Miller, C. [Environmental Industry Associations, Washington, DC (United States)

    1996-10-01

    Plastic film is recycled by being pelletized following a granulation or densifying process. Manufacturing and converting plants are the major sources of plastic film for recycling because they can supply sufficient amounts of clean raw material of a known resin type. Post-consumer collection programs are more recent. They tend to focus on businesses such as grocery stores that are large generators of plastic bags. In this case, the recycling process is more complex, requiring sorting, washing, and removal of contaminants as a first step. Curbside collection of plastic bags is rare.

  15. Recycling of plastics

    Energy Technology Data Exchange (ETDEWEB)

    Kaminsky, W; Menzel, J; Sinn, H

    1976-01-01

    Considering the shortage of raw materials and environmental pollution, the recycling of plastic waste is a very important topic. Pilot plants for research in Funabashi Japan, Franklin (Ohio) U.S.A., and the R 80-process of Krauss Maffei, W. Germany, have demonstrated the possibility of reclaiming plastics from refuse. Old tires and waste from the plastic producing and manufacturing industries are readily available. The pyrolysis of plastic yields gaseous and liquid products, and the exploitation of this cracking reaction has been demonstrated by pilot plants in Japan and Great Britain. Further laboratory scale experiments are taking place in W. Germany. In continuous fluidized beds and in molten salts, polyethylene, polypropylene, polyvinylchloride, polystyrene and rubber are pyrolysed and better than 98 percent conversion is obtained. Up to 40 percent of the feed can be obtained as aromatic compounds, and a pilot plant is under construction. As a first step PVC-containing material can be almost quantitatively dehydrochlorinated.

  16. Plasticity of the Leishmania genome leading to gene copy number variations and drug resistance [version 1; referees: 5 approved

    Directory of Open Access Journals (Sweden)

    Marie-Claude N. Laffitte

    2016-09-01

    Full Text Available Leishmania has a plastic genome, and drug pressure can select for gene copy number variation (CNV. CNVs can apply either to whole chromosomes, leading to aneuploidy, or to specific genomic regions. For the latter, the amplification of chromosomal regions occurs at the level of homologous direct or inverted repeated sequences leading to extrachromosomal circular or linear amplified DNAs. This ability of Leishmania to respond to drug pressure by CNVs has led to the development of genomic screens such as Cos-Seq, which has the potential of expediting the discovery of drug targets for novel promising drug candidates.

  17. Media milling process optimization for manufacture of drug nanoparticles using design of experiments (DOE).

    Science.gov (United States)

    Nekkanti, Vijaykumar; Marwah, Ashwani; Pillai, Raviraj

    2015-01-01

    Design of experiments (DOE), a component of Quality by Design (QbD), is systematic and simultaneous evaluation of process variables to develop a product with predetermined quality attributes. This article presents a case study to understand the effects of process variables in a bead milling process used for manufacture of drug nanoparticles. Experiments were designed and results were computed according to a 3-factor, 3-level face-centered central composite design (CCD). The factors investigated were motor speed, pump speed and bead volume. Responses analyzed for evaluating these effects and interactions were milling time, particle size and process yield. Process validation batches were executed using the optimum process conditions obtained from software Design-Expert® to evaluate both the repeatability and reproducibility of bead milling technique. Milling time was optimized to process variables by applying DOE resulted in considerable decrease in milling time to achieve the desired particle size. The study indicates the applicability of DOE approach to optimize critical process parameters in the manufacture of drug nanoparticles.

  18. 21 CFR 872.5470 - Orthodontic plastic bracket.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Orthodontic plastic bracket. 872.5470 Section 872...) MEDICAL DEVICES DENTAL DEVICES Therapeutic Devices § 872.5470 Orthodontic plastic bracket. (a) Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply...

  19. Biocide Usage in Plastic Products

    OpenAIRE

    Kavak, Nergizhan; Çakır, Ayşegül; Koltuk, Fatmagül; Uzun, Utku

    2015-01-01

    People’s demand of improving their life quality caused to the term of hygiene become popular and increased the tendency to use more reliable and healthy products. This tendency makes the continuous developments in the properties of the materials used in manufactured goods compulsory. It is possible to create anti-bacterial plastic products by adding biocidal additives to plastic materials which have a wide-range of application in the areas such as health (medicine), food and many other indust...

  20. sampling plans for monitoring quality control process at a plastic

    African Journals Online (AJOL)

    Dr Obe

    AT A PLASTIC MANUFACTURING FIRM IN NIGERIA: A CASE STUDY. By. E.A. Onyeagoro ... manufacture similar products, so that each company ... monitoring of production to maintain process ... concept of designing quality into product, with.

  1. 21 CFR 225.1 - Current good manufacturing practice.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Current good manufacturing practice. 225.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS General Provisions § 225.1 Current good manufacturing practice. (a) Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act...

  2. 49 CFR 178.925 - Standards for rigid plastic Large Packagings.

    Science.gov (United States)

    2010-10-01

    ... manufacture of the tested design type, retesting may be omitted if changes in the carbon black content, the... or chemical properties of the material of construction. (3) No used material other than production residues or regrind from the same manufacturing process may be used in the manufacture of rigid plastic...

  3. L-type Ca²⁺ channel blockade with antihypertensive medication disrupts VTA synaptic plasticity and drug-associated contextual memory.

    Science.gov (United States)

    Degoulet, M; Stelly, C E; Ahn, K-C; Morikawa, H

    2016-03-01

    Drug addiction is driven, in part, by powerful and enduring memories of sensory cues associated with drug intake. As such, relapse to drug use during abstinence is frequently triggered by an encounter with drug-associated cues, including the drug itself. L-type Ca(2+) channels (LTCCs) are known to regulate different forms of synaptic plasticity, the major neural substrate for learning and memory, in various brain areas. Long-term potentiation (LTP) of NMDA receptor (NMDAR)-mediated glutamatergic transmission in the ventral tegmental area (VTA) may contribute to the increased motivational valence of drug-associated cues triggering relapse. In this study, using rat brain slices, we found that isradipine, a general LTCC antagonist used as antihypertensive medication, not only blocks the induction of NMDAR LTP but also promotes the reversal of previously induced LTP in the VTA. In behaving rats, isradipine injected into the VTA suppressed the acquisition of cocaine-paired contextual cue memory assessed using a conditioned place preference (CPP) paradigm. Furthermore, administration of isradipine or a CaV1.3 subtype-selective LTCC antagonist (systemic or intra-VTA) before a single extinction or reinstatement session, while having no immediate effect at the time of administration, abolished previously acquired cocaine and alcohol (ethanol) CPP on subsequent days. Notably, CPP thus extinguished cannot be reinstated by drug re-exposure, even after 2 weeks of withdrawal. These results suggest that LTCC blockade during exposure to drug-associated cues may cause unlearning of the increased valence of those cues, presumably via reversal of glutamatergic synaptic plasticity in the VTA.

  4. 78 FR 18234 - Service of Process on Manufacturers; Manufacturers Importing Electronic Products Into the United...

    Science.gov (United States)

    2013-03-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 1005 [Docket No. FDA-2007-N-0091; (formerly 2007N-0104)] Service of Process on Manufacturers; Manufacturers Importing Electronic Products Into the United States; Agent Designation; Change of Address AGENCY: Food and Drug...

  5. Drug Pollution from Manufacturing and Antimicrobial Resistance: How Does the European Union Manage the Potential Environmental and Health Risks of Importing Pharmaceutical Active Ingredients From Third Countries?

    DEFF Research Database (Denmark)

    le Gal, Elodie Jeanine Odette

    pollution and anti-micro-bacterial resistance within their own borders by buying and importing drugs manufactured in third countries, such as India and China. With a focus on drug pollution from manufacturing, the goal of this paper is to explore the European drug import safety regime. It intends to better...... and environmental failures. Over the past three decades, the scientific literature has been increasingly reporting case studies on environmental pollution from drug manufacturing, human excretions and improper disposal of unused or expired drug residues in different parts of the world. Active ingredients, which...... are responsible for the biological activity of drugs, have been identified as the main vector of pharmaceutical pollution. Associated with the environmental risk of pharmaceutical pollution in soils and waterways is the predicted risk of antimicrobial resistance (AMR) expected to increase and to dramatically...

  6. Improving drug manufacturing with process analytical technology.

    Science.gov (United States)

    Rodrigues, Licinia O; Alves, Teresa P; Cardoso, Joaquim P; Menezes, José C

    2006-01-01

    Within the process analytical technology (PAT) framework, as presented in the US Food and Drug Administration guidelines, the aim is to design, develop and operate processes consistently to ensure a pre-defined level of quality at the end of the manufacturing process. Three PAT implementation scenarios can be envisaged. Firstly, PAT could be used in its most modest version (in an almost non-PAT manner) to simply replace an existing quality control protocol (eg, using near-infrared spectroscopy for an in-process quality control, such as moisture content). Secondly, the use of in-process monitoring and process analysis could be integrated to enhance process understanding and operation for an existing industrial process. Thirdly, PAT could be used extensively and exclusively throughout development, scale-up and full-scale production of a new product and process. Although the first type of implementations are well known, reports of the second and third types remain scarce. Herein, results obtained from PAT implementations of the second and third types are described for two industrial processes for preparing bulk active pharmaceutical ingredients, demonstrating the benefits in terms of increased process understanding and process control.

  7. A Method of Retrospective Computerized System Validation for Drug Manufacturing Software Considering Modifications

    Science.gov (United States)

    Takahashi, Masakazu; Fukue, Yoshinori

    This paper proposes a Retrospective Computerized System Validation (RCSV) method for Drug Manufacturing Software (DMSW) that relates to drug production considering software modification. Because DMSW that is used for quality management and facility control affects big impact to quality of drugs, regulatory agency required proofs of adequacy for DMSW's functions and performance based on developed documents and test results. Especially, the work that explains adequacy for previously developed DMSW based on existing documents and operational records is called RCSV. When modifying RCSV conducted DMSW, it was difficult to secure consistency between developed documents and test results for modified DMSW parts and existing documents and operational records for non-modified DMSW parts. This made conducting RCSV difficult. In this paper, we proposed (a) definition of documents architecture, (b) definition of descriptive items and levels in the documents, (c) management of design information using database, (d) exhaustive testing, and (e) integrated RCSV procedure. As a result, we could conduct adequate RCSV securing consistency.

  8. The machines maintenance conditions assessment in the plastic industry

    Directory of Open Access Journals (Sweden)

    Stanisław Borkowski

    2015-12-01

    Full Text Available The purpose, methodology, main findings, the originality of the subject area (research, way of using. The main research analysis purpose is a presentation, an assessment and an interpretation of the research findings on the machines maintenance conditions in the plastic industry. The research analysis was carried out with applying Technology ABC method and TPM coefficients calculations connected with Techno pak machine components maintenance. The research was carried out in the chosen manufacturing enterprise of the plastic industry. Research findings interpretation results have been introduced in the analyzed enterprise in the form of the manufacturing processes improvement.

  9. Surface flow in severe plastic deformation of metals by sliding

    International Nuclear Information System (INIS)

    Mahato, A; Yeung, H; Chandrasekar, S; Guo, Y

    2014-01-01

    An in situ study of flow in severe plastic deformation (SPD) of surfaces by sliding is described. The model system – a hard wedge sliding against a metal surface – is representative of surface conditioning processes typical of manufacturing, and sliding wear. By combining high speed imaging and image analysis, important characteristics of unconstrained plastic flow inherent to this system are highlighted. These characteristics include development of large plastic strains on the surface and in the subsurface by laminar type flow, unusual fluid-like flow with vortex formation and surface folding, and defect and particle generation. Preferred conditions, as well as undesirable regimes, for surface SPD are demarcated. Implications for surface conditioning in manufacturing, modeling of surface deformation and wear are discussed

  10. HYGROSCOPICITY OF WOOD PLASTIC COMPOSITES MADE WITH PADOU FLOUR AND POLYPROPYLENE PELLETS

    OpenAIRE

    Moise Emmanuel NZUDJOM SOUOP; Joseph Albert MUKAM FOTSING

    2012-01-01

    The manufacture of objects in wood-plastic composites which is a material already available in many developed countries seems almost unknown in Cameroon since the production factory of objects in wood-plastic composites does not exist up till here. Interested in the study of properties of wood-plastic composites throughconnection of simple plastic and wood, we have oriented our paper in the elaboration, realization and physical characterization of wood-plastic composites with Padou and polypr...

  11. 77 FR 16158 - Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs...

    Science.gov (United States)

    2012-03-20

    .... FDA-1997-N-0518] (formerly 97N-0300) Current Good Manufacturing Practice in Manufacturing, Processing... labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and... GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS 0 1. The authority citation for 21 CFR part...

  12. A Proposal of Operational Risk Management Method Using FMEA for Drug Manufacturing Computerized System

    Science.gov (United States)

    Takahashi, Masakazu; Nanba, Reiji; Fukue, Yoshinori

    This paper proposes operational Risk Management (RM) method using Failure Mode and Effects Analysis (FMEA) for drug manufacturing computerlized system (DMCS). The quality of drug must not be influenced by failures and operational mistakes of DMCS. To avoid such situation, DMCS has to be conducted enough risk assessment and taken precautions. We propose operational RM method using FMEA for DMCS. To propose the method, we gathered and compared the FMEA results of DMCS, and develop a list that contains failure modes, failures and countermeasures. To apply this list, we can conduct RM in design phase, find failures, and conduct countermeasures efficiently. Additionally, we can find some failures that have not been found yet.

  13. Interaction between vegetable oil based plasticizer molecules and polyvinyl chloride, and their plasticization effect

    Science.gov (United States)

    Haryono, Agus; Triwulandari, Evi; Jiang, Pingping

    2017-01-01

    Plasticizer molecules are low molecular weight compounds that are widely used in polymer industries especially in polyvinyl chloride (PVC) resin. As an additive in PVC resin, the important role of plasticizer molecules is to improve the flexibility and processability of PVC by lowering the glass transition temperature (Tg). However, the commercial plasticizer like di(2-ethylhexyl)phthalate (DEHP) is known to cause liver cancer, at least in laboratory rats. DEHP can leach out from PVC into blood, certain drug solutions and fatty foods, which has been detected in the bloodstream of patients undergoing transfusion. Vegetable oil based plasticizers have some attractive properties such as non-toxic, bio-degradable, good heat and light stability, renewable resources, and environmentally friendly. Here we discussed the main results and development of vegetable oil based plasticizer, and especially palm oil based plasticizer. The interaction between plasticizer and polymer was discussed from the properties of the plasticized polymeric material.

  14. Taking plastics packaging to the future through improving barrier properties

    CSIR Research Space (South Africa)

    Labuschagne, Philip W

    2011-11-01

    Full Text Available , trimethylaluminium) + O2, Ar ? Covalently bonded to substrate ? adhesion ?; brittleness ? ? Process variables: power, pressure, O2 % ? BIF PET: 5 ? 200x; PP: 2 ? 60x ? Prone to pinholes (contaminants), microcracks: Supporting the Manufacturing and Materials... the Manufacturing and Materials Industry in its quest for global competitiveness orting the Manufacturing and Materials Industry in it quest for global competitiveness CSIR Manufacturing and Materials Technology Taking Plastics Packaging to the Future Through...

  15. Spatial distribution, input and dispersion of plastic pellets in coastal zones

    OpenAIRE

    Danilo Balthazar Silva

    2016-01-01

    The production and the usage of plastic material increases since the decade of 1950. Nowadays, the elevated production rate, the misusing and the waste turned plastic material in an urgent environmental and economic problem. One of the major environmental problems related to this issue is the contamination of marine environments by microplastics. These constitute plastic particles of size between 1 and 5 mm. Microplastics might occur by breaking of larger plastic pieces or as a manufactured p...

  16. Influence of Manufacturing Processes on the Performance of Phantom Lungs

    International Nuclear Information System (INIS)

    Traub, Richard J.

    2008-01-01

    Chest counting is an important tool for estimating the radiation dose to individuals who have inhaled radioactive materials. Chest counting systems are calibrated by counting the activity in the lungs of phantoms where the activity in the phantom lungs is known. In the United States a commonly used calibration phantom was developed at the Lawrence Livermore National Laboratory and is referred to as the Livermore Torso Phantom. An important feature of this phantom is that the phantom lungs can be interchanged so that the counting system can be challenged by different combinations of radionuclides and activity. Phantom lungs are made from lung tissue substitutes whose constituents are foaming plastics and various adjuvants selected to make the lung tissue substitute similar to normal healthy lung tissue. Some of the properties of phantom lungs cannot be readily controlled by phantom lung manufacturers. Some, such as density, are a complex function of the manufacturing process, while others, such as elemental composition of the bulk plastic are controlled by the plastics manufacturer without input, or knowledge of the phantom manufacturer. Despite the fact that some of these items cannot be controlled, they can be measured and accounted for. This report describes how manufacturing processes can influence the performance of phantom lungs. It is proposed that a metric that describes the brightness of the lung be employed by the phantom lung manufacturer to determine how well the phantom lung approximates the characteristics of a human lung. For many purposes, the linear attenuation of the lung tissue substitute is an appropriate surrogate for the brightness

  17. 21 CFR 878.3925 - Plastic surgery kit and accessories.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Plastic surgery kit and accessories. 878.3925... (CONTINUED) MEDICAL DEVICES GENERAL AND PLASTIC SURGERY DEVICES Prosthetic Devices § 878.3925 Plastic surgery kit and accessories. (a) Identification. A plastic surgery kit and accessories is a device intended to...

  18. Systematic review of drug administration costs and implications for biopharmaceutical manufacturing.

    Science.gov (United States)

    Tetteh, Ebenezer; Morris, Stephen

    2013-10-01

    The acquisition costs of biologic drugs are often considered to be relatively high compared with those of nonbiologics. However, the total costs of delivering these drugs also depend on the cost of administration. Ignoring drug administration costs may distort resource allocation decisions because these affect cost effectiveness. The objectives of this systematic review were to develop a framework of drug administration costs that considers both the costs of physical administration and the associated proximal costs; and, as a case example, to use this framework to evaluate administration costs for biologics within the UK National Health Service (NHS). We reviewed literature that reported estimates of administration costs for biologics within the UK NHS to identify how these costs were quantified and to examine how differences in dosage forms and regimens influenced administration costs. The literature reviewed were identified by searching the Centre for Review and Dissemination Databases (DARE, NHS EED and HTA); EMBASE (The Excerpta Medica Database); MEDLINE (using the OVID interface); Econlit (EBSCO); Tufts Medical Center Cost Effectiveness Analysis (CEA) Registry; and Google Scholar. We identified 4,344 potentially relevant studies, of which 43 studies were selected for this systematic review. We extracted estimates of the administration costs of biologics from these studies. We found evidence of variation in the way that administration costs were measured, and that this affected the magnitude of costs reported, which could then influence cost effectiveness. Our findings suggested that manufacturers of biologic medicines should pay attention to formulation issues and their impact on administration costs, because these affect the total costs of healthcare delivery and cost effectiveness.

  19. Mechanics and energetics in tool manufacture and use: a synthetic approach.

    Science.gov (United States)

    Wang, Liyu; Brodbeck, Luzius; Iida, Fumiya

    2014-11-06

    Tool manufacture and use are observed not only in humans but also in other animals such as mammals, birds and insects. Manufactured tools are used for biomechanical functions such as effective control of fluids and small solid objects and extension of reaching. These tools are passive and used with gravity and the animal users' own energy. From the perspective of evolutionary biology, manufactured tools are extended phenotypes of the genes of the animal and exhibit phenotypic plasticity. This incurs energetic cost of manufacture as compared to the case with a fixed tool. This paper studies mechanics and energetics aspects of tool manufacture and use in non-human beings. Firstly, it investigates possible mechanical mechanisms of the use of passive manufactured tools. Secondly, it formulates the energetic cost of manufacture and analyses when phenotypic plasticity benefits an animal tool maker and user. We take a synthetic approach and use a controlled physical model, i.e. a robot arm. The robot is capable of additively manufacturing scoop and gripper structures from thermoplastic adhesives to pick and place fluid and solid objects, mimicking primates and birds manufacturing tools for a similar function. We evaluate the effectiveness of tool use in pick-and-place and explain the mechanism for gripper tools picking up solid objects with a solid-mechanics model. We propose a way to formulate the energetic cost of tool manufacture that includes modes of addition and reshaping, and use it to analyse the case of scoop tools. Experiment results show that with a single motor trajectory, the robot was able to effectively pick and place water, rice grains, a pebble and a plastic box with a scoop tool or gripper tools that were manufactured by itself. They also show that by changing the dimension of scoop tools, the energetic cost of tool manufacture and use could be reduced. The work should also be interesting for engineers to design adaptive machines. © 2014 The Author

  20. Mechanics and energetics in tool manufacture and use: a synthetic approach

    Science.gov (United States)

    Wang, Liyu; Brodbeck, Luzius; Iida, Fumiya

    2014-01-01

    Tool manufacture and use are observed not only in humans but also in other animals such as mammals, birds and insects. Manufactured tools are used for biomechanical functions such as effective control of fluids and small solid objects and extension of reaching. These tools are passive and used with gravity and the animal users' own energy. From the perspective of evolutionary biology, manufactured tools are extended phenotypes of the genes of the animal and exhibit phenotypic plasticity. This incurs energetic cost of manufacture as compared to the case with a fixed tool. This paper studies mechanics and energetics aspects of tool manufacture and use in non-human beings. Firstly, it investigates possible mechanical mechanisms of the use of passive manufactured tools. Secondly, it formulates the energetic cost of manufacture and analyses when phenotypic plasticity benefits an animal tool maker and user. We take a synthetic approach and use a controlled physical model, i.e. a robot arm. The robot is capable of additively manufacturing scoop and gripper structures from thermoplastic adhesives to pick and place fluid and solid objects, mimicking primates and birds manufacturing tools for a similar function. We evaluate the effectiveness of tool use in pick-and-place and explain the mechanism for gripper tools picking up solid objects with a solid-mechanics model. We propose a way to formulate the energetic cost of tool manufacture that includes modes of addition and reshaping, and use it to analyse the case of scoop tools. Experiment results show that with a single motor trajectory, the robot was able to effectively pick and place water, rice grains, a pebble and a plastic box with a scoop tool or gripper tools that were manufactured by itself. They also show that by changing the dimension of scoop tools, the energetic cost of tool manufacture and use could be reduced. The work should also be interesting for engineers to design adaptive machines. PMID:25209405

  1. 21 CFR 226.1 - Current good manufacturing practice.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Current good manufacturing practice. 226.1 Section...) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES General Provisions § 226.1 Current good manufacturing practice. (a) The criteria in §§ 226.10 through 226.115, inclusive...

  2. Sustainable Product: Personal Protective Equipment Manufactured with Green Plastic

    Directory of Open Access Journals (Sweden)

    Hamilton Aparecido Boa Vista

    2015-04-01

    Full Text Available This study analyzed the case of manufacturing of Personal Protective Equipment (PPE using as raw material biopolymers produced from ethanol from sugar cane, known as green polypropylene, produced since 2008 by BRASKEM. This article studied the PPE for the employee’s head protection, named helmet by NR 6, which is used in situations of exposure to weather and work scenarios in places where there is risk of impact from falling or projecting objects, burns, electric shock, and solar radiation. The MSA, green helmet manufacturer, made an inventory of greenhouse gas emissions into the atmosphere by comparing the two manufacturing processes of the helmet shell, covering the January 1 to December 31, 2011 period. It concluded that the sustainable helmet (green polyethylene and pigments robs 231g of CO2 from the atmosphere per produced unit, while the helmet’s production with traditional raw materials (polyethylene and petrochemical pigments found that, for each unit produced, 1029g of CO2 are emitted into the atmosphere. The study showed that substitution of raw materials has led to reduction in the impact generated in the helmets’ production.

  3. Synthesis of biodegradable plastic from tapioca with N-Isopropylacrylamid and chitosan using glycerol as plasticizer

    Science.gov (United States)

    Syaubari; Safwani, S.; Riza, M.

    2018-04-01

    One of natural polymers that can be used as raw material in the manufacture of biodegradable plastic is tapioca and chitosan. The addition of other compounds such as glycerol as plasticizer is to improve the characteristics of the plastic that already produced. N- Isopropylacrylamid (NIPAm) is an organic compound that can be synthesized into a polymer or polymer grafting which also biodegradable too. This research aims tostudy the synthesis of biodegradable plastics from tapioca with the addition of chitosan, NIPAm, poly(NIPAm) and analyze the characteristics of biodegradable plastics that already produced. This research was done in three stages, there are (1) polymerization NIPAm, (2) the grafting of chitosan-poly NIPAm and (3) the synthesis of biodegradable plastics from starch mixture with variation of addition chitosan, NIPAm, poly(NIPAm), chitosan-graft-poly(NIPAm) and also variations of glycerol as plasticizer. The results of this research is a thin sheet of plastic which is will get analyzed for the characteristics of functional groups, mechanical, morphological and its biodegradability. FTIR spectra showed the grafting process with the new group formation of CO single-bond at 850 cm-1. Plastic with the addition of NIPAm and 1 ml glycerol has the highest tensile strength value about 31.1 MPa. Plastic with poly(NIPAm) and 4 ml glycerol produces the highest elongation value about 153.72%. Plastic with Chitosan-graft-poly(NIPAm) with 1 ml glycerol has the longest biodegradation because of the small mass-loss for six weeks which is about 6.6%.

  4. Extraction of Organochlorine Pesticides from Plastic Pellets and Plastic Type Analysis.

    Science.gov (United States)

    Pflieger, Marilyne; Makorič, Petra; Kovač Viršek, Manca; Koren, Špela

    2017-07-01

    Plastic resin pellets, categorized as microplastics (≤5 mm in diameter), are small granules that can be unintentionally released to the environment during manufacturing and transport. Because of their environmental persistence, they are widely distributed in the oceans and on beaches all over the world. They can act as a vector of potentially toxic organic compounds (e.g., polychlorinated biphenyls) and might consequently negatively affect marine organisms. Their possible impacts along the food chain are not yet well understood. In order to assess the hazards associated with the occurrence of plastic pellets in the marine environment, it is necessary to develop methodologies that allow for rapid determination of associated organic contaminant levels. The present protocol describes the different steps required for sampling resin pellets, analyzing adsorbed organochlorine pesticides (OCPs) and identifying the plastic type. The focus is on the extraction of OCPs from plastic pellets by means of a pressurized fluid extractor (PFE) and on the polymer chemical analysis applying Fourier Transform-InfraRed (FT-IR) spectroscopy. The developed methodology focuses on 11 OCPs and related compounds, including dichlorodiphenyltrichloroethane (DDT) and its two main metabolites, lindane and two production isomers, as well as the two biologically active isomers of technical endosulfan. This protocol constitutes a simple and rapid alternative to existing methodology for evaluating the concentration of organic contaminants adsorbed on plastic pieces.

  5. Extraction of Organochlorine Pesticides from Plastic Pellets and Plastic Type Analysis

    OpenAIRE

    Pflieger, Maryline; Makorič, Petra; Kovač Viršek, Manca; Koren, Špela

    2017-01-01

    Plastic resin pellets, categorized as microplastics (≤5 mm in diameter), are small granules that can be unintentionally released to the environment during manufacturing and transport. Because of their environmental persistence, they are widely distributed in the oceans and on beaches all over the world. They can act as a vector of potentially toxic organic compounds (e.g., polychlorinated biphenyls) and might consequently negatively affect marine organisms. Their possible impacts alo...

  6. Photodegradable plastics useful for global environment conservation. Chikyu ni yasashii hikaribunkaisei plastic

    Energy Technology Data Exchange (ETDEWEB)

    Iwasa, T. (Harima Kasei K.K., Osaka (Japan))

    1991-10-11

    Photodegradable plastics and their additives were explained.Two methods are used to manufacture photodegradable plastics.The first method is made by using a copolymer and a monomer containing a functional group and the second method is made by adding a photodegradable agent to an undecomposable plastics.The copolymer based on ethylene and carbon monoxide is included in the first type. The copolymer based on the vinyl ketone to which the carboxyl group is introduced, and ethylene or styrene is also included in this type. A metal dithiocarbamate is included in the second additive type, for which several methods to improve weak points of the pigment compounding system have been proposed later. Benzophenone derivatives, transition metal salts of organic acids and anatase type titanium dioxide are also included in the second type. Any additives are usually supplied as the masterbatch. The performance evaluation and degrading mechanism of ferric tri(2-(methylbenzoyl)benzoate) of adittion type additives were explained. 8 refs., 3 figs., 1 tab.

  7. Plastic Encapsulated Microcircuits (PEMs) Reliability Guide

    Science.gov (United States)

    Sandor, M.

    2000-01-01

    It is reported by some users and has been demonstrated by others via testing and qualification that the quality and reliability of plastic-encapsulated microcircuits (PEMs) manufactured today are excellent in commercial applications and closely equivalent, and in some cases superior to their hemetic counterparts.

  8. Influence of Different Container Closure Systems and Capping Process Parameters on Product Quality and Container Closure Integrity (CCI) in GMP Drug Product Manufacturing.

    Science.gov (United States)

    Mathaes, Roman; Mahler, Hanns-Christian; Roggo, Yves; Huwyler, Joerg; Eder, Juergen; Fritsch, Kamila; Posset, Tobias; Mohl, Silke; Streubel, Alexander

    2016-01-01

    Capping equipment used in good manufacturing practice manufacturing features different designs and a variety of adjustable process parameters. The overall capping result is a complex interplay of the different capping process parameters and is insufficiently described in literature. It remains poorly studied how the different capping equipment designs and capping equipment process parameters (e.g., pre-compression force, capping plate height, turntable rotating speed) contribute to the final residual seal force of a sealed container closure system and its relation to container closure integrity and other drug product quality parameters. Stopper compression measured by computer tomography correlated to residual seal force measurements.In our studies, we used different container closure system configurations from different good manufacturing practice drug product fill & finish facilities to investigate the influence of differences in primary packaging, that is, vial size and rubber stopper design on the capping process and the capped drug product. In addition, we compared two large-scale good manufacturing practice manufacturing capping equipment and different capping equipment settings and their impact on product quality and integrity, as determined by residual seal force.The capping plate to plunger distance had a major influence on the obtained residual seal force values of a sealed vial, whereas the capping pre-compression force and the turntable rotation speed showed only a minor influence on the residual seal force of a sealed vial. Capping process parameters could not easily be transferred from capping equipment of different manufacturers. However, the residual seal force tester did provide a valuable tool to compare capping performance of different capping equipment. No vial showed any leakage greater than 10(-8)mbar L/s as measured by a helium mass spectrometry system, suggesting that container closure integrity was warranted in the residual seal force range

  9. Production low cost plastic scintillator by using commercial polystyrene

    International Nuclear Information System (INIS)

    2011-01-01

    Plastic Scintillators can be described as solid materials which contain organic fluorescent compounds dissolved within a polymer matrix. Transparent plastics commonly used for light scintillation are Polystyrene (or PS, poly-vinyl-benzene) and polyvinyl-toluene (or PVT, poly-methyl-styron). By changing the composition of plastic Scintillators some features such as light yield, radiation hardening, decay time etc. can be controlled. Plastic scintillation detectors have been used in nuclear and high energy physics for many decades. Among their benefits are fast response, ease of manufacture and versatility. Their main drawbacks are radiation resistance and cost. Many research projects have concentrated on improving the fundamental properties of plastic scintillators, but little attention has focussed on their cost and easier manufacturing techniques. First plastic Scintillators were produced in 1950's. Activities for production of low cost Scintillators accelerated in second half of 1970's. In 1975 acrylic based Plexipop Scintillator was developed. Despite its low cost, since its structure was not aromatic the light yield of Plexipop was about one quarter of classical Scintillators. Problems arising from slow response time and weak mechanical properties in scintillators developed, has not been solved until 1980. Within the last decade extrusion method became very popular in preparation of low cost and high quality plastic scintillators. In this activity, preliminary studies for low cost plastic scintillator production by using commercial polystyrene pellets and extrusion plus compression method were aimed. For this purpose, PS blocks consist of commercial fluorescent dopant were prepared in June 2008 by use of the extruder and pres in SANAEM. Molds suitable for accoupling to extruder were designed and manufactured and optimum production parameters such as extrusion temperature profile, extrusion rate and moulding pressure were obtained hence, PS Scintillator Blocks

  10. Influence of a Double-Lumen Extension Tube on Drug Delivery: Examples of Isosorbide Dinitrate and Diazepam.

    Directory of Open Access Journals (Sweden)

    Aurélie Maiguy-Foinard

    Full Text Available Plastic materials such as polyurethane (PUR, polyethylene (PE, polypropylene (PP and polyvinyl chloride (PVC are widely used in double-lumen extension tubing. The purposes of our study were to 1 compare in vitro drug delivery through the double extension tubes available on the market 2 assess the plastic properties of PUR in infusion devices and their impact on drug delivery.The study compared eight double-lumen extension tubes in PUR, co-extruded (PE/PVC plastic and plasticised PVC from different manufacturers. Isosorbide dinitrate and diazepam were used as model compounds to evaluate their sorption on the internal surface of the infusion device. Control experiments were performed using norepinephrine known not to absorb to plastics. Drug concentrations delivered at the egress of extension tubes were determined over time by an analytical spectrophotometric UV-Vis method. The main characteristics of plastics were also determined.Significant differences in the sorption phenomenon were observed among the eight double-lumen extension tubes and between pairs of extension tubes. Mean concentrations of isosorbide dinitrate delivered at the egress of double-lumen extension tubes after a 150-minute infusion (mean values ± standard deviation in percentage of the initial concentrations in the prepared syringes ranged between 80.53 ± 1.66 (one of the PUR tubes and 92.84 ± 2.73 (PE/PVC tube. The same parameters measured during diazepam infusion ranged between 48.58 ± 2.88 (one of the PUR tubes and 85.06 ± 3.94 (PE/PVC tube. The double-lumen extension tubes in PUR were either thermosetting (resin or thermoplastic according to reference.Clinicians must be aware of potential drug interactions with extension tube materials and so must consider their nature as well as the sterilisation method used before selecting an infusion device.

  11. Review of the partitioning of chemicals into different plastics: Consequences for the risk assessment of marine plastic debris

    International Nuclear Information System (INIS)

    O'Connor, Isabel A.; Golsteijn, Laura; Hendriks, A. Jan

    2016-01-01

    Marine plastic debris are found worldwide in oceans and coastal areas. They degrade only slowly and contain chemicals added during manufacture or absorbed from the seawater. Therefore, they can pose a long-lasting contaminant source and potentially transfer chemicals to marine organisms when ingested. In order to assess their risk, the contaminant concentration in the plastics needs to be estimated and differences understood. We collected from literature plastic water partition coefficients of various organic chemicals for seven plastic types: polydimethylsiloxane (PDMS), high-density, low-density and ultra-high molecular weight polyethylene (LDPE, HDPE, UHMWPE), polystyrene (PS), polypropylene (PP), and polyvinyl chloride (PVC). Most data was available for PDMS (1060) and LDPE (220), but much less for the remaining plastics (73). Where possible, regression models were developed and the partitioning was compared between the different plastic types. The partitioning of chemicals follows the order of LDPE ≈ HDPE ≥ PP > PVC ≈ PS. Data describing the impact of weathering are urgently needed. - Highlights: • Comparison of organic chemicals partitioning into seven plastic types • Linear correlation between plastic-water partition coefficient K pw and K ow • More data is needed for polypropylene, polystyrene and polyvinyl chloride. • In all plastic types, most K pw were similar to/smaller than the corresponding K ow .

  12. Chemical Pollutants Released to the Marine Environment by Degradation of Plastic Debris

    OpenAIRE

    Gewert, Berit

    2018-01-01

    Since the beginning of the mass production in the 1940s, plastic has been manufactured in quickly increasing amounts. Plastic debris accumulates in the environment and lately much attention has been drawn to the pollution in the world’s oceans. Despite the rapid development and ubiquitous presence of plastic, degradation in the marine environment and potential risks associated with plastic are not fully understood. Thus, these knowledge gaps were addressed in this thesis, which adds informati...

  13. Durability Characteristics Analysis of Plastic Worm Wheel with Glass Fiber Reinforced Polyamide

    OpenAIRE

    Kim, Gun-Hee; Lee, Jeong-Won; Seo, Tae-Il

    2013-01-01

    Plastic worm wheel is widely used in the vehicle manufacturing field because it is favorable for weight lightening, vibration and noise reduction, as well as corrosion resistance. However, it is very difficult for general plastics to secure the mechanical properties that are required for vehicle gears. If the plastic resin is reinforced by glass fiber in the fabrication process of plastic worm wheel, it is possible to achieve the mechanical properties of metallic material levels. In this stud...

  14. Injection moulding of plastic parts with laser textured surfaces with optical applications

    Science.gov (United States)

    Pina-Estany, J.; García-Granada, A. A.; Corull-Massana, E.

    2018-05-01

    The purpose of this work is to manufacture micro and nanotextured surfaces on plastic injection moulds with the aim of replicating them and obtaining plastic parts with optical applications. Different patterns are manufactured with nanosecond and femtosecond lasers in order to obtain three different optical applications: (i) homogeneous light diffusion (ii) 1D light directionality and (iii) 2D light directionality. Induction heating is used in the injections in order to improve the textures degree of replication. The steel mould and the plastic parts are analyzed with a confocal/focus variation microscope and with a surface roughness tester. A mock-up and a luminance camera are used to evaluate the homogeneity and luminance of the homogeneous light diffusion application in comparison with the current industrial solutions.

  15. Sampling Plans for Monitoring Quality Control Process at a Plastic ...

    African Journals Online (AJOL)

    This paper explores the problem of high quality cost at a medium –sized firm manufacturing various types and sizes of plastic container, using a real life data. In pursuance of their quality objectives, the company established a policy that dictates and expensive and time-consuming post-manufacturing process. While the ...

  16. Review of the partitioning of chemicals into different plastics: Consequences for the risk assessment of marine plastic debris

    NARCIS (Netherlands)

    O'Connor, I.A.; Golsteijn, L.; Hendriks, A.J.

    2016-01-01

    Marine plastic debris are found worldwide in oceans and coastal areas. They degrade only slowly and contain chemicals added during manufacture or absorbed from the seawater. Therefore, they can pose a long-lasting contaminant source and potentially transfer chemicals to marine organisms when

  17. Drug Products in the Medicaid Drug Rebate Program

    Data.gov (United States)

    U.S. Department of Health & Human Services — Active drugs that have been reported by participating drug manufacturers under the Medicaid Drug Rebate Program. All drugs are identified by National Drug Code...

  18. Green plasticizers for multibase gun propellants (Lecture)

    NARCIS (Netherlands)

    Schoolderman, C.; Driel, C.A. van; Zebregs, M.

    2007-01-01

    TNO Defence, Security and Safety has a long history of research on gun propellants. Areas investigated are formulating (new ingredients, optimization), manufacturing, charge design and lifetime assessment [1,2,3,4,5]. In conventional propellants inert plasticizers are used to alter performance,

  19. Characterization of plastic and boron carbide additive manufactured neutron collimators

    Science.gov (United States)

    Stone, M. B.; Siddel, D. H.; Elliott, A. M.; Anderson, D.; Abernathy, D. L.

    2017-12-01

    Additive manufacturing techniques allow for the production of materials with complicated geometries with reduced costs and production time over traditional methods. We have applied this technique to the production of neutron collimators for use in thermal and cold neutron scattering instrumentation directly out of boron carbide. We discuss the design and generation of these collimators. We also provide measurements at neutron scattering beamlines which serve to characterize the performance of these collimators. Additive manufacturing of parts using neutron absorbing material may also find applications in radiography and neutron moderation.

  20. 76 FR 21917 - Manufacturer of Controlled Substances; Notice of Registration

    Science.gov (United States)

    2011-04-19

    ... manufacturer of the following basic classes of controlled substances: Drug Schedule Marihuana (7360) I Tetrahydrocannabinols (7370) I The company plans to manufacture small quantities of marihuana derivatives for research purposes. In reference to drug code 7360 (Marihuana), the company plans to bulk manufacture cannabidiol. In...

  1. Core Characteristics Deterioration due to Plastic Deformation

    Science.gov (United States)

    Kaido, Chikara; Arai, Satoshi

    This paper discusses the effect of plastic deformation at core manufacturing on the characteristics of cores where non-oriented electrical steel sheets are used as core material. Exciting field and iron loss increase proportionally to plastic deformation in the case of rPeddy currents increase because plastic deformations of crystalline grains are distributed and then the flux distribution is induced. In the case of rP>20, the deterioration tend to saturate, and the increases in magnetic field and iron loss are 1000 to 1500A/m and 2 to 4W/kg. They are related to grain size, and high grade with larger grain may have lager field increase and smaller iron loss increase. Anomalous eddy current losses scarcely increase in this region. In actual motors, the plastic deformation affects iron loss increase although exciting current increases a little.

  2. 21 CFR 640.102 - Manufacture of Immune Globulin (Human).

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Manufacture of Immune Globulin (Human). 640.102 Section 640.102 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES....102 Manufacture of Immune Globulin (Human). (a) Processing method. The processing method shall be one...

  3. Pharmaceutical Additive Manufacturing: a Novel Tool for Complex and Personalized Drug Delivery Systems.

    Science.gov (United States)

    Zhang, Jiaxiang; Vo, Anh Q; Feng, Xin; Bandari, Suresh; Repka, Michael A

    2018-06-25

    Inter-individual variability is always an issue when treating patients of different races, genders, ages, pharmacogenetics, and pharmacokinetic characteristics. However, the development of novel dosage forms is limited by the huge investments required for production line modifications and dosages diversity. Additive manufacturing (AM) or 3D printing can be a novel alternative solution for the development of controlled release dosages because it can produce personalized or unique dosage forms and more complex drug-release profiles. The primary objective of this manuscript is to review the 3D printing processes that have been used in the pharmaceutical area, including their general aspects, materials, and the operation of each AM technique. Advantages and shortcomings of the technologies are discussed with respect to practice and practical applications. Thus, this review will provide an overview and discussion on advanced pharmaceutical AM technologies, which can be used to produce unique controlled drug delivery systems and personalized dosages for the future of personalized medicine.

  4. Potential use of Plastic Waste as Construction Materials: Recent Progress and Future Prospect

    Science.gov (United States)

    Kamaruddin, M. A.; Abdullah, M. M. A.; Zawawi, M. H.; Zainol, M. R. R. A.

    2017-11-01

    Plastic associates products based have been considered as the world most consumer packaging solution. However, substantial quantities of plastic consumption have led to exponential increase of plastic derived waste. Recycling of plastic waste as valued added product such as concrete appears as one of promising solution for alternative use of plastic waste. This paper summarized recent progress on the development of concrete mixture which incorporates plastic wastes as partial aggregate replacement during concrete manufacturing. A collection of data from previous studies that have been researched which employed plastic waste in concrete mixtures were evaluated and conclusions are drawn based on the laboratory results of all the mentioned research papers studied.

  5. Applications of Fiber-Reinforced Polymers in Additive Manufacturing

    DEFF Research Database (Denmark)

    Hofstätter, Thomas; Pedersen, David Bue; Tosello, Guido

    2017-01-01

    Additive manufacturing technologies are these years entering the market of functional final parts. Initial research has been performed targeting the integration of fibers into additive manufactured plastic composites. Major advantages, among others, are for example increased tensile strength...... and Young's modulus. Key challenges in the field, as of now, are proper fiber placement, fiber seizing, an increased knowledge in the used materials and how they are applied into engineering solutions through proper control of the additive manufacturing process. The aim of this research is the improved...... understanding of fiber-reinforcement in additive manufacturing in terms of production and application. Vat polymerization and material extrusion techniques for composite additive manufacturing were investigated with respect of increasing adhesion between the matrix material and the fibers. Process optimization...

  6. Production of the Large-area Plastic Scintillator for Beta-ray Detection using Epoxy Resin

    International Nuclear Information System (INIS)

    Nam, Jong Soo; Choi, Yong Seok; Hong, Sang Bum; Seo, Bum Kyung; Moon, Jei Kwon; Choi, Jong Won

    2016-01-01

    In this study, we prepared a plastic scintillator whose manufacturing process is simple and can be freely shaped. A thin plate of the plastic scintillator was manufactured using epoxy resin as a polymer. The plastic scintillator was made by mixing epoxy resin and organic scintillators under various conditions. The optimal mixture ratio to prepare the plastic scintillator was derived from the above results. Using the derived results, we made the large-area plastic scintillator which can quickly measure the contamination site and evaluated characteristics of the large-area plastic scintillator in the laboratory. A thin plate of a plastic scintillator with a simple preparation process can be freely shaped using epoxy resin and organic scintillators such as PPO and POPOP. PPO emits scintillation of light in the ultraviolet range, and POPOP is a wave shifter for moving the wavelength responsible for the PMT. The mixture ratio of PPO and POPOP was determined using their emission spectra. The optimal weight percentage of PPO and POPOP in an organic scintillator was determined to be 0.2 wt%:0.01 wt%. Based on the above results, the large-area plastic scintillator of the window size of a typical pancake-type αβ surface contamination counter was prepared. We want to evaluate the characteristics of the large-area plastic scintillator. However, there were the difficulties in evaluating characteristics of the large-area plastic scintillator. The cross-sectional area of the large-area plastic scintillator is significantly different to PMT

  7. Production of the Large-area Plastic Scintillator for Beta-ray Detection using Epoxy Resin

    Energy Technology Data Exchange (ETDEWEB)

    Nam, Jong Soo; Choi, Yong Seok; Hong, Sang Bum; Seo, Bum Kyung; Moon, Jei Kwon; Choi, Jong Won [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2016-10-15

    In this study, we prepared a plastic scintillator whose manufacturing process is simple and can be freely shaped. A thin plate of the plastic scintillator was manufactured using epoxy resin as a polymer. The plastic scintillator was made by mixing epoxy resin and organic scintillators under various conditions. The optimal mixture ratio to prepare the plastic scintillator was derived from the above results. Using the derived results, we made the large-area plastic scintillator which can quickly measure the contamination site and evaluated characteristics of the large-area plastic scintillator in the laboratory. A thin plate of a plastic scintillator with a simple preparation process can be freely shaped using epoxy resin and organic scintillators such as PPO and POPOP. PPO emits scintillation of light in the ultraviolet range, and POPOP is a wave shifter for moving the wavelength responsible for the PMT. The mixture ratio of PPO and POPOP was determined using their emission spectra. The optimal weight percentage of PPO and POPOP in an organic scintillator was determined to be 0.2 wt%:0.01 wt%. Based on the above results, the large-area plastic scintillator of the window size of a typical pancake-type αβ surface contamination counter was prepared. We want to evaluate the characteristics of the large-area plastic scintillator. However, there were the difficulties in evaluating characteristics of the large-area plastic scintillator. The cross-sectional area of the large-area plastic scintillator is significantly different to PMT.

  8. Ultrasonic-assisted manufacturing processes: Variational model and numerical simulations

    KAUST Repository

    Siddiq, Amir; El Sayed, Tamer

    2012-01-01

    We present a computational study of ultrasonic assisted manufacturing processes including sheet metal forming, upsetting, and wire drawing. A fully variational porous plasticity model is modified to include ultrasonic softening effects

  9. Durability of Capped Wood Plastic Composites

    Science.gov (United States)

    Mark Mankowski; Mark J. Manning; Damien P. Slowik

    2015-01-01

    Manufacturers of wood plastic composites (WPCs) have recently introduced capped decking to their product lines. These new materials have begun to take market share from the previous generation of uncapped products that possessed a homogenous composition throughout the thickness of their cross-section. These capped offerings have been introduced with claims that the...

  10. Transforming plastic surfaces with electrophilic backbones from hydrophobic to hydrophilic.

    Science.gov (United States)

    Kim, Samuel; Bowen, Raffick A R; Zare, Richard N

    2015-01-28

    We demonstrate a simple nonaqueous reaction scheme for transforming the surface of plastics from hydrophobic to hydrophilic. The chemical modification is achieved by base-catalyzed trans-esterification with polyols. It is permanent, does not release contaminants, and causes no optical or mechanical distortion of the plastic. We present contact angle measurements to show successful modification of several types of plastics including poly(ethylene terephthalate) (PET) and polycarbonate (PC). Its applicability to blood analysis is explored using chemically modified PET blood collection tubes and found to be quite satisfactory. We expect this approach will reduce the cost of manufacturing plastic devices with optimized wettability and can be generalized to other types of plastic materials having an electrophilic linkage as its backbone.

  11. Effect of ca2+ to salicylic acid release in pectin based controlled drug delivery system

    Science.gov (United States)

    Kistriyani, L.; Wirawan, S. K.; Sediawan, W. B.

    2016-01-01

    Wastes from orange peel are potentially be utilized to produce pectin, which are currently an import commodity. Pectin can be used in making edible film. Edible films are potentially used as a drug delivery system membrane after a tooth extraction. Drug which is used in the drug delivery system is salicylic acid. It is an antiseptic. In order to control the drug release rate, crosslinking process is added in the manufacturing of membrane with CaCl2.2H2O as crosslinker. Pectin was diluted in water and mixed with a plasticizer and CaCl2.2H2O solution at 66°C to make edible film. Then the mixture was dried in an oven at 50 °C. After edible film was formed, it was coated using plasticizer and CaCl2.2H2O solution with various concentration 0, 0.015, 0.03 and 0.05g/mL. This study showed that the more concentration of crosslinker added, the slower release of salicylic acid would be. This was indicated by the value of diffusivites were getting smaller respectively. The addition of crosslinker also caused smaller gels swelling value,which made the membrane is mechanically stronger

  12. 76 FR 5829 - Manufacturer of Controlled Substances; Notice of Application

    Science.gov (United States)

    2011-02-02

    ... bulk manufacturer of the following basic classes of controlled substances: Drug Schedule Marihuana.... In reference to drug code 7360 (Marihuana), the company plans to bulk manufacture cannabidiol as a...

  13. Do single-use medical devices containing biopolymers reduce the environmental impacts of surgical procedures compared with their plastic equivalents?

    Science.gov (United States)

    Unger, Scott R; Hottle, Troy A; Hobbs, Shakira R; Thiel, Cassandra L; Campion, Nicole; Bilec, Melissa M; Landis, Amy E

    2017-01-01

    Background While petroleum-based plastics are extensively used in health care, recent developments in biopolymer manufacturing have created new opportunities for increased integration of biopolymers into medical products, devices and services. This study compared the environmental impacts of single-use disposable devices with increased biopolymer content versus typically manufactured devices in hysterectomy. Methods A comparative life cycle assessment of single-use disposable medical products containing plastic(s) versus the same single-use medical devices with biopolymers substituted for plastic(s) at Magee-Women's Hospital (Magee) in Pittsburgh, PA and the products used in four types of hysterectomies that contained plastics potentially suitable for biopolymer substitution. Magee is a 360-bed teaching hospital, which performs approximately 1400 hysterectomies annually. Results There are life cycle environmental impact tradeoffs when substituting biopolymers for petroplastics in procedures such as hysterectomies. The substitution of biopolymers for petroleum-based plastics increased smog-related impacts by approximately 900% for laparoscopic and robotic hysterectomies, and increased ozone depletion-related impacts by approximately 125% for laparoscopic and robotic hysterectomies. Conversely, biopolymers reduced life cycle human health impacts, acidification and cumulative energy demand for the four hysterectomy procedures. The integration of biopolymers into medical products is correlated with reductions in carcinogenic impacts, non-carcinogenic impacts and respiratory effects. However, the significant agricultural inputs associated with manufacturing biopolymers exacerbate environmental impacts of products and devices made using biopolymers. Conclusions The integration of biopolymers into medical products is correlated with reductions in carcinogenic impacts, non-carcinogenic impacts and respiratory effects; however, the significant agricultural inputs associated

  14. Production, use, and fate of all plastics ever made.

    Science.gov (United States)

    Geyer, Roland; Jambeck, Jenna R; Law, Kara Lavender

    2017-07-01

    Plastics have outgrown most man-made materials and have long been under environmental scrutiny. However, robust global information, particularly about their end-of-life fate, is lacking. By identifying and synthesizing dispersed data on production, use, and end-of-life management of polymer resins, synthetic fibers, and additives, we present the first global analysis of all mass-produced plastics ever manufactured. We estimate that 8300 million metric tons (Mt) as of virgin plastics have been produced to date. As of 2015, approximately 6300 Mt of plastic waste had been generated, around 9% of which had been recycled, 12% was incinerated, and 79% was accumulated in landfills or the natural environment. If current production and waste management trends continue, roughly 12,000 Mt of plastic waste will be in landfills or in the natural environment by 2050.

  15. Innovative Techniques for Micro-scale Additive Manufacturing for Sensors

    Data.gov (United States)

    National Aeronautics and Space Administration — The field of additive manufacturing with real materials (such as metals) has evolved from 3D printing of plastics.  The primary approach uses powder bed fusion...

  16. Neutron activation analysis for chemical characterization of Brazilian oxo-biodegradable plastics

    International Nuclear Information System (INIS)

    Mateus Eugenio Boscaro; De Nadai Fernandes, E.A.; Marcio Arruda Bacchi; Luis Gustavo Cofani dos Santos; Cofani dos Santos, S.N.S.; Sandra Mara Martins-Franchetti

    2015-01-01

    The chemical characterization of oxo-biodegradable plastic bags was performed by neutron activation analysis. The presence of several chemical elements (As, Br, Ca, Co, Cr, Fe, Hf, K, La, Na, Sb, Sc, Ta and Zn) with large variability of mass fractions amongst samples indicates that these plastics receive additives and may have been contaminated during manufacturing process thereby becoming potential environmental pollutants. (author)

  17. 21 CFR 110.5 - Current good manufacturing practice.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 110.5 Section...) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD General Provisions § 110.5 Current good manufacturing practice. (a) The criteria and...

  18. Utilization starch of jackfruit seed (Artocarpus heterophyllus) as raw material for bioplastics manufacturing using sorbitol as plasticizer and chitosan as filler

    Science.gov (United States)

    Lubis, M.; Harahap, M. B.; Manullang, A.; Alfarodo; Ginting, M. H. S.; Sartika, M.

    2017-01-01

    Starch is a natural polymer that can be used for the production of bioplastics because its source is abundant, renewable and easily degraded. Jackfruit seeds can be used as raw material for bioplastics because its contains starch. The aim of this study to determine the characteristics of jackfruit seeds and determine the effect of chitosan and sorbitol on the physicochemical properties of bioplastics from jackfruit seeds. Starch is extracted from jackfruit seeds were then characterized to determine its chemical composition. In the manufacture of bioplastics starch composition jackfruit seeds - chitosan used was 7: 3, 8: 2 and 9: 1 (g/g), while the concentration of sorbitol used was 20%, 25%, 30%, 35%, and 40% by weight dry ingredients. From the analysis of jackfruit seed starch obtained water content of 6.04%, ash content of 1.08%, the starch content of 70.22%, 16.39% amylose content, amylopectin content of 53.83%, 4.68% protein content, fat content 0.54%. The best conditions of starch bioplastics jackfruit seeds obtained at a ratio of starch: chitosan (w/w) = 8: 2 and the concentration of plasticizer sorbitol 25% with tensile strength 13.524 MPa. From the results of FT-IR analysis indicated an increase for the OH group and the group NH on bioplastics due to the addition of chitosan and sorbitol. The results of mechanical tests is further supported by analysis of scanning electron microscopy (SEM) showing jackfruit seed starch has a small granule size with the size of 7.6 μm and in bioplastics with chitosan filler and plasticizer sorbitol their fracture surface is smooth and slightly hollow compared bioplastics without fillers chitosan and plasticizer sorbitol.

  19. Social aspects in additive manufacturing of pharmaceutical products

    DEFF Research Database (Denmark)

    Lind, Johanna Lena Maria; Kälvemark Sporrong, Sofia; Kaae, Susanne

    2016-01-01

    INTRODUCTION: Additive manufacturing (AM) techniques, such as drug printing, represent a new engineering approach that can implement the concept of personalized medicine via on-demand manufacturing of dosage forms with individually adjusted doses. Implementation of AM principles...... will be used for production of on-demand medicine. The impact of such changes in the distribution chain on regulation, healthcare professionals and patients are highlighted. Expert opinion: Drug manufacturing by traditional methods is well-established, but it lacks the possibility for on-demand personalized...

  20. Transition from glass to graphite in manufacture of composite aircraft structure

    Science.gov (United States)

    Buffum, H. E.; Thompson, V. S.

    1978-01-01

    The transition from fiberglass reinforced plastic composites to graphite reinforced plastic composites is described. Structural fiberglass design and manufacturing background are summarized. How this experience provides a technology base for moving into graphite composite secondary structure and then to composite primary structure is considered. The technical requirements that must be fulfilled in the transition from glass to graphite composite structure are also included.

  1. Survey of US Department of Defense Manufacturing Technology Program activities applicable to civilian manufacturing industries. Final report

    Energy Technology Data Exchange (ETDEWEB)

    Azimi, S.A.; Conrad, J.L.; Reed, J.E.

    1985-03-01

    Intent of the survey was to identify and characterize activities potentially applicable to improving energy efficiency and overall productivity in the civilian manufacturing industries. The civilian industries emphasized were the general manufacturing industries (including fabricated metals, glass, machinery, paper, plastic, textile, and transportation equipment manufacturing) and the primary metals industries (including primary aluminum, copper, steel, and zinc production). The principal steps in the survey were to: develop overview taxonomies of the general manufacturing and primary metals industries as well as specific industry taxonomies; identify needs and opportunities for improving process energy efficiency and productivity in the industries included; identify federal programs, capabilities, and special technical expertise that might be relevant to industry's needs and opportunities; contact federal laboratories/facilities, through visits and other forms of inquiry; prepare formatted profiles (descriptions) potentially applicable work efforts; review findings with industry; and compile and evaluate industry responses.

  2. Reinforced Plastic Composites Production: National Emission Standards for Hazardous Air Pollutants

    Science.gov (United States)

    National emissions standards for hazardous air pollutants for reinforced plastic composites production facilities. Regulates production and ancillary processes used to manufacture products with thermoset resins and gel coats.

  3. Development and Justification of a Risk Evaluation Matrix To Guide Chemical Testing Necessary To Select and Qualify Plastic Components Used in Production Systems for Pharmaceutical Products.

    Science.gov (United States)

    Jenke, Dennis

    2015-01-01

    An accelerating trend in the pharmaceutical industry is the use of plastic components in systems used to produce an active pharmaceutical ingredient or a finished drug product. If the active pharmaceutical ingredient, the finished drug product, or any solution used to generate them (for example, a process stream such as media, buffers, eluents, and the like) is contacted by a plastic component at any time during the production process, substances leached from the component may accumulate in the active pharmaceutical ingredient or finished drug product, affecting its safety and/or efficacy. In this article the author develops and justifies a semi-quantitative risk evaluation matrix that is used to determine the amount and rigor of component testing necessary and appropriate to establish that the component is chemically suitable for its intended use. By considering key properties of the component, the contact medium, the contact conditions, and the active pharmaceutical ingredient's or finished drug product's clinical conditions of use, use of the risk evaluation matrix produces a risk score whose magnitude reflects the accumulated risk that the component will interact with the contact solution to such an extent that component-related extractables will accumulate in the active pharmaceutical ingredient or finished drug product as leachables at levels sufficiently high to adversely affect user safety. The magnitude of the risk score establishes the amount and rigor of the testing that is required to select and qualify the component, and such testing is broadly grouped into three categories: baseline assessment, general testing, and full testing (extractables profiling). Production suites used to generate pharmaceuticals can include plastic components. It is possible that substances in the components could leach into manufacturing solutions and accumulate in the pharmaceutical product. In this article the author develops and justifies a semi-quantitative risk

  4. Control systems engineering in continuous pharmaceutical manufacturing. May 20-21, 2014 Continuous Manufacturing Symposium.

    Science.gov (United States)

    Myerson, Allan S; Krumme, Markus; Nasr, Moheb; Thomas, Hayden; Braatz, Richard D

    2015-03-01

    This white paper provides a perspective of the challenges, research needs, and future directions for control systems engineering in continuous pharmaceutical processing. The main motivation for writing this paper is to facilitate the development and deployment of control systems technologies so as to ensure quality of the drug product. Although the main focus is on small-molecule pharmaceutical products, most of the same statements apply to biological drug products. An introduction to continuous manufacturing and control systems is followed by a discussion of the current status and technical needs in process monitoring and control, systems integration, and risk analysis. Some key points are that: (1) the desired objective in continuous manufacturing should be the satisfaction of all critical quality attributes (CQAs), not for all variables to operate at steady-state values; (2) the design of start-up and shutdown procedures can significantly affect the economic operation of a continuous manufacturing process; (3) the traceability of material as it moves through the manufacturing facility is an important consideration that can at least in part be addressed using residence time distributions; and (4) the control systems technologies must assure quality in the presence of disturbances, dynamics, uncertainties, nonlinearities, and constraints. Direct measurement, first-principles and empirical model-based predictions, and design space approaches are described for ensuring that CQA specifications are met. Ways are discussed for universities, regulatory bodies, and industry to facilitate working around or through barriers to the development of control systems engineering technologies for continuous drug manufacturing. Industry and regulatory bodies should work with federal agencies to create federal funding mechanisms to attract faculty to this area. Universities should hire faculty interested in developing first-principles models and control systems technologies for

  5. The Future of Pharmaceutical Manufacturing Sciences

    DEFF Research Database (Denmark)

    Rantanen, Jukka; Khinast, Johannes

    2015-01-01

    The entire pharmaceutical sector is in an urgent need of both innovative technological solutions and fundamental scientific work, enabling the production of highly engineered drug products. Commercial-scale manufacturing of complex drug delivery systems (DDSs) using the existing technologies...... is challenging. This review covers important elements of manufacturing sciences, beginning with risk management strategies and design of experiments (DoE) techniques. Experimental techniques should, where possible, be supported by computational approaches. With that regard, state-of-art mechanistic process...... control solutions. Last part of the review addresses future manufacturing solutions, covering continuous processing and, specifically, hot-melt processing and printing-based technologies. Finally, challenges related to implementing these technologies as a part of future health care systems are discussed....

  6. Stable isotope ratio mass spectrometry and physical comparison for the forensic examination of grip-seal plastic bags.

    Science.gov (United States)

    Taylor, Erica; Carter, James F; Hill, Jenny C; Morton, Carolyn; Daeid, Niamh Nic; Sleeman, Richard

    2008-05-20

    Plastic bags are frequently used to package drugs, explosives and other contraband. There exists, therefore, a requirement in forensic casework to compare bags found at different locations. This is currently achieved almost exclusively by the use of physical comparisons such as birefringence patterns. This paper discusses some of the advantages and shortcomings of this approach, and presents stable isotope ratio mass spectrometry (IRMS) as a supplementary tool for effecting comparisons of this nature. Carbon and hydrogen isotopic data are presented for sixteen grip-seal plastic bags from a wide range of sources, in order to demonstrate the range of values which is likely to be encountered. Both isotopic and physical comparison (specifically birefringence) techniques are then applied to the analysis of rolls of bags from different manufacturing lots from a leading manufacturer. Both approaches are able to associate bags from a common production batch. IRMS can be applied to small fragments which are not amenable to physical comparisons, and is able to discriminate bags which could be confused using birefringence patterns alone. Similarly, in certain cases birefringence patterns discriminate bags with similar isotopic compositions. The two approaches are therefore complementary. When more than one isotopically distinct region exists within a bag (e.g. the grip-seal is distinct from the body) the ability to discriminate and associate bags is greatly increased.

  7. Plastics and environmental health: the road ahead.

    Science.gov (United States)

    North, Emily J; Halden, Rolf U

    2013-01-01

    Plastics continue to benefit society in innumerable ways, even though recent public focus on plastics has centered mostly on human health and environmental concerns, including their endocrine-disrupting properties and the long-term pollution they represent. The benefits of plastics are particularly apparent in medicine and public health. Plastics are versatile, cost-effective, require less energy to produce than alternative materials like metal or glass, and can be manufactured to have many different properties. Due to these characteristics, polymers are used in diverse health applications like disposable syringes and intravenous bags, sterile packaging for medical instruments as well as in joint replacements, tissue engineering, etc. However, not all current uses of plastics are prudent and sustainable, as illustrated by the widespread, unwanted human exposure to endocrine-disrupting bisphenol A (BPA) and di-(2-ethylhexyl)phthalate (DEHP), problems arising from the large quantities of plastic being disposed of, and depletion of non-renewable petroleum resources as a result of the ever-increasing mass production of plastic consumer articles. Using the health-care sector as example, this review concentrates on the benefits and downsides of plastics and identifies opportunities to change the composition and disposal practices of these invaluable polymers for a more sustainable future consumption. It highlights ongoing efforts to phase out DEHP and BPA in the health-care and food industry and discusses biodegradable options for plastic packaging, opportunities for reducing plastic medical waste, and recycling in medical facilities in the quest to reap a maximum of benefits from polymers without compromising human health or the environment in the process.

  8. Plastics and Environmental Health: The Road Ahead

    Science.gov (United States)

    North, Emily J.; Halden, Rolf U.

    2013-01-01

    Plastics continue to benefit society in innumerable ways, even though recent public focus on plastics has centered mostly on human health and environmental concerns, including endocrine-disrupting properties and long-term pollution. The benefits of plastics are particularly apparent in medicine and public health. Plastics are versatile, cost-effective, require less energy to produce than alternative materials – such as metal or glass – and can be manufactured to have many different properties. Due to these characteristics, polymers are used in diverse health applications, such as disposable syringes and intravenous bags, sterile packaging for medical instruments as well as in joint replacements, tissue engineering, etc. However, not all current uses of plastics are prudent and sustainable, as illustrated by widespread, unwanted human exposure to endocrine-disrupting bisphenol-A (BPA) and di-(2-ethylhexyl)phthalate (DEHP), problems arising from the large quantities of plastic being disposed of, and depletion of non-renewable petroleum resources as a result of ever increasing mass-production of plastic consumer articles. By example of the healthcare sector, this review concentrates on benefits and downsides of plastics and identities opportunities to change the composition and disposal practices of these invaluable polymers for a more sustainable future consumption. It highlights ongoing efforts to phase out DEHP and BPA in the healthcare and food industry, and discusses biodegradable options for plastic packaging, opportunities for reducing plastic medical waste, and recycling in medical facilities in the quest to reap a maximum of benefits from polymers without compromising human health or the environment in the process. PMID:23337043

  9. 21 CFR 1303.21 - Individual manufacturing quotas.

    Science.gov (United States)

    2010-04-01

    ... controlled substance listed in Schedule I or II, and who applies for a manufacturing quota, an individual... basic class. Any manufacturing quota fixed and issued by the Administrator shall be subject to his... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Individual manufacturing quotas. 1303.21 Section...

  10. Commercial Implementation of Model-Based Manufacturing of Nanostructured Metals

    Energy Technology Data Exchange (ETDEWEB)

    Lowe, Terry C. [Los Alamos National Laboratory

    2012-07-24

    Computational modeling is an essential tool for commercial production of nanostructured metals. Strength is limited by imperfections at the high strength levels that are achievable in nanostructured metals. Processing to achieve homogeneity at the micro- and nano-scales is critical. Manufacturing of nanostructured metals is intrinsically a multi-scale problem. Manufacturing of nanostructured metal products requires computer control, monitoring and modeling. Large scale manufacturing of bulk nanostructured metals by Severe Plastic Deformation is a multi-scale problem. Computational modeling at all scales is essential. Multiple scales of modeling must be integrated to predict and control nanostructural, microstructural, macrostructural product characteristics and production processes.

  11. The future of A-150 TE plastic

    International Nuclear Information System (INIS)

    Goodman, L.J.

    1985-01-01

    For the past 26 years a large number of laboratories have constructed or purchased ionization chambers, proportional counters, and phantoms made of A-150 tissue-equivalent plastic, and they have amassed a considerable amount of data and experience in its properties and uses. The United States National Bureau of Standards is now considering the desirability of supplying A-150 plastic as a research material with a certified homogeneity. We are, however, faced with a problem since the nylon used in A-150 has been discontinued by the manufacturer and the current stock of A-150 has been estimated to be adequate to supply the demand for only the next 2 or 3 years. Thus, it will be necessary to reformulate the plastic mixture we will be using in the future. This situation offers us the opportunity to change the composition of tissue-equivalent plastic to better conform to present-day requirements. To elucidate just what these requirements are, we have conducted a postal survey of the opinions of neutron dosimetrists and the results are presented and discussed. It is concluded that the present A-150 plastic and a future tissue-equivalent plastic formulation should be made research materials, and that a future tissue-equivalent plastic should be made to conform as closely as possible to the soft tissue composition given in ICRU Report 33

  12. The manufacturing engineering of a hermetic cast fiber calorimeter

    International Nuclear Information System (INIS)

    Coan, T.; Higby, D.; Sulak, L.; Worstell, W.; Winn, D.; Ayer, F.; Elder, C.; Sullivan, D.

    1990-01-01

    The authors have made the first pass at designing and engineering a cast lead calorimeter with a rapidity coverage to η = 5.5. The design preserves detector hermeticity. Plastic scintillating fibers provide a fast, hadronically compensated, high-resolution device. A lead-eutectic, which melts below the softening point of the plastic, provides an easily manufactured high Z absorber. This calorimeter, designed with the TEXAS SSC detector as a baseline, is easily scaled in size and in segmentation without major design changes

  13. Process combinations for the manufacturing of metal-plastic hybrid parts

    OpenAIRE

    Drossel, Welf-Guntram; Lies, Carsten; Albert, André; Haase, Rico; Müller, Roland; Scholz, Peter

    2016-01-01

    The usage of innovative lightweight materials and processing technologies gains importance in manifold industrial scopes. Especially for moving parts and mobility products the weight is decisively. The aerospace and automotive industries use light and high-strength materials to reduce weight and energy consumption and thereby improve the performance of their products. Composites with reinforced plastics are of particular importance. They offer a low density in combination with high specific s...

  14. Comparison of solute-binding properties of plastic materials used as pharmaceutical product containers.

    Science.gov (United States)

    Jenke, Dennis; Couch, Tom; Gillum, Amy

    2010-01-01

    Material/water equilibrium binding constants (E(b)) were determined for 11 organic solutes and 2 plastic materials commonly used in pharmaceutical product containers (plasticized polyvinyl chloride and polyolefin). In general, solute binding by the plasticized polyvinyl chloride material was greater, by nearly an order of magnitude, than the binding by the polyolefin (on an equal weight basis). The utilization of the binding constants to facilitate container compatibility assessments (e.g., drug loss by container binding) for drug-containing products is discussed.

  15. 21 CFR 610.50 - Date of manufacture.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Date of manufacture. 610.50 Section 610.50 Food... GENERAL BIOLOGICAL PRODUCTS STANDARDS Dating Period Limitations § 610.50 Date of manufacture. The date of manufacture shall be determined as follows: (a) For products for which an official standard of potency is...

  16. Low-cost solar collectors using thin-film plastics absorbers and glazings

    Energy Technology Data Exchange (ETDEWEB)

    Wilhelm, W.G.

    1980-01-01

    The design, fabrication, performance, cost, and marketing of flat plate solar collectors using plastic absorbers and glazings are described. Manufacturing cost breakdowns are given for single-glazed and double-glazed collectors. (WHK)

  17. 75 FR 9614 - Manufacturer of Controlled Substances; Notice of Registration

    Science.gov (United States)

    2010-03-03

    ... manufacturer of the basic classes of controlled substances listed in schedule I: Drug Schedule Marihuana (7360) I Tetrahydrocannabinols (7370) I The company plans to manufacture small quantities of marihuana derivatives for research purposes. In reference to drug code 7360 (Marihuana), the company plans to bulk...

  18. 75 FR 64744 - Manufacturer of Controlled Substances; Notice of Application

    Science.gov (United States)

    2010-10-20

    ... manufacturer of the basic classes of controlled substances listed in schedule I: Drug Schedule Marihuana (7360) I Tetrahydrocannabinols (7370) I The company plans to manufacture small quantities of marihuana derivatives for research purposes. In reference to drug code 7360 (Marihuana), the company plans to bulk...

  19. Titanium-Based Hip Stems with Drug Delivery Functionality through Additive Manufacturing.

    Science.gov (United States)

    Bezuidenhout, Martin B; Dimitrov, Dimitar M; van Staden, Anton D; Oosthuizen, Gert A; Dicks, Leon M T

    2015-01-01

    Postoperative infections are a major concern in patients that receive implants. These infections generally occur in areas with poor blood flow and pathogens do not always respond to antibiotic treatment. With the latest developments in nanotechnology, the incorporation of antibiotics into prosthetic implants may soon become a standard procedure. The success will, however, depend on the ability to control the release of antibiotics at concentrations high enough to prevent the development of antibiotic-resistant strains. Through additive manufacturing, antibiotics can be incorporated into cementless femoral stems to produce prosthetic devices with antimicrobial properties. With the emerging increase in resistance to antibiotics, the incorporation of antimicrobial compounds other than antibiotics, preferably drugs with a broader spectrum of antimicrobial activity, will have to be explored. This review highlights the microorganisms associated with total hip arthroplasty (THA), discusses the advantages and disadvantages of the latest materials used in hip implants, compares different antimicrobial agents that could be incorporated, and addresses novel ideas for future research.

  20. Titanium-Based Hip Stems with Drug Delivery Functionality through Additive Manufacturing

    Directory of Open Access Journals (Sweden)

    Martin B. Bezuidenhout

    2015-01-01

    Full Text Available Postoperative infections are a major concern in patients that receive implants. These infections generally occur in areas with poor blood flow and pathogens do not always respond to antibiotic treatment. With the latest developments in nanotechnology, the incorporation of antibiotics into prosthetic implants may soon become a standard procedure. The success will, however, depend on the ability to control the release of antibiotics at concentrations high enough to prevent the development of antibiotic-resistant strains. Through additive manufacturing, antibiotics can be incorporated into cementless femoral stems to produce prosthetic devices with antimicrobial properties. With the emerging increase in resistance to antibiotics, the incorporation of antimicrobial compounds other than antibiotics, preferably drugs with a broader spectrum of antimicrobial activity, will have to be explored. This review highlights the microorganisms associated with total hip arthroplasty (THA, discusses the advantages and disadvantages of the latest materials used in hip implants, compares different antimicrobial agents that could be incorporated, and addresses novel ideas for future research.

  1. Social aspects in additive manufacturing of pharmaceutical products.

    Science.gov (United States)

    Lind, Johanna; Kälvemark Sporrong, Sofia; Kaae, Susanne; Rantanen, Jukka; Genina, Natalja

    2017-08-01

    Additive manufacturing (AM) techniques, such as drug printing, represent a new engineering approach that can implement the concept of personalized medicine via on-demand manufacturing of dosage forms with individually adjusted doses. Implementation of AM principles, such as pharmacoprinting, will challenge the entire drug distribution chain and affect the society at different levels. Areas covered: This work summarizes the concept of personalized medicine and gives an overview of possibilities for monitoring patients' health. The most recent activities in the field of printing technologies for fabrication of dosage forms and 'polypills' with flexible doses and tailored release profiles are reviewed. Different scenarios for the drug distribution chain with the required adjustments in drug logistics, quality systems and environmental safety are discussed, as well as whether AM will be used for production of on-demand medicine. The impact of such changes in the distribution chain on regulation, healthcare professionals and patients are highlighted. Expert opinion: Drug manufacturing by traditional methods is well-established, but it lacks the possibility for on-demand personalized drug production. With the recent approval of the first printed medicine, society should be prepared for the changes that will follow the introduction of printed pharmaceuticals.

  2. 21 CFR 1005.25 - Service of process on manufacturers.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Service of process on manufacturers. 1005.25....25 Service of process on manufacturers. (a) Every manufacturer of electronic products, prior to... United States as the manufacturer's agent upon whom service of all processes, notices, orders, decisions...

  3. 21 CFR 680.2 - Manufacture of Allergenic Products.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Manufacture of Allergenic Products. 680.2 Section...) BIOLOGICS ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS § 680.2 Manufacture of Allergenic Products. (a...) Cultures derived from microorganisms. Culture media into which organisms are inoculated for the manufacture...

  4. 21 CFR 111.355 - What are the design requirements for manufacturing operations?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What are the design requirements for manufacturing operations? 111.355 Section 111.355 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

  5. The Frontiers of Additive Manufacturing

    Energy Technology Data Exchange (ETDEWEB)

    Grote, Christopher John [Los Alamos National Lab. (LANL), Los Alamos, NM (United States)

    2016-03-03

    Additive manufacturing, more commonly known as 3-D printing, has become a ubiquitous tool in science for its precise control over mechanical design. For additive manufacturing to work, a 3-D structure is split into thin 2D slices, and then different physical properties, such as photo-polymerization or melting, are used to grow the sequential layers. The level of control allows not only for devices to be made with a variety of materials: e.g. plastics, metals, and quantum dots, but to also have finely controlled structures leading to other novel properties. While 3-D printing is widely used by hobbyists for making models, it also has industrial applications in structural engineering, biological tissue scaffolding, customized electric circuitry, fuel cells, security, and more.

  6. Achievement report for fiscal 1998 on the research cooperation project for a technology to facilitate setting forming conditions for engineering plastics; 1998 nendo engineering plastic no seikei joken kan'i settei gijutsu ni kansuru kenkyu kyoryoku jigyo seika hokokusho

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1999-03-01

    This project is intended to support plastics manufacturing being the important supporting industry in Thailand for manufacture of household electric appliances and automobiles, particularly the manufacture of engineering plastics having excellent heat and impact resistance. In order to achieve the target, a supporting system is being developed to allow injection molding of engineering plastics to be performed easily. The project aims particularly at developing a system that suits climate conditions in Thailand, properties of plastic materials procurable in Thailand, and skills of Thai engineers. The current fiscal year has carried out the following activities: evaluating materials required for the research and development, deciding the specifications for and ordering product evaluating and testing facilities, molds and mold cooling and heating adjustment devices, and an injection molding CAE system; these items were introduced and installed in Thailand; engineers were sent from Japan to perform technical guidance on operation, maintenance and management of the material and product evaluating and testing facilities, as well as joint researches; and Thai researchers were received to execute training on product evaluating and testing technologies, forming and processing technologies, and CAE utilizing technologies. (NEDO)

  7. Determination of the external contamination and cross-contamination by cytotoxic drugs on the surfaces of vials available on the Swiss market.

    Science.gov (United States)

    Fleury-Souverain, Sandrine; Nussbaumer, Susanne; Mattiuzzo, Marc; Bonnabry, Pascal

    2014-04-01

    The external contamination and cross-contamination by cytotoxic drugs on the surface (outside and septum) of 133 vials from various manufacturers and available on the Swiss market were evaluated. All of the tested vials contained one of the following active ingredients: cyclophosphamide, cytarabine, doxorubicin, epirubicin, etoposide phosphate, gemcitabine, ifosfamide, irinotecan, methotrexate or vincristine. The validated wiping liquid chromatography-mass spectrometry method used in this study allowed for the simultaneous determination of these 10 cytotoxic drugs in less than 30 min. External contamination by cytotoxic drugs was detected on 63% of tested vials (outside and septum). The highest contamination level was observed on etoposide phosphate vials with 1896.66 ng of active ingredient on the outside of the vial. Approximately 20% of the contaminated vials had greater than 10 ng of cytotoxic drugs. Chemical contamination on the septum was detected on 38% of the vials. No contamination or very low levels of cytotoxic drugs, less than 1 ng per vial, were detected on the vials protected by plastic shrink-wrap. Traces of cytotoxic drugs different from the active ingredient were detected on 35% of the tested vials. Handling cytotoxic vials with gloves and having a procedure for the decontamination of vials are of the utmost importance for reducing exposure to cytotoxic drugs. Moreover, manufacturers must improve their procedures to provide products free from any contamination.

  8. Glutamatergic synaptic plasticity in the mesocorticolimbic system in addiction.

    NARCIS (Netherlands)

    van Huijstee, A.N.; Mansvelder, H.D.

    2015-01-01

    Addictive drugs remodel the brain’s reward circuitry, the mesocorticolimbic dopamine (DA) system, by inducing widespread adaptations of glutamatergic synapses. This drug-induced synaptic plasticity is thought to contribute to both the development and the persistence of addiction. This review

  9. Integrated Plastic Substrates for OLED Lighting

    Energy Technology Data Exchange (ETDEWEB)

    Gaynor, Whitney

    2015-08-01

    OLED lighting has immense potential as aesthetically pleasing, energy-efficient general illumination. Unlike other light sources, such as incandescents, fluorescents, and inorganic LEDs, OLEDs naturally emit over a large-area surface. They are glare free, do not need to be shaded, and are cool to the touch, requiring no heatsink. The best efficiencies and lifetimes reported are on par with or better than current forms of illumination. However, the cost for OLED lighting remains high – so much so that these products are not market competitive and there is very low consumer demand. We believe that flexible, plastic-based devices will highlight the advantages of aesthetically-pleasing OLED lighting systems while paving the way for lowering both materials and manufacturing costs. These flexible devices require new development in substrate and support technology, which was the focus of the work reported here. The project team, led by Sinovia Technologies, has developed integrated plastic substrates to serve as supports for flexible OLED lighting. The substrates created in this project would enable large-area, flexible devices and are specified to perform three functions. They include a barrier to protect the OLED from moisture and oxygen-related degradation, a smooth, highly conductive transparent electrode to enable large-area device operation, and a light scattering layer to improve emission efficiency. Through the course of this project, integrated substrates were fabricated, characterized, evaluated for manufacturing feasibility and cost, and used in white OLED demonstrations to test their impact on flexible OLED lighting. Our integrated substrates meet or exceed the DOE specifications for barrier performance in water vapor and oxygen transport rates, as well as the transparency and conductivity of the anode film. We find that these integrated substrates can be manufactured in a completely roll-to-roll, high throughput process and have developed and demonstrated

  10. Structural Composite Construction Materials Manufactured from Municipal Solid Waste

    Science.gov (United States)

    1994-04-20

    alternatives. One company uses the wastes from leg cutouts in disposable diaper manufacture as a supply stream. Another is turning used carpet into plastic...sheathing type applications. While it offers a number of desirable properties, fiberglass suffers from degradation from solar exposure and embrittlement

  11. Signals from the Fourth Dimension Regulate Drug Relapse.

    Science.gov (United States)

    Mulholland, Patrick J; Chandler, L Judson; Kalivas, Peter W

    2016-07-01

    Despite the enormous societal burden of alcohol and drug addiction and abundant research describing drug-induced maladaptive synaptic plasticity, there are few effective strategies for treating substance use disorders. Recent awareness that synaptic plasticity involves astroglia and the extracellular matrix is revealing new possibilities for understanding and treating addiction. We first review constitutive corticostriatal adaptations that are elicited by and shared between all abused drugs from the perspective of tetrapartite synapses, and integrate recent discoveries regarding cell type-specificity in striatal neurons. Next, we describe recent discoveries that drug-seeking is associated with transient synaptic plasticity that requires all four synaptic elements and is shared across drug classes. Finally, we prognosticate how considering tetrapartite synapses can provide new treatment strategies for addiction. Copyright © 2016 Elsevier Ltd. All rights reserved.

  12. 21 CFR 113.5 - Current good manufacturing practice.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 113.5 Section... CONTAINERS General Provisions § 113.5 Current good manufacturing practice. The criteria in §§ 113.10, 113.40..., methods, practices, and controls used by the commercial processor in the manufacture, processing, or...

  13. 21 CFR 146.151 - Orange juice for manufacturing.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Orange juice for manufacturing. 146.151 Section... Fruit Juices and Beverages § 146.151 Orange juice for manufacturing. (a) Orange juice for manufacturing... from oranges as provided in § 146.135, except that the oranges may deviate from the standards for...

  14. 76 FR 38187 - International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of...

    Science.gov (United States)

    2011-06-29

    ...] International Conference on Harmonisation; Draft Guidance on Q11 Development and Manufacture of Drug Substances... Manufacture of Drug Substances.'' The draft guidance was prepared under the auspices of the International... that a draft guidance entitled ``Q11 Development and Manufacture of Drug Substances'' should be made...

  15. Replacing fossil based plastic performance products by bio-based plastic products-Technical feasibility.

    Science.gov (United States)

    van den Oever, Martien; Molenveld, Karin

    2017-07-25

    Larger scale market introduction of new bio-based products requires a clear advantage regarding sustainability, as well as an adequate techno-economic positioning relative to fossil based products. In a previous paper [Broeren et al., 2016], LCA results per kg and per functionality equivalent of bio-based plastics were presented, together with economic considerations. The present paper discusses the mechanical and thermal properties of a range of commercially available bio-based plastics based on polylactic acid (PLA), cellulose esters, starch and polyamides, and the feasibility of replacing fossil-based counterparts based on performance. The evaluation is approached from an end user perspective. First, potentially suitable bio-based plastics are selected based on manufacturers' specifications in technical data sheets, then a first experimental evaluation is performed on injection moulded ISO specimens, and finally a further selection of plastics is tested on large 50×70cm panels. This technical feasibility study indicates that so far bio-based plastics do not completely match the properties of high performance materials like flame retardant V-0 PC/ABS blends used in electronic devices. The performance gap is being decreased by the development of stereocomplex PLA and hybrid PLA blends with polycarbonate, which offer clearly improved properties with respect to maximum usage temperature and toughness. In addition, several materials meet the V-0 flammability requirements needed in specific durable applications. On the other hand, improving these properties so far has negative consequences for the bio-based content. This study also shows that replacement of bulk polymers like PS is feasible using PLA compounds with a bio-based content as high as 85%. Copyright © 2016 Elsevier B.V. All rights reserved.

  16. Compulsory patent licensing and local drug manufacturing capacity in Africa

    Science.gov (United States)

    2014-01-01

    Abstract Africa has the highest disease burden in the world and continues to depend on pharmaceutical imports to meet public health needs. As Asian manufacturers of generic medicines begin to operate under a more protectionist intellectual property regime, their ability to manufacture medicines at prices that are affordable to poorer countries is becoming more circumscribed. The Doha Declaration on the TRIPS Agreement and Public Health gives member states of the World Trade Organization (WTO) the right to adopt legislation permitting the use of patented material without authorization by the patent holder, a provision known as “compulsory licensing”. For African countries to take full advantage of compulsory licensing they must develop substantial local manufacturing capacity. Because building manufacturing capacity in each African country is daunting and almost illusory, an African free trade area should be developed to serve as a platform not only for the free movement of goods made pursuant to compulsory licences, but also for an economic or financial collaboration towards the development of strong pharmaceutical manufacturing capacity in the continent. Most countries in Africa are in the United Nations list of least developed countries, and this allows them, under WTO law, to refuse to grant patents for pharmaceuticals until 2021. Thus, there is a compelling need for African countries to collaborate to build strong pharmaceutical manufacturing capacity in the continent now, while the current flexibilities in international intellectual property law offer considerable benefits. PMID:24700981

  17. Challenges and Alternatives to Plastics Recycling in the Automotive Sector

    Directory of Open Access Journals (Sweden)

    Lindsay Miller

    2014-08-01

    Full Text Available Plastics are increasingly a preferred material choice in designing and developing complex, consumer products, such as automobiles, because they are mouldable, lightweight, and are often perceived to be highly recyclable materials. However, actually recycling the heterogeneous plastics used in such durable items is challenging, and presents very different scenarios to how simple products, such as water bottles, are recovered via curbside or container recycling initiatives. While the technology exists to recycle plastics, their feasibility to do so from high level consumer or industrial applications is bounded by technological and economical restraints. Obstacles include the lack of market for recyclates, and the lack of cost efficient recovery infrastructures or processes. Furthermore, there is a knowledge gap between manufacturers, consumers, and end-of-life facility operators. For these reasons, end-of-life plastics are more likely to end up down-cycled, or as shredder residue and then landfilled. This paper reviews these challenges and several alternatives to recycling plastics in order to broaden the mindset surrounding plastics recycling to improve their sustainability. The paper focuses on the automotive sector for examples, but discussion can be applied to a wide range of plastic components from similarly complex products.

  18. Challenges and Alternatives to Plastics Recycling in the Automotive Sector

    Science.gov (United States)

    Miller, Lindsay; Soulliere, Katie; Sawyer-Beaulieu, Susan; Tseng, Simon; Tam, Edwin

    2014-01-01

    Plastics are increasingly a preferred material choice in designing and developing complex, consumer products, such as automobiles, because they are mouldable, lightweight, and are often perceived to be highly recyclable materials. However, actually recycling the heterogeneous plastics used in such durable items is challenging, and presents very different scenarios to how simple products, such as water bottles, are recovered via curbside or container recycling initiatives. While the technology exists to recycle plastics, their feasibility to do so from high level consumer or industrial applications is bounded by technological and economical restraints. Obstacles include the lack of market for recyclates, and the lack of cost efficient recovery infrastructures or processes. Furthermore, there is a knowledge gap between manufacturers, consumers, and end-of-life facility operators. For these reasons, end-of-life plastics are more likely to end up down-cycled, or as shredder residue and then landfilled. This paper reviews these challenges and several alternatives to recycling plastics in order to broaden the mindset surrounding plastics recycling to improve their sustainability. The paper focuses on the automotive sector for examples, but discussion can be applied to a wide range of plastic components from similarly complex products. PMID:28788167

  19. Dropwise additive manufacturing of pharmaceutical products for solvent-based dosage forms.

    Science.gov (United States)

    Hirshfield, Laura; Giridhar, Arun; Taylor, Lynne S; Harris, Michael T; Reklaitis, Gintaras V

    2014-02-01

    In recent years, the US Food and Drug Administration has encouraged pharmaceutical companies to develop more innovative and efficient manufacturing methods with improved online monitoring and control. Mini-manufacturing of medicine is one such method enabling the creation of individualized product forms for each patient. This work presents dropwise additive manufacturing of pharmaceutical products (DAMPP), an automated, controlled mini-manufacturing method that deposits active pharmaceutical ingredients (APIs) directly onto edible substrates using drop-on-demand (DoD) inkjet printing technology. The use of DoD technology allows for precise control over the material properties, drug solid state form, drop size, and drop dynamics and can be beneficial in the creation of high-potency drug forms, combination drugs with multiple APIs or individualized medicine products tailored to a specific patient. In this work, DAMPP was used to create dosage forms from solvent-based formulations consisting of API, polymer, and solvent carrier. The forms were then analyzed to determine the reproducibility of creating an on-target dosage form, the morphology of the API of the final form and the dissolution behavior of the drug over time. DAMPP is found to be a viable alternative to traditional mass-manufacturing methods for solvent-based oral dosage forms. © 2013 Wiley Periodicals, Inc. and the American Pharmacists Association.

  20. Glutamatergic synaptic plasticity in the mesocorticolimbic system in addiction

    Directory of Open Access Journals (Sweden)

    Aile evan Huijstee

    2015-01-01

    Full Text Available Addictive drugs remodel the brain’s reward circuitry, the mesocorticolimbic dopamine system, by inducing widespread adaptations of glutamatergic synapses. This drug-induced synaptic plasticity is thought to contribute to both the development and the persistence of addiction. This review highlights the synaptic modifications that are induced by in vivo exposure to addictive drugs and describes how these drug-induced synaptic changes may contribute to the different components of addictive behaviour, such as compulsive drug use despite negative consequences and relapse. Initially, exposure to an addictive drug induces synaptic changes in the ventral tegmental area (VTA. This drug-induced synaptic potentiation in the VTA subsequently triggers synaptic changes in downstream areas of the mesocorticolimbic system, such as the nucleus accumbens (NAc and the prefrontal cortex (PFC, with further drug exposure. These glutamatergic synaptic alterations are then thought to mediate many of the behavioural symptoms that characterize addiction. The later stages of glutamatergic synaptic plasticity in the NAc and in particular in the PFC play a role in maintaining addiction and drive relapse to drug-taking induced by drug-associated cues. Remodelling of PFC glutamatergic circuits can persist into adulthood, causing a lasting vulnerability to relapse. We will discuss how these neurobiological changes produced by drugs of abuse may provide novel targets for potential treatment strategies for addiction.

  1. Glutamatergic synaptic plasticity in the mesocorticolimbic system in addiction

    Science.gov (United States)

    van Huijstee, Aile N.; Mansvelder, Huibert D.

    2015-01-01

    Addictive drugs remodel the brain’s reward circuitry, the mesocorticolimbic dopamine (DA) system, by inducing widespread adaptations of glutamatergic synapses. This drug-induced synaptic plasticity is thought to contribute to both the development and the persistence of addiction. This review highlights the synaptic modifications that are induced by in vivo exposure to addictive drugs and describes how these drug-induced synaptic changes may contribute to the different components of addictive behavior, such as compulsive drug use despite negative consequences and relapse. Initially, exposure to an addictive drug induces synaptic changes in the ventral tegmental area (VTA). This drug-induced synaptic potentiation in the VTA subsequently triggers synaptic changes in downstream areas of the mesocorticolimbic system, such as the nucleus accumbens (NAc) and the prefrontal cortex (PFC), with further drug exposure. These glutamatergic synaptic alterations are then thought to mediate many of the behavioral symptoms that characterize addiction. The later stages of glutamatergic synaptic plasticity in the NAc and in particular in the PFC play a role in maintaining addiction and drive relapse to drug-taking induced by drug-associated cues. Remodeling of PFC glutamatergic circuits can persist into adulthood, causing a lasting vulnerability to relapse. We will discuss how these neurobiological changes produced by drugs of abuse may provide novel targets for potential treatment strategies for addiction. PMID:25653591

  2. Raw materials in the manufacture of biotechnology products: regulatory considerations.

    Science.gov (United States)

    Cordoba-Rodriguez, Ruth

    2010-01-01

    The Food and Drug Administration's Pharmaceutical cGMPs for the 21st Century initiative emphasizes science and risk-based approaches in the manufacture of drugs. These approaches are reflected in the International Conference on Harmonization (ICH) guidances ICH Q8, Q9, and Q10 and encourage a comprehensive assessment of the manufacture of a biologic, including all aspects of manufacture that have the potential to affect the finished drug product. Appropriate assessment and management of raw materials are an important part of this initiative. Ideally, a raw materials program should strive to assess and minimize the risk to product quality. With this in mind, risk-assessment concepts and control strategies will be discussed and illustrated by examples, with an emphasis on the impact of raw materials on cell substrates. Finally, the life cycle of the raw material will be considered, including its potential to affect the drug product life cycle. In this framework, the supply chain and the vendor-manufacturer relationship will be explored as important parts of an adequate raw materials control strategy.

  3. Aberrant cortical associative plasticity associated with severe adult Tourette syndrome.

    Science.gov (United States)

    Martín-Rodríguez, Juan Francisco; Ruiz-Rodríguez, María Adilia; Palomar, Francisco J; Cáceres-Redondo, María Teresa; Vargas, Laura; Porcacchia, Paolo; Gómez-Crespo, Mercedes; Huertas-Fernández, Ismael; Carrillo, Fátima; Madruga-Garrido, Marcos; Mir, Pablo

    2015-03-01

    Recent studies have shown altered cortical plasticity in adult patients with Tourette syndrome. However, the clinical significance of this finding remains elusive. Motor cortical plasticity was evaluated in 15 adult patients with severe Tourette syndrome and 16 healthy controls using the paired associative stimulation protocol by transcranial magnetic stimulation. Associations between paired associative stimulation-induced plasticity and relevant clinical variables, including cortical excitability, psychiatric comorbidities, drug treatment and tic severity, were assessed. Motor cortical plasticity was abnormally increased in patients with Tourette syndrome compared with healthy subjects. This abnormal plasticity was independently associated with tic severity. Patients with severe Tourette syndrome display abnormally increased cortical associative plasticity. This aberrant cortical plasticity was associated with tic severity, suggesting an underlying mechanism for tic pathophysiology. © 2015 International Parkinson and Movement Disorder Society.

  4. The Prescription Drug Marketing Act of 1987.

    Science.gov (United States)

    Greenberg, R B

    1988-10-01

    The Prescription Drug Marketing Act of 1987 is described, and its implications for hospitals and other health-care entities are discussed. The act, which became effective on July 21, 1988, is intended to reduce public health risks from adulterated, misbranded, and counterfeit drug products that enter the marketplace through drug diversion. The law provides that prescription drug products manufactured in the United States and exported can no longer be reimported, except by the product's manufacturer. It also establishes restrictions on sales of prescription drug products and samples. Samples of prescription drug products may be distributed only if a licensed prescriber requests them. Other distribution channels for samples specified in the law are permissible, provided records are maintained. Under the law, wholesale distributors must be licensed by the state and meet uniform standards. Penalties for violations of the law are also identified. According to FDA's advisory guidelines on the statute, the law will permit hospitals to return drug products, provided the return is made to the manufacturer or wholesaler and provided written notice is secured that the goods were received (for manufacturers) or the goods were destroyed or returned to the manufacturer (for wholesalers). The final chapter on drug diversion must await issuance of final FDA regulations.

  5. A General LC-MS/MS Method for Monitoring Potential β-Lactam Contamination in Drugs and Drug-Manufacturing Surfaces.

    Science.gov (United States)

    Qiu, Chen; Zhu, Hongbin; Ruzicka, Connie; Keire, David; Ye, Hongping

    2018-05-15

    Penicillins and some non-penicillin β-lactams may cause potentially life-threatening allergic reactions. Thus, possible cross contamination of β-lactams in food or drugs can put people at risk. Therefore, when there is a reasonable possibility that a non-penicillin product could be contaminated by penicillin, the drug products are tested for penicillin contamination. Here, a sensitive and rapid method for simultaneous determination of multiple β-lactam antibiotics using high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS) was developed and validated. Mass spectral acquisition was performed on a Q-Exactive HF mass spectrometer in positive ion mode with parallel reaction monitoring (PRM). The method was validated for seven β-lactam antibiotics including one or two from each class and a synthetic intermediate. The quantification precision and accuracy at 200 ppb were in the range of ± 1.84 to ± 4.56 and - 5.20 to 3.44%, respectively. The limit of detection (LOD) was 0.2 ppb, and the limit of quantitation (LOQ) was 2 ppb with a linear dynamic range (LDR) of 2-2000 ppb for all eight β-lactams. From various drug products, the recoveries of eight β-lactams at 200 and 2 ppb ranged from 93.8 ± 3.2 to 112.1 ± 4.2% and 89.7 ± 4.6 to 110.6 ± 1.9%, respectively. The application of the method for detecting cross contamination of trace β-lactams (0.2 ppb) and for monitoring facility surface cleaning was also investigated. This sensitive and fast method was fit-for-purpose for detecting and quantifying trace amount of β-lactam contamination, monitoring cross contamination in manufacturing processes, and determining potency for regulatory purposes and for quality control.

  6. National Drug Code Directory

    Data.gov (United States)

    U.S. Department of Health & Human Services — The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured,...

  7. Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. Final rule; further delay of effective date.

    Science.gov (United States)

    2017-09-29

    The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), known as the "340B Drug Pricing Program" or the "340B Program." HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. On August 21, 2017, HHS solicited comments on further delaying the effective date of the January 5, 2017, final rule to July 1, 2018 (82 FR 39553). HHS proposed this action to allow a more deliberate process of considering alternative and supplemental regulatory provisions and to allow for sufficient time for additional rulemaking. After consideration of the comments received on the proposed rule, HHS is delaying the effective date of the January 5, 2017, final rule, to July 1, 2018.

  8. 21 CFR 610.42 - Restrictions on use for further manufacture of medical devices.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Restrictions on use for further manufacture of medical devices. 610.42 Section 610.42 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH... for Communicable Disease Agents § 610.42 Restrictions on use for further manufacture of medical...

  9. Automotive Manufacturers' Cost/Revenue, Financial and Risk Analysis : Projected Impact of Automobile Manufacturing on the Plastics Industry

    Science.gov (United States)

    1979-08-01

    The report is part of a study to update the historical and projected cost/revenue analysis of the U.S. domestic automobile manufacturers. It includes the evaluation of the historical and projected financial data to assess the corporate financial posi...

  10. Process chains for the manufacturing of moulded interconnect devices

    DEFF Research Database (Denmark)

    Islam, Mohammad Aminul; Hansen, Hans Nørgaard; Tang, Peter Torben

    2009-01-01

    process chains for the manufacturing of MIDs. This paper presents a comparison among the MID manufacturing process chains, and it presents experimental results based on two of the most industrially adapted processes. Experiments with two-component (2k) injection molding and subsequent selective......) process show that the success of the process is heavily dependant on the choice of material. It presents how the surface topographies are varied as a function of laser type and material choice. The amount of seed metal particles in the plastic material is a crucial factor that controls laser...

  11. The conversion of waste plastics/petroleum residue mixtures to transportation fuels

    International Nuclear Information System (INIS)

    Ali, M.F.; Siddiqui, M.N.

    2005-01-01

    Plastics have become the material of choice in the modern world and its applications in the industrial field are continually increasing. Presently the plastics are manufactured for various uses such as: consumer packaging, wires, pipes, containers, bottles, appliances, electrical/electronic parts, computers and automotive parts. Most of he post consumer, plastic products are discarded and end up as mixed plastic municipal waste. The disposal of his waste has become a major social concern. Mixed plastic waste (MPW) recycling is still very much in its infancy. Approximately 20 million tons of plastic waste is generated in the United States of America, while about 15 million tons is generated throughout the Europe. With existing recycle efforts, only 7% of the MPW are recycled to produce low-grade plastic products such as plastic sacks, pipes, plastic fencing, and garden furniture. The current plastic reclamation technology options are generally grouped into the following four types: (i) Primary: The processing of plastic for use comparable to the original application. (ii) Secondary: The processing of plastics waste into new products with a lower quality level. (iii) Tertiary: The chemical or thermal processing of plastic waste to their basic hydrocarbon feedstock. The resulting raw materials are then reprocessed into plastic material or other products of the oil refining process. (iv) Quaternary: The incineration of plastics waste to recover energy. This paper deals exclusively with tertiary recycling by pyrolysis and catalytic cracking of plastics waste alone and by coprocessing with petroleum residue or heavy oils to fuels and petrochemical feedstock for further processing in existing refinery and petrochemical units. (author)

  12. 78 FR 12068 - Device Good Manufacturing Practice Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-02-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Device Good Manufacturing Practice Advisory Committee; Notice of Meeting AGENCY: Food and Drug... Committee: Device Good Manufacturing Practice Advisory Committee. General Function of the Committee: To...

  13. Migration of toxicants from plastics into drinking water during storage ...

    African Journals Online (AJOL)

    In this study, migration of toxicants, such as, manufacturing additives and previously adsorbed materials into drinking water stored inside plastic containers was investigated. The study considered virgin containers as well as those previously used to store sulphuric acid, calcium hypochlorite, methyl ethyl ketone (MEK) and ...

  14. From waste plastics to industrial raw materials: A life cycle assessment of mechanical plastic recycling practice based on a real-world case study.

    Science.gov (United States)

    Gu, Fu; Guo, Jianfeng; Zhang, Wujie; Summers, Peter A; Hall, Philip

    2017-12-01

    Mechanical recycling of waste plastics is an environmental solution to the problem of waste plastic disposal, and has already become a common practice in industry. However, limited information can be found on either the industralised plastic recycling or the recycled materials, despite the use of recycled plastics has already extended to automobile production. This study investigates the life cycle environmental impacts of mechanical plastic recycling practice of a plastic recycling company in China. Waste plastics from various sources, such as agricultural wastes, plastic product manufacturers, collected solid plastic wastes and parts dismantled from waste electric and electronic equipments, are processed in three routes with products end up in different markets. The results of life cycle assessments show that the extrusion process has the largest environmental impacts, followed by the use of fillers and additives. Compared to production of virgin plastics and composites, the mechanical recycling is proved to be a superior alternative in most environmental aspects. Substituting virgin plastic composites with recycled plastic composites has achieved the highest environmental benefits, as virgin composite production has an impact almost 4 times higher that of the recycled composite production in each ReCiPe endpoint damage factor. Sensitivity analysis shows that the coverage of collecting network contribute affect little to overall environmental impact, and centralisation plays an important role in reducing overall environmental impacts. Among the fillers and additives, impact modifiers account for the most significant contributions to the environmental impacts of recycled composites. This study provides necessary information about the existing industrialised plastic recycling practice, and recommendations are given. Research implications are presented with the purpose to achieve higher substitution rate and lower environmental impact. Copyright © 2017 Elsevier B

  15. Assessment of metal contaminations leaching out from recycling plastic bottles upon treatments.

    Science.gov (United States)

    Cheng, Xiaoliang; Shi, Honglan; Adams, Craig D; Ma, Yinfa

    2010-08-01

    concentration between washing procedure involved and no washing procedure involved (AC) was larger than zero for samples A to G. This interesting result showed that higher antimony concentration was detected in experiments with no washing procedures compared with those experiments with washing procedures. Our study results indicate that partial antimony leaching from PET bottles comes from contaminations on the surface of plastic during manufacturing process, while major antimony leaching comes from conditional changes. The results revealed that heating and microwaving enhance antimony leaching significantly in PET plastic bottles. Plastic bottle manufacturers should consider the contaminations during manufacturing process and washing bottles before first use was strongly recommended to remove those contaminants.

  16. Good manufacturing practice

    International Nuclear Information System (INIS)

    Schlyer, D.J.

    2001-01-01

    In this presentation author deals with the Implementation of good manufacturing practice for radiopharmaceuticals. The presentation is divided into next parts: Batch size; Expiration date; QC Testing; Environmental concerns; Personnel aspects; Radiation concerns; Theoretical yields; Sterilizing filters; Control and reconciliation of materials and components; Product strength; In process sampling and testing; Holding and distribution; Drug product inspection; Buildings and facilities; Renovations at BNL for GMP; Aseptic processing and sterility assurance; Process validation and control; Quality control and drug product stability; Documentation and other GMP topics; Building design considerations; Equipment; and Summary

  17. Plastic Deformation Characteristics Of AZ31 Magnesium Alloy Sheets At Elevated Temperature

    International Nuclear Information System (INIS)

    Park, Jingee; Lee, Jongshin; You, Bongsun; Choi, Seogou; Kim, Youngsuk

    2007-01-01

    Using lightweight materials is the emerging need in order to reduce the vehicle's energy consumption and pollutant emissions. Being a lightweight material, magnesium alloys are increasingly employed in the fabrication of automotive and electronic parts. Presently, magnesium alloys used in automotive and electronic parts are mainly processed by die casting. The die casting technology allows the manufacturing of parts with complex geometry. However, the mechanical properties of these parts often do not meet the requirements concerning the mechanical properties (e.g. endurance strength and ductility). A promising alternative can be forming process. The parts manufactured by forming could have fine-grained structure without porosity and improved mechanical properties such as endurance strength and ductility. Because magnesium alloy has low formability resulted form its small slip system at room temperature it is usually formed at elevated temperature. Due to a rapid increase of usage of magnesium sheets in automotive and electronic industry it is necessary to assure database for sheet metal formability and plastic yielding properties in order to optimize its usage. Especially, plastic yielding criterion is a critical property to predict plastic deformation of sheet metal parts in optimizing process using CAE simulation. Von-Mises yield criterion generally well predicts plastic deformation of steel sheets and Hill'1979 yield criterion predicts plastic deformation of aluminum sheets. In this study, using biaxial tensile test machine yield loci of AZ31 magnesium alloy sheet were obtained at elevated temperature. The yield loci ensured experimentally were compared with the theoretical predictions based on the Von-Mises, Hill, Logan-Hosford, and Barlat model

  18. 21 CFR 111.205 - What is the requirement to establish a master manufacturing record?

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false What is the requirement to establish a master manufacturing record? 111.205 Section 111.205 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) FOOD FOR HUMAN CONSUMPTION CURRENT GOOD MANUFACTURING PRACTICE IN...

  19. Materials Testing and Cost Modeling for Composite Parts Through Additive Manufacturing

    Science.gov (United States)

    2016-04-30

    FDM include plastic jet printing (PJP), fused filament modeling ( FFM ), and fused filament fabrication (FFF). FFF was coined by the RepRap project to...additive manufacturing processes? • Fused deposition modeling (FDM) trademarked by Stratasys • Fused filament modeling ( FFM ) and fused filament

  20. Cost effective manufacturing of the SEA 10X concentrator array

    Energy Technology Data Exchange (ETDEWEB)

    Kaminar, N.; McEntee, J.; Curchod, D. (Solar Engineering Applications Corp., San Jose, CA (United States))

    1991-11-01

    This report describes a low-cost, mass-producible 10X concentrator system that has been claimed to produce electricity at $0.04/kWh. It details changes in manufacturing techniques that could produce a concentrator system at a selling price of $0.71/W. (A simple design and a minimum number of parts and manufacturing steps reduced production costs.) Present production techniques, changes to improve these techniques, impediments to changes, and solutions to the impediments are described. This 10X concentrator system uses available components and manufacturing processes and one-sun solar cells in conjunction with inexpensive plastic lenses to generate about eight times the amount of electricity normally produced by these cells.

  1. Physical and biological treatments of polyethylene-rice starch plastic films

    Energy Technology Data Exchange (ETDEWEB)

    El-Naggar, Manal M.A., E-mail: mmelnaggar@yahoo.com [Microbiology Lab., National Institute of Oceanography and Fisheries, Alexandria (Egypt); Farag, Magdy Gh. [Development Plastic Center, Victoria, Alexandria (Egypt)

    2010-04-15

    This study aimed to produce an industrial applicable thermo-stable {alpha}-amylase from marine Bacillus amyloliquefaciens which isolated and selected according to its significant enzyme production. The effect of different pH values and temperatures on the bacterial growth and the enzyme production was estimated using an experimental statistical design; maximum amylase production and bacterial growth was obtained at pH 7.0 and 50 deg. C. Some biodegradable polyethylene rice starch plastic films (PERS-P) were manufactured using 0, 2.5, 5, 7.5 and 10% starch concentrations. The biodegradability (reduction in the plastic elongation%) was tested using the exposure to UV radiation at {lambda}{sub 300-400nm} (intensity of about 1000 W/m{sup 2}) and the produced B. amyloliquefaciens thermo-stable {alpha}-amylase. A significant reduction in the elongation% of these biodegradable plastics was observed in both cases especially on testing the 10% PERS-P; they showed a reduction of 26% and 20%, respectively, compared to the untreated plastic films (180 {+-} 5).

  2. Physical and biological treatments of polyethylene-rice starch plastic films

    International Nuclear Information System (INIS)

    El-Naggar, Manal M.A.; Farag, Magdy Gh.

    2010-01-01

    This study aimed to produce an industrial applicable thermo-stable α-amylase from marine Bacillus amyloliquefaciens which isolated and selected according to its significant enzyme production. The effect of different pH values and temperatures on the bacterial growth and the enzyme production was estimated using an experimental statistical design; maximum amylase production and bacterial growth was obtained at pH 7.0 and 50 deg. C. Some biodegradable polyethylene rice starch plastic films (PERS-P) were manufactured using 0, 2.5, 5, 7.5 and 10% starch concentrations. The biodegradability (reduction in the plastic elongation%) was tested using the exposure to UV radiation at λ 300-400nm (intensity of about 1000 W/m 2 ) and the produced B. amyloliquefaciens thermo-stable α-amylase. A significant reduction in the elongation% of these biodegradable plastics was observed in both cases especially on testing the 10% PERS-P; they showed a reduction of 26% and 20%, respectively, compared to the untreated plastic films (180 ± 5).

  3. Field and Laboratory Decay Evaluations of wood-plastic Composites

    Science.gov (United States)

    Rebecca E. Ibach; Marek Gnatowski; Grace Sun

    2013-01-01

    Experimental wood–plastic composites (WPCs) were made so that they matched the manufacturing process, dimensions, and water absorption of some commercial decking boards. WPC samples from selected formulations were divided into two identical groups. The first group was exposed in exterior conditions in Vancouver, British Columbia, and Hilo, Hawaii, at sun and shadow...

  4. 21 CFR 701.12 - Name and place of business of manufacturer, packer, or distributor.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Name and place of business of manufacturer, packer, or distributor. 701.12 Section 701.12 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF... business of manufacturer, packer, or distributor. (a) The label of a cosmetic in package form shall specify...

  5. WASTE MINIMIZATION ASSESSMENT FOR A MANUFACTURER OF CUSTOM MOLDED PLASTIC PRODUCTS

    Science.gov (United States)

    The U.S. Environmental Protection Agency (EPA) has funded a pilot project to assist small- and medium-size manufacturers who want to minimize their generation of waste but who lack the expertise to do so. Waste Minimization Assessment Centers (WMACs) were established at selected ...

  6. 77 FR 70189 - Manufacturer of Controlled Substances; Notice of Registration; Cayman Chemical Company

    Science.gov (United States)

    2012-11-23

    ... propylthiophenethylamine (7348). Marihuana (7360) I Tetrahydrocannabinols (7370) I Mescaline (7381) I 3,4,5... manufacture small quantities of marihuana derivatives for research purposes. In reference to drug code 7360 (Marihuana), the company plans to bulk manufacture cannabidiol. In reference to drug code 7370...

  7. Ultrasonic-assisted manufacturing processes: Variational model and numerical simulations

    KAUST Repository

    Siddiq, Amir

    2012-04-01

    We present a computational study of ultrasonic assisted manufacturing processes including sheet metal forming, upsetting, and wire drawing. A fully variational porous plasticity model is modified to include ultrasonic softening effects and then utilized to account for instantaneous softening when ultrasonic energy is applied during deformation. Material model parameters are identified via inverse modeling, i.e. by using experimental data. The versatility and predictive ability of the model are demonstrated and the effect of ultrasonic intensity on the manufacturing process at hand is investigated and compared qualitatively with experimental results reported in the literature. © 2011 Elsevier B.V. All rights reserved.

  8. A plastic surgery application in evolution: three-dimensional printing.

    Science.gov (United States)

    Gerstle, Theodore L; Ibrahim, Ahmed M S; Kim, Peter S; Lee, Bernard T; Lin, Samuel J

    2014-02-01

    Three-dimensional printing represents an evolving technology still in its infancy. Currently, individuals and small business entities have the ability to manufacture physical objects from digital renderings, computer-aided design, and open source files. Design modifications and improvements in extrusion methods have made this technology much more affordable. This article explores the potential uses of three-dimensional printing in plastic surgery. A review was performed detailing the known uses of three-dimensional printing in medicine. The potential applications of three-dimensional printing in plastic surgery are discussed. Various applications for three-dimensional printing technology have emerged in medicine, including printing organs, printing body parts, bio-printing, and computer-aided tissue engineering. In plastic surgery, these tools offer various prospective applications for surgical planning, resident education, and the development of custom prosthetics. Numerous applications exist in medicine, including the printing of devices, implants, tissue replacements, and even whole organs. Plastic surgeons may likely find this technology indispensable in surgical planning, education, and prosthetic device design and development in the near future.

  9. Use of recycled plastic in concrete: a review.

    Science.gov (United States)

    Siddique, Rafat; Khatib, Jamal; Kaur, Inderpreet

    2008-01-01

    Numerous waste materials are generated from manufacturing processes, service industries and municipal solid wastes. The increasing awareness about the environment has tremendously contributed to the concerns related with disposal of the generated wastes. Solid waste management is one of the major environmental concerns in the world. With the scarcity of space for landfilling and due to its ever increasing cost, waste utilization has become an attractive alternative to disposal. Research is being carried out on the utilization of waste products in concrete. Such waste products include discarded tires, plastic, glass, steel, burnt foundry sand, and coal combustion by-products (CCBs). Each of these waste products has provided a specific effect on the properties of fresh and hardened concrete. The use of waste products in concrete not only makes it economical, but also helps in reducing disposal problems. Reuse of bulky wastes is considered the best environmental alternative for solving the problem of disposal. One such waste is plastic, which could be used in various applications. However, efforts have also been made to explore its use in concrete/asphalt concrete. The development of new construction materials using recycled plastics is important to both the construction and the plastic recycling industries. This paper presents a detailed review about waste and recycled plastics, waste management options, and research published on the effect of recycled plastic on the fresh and hardened properties of concrete. The effect of recycled and waste plastic on bulk density, air content, workability, compressive strength, splitting tensile strength, modulus of elasticity, impact resistance, permeability, and abrasion resistance is discussed in this paper.

  10. Use of recycled plastic in concrete: A review

    International Nuclear Information System (INIS)

    Siddique, Rafat; Khatib, Jamal; Kaur, Inderpreet

    2008-01-01

    Numerous waste materials are generated from manufacturing processes, service industries and municipal solid wastes. The increasing awareness about the environment has tremendously contributed to the concerns related with disposal of the generated wastes. Solid waste management is one of the major environmental concerns in the world. With the scarcity of space for landfilling and due to its ever increasing cost, waste utilization has become an attractive alternative to disposal. Research is being carried out on the utilization of waste products in concrete. Such waste products include discarded tires, plastic, glass, steel, burnt foundry sand, and coal combustion by-products (CCBs). Each of these waste products has provided a specific effect on the properties of fresh and hardened concrete. The use of waste products in concrete not only makes it economical, but also helps in reducing disposal problems. Reuse of bulky wastes is considered the best environmental alternative for solving the problem of disposal. One such waste is plastic, which could be used in various applications. However, efforts have also been made to explore its use in concrete/asphalt concrete. The development of new construction materials using recycled plastics is important to both the construction and the plastic recycling industries. This paper presents a detailed review about waste and recycled plastics, waste management options, and research published on the effect of recycled plastic on the fresh and hardened properties of concrete. The effect of recycled and waste plastic on bulk density, air content, workability, compressive strength, splitting tensile strength, modulus of elasticity, impact resistance, permeability, and abrasion resistance is discussed in this paper

  11. Coldness applied to plastic engineering techniques and rooms; Le froid applique aux techniques de la plasturgie et a ses locaux

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-07-01

    This technical dossier is the result of a collaboration between the CFE, EdF Industrie and the French federation of plastic engineering. It aims at answering all questions relative to plastic materials processing: 1 - general study on the economical aspects of plastic engineering, plastic materials, and manufacturing processes; 2 - the different cold processing techniques (air cooling and refrigerating systems); 3 - the main transformation processes for thermo-plastic materials and the advantage of cooling techniques; 4 - the environmental conditioning of rooms (clean rooms); 5 - examples of realizations. (J.S.)

  12. Plastic

    International Nuclear Information System (INIS)

    Jeong Gi Hyeon

    1987-04-01

    This book deals with plastic, which includes introduction for plastic, chemistry of high polymers, polymerization, speciality and structure of a high molecule property of plastic, molding, thermosetting plastic, such as polyethylene, polyether, polyamide and polyvinyl acetyl, thermal plastic like phenolic resins, xylene resins, melamine resin, epoxy resin, alkyd resin and poly urethan resin, new plastic like ionomer and PPS resin, synthetic laminated tape and synthetic wood, mixed materials in plastic, reprocessing of waste plastic, polymer blend, test method for plastic materials and auxiliary materials of plastic.

  13. Reversal of Cocaine-Associated Synaptic Plasticity in Medial Prefrontal Cortex Parallels Elimination of Memory Retrieval.

    Science.gov (United States)

    Otis, James M; Mueller, Devin

    2017-09-01

    Addiction is characterized by abnormalities in prefrontal cortex that are thought to allow drug-associated cues to drive compulsive drug seeking and taking. Identification and reversal of these pathologic neuroadaptations are therefore critical for treatment of addiction. Previous studies using rodents reveal that drugs of abuse cause dendritic spine plasticity in prelimbic medial prefrontal cortex (PL-mPFC) pyramidal neurons, a phenomenon that correlates with the strength of drug-associated memories in vivo. Thus, we hypothesized that cocaine-evoked plasticity in PL-mPFC may underlie cocaine-associated memory retrieval, and therefore disruption of this plasticity would prevent retrieval. Indeed, using patch clamp electrophysiology we find that cocaine place conditioning increases excitatory presynaptic and postsynaptic transmission in rat PL-mPFC pyramidal neurons. This was accounted for by increases in excitatory presynaptic release, paired-pulse facilitation, and increased AMPA receptor transmission. Noradrenergic signaling is known to maintain glutamatergic plasticity upon reactivation of modified circuits, and we therefore next determined whether inhibition of noradrenergic signaling during memory reactivation would reverse the cocaine-evoked plasticity and/or disrupt the cocaine-associated memory. We find that administration of the β-adrenergic receptor antagonist propranolol before memory retrieval, but not after (during memory reconsolidation), reverses the cocaine-evoked presynaptic and postsynaptic modifications in PL-mPFC and causes long-lasting memory impairments. Taken together, these data reveal that cocaine-evoked synaptic plasticity in PL-mPFC is reversible in vivo, and suggest a novel strategy that would allow normalization of prefrontal circuitry in addiction.

  14. 21 CFR 123.5 - Current good manufacturing practice.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 123.5 Section...) FOOD FOR HUMAN CONSUMPTION FISH AND FISHERY PRODUCTS General Provisions § 123.5 Current good manufacturing practice. (a) Part 110 of this chapter applies in determining whether the facilities, methods...

  15. Improving the circular economy via hydrothermal processing of high-density waste plastics.

    Science.gov (United States)

    Helmer Pedersen, Thomas; Conti, Federica

    2017-10-01

    Rising environmental concerns on climate changes are causing an increasing attention on circular economies. The plastic economy, in particular, is in focus due to the accelerating consumption of plastics, mainly derived from virgin feedstock, combined with the lack of plastic recycling strategies. This work presents a novel outlook on the potential of using supercritical hydrothermal processing of waste plastic fractions for tertiary recycling. The study investigates hydrothermal processing of nine different, high-density types of plastics into original resin monomers and other value-added chemical compounds. The outlook presents conversion yields, carbon balances, and chemical details on the products obtained. It is found that all the investigated resins are prone to hydrothermal treatment, and that high yields of monomers and high value compounds (up to nearly 100%), suitable for chemicals and fuels applications, can be obtained. For instance, for polycarbonate, styrene-butadiene, poly(lactic acid), poly(ethylene terephthalate), and poly(butylene terephthalate), original monomeric compounds can be reclaimed for manufacturing new resins. The promising results presented demonstrate that hydrothermal processing of high-density plastics is a prospective technology for increasing the circularity of the plastic economy. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. Simulation of finite-strain inelastic phenomena governed by creep and plasticity

    Science.gov (United States)

    Li, Zhen; Bloomfield, Max O.; Oberai, Assad A.

    2017-11-01

    Inelastic mechanical behavior plays an important role in many applications in science and engineering. Phenomenologically, this behavior is often modeled as plasticity or creep. Plasticity is used to represent the rate-independent component of inelastic deformation and creep is used to represent the rate-dependent component. In several applications, especially those at elevated temperatures and stresses, these processes occur simultaneously. In order to model these process, we develop a rate-objective, finite-deformation constitutive model for plasticity and creep. The plastic component of this model is based on rate-independent J_2 plasticity, and the creep component is based on a thermally activated Norton model. We describe the implementation of this model within a finite element formulation, and present a radial return mapping algorithm for it. This approach reduces the additional complexity of modeling plasticity and creep, over thermoelasticity, to just solving one nonlinear scalar equation at each quadrature point. We implement this algorithm within a multiphysics finite element code and evaluate the consistent tangent through automatic differentiation. We verify and validate the implementation, apply it to modeling the evolution of stresses in the flip chip manufacturing process, and test its parallel strong-scaling performance.

  17. GREEN PLASTIC: A NEW PLASTIC FOR PACKAGING

    OpenAIRE

    Mr. Pankaj Kumar*, Sonia

    2016-01-01

    This paper gives a brief idea about a new type of plastic called as bio-plastic or green plastic. Plastic is used as a packaging material for various products, but this plastic is made up of non renewable raw materials. There are various disadvantages of using conventional plastic like littering, CO2 production, non-degradable in nature etc. To overcome these problems a new type of plastic is discovered called bio-plastic or green plastic. Bio-plastic is made from renewable resources and also...

  18. Increases in self-reported fentanyl use among a population entering drug treatment: The need for systematic surveillance of illicitly manufactured opioids.

    Science.gov (United States)

    Cicero, Theodore J; Ellis, Matthew S; Kasper, Zachary A

    2017-08-01

    Recent reports indicate a sharp increase in fentanyl-related overdose deaths across the United States, much of which is likely related to the introduction of cheap, illicitly manufactured fentanyl derivatives. In this study, we sought to estimate the magnitude of illicit fentanyl use from 2012 to 2016 using a national opioid abuse surveillance system. The study program surveyed 10,900 individuals entering substance abuse treatment for opioid use disorder, with participants asked to endorse past month 'use to get high' of fentanyl drugs, stratified by identifiable (i.e., branded) fentanyl formulations or a 'type unknown' drug alleged to contain fentanyl. Total past-month fentanyl-use rose modestly from 2012 to 2016. While use of known fentanyl products remained relatively stable (mean=10.9%; P=0.25), endorsements of 'unknown' fentanyl products nearly doubled from 9% in 2013 to 15.1% by 2016 (Pfentanyl use shows that recent increases in fentanyl use seem to be due almost entirely to 'unknown' fentanyl presumed to be illicitly manufactured. Given that it is difficult to assess the extent to which fentanyl may have been substituted for another drug (i.e., oxycodone, alprazolam, etc.) or was used as a heroin admixture, our data likely represent an underestimation of the full magnitude of illicit fentanyl abuse. As such, this growing public health problem requires immediate attention and more systematic efforts to identify and track its abuse. Copyright © 2017. Published by Elsevier B.V.

  19. Hidden costs of HIV treatment in Spain: inefficiency of the antiretroviral drug packaging.

    Science.gov (United States)

    Llibre-Codina, Josep M; Andreu-Crespo, Angels; Cardona-Peitx, Gloria; Sala-Piñol, Ferran; Clotet-Sala, Bonaventura; Bonafont-Pujol, Xavier

    2014-01-01

    Antiretroviral drugs in Spain are delivered by law only in hospital pharmacies. Commercial packages meet variable quality standards when dispensed drugs are returned due to treatment changes or adherence problems Nearly 20-25% of the initial regimens will be changed at 48 weeks for different reasons. We evaluated the economic impact on public health system of the inability of using returned drugs due to inefficient packaging. We defined socially efficient packaging as the best adapted one to being delivered in unit dose to outpatients and classified: Class A - Drug packed in unit doses with complete info (name of drug, dosage in mg, lot, and expiring date) in each unit, maintaining complete information of the drug if returned when the external package is opened. Class B - packed in blisters with complete info in the blister, but not in unit doses, without special conservation conditions (should be re-packed in unit doses in the pharmacy before its dispensation to assure a class A excellence). Class C - packed in plastic containers with complete info written only on a label over the container, would allow repackaging only before its initial delivery, but not when returned. Class D - drug packed in plastic containers with manufacturer's warning that the product cannot be placed outside of the original package due to special conditions of conservation (fridge, humidity) that doesn't allow a unit dose repackaging or reusing an opened container. We analysed a 12-month period (July 2011-June 2012) in a hospital-based HIV outpatient pharmacy that serves 2413 treated individuals. Patients generated 23,574 visits to pharmacy, and received 48,325 drug packages, with 2.529.137 pills delivered. The patients suffered 1051 treatment changes for any reason. A total amount of 122.945€ in treatment were returned to pharmacy in opened packages during the study period. 47.139.91€ would be totally lost, mainly due to being packaged in class C and D boxes, the equivalent of

  20. Plastic Muscles TM as lightweight, low voltage actuators and sensors

    Science.gov (United States)

    Bennett, Matthew; Leo, Donald; Duncan, Andrew

    2008-03-01

    Using proprietary technology, Discover Technologies has developed ionomeric polymer transducers that are capable of long-term operation in air. These "Plastic Muscle TM" transducers are useful as soft distributed actuators and sensors and have a wide range of applications in the aerospace, robotics, automotive, electronics, and biomedical industries. Discover Technologies is developing novel fabrication methods that allow the Plastic Muscles TM to be manufactured on a commercial scale. The Plastic Muscle TM transducers are capable of generating more than 0.5% bending strain at a peak strain rate of over 0.1 %/s with a 3 V input. Because the Plastic Muscles TM use an ionic liquid as a replacement solvent for water, they are able to operate in air for long periods of time. Also, the Plastic Muscles TM do not exhibit the characteristic "back relaxation" phenomenon that is common in water-swollen devices. The elastic modulus of the Plastic Muscle TM transducers is estimated to be 200 MPa and the maximum generated stress is estimated to be 1 MPa. Based on these values, the maximum blocked force at the tip of a 6 mm wide, 35 mm long actuator is estimated to be 19 mN. Modeling of the step response with an exponential series reveals nonlinearity in the transducers' behavior.

  1. Plasticity in the Prefrontal Cortex of Adult Rats

    Directory of Open Access Journals (Sweden)

    Bryan eKolb

    2015-02-01

    Full Text Available We review the plastic changes of the prefrontal cortex of the rat in response to a wide range of experiences including sensory and motor experience, gonadal hormones, psychoactive drugs, learning tasks, stress, social experience, metaplastic experiences, and brain injury. Our focus is on synaptic changes (dendritic morphology and spine density in pyramidal neurons and the relationship to behavioral changes. The most general conclusion we can reach is that the prefrontal cortex is extremely plastic and that the medial and orbital prefrontal regions frequently respond very differently to the same experience in the same brain and the rules that govern prefrontal plasticity appear to differ for those of other cortical regions.

  2. Twin Screw Extruders as Continuous Mixers for Thermal Processing: a Technical and Historical Perspective.

    Science.gov (United States)

    Martin, Charlie

    2016-02-01

    Developed approximately 100 years ago for natural rubber/plastics applications, processes via twin screw extrusion (TSE) now generate some of the most cutting-edge drug delivery systems available. After 25 or so years of usage in pharmaceutical environments, it has become evident why TSE processing offers significant advantages as compared to other manufacturing techniques. The well-characterized nature of the TSE process lends itself to ease of scale-up and process optimization while also affording the benefits of continuous manufacturing. Interestingly, the evolution of twin screw extrusion for pharmaceutical products has followed a similar path as previously trodden by plastics processing pioneers. Almost every plastic has been processed at some stage in the manufacturing train on a twin screw extruder, which is utilized to mix materials together to impart desired properties into a final part. The evolution of processing via TSEs since the early/mid 1900s is recounted for plastics and also for pharmaceuticals from the late 1980s until today. The similarities are apparent. The basic theory and development of continuous mixing via corotating and counterrotating TSEs for plastics and drug is also described. The similarities between plastics and pharmaceutical applications are striking. The superior mixing characteristics inherent with a TSE have allowed this device to dominate other continuous mixers and spurred intensive development efforts and experimentation that spawned highly engineered formulations for the commodity and high-tech plastic products we use every day. Today, twin screw extrusion is a battle hardened, well-proven, manufacturing process that has been validated in 24-h/day industrial settings. The same thing is happening today with new extrusion technologies being applied to advanced drug delivery systems to facilitate commodity, targeted, and alternative delivery systems. It seems that the "extrusion evolution" will continue for wide

  3. 21 CFR 120.5 - Current good manufacturing practice.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 120.5 Section... Provisions § 120.5 Current good manufacturing practice. Part 110 of this chapter applies in determining whether the facilities, methods, practices, and controls used to process juice are safe, and whether the...

  4. 21 CFR 129.1 - Current good manufacturing practice.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 129.1 Section... Current good manufacturing practice. The applicable criteria in part 110 of this chapter, as well as the..., methods, practices, and controls used in the processing, bottling, holding, and shipping of bottled...

  5. 76 FR 11790 - Drugs for Human Use; Drug Efficacy Study Implementation; Oral Prescription Drugs Offered for...

    Science.gov (United States)

    2011-03-03

    ... subject of an approved new drug application (NDA) or abbreviated new drug application (ANDA) (other than... 23, 1983, notice, the manufacturer had submitted supplemental applications proposing to reformulate... Laboratories, a subsidiary of Elan Corp., PLC, 800 Gateway Blvd., South San Francisco, CA 94080; Copley...

  6. Durability Characteristics Analysis of Plastic Worm Wheel with Glass Fiber Reinforced Polyamide.

    Science.gov (United States)

    Kim, Gun-Hee; Lee, Jeong-Won; Seo, Tae-Il

    2013-05-10

    Plastic worm wheel is widely used in the vehicle manufacturing field because it is favorable for weight lightening, vibration and noise reduction, as well as corrosion resistance. However, it is very difficult for general plastics to secure the mechanical properties that are required for vehicle gears. If the plastic resin is reinforced by glass fiber in the fabrication process of plastic worm wheel, it is possible to achieve the mechanical properties of metallic material levels. In this study, the mechanical characteristic analysis of the glass-reinforced plastic worm wheel, according to the contents of glass fiber, is performed by analytic and experimental methods. In the case of the glass fiber-reinforced resin, the orientation and contents of glass fibers can influence the mechanical properties. For the characteristic prediction of plastic worm wheel, computer-aided engineering (CAE) analysis processes such as structural and injection molding analysis were executed with the polyamide resin reinforcement glass fiber (25 wt %, 50 wt %). The injection mold for fabricating the prototype plastic worm wheel was designed and made to reflect the CAE analysis results. Finally, the durability of prototype plastic worm wheel fabricated by the injection molding process was evaluated by the experimental method and the characteristics according to the glass fiber contents.

  7. Emerging technology: A key enabler for modernizing pharmaceutical manufacturing and advancing product quality.

    Science.gov (United States)

    O'Connor, Thomas F; Yu, Lawrence X; Lee, Sau L

    2016-07-25

    Issues in product quality have produced recalls and caused drug shortages in United States (U.S.) in the past few years. These quality issues were often due to outdated manufacturing technologies and equipment as well as lack of an effective quality management system. To ensure consistent supply of safe, effective and high-quality drug products available to the patients, the U.S. Food and Drug Administration (FDA) supports modernizing pharmaceutical manufacturing for improvements in product quality. Specifically, five new initiatives are proposed here to achieve this goal. They include: (i) advancing regulatory science for pharmaceutical manufacturing; (ii) establishing a public-private institute for pharmaceutical manufacturing innovation; (iii) creating incentives for investment in the technological upgrade of manufacturing processes and facilities; (iv) leveraging external expertise for regulatory quality assessment of emerging technologies; and (v) promoting the international harmonization of approaches for expediting the global adoption of emerging technologies. Published by Elsevier B.V.

  8. Next Generation Print-based Manufacturing for Photovoltaics and Solid State Lighting

    Energy Technology Data Exchange (ETDEWEB)

    Sue A. Carter

    2012-09-07

    For the grand challenge of reducing our energy and carbon footprint, the development of renewable energy and energy efficient technologies offer a potential solution. Energy technologies can reduce our dependence on foreign oil as well as the energy consumed by the petroleum industry, the leading consumer of energy by a U.S. industry sector. Nonetheless, the manufacturing processes utilized to manufacture equipment for alternative energy technologies often involve energy-intensive processes. This undermines some of the advantages to moving to 'green' technologies in the first place. Our answer to the Industrial Technology Program's (ITP) Grand Challenge FOA was to develop a transformational low cost manufacturing process for plastic-based photovoltaics that will lower by over 50% both energy consumption and greenhouse emissions and offer a return-of-investment of over 20%. We demonstrated a Luminescent Solar Concentrator fabricated on a plastic acrylic substrate (i.e. no glass) that increases the power output of the PV cell by 2.2x with a 2% power efficiency as well as an LSC with a 7% power efficiency that increased the power output from the PV cells by 35%. S large area 20-inch x 60-inch building-integrated photovoltaic window was fabricated using contract manufacturing with a 4% power efficiency which improved the power output of the PV cell by over 50%. In addition, accelerated lifetimes of the luminescent material demonstrate lifetimes of 20-years.

  9. 77 FR 71802 - Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs...

    Science.gov (United States)

    2012-12-04

    ... Positron Emission Tomography (PET) Drugs.'' The guidance is intended to assist manufacturers of PET drugs... one self-addressed adhesive label to assist that office in processing your requests. See the... ``Investigational New Drug Applications for Positron Emission Tomography (PET) Drugs.'' The guidance summarizes the...

  10. Plastic waste disposal apparatus

    Energy Technology Data Exchange (ETDEWEB)

    Kito, S

    1972-05-01

    A test plant plastic incinerator was constructed by the Takuma Boiler Manufacturing Co. for Sekisui Chemical Industries, and the use of a continuous feed spreader was found to be most effective for prevention of black smoke, and the use of a venturi scrubber proved to be effective for elimination of hydrogen chloride gas. The incinerator was designed for combustion of polyvinyl chloride exclusively, but it is also applicable for combustion of other plastics. When burning polyethylene, polypropylene, or polystyrene, (those plastics which do not produce toxic gases), the incinerator requires no scrubber for the combustion gas. The system may or may not have a pretreatment apparatus. For an incinerator with a pretreatment system, the flow chart comprises a pit, a supply crane, a vibration feeder, a metal eliminator, a rotation shredder, a continuous screw feeder with a quantitative supply hopper, a pretreatment chamber (300 C dry distillation), a quantitative supply hopper, and the incinerator. The incinerator is a flat non-grid type combustion chamber with an oil burner and many air nozzles. From the incinerator, ashes are sent by an ash conveyor to an ash bunker. The combustion gas goes to the boiler, and the water supplied the boiler water pump creates steam. The heat from the gas is sent back to the pretreatment system through a heat exchanger. The gas then goes to a venturi scrubber and goes out from a stack.

  11. Aggregates in monoclonal antibody manufacturing processes.

    Science.gov (United States)

    Vázquez-Rey, María; Lang, Dietmar A

    2011-07-01

    Monoclonal antibodies have proved to be a highly successful class of therapeutic products. Large-scale manufacturing of pharmaceutical antibodies is a complex activity that requires considerable effort in both process and analytical development. If a therapeutic protein cannot be stabilized adequately, it will lose partially or totally its therapeutic properties or even cause immunogenic reactions thus potentially further endangering the patients' health. The phenomenon of protein aggregation is a common issue that compromises the quality, safety, and efficacy of antibodies and can happen at different steps of the manufacturing process, including fermentation, purification, final formulation, and storage. Aggregate levels in drug substance and final drug product are a key factor when assessing quality attributes of the molecule, since aggregation might impact biological activity of the biopharmaceutical. In this review it is analyzed how aggregates are formed during monoclonal antibody industrial production, why they have to be removed and the manufacturing process steps that are designed to either minimize or remove aggregates in the final product. Copyright © 2011 Wiley Periodicals, Inc.

  12. Dimensional accuracy optimization of the micro-plastic injection molding process using the Taguchi design method

    Directory of Open Access Journals (Sweden)

    Chil-Chyuan KUO KUO

    2015-06-01

    Full Text Available Plastic injection molding is an important field in manufacturing industry because there are many plastic products that produced by injection molding. However, the time and cost required for producing a precision mold are the most troublesome problems that limit the application at the development stage of a new product in precision machinery industry. This study presents an approach of manufacturing a hard mold with microfeatures for micro-plastic injection molding. This study also focuses on Taguchi design method for investigating the effect of injection parameters on the dimensional accuracy of Fresnel lens during plastic injection molding. It was found that the dominant factor affecting the microgroove depth of Fresnel lens is packing pressure. The optimum processing parameters are packing pressure of 80 MPa, melt temperature of 240 °C, mold temperature of 90 °C and injection speed of 50 m/s. The dimensional accuracy of Fresnel lens can be controlled within ±3 µm using the optimum level of process parameters through the confirmation test. The research results of this study have industrial application values because electro-optical industries are able to significantly reduce a new optical element development cycle time.DOI: http://dx.doi.org/10.5755/j01.ms.21.2.5864

  13. Usage of Failure Mode & EffectAnalysis Method (FMEA forsafety assessment in a drug manufacture

    Directory of Open Access Journals (Sweden)

    Y Nazari

    2006-04-01

    Full Text Available Background and Aims: This study was hold in purpose of recognizing and controlling workplacehazards in production units of a drag ManufactureMethod:So for recognition and assessment of hazards, FMEA Method was used. FMEASystematically investigates the effects of equipment and system failures leading often toequipment design improvements. At first the level of the study defined as system. Then accordingto observations, accident statistic, and interview with managers, supervisory, and workers highrisk system were determiner. So the boundaries of the system established and informationregarding the relevant Components, their function and interactions gathered. To preventConfusion between Similar pieces of equipment, a unique system identifier developed. After thatall failure modes and their causes for each equipment or system listed, the immediate effects ofeach failure mode and interactive effect on other equipment or system was described too. Riskpriority number was determined according to global and local criteriaResults: After all some actions and solution proposed to reduce the likelihood and severity offailures and raise their delectability.Conclusion :This study illustrated that although of the first step drug manufacture may seem safe,but there are still many hazardous condition that could cause serious accidents, The result proposedit is necessary: (1 to develop comprehensive manual for periodical and regular inspection ofinstruments of workplaces in purpose of recognize unknown failures and their causes, (2 developa comprehensive program for systems maintenance and repair, and (3 conduct worker training.

  14. Characterization and ageing study of poly(lactic acid) films plasticized with oligomeric lactic acid

    OpenAIRE

    Burgos, Nuria; Martino, Verónica P.; Jiménez, Alfonso

    2013-01-01

    Poly(lactic acid) (PLA) was melt-blended with a bio-based oligomeric lactic acid (OLA) plasticizer at different concentrations between 15 wt% and 25 wt% in order to enhance PLA ductility and to get a fully biodegradable material with potential application in films manufacturing. OLA was an efficient plasticizer for PLA, as it caused a significant decrease on glass transition temperature (Tg) while improving considerably ductile properties. Only one Tg value was observed in all cases and no ap...

  15. 21 CFR 212.5 - To what drugs do the regulations in this part apply?

    Science.gov (United States)

    2010-04-01

    ... SERVICES (CONTINUED) DRUGS: GENERAL CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY..., quality assurance, holding, and distribution of PET drugs. Any human drug that does not meet the definition of a PET drug must be manufactured in accordance with the current good manufacturing practice...

  16. 76 FR 51401 - Manufacturer of Controlled Substances; Notice of Application

    Science.gov (United States)

    2011-08-18

    ... a bulk manufacturer of the following basic classes of controlled substances: Drug Schedule Marihuana... ingredients (APIs) for distribution to its customers. In reference to drug code 7360 (Marihuana), the company...

  17. DRUG INTERACTIONS WITH DIAZEPAM

    Directory of Open Access Journals (Sweden)

    Zoran Bojanić

    2011-06-01

    Full Text Available Diazepam is a benzodiazepine derivative with anxyolitic, anticonvulsant, hypnotic, sedative, skeletal muscle relaxant, antitremor, and amnestic activity. It is metabolized in the liver by the cytochrome P (CYP 450 enzyme system. Diazepam is N-demethylated by CYP3A4 and CYP2C19 to the active metabolite N-desmethyldiazepam, and is hydroxylated by CYP3A4 to the active metabolite temazepam. N-desmethyl-diazepam and temazepam are both further metabolized to oxazepam. Concomitant intake of inhibitors or inducers of the CYP isozymes involved in the biotransformation of diazepam may alter plasma concentrations of this drug, although this effect is unlikely to be associated with clinically relevant interactions.The goal of this article was to review the current literature on clinically relevant pharmacokinetic drug interactions with diazepam.A search of MEDLINE and EMBASE was conducted for original research and review articles published in English between January 1971. and May 2011. Among the search terms were drug interactions, diazepam, pharmacokinetics, drug metabolism, and cytochrome P450. Only articles published in peer-reviewed journals were included, and meeting abstracts were excluded. The reference lists of relevant articles were hand-searched for additional publications.Diazepam is substantially sorbed by the plastics in flexible containers, volume control set chambers, and tubings of intravenous administration sets. Manufacturers recommend not mixing with any other drug or solution in syringe or solution, although diazepam is compatible in syringe with cimetidine and ranitidine, and in Y-site with cisatracurium, dobutamine, fentanyl, hydromorphone, methadone, morphine, nafcillin, quinidine gluconate, remifentanil, and sufentanil. Diazepam is compatible with: dextrose 5% in water, Ringers injection, Ringers injection lactated and sodium chloride 0.9%. Emulsified diazepam is compatible with Intralipid and Nutralipid.Diazepam has low potential

  18. Phenotypic Plasticity, Bet-Hedging, and Androgen Independence in Prostate Cancer: Role of Non-Genetic Heterogeneity

    Directory of Open Access Journals (Sweden)

    Mohit Kumar Jolly

    2018-03-01

    Full Text Available It is well known that genetic mutations can drive drug resistance and lead to tumor relapse. Here, we focus on alternate mechanisms—those without mutations, such as phenotypic plasticity and stochastic cell-to-cell variability that can also evade drug attacks by giving rise to drug-tolerant persisters. The phenomenon of persistence has been well-studied in bacteria and has also recently garnered attention in cancer. We draw a parallel between bacterial persistence and resistance against androgen deprivation therapy in prostate cancer (PCa, the primary standard care for metastatic disease. We illustrate how phenotypic plasticity and consequent mutation-independent or non-genetic heterogeneity possibly driven by protein conformational dynamics can stochastically give rise to androgen independence in PCa, and suggest that dynamic phenotypic plasticity should be considered in devising therapeutic dosing strategies designed to treat and manage PCa.

  19. Die design and process optimization of plastic gear extrusion

    Science.gov (United States)

    Zhang, Lei; Fu, Zhihong; Yao, Chen; Zang, Gongzheng; Wan, Yue

    2018-01-01

    The flow velocity of the melt in the extruder was simulated by using software Polyflow, and the size of the die channel with the best flow uniformity was obtained. The die profile shape is obtained by reverse design. The length of the shaping section is determined by Ansys transient thermal analysis. According to the simulation results, the design and manufacture of extrusion die of plastic gear and vacuum cooling setting were obtained. The influence of the five process parameters on the precision of the plastic gear were studied by the single factor analysis method, such as the die temperature T, the screw speed R, the die spacing S, the vacuum degree M and the hauling speed V. The optimal combination of process parameters was obtained by using the neural network particle swarm optimization algorithm(T = 197.05 °C, R = 9.04rpm, S = 67mm, M = -0.0194MPa). The tooth profile deviation of the extruded plastic gear can reach 9 level of accuracy.

  20. Shrink-Induced Superhydrophobic and Antibacterial Surfaces in Consumer Plastics

    Science.gov (United States)

    Freschauf, Lauren R.; McLane, Jolie; Sharma, Himanshu; Khine, Michelle

    2012-01-01

    Structurally modified superhydrophobic surfaces have become particularly desirable as stable antibacterial surfaces. Because their self-cleaning and water resistant properties prohibit bacteria growth, structurally modified superhydrophobic surfaces obviate bacterial resistance common with chemical agents, and therefore a robust and stable means to prevent bacteria growth is possible. In this study, we present a rapid fabrication method for creating such superhydrophobic surfaces in consumer hard plastic materials with resulting antibacterial effects. To replace complex fabrication materials and techniques, the initial mold is made with commodity shrink-wrap film and is compatible with large plastic roll-to-roll manufacturing and scale-up techniques. This method involves a purely structural modification free of chemical additives leading to its inherent consistency over time and successive recasting from the same molds. Finally, antibacterial properties are demonstrated in polystyrene (PS), polycarbonate (PC), and polyethylene (PE) by demonstrating the prevention of gram-negative Escherichia coli (E. coli) bacteria growth on our structured plastic surfaces. PMID:22916100

  1. Improved Manufacturing Process for Pyronaridine Tetraphosphate

    International Nuclear Information System (INIS)

    Lee, Dong Won; Lee, Seung Kyu; Cho, Jun Ho; Yoon, Seung Soo

    2014-01-01

    Pyronaridine tetraphosphate (1) is a well-known antimalarial drug. However, it required a carefully optimized production process for the manufacture of pyronaridine tetraphosphate. Each step of its manufacturing process was reinvestigated. For the cyclization of 4-chloro-2-(6-methoxy-pyridin-3-yl-amino)-benzoic acid 6 to 7,10-dichloro-2-methoxybenzo[b]-1,5-naphthyridine 5, an improved process was developed to eliminated critical process impurity (BIA). By the redesign of the formation of triphosphate salt, the purity as API grade was increased. Thus, a robust manufacturing process with an acceptable process performance has been developed to produce high quality pyronaridine tetraphosphate

  2. Plastics disassembly versus bulk recycling: engineering design for end-of-life electronics resource recovery.

    Science.gov (United States)

    Rios, Pedro; Stuart, Julie Ann; Grant, Ed

    2003-12-01

    Annual plastic flows through the business and consumer electronics manufacturing supply chain include nearly 3 billion lb of high-value engineering plastics derived from petroleum. The recovery of resource value from this stream presents critical challenges in areas of materials identification and recycling process design that demand new green engineering technologies applied together with life cycle assessment and ecological supply chain analysis to create viable plastics-to-plastics supply cycles. The sustainable recovery of potentially high-value engineering plastics streams requires that recyclers either avoid mixing plastic parts or purify later by separating smaller plastic pieces created in volume reduction (shredding) steps. Identification and separation constitute significant barriers in the plastics-to-plastics recycling value proposition. In the present work, we develop a model that accepts randomly arriving electronic products to study scenarios by which a recycler might identify and separate high-value engineering plastics as well as metals. Using discrete eventsimulation,we compare current mixed plastics recovery with spectrochemical plastic resin identification and subsequent sorting. Our results show that limited disassembly with whole-part identification can produce substantial yields in separated streams of recovered engineering thermoplastics. We find that disassembly with identification does not constitute a bottleneck, but rather, with relatively few workers, can be configured to pull the process and thus decrease maximum staging space requirements.

  3. Natural Rewards, Neuroplasticity, and Non-Drug Addictions

    Science.gov (United States)

    Olsen, Christopher M.

    2011-01-01

    There is a high degree of overlap between brain regions involved in processing natural rewards and drugs of abuse. “Non-drug” or “behavioral” addictions have become increasingly documented in the clinic, and pathologies include compulsive activities such as shopping, eating, exercising, sexual behavior, and gambling. Like drug addiction, non-drug addictions manifest in symptoms including craving, impaired control over the behavior, tolerance, withdrawal, and high rates of relapse. These alterations in behavior suggest that plasticity may be occurring in brain regions associated with drug addiction. In this review, I summarize data demonstrating that exposure to non-drug rewards can alter neural plasticity in regions of the brain that are affected by drugs of abuse. Research suggests that there are several similarities between neuroplasticity induced by natural and drug rewards and that, depending on the reward, repeated exposure to natural rewards might induce neuroplasticity that either promotes or counteracts addictive behavior. PMID:21459101

  4. Transport and release of chemicals from plastics to the environment and to wildlife

    Science.gov (United States)

    Teuten, Emma L.; Saquing, Jovita M.; Knappe, Detlef R. U.; Barlaz, Morton A.; Jonsson, Susanne; Björn, Annika; Rowland, Steven J.; Thompson, Richard C.; Galloway, Tamara S.; Yamashita, Rei; Ochi, Daisuke; Watanuki, Yutaka; Moore, Charles; Viet, Pham Hung; Tana, Touch Seang; Prudente, Maricar; Boonyatumanond, Ruchaya; Zakaria, Mohamad P.; Akkhavong, Kongsap; Ogata, Yuko; Hirai, Hisashi; Iwasa, Satoru; Mizukawa, Kaoruko; Hagino, Yuki; Imamura, Ayako; Saha, Mahua; Takada, Hideshige

    2009-01-01

    Plastics debris in the marine environment, including resin pellets, fragments and microscopic plastic fragments, contain organic contaminants, including polychlorinated biphenyls (PCBs), polycyclic aromatic hydrocarbons, petroleum hydrocarbons, organochlorine pesticides (2,2′-bis(p-chlorophenyl)-1,1,1-trichloroethane, hexachlorinated hexanes), polybrominated diphenylethers, alkylphenols and bisphenol A, at concentrations from sub ng g–1 to µg g–1. Some of these compounds are added during plastics manufacture, while others adsorb from the surrounding seawater. Concentrations of hydrophobic contaminants adsorbed on plastics showed distinct spatial variations reflecting global pollution patterns. Model calculations and experimental observations consistently show that polyethylene accumulates more organic contaminants than other plastics such as polypropylene and polyvinyl chloride. Both a mathematical model using equilibrium partitioning and experimental data have demonstrated the transfer of contaminants from plastic to organisms. A feeding experiment indicated that PCBs could transfer from contaminated plastics to streaked shearwater chicks. Plasticizers, other plastics additives and constitutional monomers also present potential threats in terrestrial environments because they can leach from waste disposal sites into groundwater and/or surface waters. Leaching and degradation of plasticizers and polymers are complex phenomena dependent on environmental conditions in the landfill and the chemical properties of each additive. Bisphenol A concentrations in leachates from municipal waste disposal sites in tropical Asia ranged from sub µg l–1 to mg l–1 and were correlated with the level of economic development. PMID:19528054

  5. 21 CFR 114.5 - Current good manufacturing practice.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Current good manufacturing practice. 114.5 Section...) FOOD FOR HUMAN CONSUMPTION ACIDIFIED FOODS General Provisions § 114.5 Current good manufacturing practice. The criteria in §§ 114.10, 114.80, 114.83, 114.89, and 114.100, as well as the criteria in part...

  6. 21 CFR 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; name and place of business of manufacturer, packer or distributor. 801.1 Section 801.1 Food and Drugs FOOD AND DRUG ADMINISTRATION... § 801.1 Medical devices; name and place of business of manufacturer, packer or distributor. (a) The...

  7. FSSC 22000 Packaging Implementation: a Plastics Industry Research

    OpenAIRE

    Cantanhede, Vanessa; Pereira, Karen Signori; Barreto, Daniel Weingart

    2018-01-01

    Abstract This paper presents the outcomes of an exploratory research carried out in companies, which are located in Brazil. They are FSSC-22000-certified food plastic packaging manufacturers. In order to identify the key aspects of the implementation process and certification, a questionnaire was developed and sent to twenty certified organizations. Out of them, eleven of which participating companies responded in a collaborative way. Based on the data obtained, improving competitiveness and...

  8. 21 CFR 509.15 - Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials.

    Science.gov (United States)

    2010-04-01

    ... establishments manufacturing food-packaging materials. 509.15 Section 509.15 Food and Drugs FOOD AND DRUG... polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials. (a) Polychlorinated...). These accidents in turn caused the contamination of food products intended for human consumption (meat...

  9. 21 CFR 109.15 - Use of polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials.

    Science.gov (United States)

    2010-04-01

    ... establishments manufacturing food-packaging materials. 109.15 Section 109.15 Food and Drugs FOOD AND DRUG... polychlorinated biphenyls (PCB's) in establishments manufacturing food-packaging materials. (a) Polychlorinated...). These accidents in turn caused the contamination of food products intended for human consumption (meat...

  10. Machining of Fibre Reinforced Plastic Composite Materials

    Science.gov (United States)

    2018-01-01

    Fibre reinforced plastic composite materials are difficult to machine because of the anisotropy and inhomogeneity characterizing their microstructure and the abrasiveness of their reinforcement components. During machining, very rapid cutting tool wear development is experienced, and surface integrity damage is often produced in the machined parts. An accurate selection of the proper tool and machining conditions is therefore required, taking into account that the phenomena responsible for material removal in cutting of fibre reinforced plastic composite materials are fundamentally different from those of conventional metals and their alloys. To date, composite materials are increasingly used in several manufacturing sectors, such as the aerospace and automotive industry, and several research efforts have been spent to improve their machining processes. In the present review, the key issues that are concerning the machining of fibre reinforced plastic composite materials are discussed with reference to the main recent research works in the field, while considering both conventional and unconventional machining processes and reporting the more recent research achievements. For the different machining processes, the main results characterizing the recent research works and the trends for process developments are presented. PMID:29562635

  11. Machining of Fibre Reinforced Plastic Composite Materials

    Directory of Open Access Journals (Sweden)

    Alessandra Caggiano

    2018-03-01

    Full Text Available Fibre reinforced plastic composite materials are difficult to machine because of the anisotropy and inhomogeneity characterizing their microstructure and the abrasiveness of their reinforcement components. During machining, very rapid cutting tool wear development is experienced, and surface integrity damage is often produced in the machined parts. An accurate selection of the proper tool and machining conditions is therefore required, taking into account that the phenomena responsible for material removal in cutting of fibre reinforced plastic composite materials are fundamentally different from those of conventional metals and their alloys. To date, composite materials are increasingly used in several manufacturing sectors, such as the aerospace and automotive industry, and several research efforts have been spent to improve their machining processes. In the present review, the key issues that are concerning the machining of fibre reinforced plastic composite materials are discussed with reference to the main recent research works in the field, while considering both conventional and unconventional machining processes and reporting the more recent research achievements. For the different machining processes, the main results characterizing the recent research works and the trends for process developments are presented.

  12. Large-scale additive manufacturing with bioinspired cellulosic materials.

    Science.gov (United States)

    Sanandiya, Naresh D; Vijay, Yadunund; Dimopoulou, Marina; Dritsas, Stylianos; Fernandez, Javier G

    2018-06-05

    Cellulose is the most abundant and broadly distributed organic compound and industrial by-product on Earth. However, despite decades of extensive research, the bottom-up use of cellulose to fabricate 3D objects is still plagued with problems that restrict its practical applications: derivatives with vast polluting effects, use in combination with plastics, lack of scalability and high production cost. Here we demonstrate the general use of cellulose to manufacture large 3D objects. Our approach diverges from the common association of cellulose with green plants and it is inspired by the wall of the fungus-like oomycetes, which is reproduced introducing small amounts of chitin between cellulose fibers. The resulting fungal-like adhesive material(s) (FLAM) are strong, lightweight and inexpensive, and can be molded or processed using woodworking techniques. We believe this first large-scale additive manufacture with ubiquitous biological polymers will be the catalyst for the transition to environmentally benign and circular manufacturing models.

  13. High-shear granulation as a manufacturing method for cocrystal granules

    DEFF Research Database (Denmark)

    Rehder, Sönke; Christensen, Niels Peter Aae; Rantanen, Jukka

    2013-01-01

    and the respective excipients). The drug release was slightly decreased by cocrystal formation, most likely due to the lower solubility of the cocrystal. In the presence of calcium hydrogenphosphate however, no influence of cocrystal formation on either compactability or on drug release were observed, compared...... with the reference tablets. It was concluded that high-shear wet granulation is a valuable, however complex, manufacturing method for cocrystals. Cocrystal formation may influence compactability and drug release and thus affect drug performance and should be investigated during pre-formulation.......Cocrystal formation allows the tailoring of physicochemical as well as of mechanical properties of an API. However, there is a lack of large-scale manufacturing methods of cocrystals. Therefore, the objective of this work was to examine the suitability of high-shear wet granulation...

  14. Plastic Degradation and Its Environmental Implications with Special Reference to Poly(ethylene terephthalate

    Directory of Open Access Journals (Sweden)

    Elena P. Ivanova

    2012-12-01

    Full Text Available With increasing global consumption and their natural resistance to degradation, plastic materials and their accumulation in the environment is of increasing concern. This review aims to present a general overview of the current state of knowledge in areas that relate to biodegradation of polymers, especially poly(ethylene terephthalate (PET. This includes an outline of the problems associated with plastic pollution in the marine environment, a description of the properties, commercial manufacturing and degradability of PET, an overview of the potential for biodegradation of conventional polymers and biodegradable polymers already in production.

  15. Quantitative Analysis of Bisphenol A Leached from Household Plastics by Solid-Phase Microextraction and Gas Chromatography-Mass Spectrometry (SPME-GC-MS)

    Science.gov (United States)

    Johnson, Bettie Obi; Burke, Fernanda M.; Harrison, Rebecca; Burdette, Samantha

    2012-01-01

    The measurement of trace levels of bisphenol A (BPA) leached out of household plastics using solid-phase microextraction (SPME) with gas chromatography-mass spectrometry (GC-MS) is reported here. BPA is an endocrine-disrupting compound used in the industrial manufacture of polycarbonate plastic bottles and epoxy resin can liners. This experiment…

  16. The Effect of a Plasticizing Admixture on the Properties of Hardened Concrete

    Directory of Open Access Journals (Sweden)

    Anastasija Abasova

    2012-11-01

    Full Text Available Concrete is material obtained mixing matrix material, coarse and small aggregates and water along with additives acquiring necessary properties of hardening. The quality and properties of raw material used for manufacturing concrete, V/C ratio and the uniformity of the compaction of the mixture lead to the fundamental properties of concrete. The compressive strength of concrete is one of the most important properties of concrete. The article deals with the impact of plasticizers on the structural properties of concrete choosing an optimal content of additives. Concrete plasticizers increasing the content of additive increase the strength of samples, the density and ultrasonic pulse of velocity and decrease absorption. Test results have revealed that a plasticizing admixture under dosing or overdosing can reduce the properties of concrete.

  17. Use of plastic materials in electrical accumulators. [Comparison of properties of resins

    Energy Technology Data Exchange (ETDEWEB)

    Allievi, G

    1962-05-31

    The uses of plastics in the manufacture of lead, nickel--cadmium, and silver--zinc batteries are reviewed. Nine basic plastics are compared regarding their abilities to withstand strong acids and strong bases. PVC, polyester, and polethylene appear as most suitable. Resins are compared in mechanical and thermal respects, which are tabulated for those favored industrially. ABS made from acrilonitrile--butadiene--styrene is particularly suitable. Fibers in conjunction with resins used for making plate-tubes are best represented by high-density PE (polyester), specific weight 0.94 to 0.96, nonhygroscopic, minimum contraction on cooling. Proprietary applications of the above-mentioned plastics have established themselves as successful alternatives to glass, ebonite, cellulose, and steel in Pb, Ni--Cd and Ag--Zn cells. Specific examples of successful developments in the USA, Germany, England, and Italy are cited.

  18. Cortical and brainstem plasticity in Tourette syndrome and obsessive-compulsive disorder.

    Science.gov (United States)

    Suppa, Antonio; Marsili, Luca; Di Stasio, Flavio; Berardelli, Isabella; Roselli, Valentina; Pasquini, Massimo; Cardona, Francesco; Berardelli, Alfredo

    2014-10-01

    Gilles de la Tourette syndrome is characterized by motor/vocal tics commonly associated with psychiatric disorders, including obsessive-compulsive disorder. We investigated primary motor cortex and brainstem plasticity in Tourette patients, exposed and unexposed to chronic drug treatment, with and without psychiatric disturbances. We also investigated primary motor cortex and brainstem plasticity in obsessive-compulsive disorder. We studied 20 Tourette patients with and without psychiatric disturbances, 15 with obsessive-compulsive disorder, and 20 healthy subjects. All groups included drug-naïve patients. We conditioned the left primary motor cortex with intermittent/continuous theta-burst stimulation and recorded motor evoked potentials. We conditioned the supraorbital nerve with facilitatory/inhibitory high-frequency stimulation and recorded the blink reflex late response area. In healthy subjects, intermittent theta-burst increased and continuous theta-burst stimulation decreased motor evoked potentials. Differently, intermittent theta-burst failed to increase and continuous theta-burst stimulation failed to decrease motor evoked potentials in Tourette patients, with and without psychiatric disturbances. In obsessive-compulsive disorder, intermittent/continuous theta-burst stimulation elicited normal responses. In healthy subjects and in subjects with obsessive-compulsive disorder, the blink reflex late response area increased after facilitatory high-frequency and decreased after inhibitory high-frequency stimulation. Conversely, in Tourette patients, with and without psychiatric disturbances, facilitatory/inhibitory high-frequency stimulation left the blink reflex late response area unchanged. Theta-burst and high-frequency stimulation elicited similar responses in drug-naïve and chronically treated patients. Tourette patients have reduced plasticity regardless of psychiatric disturbances. These findings suggest that abnormal plasticity contributes to the

  19. Plasticity models of material variability based on uncertainty quantification techniques

    Energy Technology Data Exchange (ETDEWEB)

    Jones, Reese E. [Sandia National Lab. (SNL-CA), Livermore, CA (United States); Rizzi, Francesco [Sandia National Lab. (SNL-CA), Livermore, CA (United States); Boyce, Brad [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Templeton, Jeremy Alan [Sandia National Lab. (SNL-CA), Livermore, CA (United States); Ostien, Jakob [Sandia National Lab. (SNL-CA), Livermore, CA (United States)

    2017-11-01

    The advent of fabrication techniques like additive manufacturing has focused attention on the considerable variability of material response due to defects and other micro-structural aspects. This variability motivates the development of an enhanced design methodology that incorporates inherent material variability to provide robust predictions of performance. In this work, we develop plasticity models capable of representing the distribution of mechanical responses observed in experiments using traditional plasticity models of the mean response and recently developed uncertainty quantification (UQ) techniques. Lastly, we demonstrate that the new method provides predictive realizations that are superior to more traditional ones, and how these UQ techniques can be used in model selection and assessing the quality of calibrated physical parameters.

  20. [Fusion implants of carbon fiber reinforced plastic].

    Science.gov (United States)

    Früh, H J; Liebetrau, A; Bertagnoli, R

    2002-05-01

    Carbon fiber reinforced plastics (CFRP) are used in the medical field when high mechanical strength, innovative design, and radiolucency (see spinal fusion implants) are needed. During the manufacturing process of the material CFRP carbon fibers are embedded into a resin matrix. This resin material could be thermoset (e.g., epoxy resin EPN/DDS) or thermoplastic (e.g., PEAK). CFRP is biocompatible, radiolucent, and has higher mechanical capabilities compared to other implant materials. This publication demonstrates the manufacturing process of fusion implants made of a thermoset matrix system using a fiber winding process. The material has been used clinically since 1994 for fusion implants of the cervical and lumbar spine. The results of the fusion systems CORNERSTONE-SR C (cervical) and UNION (lumbar) showed no implant-related complications. New implant systems made of this CFRP material are under investigation and are presented.

  1. Radiation cross-linked plastics: a versatile material solution for packaging, automotive, Electrotechnic and Electronics

    International Nuclear Information System (INIS)

    Rouif, Sophie

    2004-01-01

    Used since the beginning of the 1970s for the production of halogen-free and heat-resistant cables and wires, for conditioning polyethylene hot-water pipes or for the manufacture of heat shrinkable tubes and of tyres, radiation cross-linking is developing fastly today on the scale of plastic-moulded parts, and not only by the mean of EB, but also under gamma rays. Indeed, it improves considerably the performances of a great number of plastics among thermoplastics, elastomers and thermoplastic elastomers (TPE). Radiation cross-linking reinforces the dimensional stability of polymers in chemically aggressive and high-temperature conditions. Radiation cross-linked-based engineering plastics offers OEM and end users in many branches of industry both technical and economical advantages in comparison with high-performances plastics. They constitute a technical and economical compromise between engineering plastics that failed and high-performances plastic, often over-tailored and expensive. This modern industrial technology gives way to new applications and perspectives in various sectors (packaging, automotive, electrotechnic and electronics, including connectors, surface-mounted devices, integrated circuits, 3D-MID, etc.) that are described in the paper

  2. Development of plastic pulley by injection molding; Shashutsu keisei ni yoru jushi pulley no kaihatsu

    Energy Technology Data Exchange (ETDEWEB)

    Yoshizumi, F; Funatsu, A; Yazawa, H [Sumitomo Bakelite Co. Ltd., Tokyo (Japan)

    1997-10-01

    We developed plastic pulley for automobile manufactured by injection molding which will reduce manufacturing cost. We have developed product design, injection molding technology especially to improve mechanical strength and phenolic molding compound with good wear resistance and high mechanical strength. We have established `Injection Compression molding` technology to improve mechanical strength of weld portion. We also developed phenolic molding compound which is composed of one step resin and long organic fiber to obtain good wear resistance and high mechanical strength. Manufacturing cost will be reduced by using injection molding combined with lower material cost of the newly developed compound. 12 figs., 2 tabs.

  3. Additive Manufacturing of Biomaterials, Tissues, and Organs.

    Science.gov (United States)

    Zadpoor, Amir A; Malda, Jos

    2017-01-01

    The introduction of additive manufacturing (AM), often referred to as three-dimensional (3D) printing, has initiated what some believe to be a manufacturing revolution, and has expedited the development of the field of biofabrication. Moreover, recent advances in AM have facilitated further development of patient-specific healthcare solutions. Customization of many healthcare products and services, such as implants, drug delivery devices, medical instruments, prosthetics, and in vitro models, would have been extremely challenging-if not impossible-without AM technologies. The current special issue of the Annals of Biomedical Engineering presents the latest trends in application of AM techniques to healthcare-related areas of research. As a prelude to this special issue, we review here the most important areas of biomedical research and clinical practice that have benefited from recent developments in additive manufacturing techniques. This editorial, therefore, aims to sketch the research landscape within which the other contributions of the special issue can be better understood and positioned. In what follows, we briefly review the application of additive manufacturing techniques in studies addressing biomaterials, (re)generation of tissues and organs, disease models, drug delivery systems, implants, medical instruments, prosthetics, orthotics, and AM objects used for medical visualization and communication.

  4. Substandard drugs: a potential crisis for public health

    Science.gov (United States)

    Johnston, Atholl; Holt, David W

    2014-01-01

    Poor-quality medicines present a serious public health problem, particularly in emerging economies and developing countries, and may have a significant impact on the national clinical and economic burden. Attention has largely focused on the increasing availability of deliberately falsified drugs, but substandard medicines are also reaching patients because of poor manufacturing and quality-control practices in the production of genuine drugs (either branded or generic). Substandard medicines are widespread and represent a threat to health because they can inadvertently lead to healthcare failures, such as antibiotic resistance and the spread of disease within a community, as well as death or additional illness in individuals. This article reviews the different aspects of substandard drug formulation that can occur (for example, pharmacological variability between drug batches or between generic and originator drugs, incorrect drug quantity and presence of impurities). The possible means of addressing substandard manufacturing practices are also discussed. A concerted effort is required on the part of governments, drug manufacturers, charities and healthcare providers to ensure that only drugs of acceptable quality reach the patient. PMID:24286459

  5. Effect of components (polymer, plasticizer and solvent as a variable in fabrication of diclofenac transdermal patch

    Directory of Open Access Journals (Sweden)

    Chetna Modi

    2012-01-01

    Full Text Available Transdermal drug delivery influence consumer acceptance and marked increase in bioavailability of some drugs which undergoes hepatic first-pass metabolism. Fabrication of transdermal patch requires lots of attention regarding the amount of components used for it. Because of varied nature of polymer and plasticizer, transdermal patches have different properties and different drug release. This study is on the basis to evaluate the amount to be needed for fabrication of diclofenac transdermal patch. Study shows that Hydroxy Propyl Methyl Cellulose has great influence on transdermal patch, if it is used alone in combination with glycerin or PEG-4000 plasticizer.

  6. Preparation and characterization of polyurethane plasticizer for flexible packaging applications: Natural oils affirmed access

    Directory of Open Access Journals (Sweden)

    Mohammed A. Mekewi

    2017-03-01

    Full Text Available Developing bio-renewable feedstock for polyurethane (PU manufacturing and polymer industry as a whole has become highly desirable for both economic and environmental reasons. In this work castor oil (CO and palm olein (PO polyols were synthesized and partially used as renewable feedstock for the manufacturing of polyurethane plasticizing resin for printing ink applications. The chemical structure of the prepared polyols and polyurethanes were characterized using IR spectra and GPC and their solubility in common solvents was tested. As well, properties such as flexibility, mechanical properties, optical properties, heat seal and freeze resistance of these prepared printing inks were determined. The results indicated that the prepared printing inks from 50% synthesized polyurethane have high thermal stability, adhesion and excellent freeze resistance. The net technical properties of the new ink formulations are relatively comparable to the printing ink prepared from standard polyurethane plasticizer.

  7. Dynamic tensile behavior of electron beam additive manufactured Ti6Al4V

    International Nuclear Information System (INIS)

    Rodriguez, O.L.; Allison, P.G.; Whittington, W.R.; Francis, D.K.; Rivera, O.G.; Chou, K.; Gong, X.; Butler, T.M.; Burroughs, J.F.

    2015-01-01

    High rate and quasi-static tensile experiments examined strain rate dependence on flow stress and strain hardening of additive manufactured Ti6Al4V. Variations on strain-hardening coefficient indicate that the rate of thermal softening is greater than strain hardening during plastic deformation. Strain rate sensitivity calculations within the plastic strain regime suggest changes in deformation mechanisms. Fractography revealed cup-and-cone fracture for quasi-static samples and shear mechanisms for high rate samples. As-deposited microstructure consisted of bimodal α+β with the presence of secondary martensitic phase

  8. Dynamic tensile behavior of electron beam additive manufactured Ti6Al4V

    Energy Technology Data Exchange (ETDEWEB)

    Rodriguez, O.L. [Department of Mechanical Engineering, University of Alabama, Tuscaloosa, AL 35487 (United States); Allison, P.G., E-mail: pallison@eng.ua.edu [Department of Mechanical Engineering, University of Alabama, Tuscaloosa, AL 35487 (United States); Whittington, W.R.; Francis, D.K. [Department of Mechanical Engineering, Mississippi State University, Starkville, MS 35759 (United States); Rivera, O.G.; Chou, K.; Gong, X. [Department of Mechanical Engineering, University of Alabama, Tuscaloosa, AL 35487 (United States); Butler, T.M. [Department of Metallurgical Engineering, University of Alabama, Tuscaloosa, AL 35487 (United States); Burroughs, J.F. [Geotechnical & Structures Laboratory, US Army ERDC, Vicksburg, MS 39180 (United States)

    2015-08-12

    High rate and quasi-static tensile experiments examined strain rate dependence on flow stress and strain hardening of additive manufactured Ti6Al4V. Variations on strain-hardening coefficient indicate that the rate of thermal softening is greater than strain hardening during plastic deformation. Strain rate sensitivity calculations within the plastic strain regime suggest changes in deformation mechanisms. Fractography revealed cup-and-cone fracture for quasi-static samples and shear mechanisms for high rate samples. As-deposited microstructure consisted of bimodal α+β with the presence of secondary martensitic phase.

  9. 3D printed metal molds for hot embossing plastic microfluidic devices.

    Science.gov (United States)

    Lin, Tung-Yi; Do, Truong; Kwon, Patrick; Lillehoj, Peter B

    2017-01-17

    Plastics are one of the most commonly used materials for fabricating microfluidic devices. While various methods exist for fabricating plastic microdevices, hot embossing offers several unique advantages including high throughput, excellent compatibility with most thermoplastics and low start-up costs. However, hot embossing requires metal or silicon molds that are fabricated using CNC milling or microfabrication techniques which are time consuming, expensive and required skilled technicians. Here, we demonstrate for the first time the fabrication of plastic microchannels using 3D printed metal molds. Through optimization of the powder composition and processing parameters, we were able to generate stainless steel molds with superior material properties (density and surface finish) than previously reported 3D printed metal parts. Molds were used to fabricate poly(methyl methacrylate) (PMMA) replicas which exhibited good feature integrity and replication quality. Microchannels fabricated using these replicas exhibited leak-free operation and comparable flow performance as those fabricated from CNC milled molds. The speed and simplicity of this approach can greatly facilitate the development (i.e. prototyping) and manufacture of plastic microfluidic devices for research and commercial applications.

  10. Processing of microencapsulated dyes for the visual inspection of fibre reinforced plastics

    Energy Technology Data Exchange (ETDEWEB)

    Hopmann, Ch., E-mail: kerschbaum@ikv.rwth-aachen.de; Kerschbaum, M., E-mail: kerschbaum@ikv.rwth-aachen.de; Küsters, K., E-mail: kerschbaum@ikv.rwth-aachen.de [Institute of Plastics Processing at RWTH Aachen University (IKV), Pontstrasse 49, 52064 Aachen (Germany)

    2014-05-15

    The evaluation of damages caused during processing, assembly or usage of fibre reinforced plastics is still a challenge. The use of inspection technology like ultrasonic scanning enables a detailed damage analysis but requires high investments and trained staff. Therefore, the visual inspection method is widely used. A drawback of this method is the difficult identification of barely visible damages, which can already be detrimental for the structural integrity. Therefore an approach is undertaken to integrate microencapsulated dyes into the laminates of fibre reinforced plastic parts to highlight damages on the surface. In case of a damage, the microcapsules rupture which leads to a release of the dye and a visible bruise on the part surface. To enable a wide application spectrum for this technology the microcapsules must be processable without rupturing with established manufacturing processes for fibre reinforced plastics. Therefore the incorporation of microcapsules in the filament winding, prepreg autoclave and resin transfer moulding (RTM) process is investigated. The results show that the use of a carrier medium is a feasible way to incorporate the microcapsules into the laminate for all investigated manufacturing processes. Impact testing of these laminates shows a bruise formation on the specimen surface which correlates with the impact energy level. This indicates a microcapsule survival during processing and shows the potential of this technology for damage detection and characterization.

  11. Processing of microencapsulated dyes for the visual inspection of fibre reinforced plastics

    International Nuclear Information System (INIS)

    Hopmann, Ch.; Kerschbaum, M.; Küsters, K.

    2014-01-01

    The evaluation of damages caused during processing, assembly or usage of fibre reinforced plastics is still a challenge. The use of inspection technology like ultrasonic scanning enables a detailed damage analysis but requires high investments and trained staff. Therefore, the visual inspection method is widely used. A drawback of this method is the difficult identification of barely visible damages, which can already be detrimental for the structural integrity. Therefore an approach is undertaken to integrate microencapsulated dyes into the laminates of fibre reinforced plastic parts to highlight damages on the surface. In case of a damage, the microcapsules rupture which leads to a release of the dye and a visible bruise on the part surface. To enable a wide application spectrum for this technology the microcapsules must be processable without rupturing with established manufacturing processes for fibre reinforced plastics. Therefore the incorporation of microcapsules in the filament winding, prepreg autoclave and resin transfer moulding (RTM) process is investigated. The results show that the use of a carrier medium is a feasible way to incorporate the microcapsules into the laminate for all investigated manufacturing processes. Impact testing of these laminates shows a bruise formation on the specimen surface which correlates with the impact energy level. This indicates a microcapsule survival during processing and shows the potential of this technology for damage detection and characterization

  12. Processing of microencapsulated dyes for the visual inspection of fibre reinforced plastics

    Science.gov (United States)

    Hopmann, Ch.; Kerschbaum, M.; Küsters, K.

    2014-05-01

    The evaluation of damages caused during processing, assembly or usage of fibre reinforced plastics is still a challenge. The use of inspection technology like ultrasonic scanning enables a detailed damage analysis but requires high investments and trained staff. Therefore, the visual inspection method is widely used. A drawback of this method is the difficult identification of barely visible damages, which can already be detrimental for the structural integrity. Therefore an approach is undertaken to integrate microencapsulated dyes into the laminates of fibre reinforced plastic parts to highlight damages on the surface. In case of a damage, the microcapsules rupture which leads to a release of the dye and a visible bruise on the part surface. To enable a wide application spectrum for this technology the microcapsules must be processable without rupturing with established manufacturing processes for fibre reinforced plastics. Therefore the incorporation of microcapsules in the filament winding, prepreg autoclave and resin transfer moulding (RTM) process is investigated. The results show that the use of a carrier medium is a feasible way to incorporate the microcapsules into the laminate for all investigated manufacturing processes. Impact testing of these laminates shows a bruise formation on the specimen surface which correlates with the impact energy level. This indicates a microcapsule survival during processing and shows the potential of this technology for damage detection and characterization.

  13. 21 CFR 1002.51 - Exemptions for manufacturers of products intended for the U.S. Government.

    Science.gov (United States)

    2010-04-01

    ... for the U.S. Government. 1002.51 Section 1002.51 Food and Drugs FOOD AND DRUG ADMINISTRATION.... Government. Upon application therefor by the manufacturer, the Director, Center for Devices and Radiological Health, may exempt from the provisions of this part a manufacturer of any electronic product intended for...

  14. Mesoporous silica formulation strategies for drug dissolution enhancement: a review.

    Science.gov (United States)

    McCarthy, Carol A; Ahern, Robert J; Dontireddy, Rakesh; Ryan, Katie B; Crean, Abina M

    2016-01-01

    Silica materials, in particular mesoporous silicas, have demonstrated excellent properties to enhance the oral bioavailability of poorly water-soluble drugs. Current research in this area is focused on investigating the kinetic profile of drug release from these carriers and manufacturing approaches to scale-up production for commercial manufacture. This review provides an overview of different methods utilized to load drugs onto mesoporous silica carriers. The influence of silica properties and silica pore architecture on drug loading and release are discussed. The kinetics of drug release from mesoporous silica systems is examined and the manufacturability and stability of these formulations are reviewed. Finally, the future prospects of mesoporous silica drug delivery systems are considered. Substantial progress has been made in the characterization and development of mesoporous drug delivery systems for drug dissolution enhancement. However, more research is required to fully understand the drug release kinetic profile from mesoporous silica materials. Incomplete drug release from the carrier and the possibility of drug re-adsorption onto the silica surface need to be investigated. Issues to be addressed include the manufacturability and regulation status of formulation approaches employing mesoporous silica to enhance drug dissolution. While more research is needed to support the move of this technology from the bench to a commercial medicinal product, it is a realistic prospect for the near future.

  15. 21 CFR 108.12 - Manufacturing, processing, or packing without a permit, or in violation of a permit.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Manufacturing, processing, or packing without a permit, or in violation of a permit. 108.12 Section 108.12 Food and Drugs FOOD AND DRUG ADMINISTRATION... General Provisions § 108.12 Manufacturing, processing, or packing without a permit, or in violation of a...

  16. Fine pitch thermosonic wire bonding: analysis of state-of-the-art manufacturing capability

    Science.gov (United States)

    Cavasin, Daniel

    1995-09-01

    A comprehensive process characterization was performed at the Motorola plastic package assembly site in Selangor, Malaysia, to document the current fine pitch wire bond process capability, using state-of-the-art equipment, in an actual manufacturing environment. Two machines, representing the latest technology from two separate manufacturers, were operated one shift per day for five days, bonding a 132 lead Plastic Quad Flat Pack. Using a test device specifically designed for fine pitch wire bonding, the bonding programs were alternated between 107 micrometers and 92 micrometers pad pitch, running each pitch for a total of 1600 units per machine. Wire, capillary type, and related materials were standardized and commercially available. A video metrology measurement system, with a demonstrated six sigma repeatability band width of 0.51 micrometers , was utilized to measure the bonded units for bond dimensions and placement. Standard Quality Assurance (QA) metrics were also performed. Results indicate that state-of-the-art thermosonic wire bonding can achieve acceptable assembly yields at these fine pad pitches.

  17. Migration of nonylphenol from food-grade plastic is toxic to the coral reef fish species Pseudochromis fridmani.

    Science.gov (United States)

    Hamlin, Heather J; Marciano, Kathleen; Downs, Craig A

    2015-11-01

    Nonylphenol (NP) is a non-ionic surfactant used extensively in industrial applications, personal care products, and many plastics. We exposed marine orchid dottybacks (Pseudochromis fridmani) for 48h to either glass, Teflon, or two bags labeled as FDA food-grade polyethylene (PE1 and PE2) from different manufacturers. The PE2 bags leached high levels of NP into the contact water, which were taken up by the fish, and decreased short and long-term survival. Concentrations of NP that leached from the bags were consistent with 96h LC50 values determined in this study, indicating NP is the likely toxic agent. Despite being similarly labeled, the NP concentrations that leached from the bags and the resultant toxicity to the fish varied dramatically between manufacturers. This study highlights that some plastics, labeled as food-safe, can be highly toxic to aquatic animals, and could pose a greater threat to humans than previously realized. This study also highlights risks for aquatic animals exposed to increasing quantities of plastic waste. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. Structural Color for Additive Manufacturing: 3D-Printed Photonic Crystals from Block Copolymers.

    Science.gov (United States)

    Boyle, Bret M; French, Tracy A; Pearson, Ryan M; McCarthy, Blaine G; Miyake, Garret M

    2017-03-28

    The incorporation of structural color into 3D printed parts is reported, presenting an alternative to the need for pigments or dyes for colored parts produced through additive manufacturing. Thermoplastic build materials composed of dendritic block copolymers were designed, synthesized, and used to additively manufacture plastic parts exhibiting structural color. The reflection properties of the photonic crystals arise from the periodic nanostructure formed through block copolymer self-assembly during polymer processing. The wavelength of reflected light could be tuned across the visible spectrum by synthetically controlling the block copolymer molecular weight and manufacture parts that reflected violet, green, or orange light with the capacity to serve as selective optical filters and light guides.

  19. Neuromodulatory neurotransmitters influence LTP-like plasticity in human cortex: a pharmaco-TMS study.

    Science.gov (United States)

    Korchounov, Alexei; Ziemann, Ulf

    2011-08-01

    Long-term potentiation (LTP) of synaptic efficacy is considered a fundamental mechanism of learning and memory. At the cellular level a large body of evidence demonstrated that the major neuromodulatory neurotransmitters dopamine (DA), norepinephrine (NE), and acetylcholine (ACh) influence LTP magnitude. Noninvasive brain stimulation protocols provide the opportunity to study LTP-like plasticity at the systems level of human cortex. Here we applied paired associative stimulation (PAS) to induce LTP-like plasticity in the primary motor cortex of eight healthy subjects. In a double-blind, randomized, placebo-controlled, crossover design, the acute effects of a single oral dose of the neuromodulatory drugs cabergoline (DA agonist), haloperidol (DA antagonist), methylphenidate (indirect NE agonist), prazosine (NE antagonist), tacrine (ACh agonist), and biperiden (ACh antagonist) on PAS-induced LTP-like plasticity were examined. The antagonists haloperidol, prazosine, and biperiden depressed significantly the PAS-induced LTP-like plasticity observed under placebo, whereas the agonists cabergoline, methylphenidate, and tacrine had no effect. Findings demonstrate that antagonists in major neuromodulatory neurotransmitter systems suppress LTP-like plasticity at the systems level of human cortex, in accord with evidence of their modulating action of LTP at the cellular level. This provides further supportive evidence for the known detrimental effects of these drugs on LTP-dependent mechanisms such as learning and memory.

  20. 78 FR 46372 - Manufacturer of Controlled Substances; Notice of Registration; Research Triangle Institute

    Science.gov (United States)

    2013-07-31

    ... bulk manufacturer of the following basic classes of controlled substances: Drug Schedule Marihuana (7360) I Cocaine (9041) II The Institute will manufacture marihuana, and cocaine derivatives for use by...

  1. Payer and Pharmaceutical Manufacturer Considerations for Outcomes-Based Agreements in the United States.

    Science.gov (United States)

    Brown, Joshua D; Sheer, Rich; Pasquale, Margaret; Sudharshan, Lavanya; Axelsen, Kirsten; Subedi, Prasun; Wiederkehr, Daniel; Brownfield, Fred; Kamal-Bahl, Sachin

    2018-01-01

    Considerable interest exists among health care payers and pharmaceutical manufacturers in designing outcomes-based agreements (OBAs) for medications for which evidence on real-world effectiveness is limited at product launch. To build hypothetical OBA models in which both payer and manufacturer can benefit. Models were developed for a hypothetical hypercholesterolemia OBA, in which the OBA was assumed to increase market access for a newly marketed medication. Fixed inputs were drug and outcome event costs from the literature over a 1-year OBA period. Model estimates were developed using a range of inputs for medication effectiveness, medical cost offsets, and the treated population size. Positive or negative feedback to the manufacturer was incorporated on the basis of expectations of drug performance through changes in the reimbursement level. Model simulations demonstrated that parameters had the greatest impact on payer cost and manufacturer reimbursement. Models suggested that changes in the size of the population treated and drug effectiveness had the largest influence on reimbursement and costs. Despite sharing risk for potential product underperformance, manufacturer reimbursement increased relative to having no OBA, if the OBA improved market access for the new product. Although reduction in medical costs did not fully offset the cost of the medication, the payer could still save on net costs per patient relative to having no OBA by tying reimbursement to drug effectiveness. Pharmaceutical manufacturers and health care payers have demonstrated interest in OBAs, and under a certain set of assumptions both may benefit. Copyright © 2018 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  2. Manufacturing the truth: From designing clinical trials to publishing trial data.

    Science.gov (United States)

    Whitstock, Margaret

    2018-01-01

    This paper expands on some of the points made by Deepak Natarajan on techniques used in designing clinical trials of new drugs to ensure favourable outcomes. It also considers the nexus between the manufacturers of new drugs and the publishers of medical journals in which edited versions of these favourable outcomes are presented to the medical fraternity. The argument will be illustrated by referring to the clinical trials of rofecoxib (Vioxx®) and etoricoxib (Arcoxia®). Both these drugs are COX-2 selective non-steroidal anti-inflammatory drugs (NSAIDs) manufactured by Merck and Co. Because of the unparalleled access to Merck's internal confidential documents, due to the subpoenaing of these documents by government and private individuals in civil and criminal actions, we are still learning about the company's unconscionable acts. What we learn can inform our judgement concerning published reports of both new and old drugs.

  3. Rooting out institutional corruption to manage inappropriate off-label drug use.

    Science.gov (United States)

    Rodwin, Marc A

    2013-01-01

    Prescribing drugs for uses that the FDA has not approved - off-label drug use - can sometimes be justified but is typically not supported by substantial evidence of effectiveness. At the root of inappropriate off-label drug use lie perverse incentives for pharmaceutical firms and flawed oversight of prescribing physicians. Typical reform proposals such as increased sanctions for manufacturers might reduce the incidence of unjustified off-label use, but they do not remove the source of the problem. Public policy should address the cause and control the practice. To manage inappropriate off-label drug use, off-label prescriptions must be tracked in order to monitor the risks and benefits and the manufacturers' conduct. Even more important, reimbursement rules should be changed so that manufacturers cannot profit from off-label sales. When off-label sales pass a critical threshold, manufacturers should also be required to pay for independent testing of the safety and effectiveness of off-label drug uses and for the FDA to review the evidence. Manufacturers should also finance, under FDA supervision, programs designed to warn physicians and the public about the risks of off-label drug use. © 2013 American Society of Law, Medicine & Ethics, Inc.

  4. Effect of indoor climate on the rate and degradation mechanism of plasticized poly (vinyl chloride)

    DEFF Research Database (Denmark)

    Shashoua, Yvonne

    2003-01-01

    Many PVC materials deteriorate only 5 years after manufacture. The extent, rate and mechanisms of deterioration of model and naturally aged PVC containing di (2-ethylhexyl) phthalate (DEHP), have been examined during thermal ageing in various environments. Weight loss was used to quantify loss...... inhibited degradation of the PVC polymer, therefore when it was lost, discolouration, tackiness and embrittlement resulted. Less plasticized materials degraded more rapidly than those more highly plasticized. Degradation was inhibited in both model sheets and naturally aged materials by enclosing them...

  5. Advantages of utilizing DMD based rapid manufacturing systems in mass customization applications

    Science.gov (United States)

    El-Siblani, A.

    2010-02-01

    The Use of DMD based Rapid Manufacturing Systems has proven to be very advantageous in the production of highly accurate plastic based components for use in mass customization market such as hearing aids, and dental markets. The voxelization process currently afforded with the DLP technology eliminates any layering effect associated with all existing additive Rapid Manufacturing technologies. The smooth accurate surfaces produced in an additive process utilizing DLP technology, through the voxelization approach, allow for the production of custom finished products. The implementation of DLP technology in rapid prototyping and rapid manufacturing systems allow for the usage of highly viscous photopolymer based liquid and paste composites for rapid manufacturing that could not be used in any other additive process prior to implementation of DLP technology in RP and RM systems. It also allowed for the greater throughput in production without sacrificing quality and accuracy.

  6. Cutting prepregs, cutting and processing polymer plastics in the manufacture of airсraft panels

    OpenAIRE

    MELUKHOV NIKITA; GRISHCHENKO TATIANA; LYUBUSHKIN VADIM

    2017-01-01

    The article presents an alternative to the solution of the problem of reduction of manual operations in manufacture. It may be achieved if cutting out prepregs and processing polymeric materials (PMP) be changed for sharp ultrasonic cutting when manufacturing components from polymeric composite materials (PCM). Described are the lines of investigations on new techniques of cutting out prepreg and processings polymeric material of the Nomex type with the use of the energy of ultrasonic waves. ...

  7. Cancer Stem Cell Plasticity Drives Therapeutic Resistance

    Directory of Open Access Journals (Sweden)

    Mary R. Doherty

    2016-01-01

    Full Text Available The connection between epithelial-mesenchymal (E-M plasticity and cancer stem cell (CSC properties has been paradigm-shifting, linking tumor cell invasion and metastasis with therapeutic recurrence. However, despite their importance, the molecular pathways involved in generating invasive, metastatic, and therapy-resistant CSCs remain poorly understood. The enrichment of cells with a mesenchymal/CSC phenotype following therapy has been interpreted in two different ways. The original interpretation posited that therapy kills non-CSCs while sparing pre-existing CSCs. However, evidence is emerging that suggests non-CSCs can be induced into a transient, drug-tolerant, CSC-like state by chemotherapy. The ability to transition between distinct cell states may be as critical for the survival of tumor cells following therapy as it is for metastatic progression. Therefore, inhibition of the pathways that promote E-M and CSC plasticity may suppress tumor recurrence following chemotherapy. Here, we review the emerging appreciation for how plasticity confers therapeutic resistance and tumor recurrence.

  8. 21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

    Science.gov (United States)

    2010-04-01

    ....122 Medical devices for processing, repacking, or manufacturing. A device intended for processing... act if its label bears the statement “Caution: For manufacturing, processing, or repacking”. ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices for processing, repacking, or...

  9. 21 CFR 178.3910 - Surface lubricants used in the manufacture of metallic articles.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Surface lubricants used in the manufacture of... lubricants used in the manufacture of metallic articles. The substances listed in this section may be safely used in surface lubricants employed in the manufacture of metallic articles that contact food, subject...

  10. Technical note: Computer-manufactured inserts for prosthetic sockets.

    Science.gov (United States)

    Sanders, Joan E; McLean, Jake B; Cagle, John C; Gardner, David W; Allyn, Katheryn J

    2016-08-01

    The objective of this research was to use computer-aided design software and a tabletop 3-D additive manufacturing system to design and fabricate custom plastic inserts for trans-tibial prosthesis users. Shape quality of inserts was tested right after they were inserted into participant's test sockets and again after four weeks of wear. Inserts remained properly positioned and intact throughout testing. Right after insertion the inserts caused the socket to be slightly under-sized, by a mean of 0.11mm, approximately 55% of the thickness of a nylon sheath. After four weeks of wear the under-sizing was less, averaging 0.03mm, approximately 15% of the thickness of a nylon sheath. Thus the inserts settled into the sockets over time. If existing prosthetic design software packages were enhanced to conduct insert design and to automatically generate fabrication files for manufacturing, then computer manufactured inserts may offer advantages over traditional methods in terms of speed of fabrication, ease of design, modification, and record keeping. Copyright © 2016 IPEM. Published by Elsevier Ltd. All rights reserved.

  11. Effect of Plastic Deformation on the Corrosion Behavior of a Super-Duplex Stainless Steel

    Science.gov (United States)

    Renton, Neill C.; Elhoud, Abdu M.; Deans, William F.

    2011-04-01

    The role of plastic deformation on the corrosion behavior of a 25Cr-7Ni super-duplex stainless steel (SDSS) in a 3.5 wt.% sodium chloride solution at 90 °C was investigated. Different levels of plastic strain between 4 and 16% were applied to solution annealed tensile specimens and the effect on the pitting potential measured using potentiodynamic electrochemical techniques. A nonlinear relationship between the pitting potential and the plastic strain was recorded, with 8 and 16% causing a significant reduction in average E p, but 4 and 12% causing no significant change when compared with the solution-annealed specimens. The corrosion morphology revealed galvanic interaction between the anodic ferrite and the cathodic austenite causing preferential dissolution of the ferrite. Mixed potential theory and the changing surface areas of the two phases caused by the plastic deformation structures explain the reductions in pitting potential at certain critical plastic strain levels. End-users and manufacturers should evaluate the corrosion behavior of specific cold-worked duplex and SDSSs using their as-produced surface finishes assessing in-service corrosion performance.

  12. Comparison of digoxin concentration in plastic serum tubes with clot activator and heparinized plasma tubes.

    Science.gov (United States)

    Dukić, Lora; Simundić, Ana-Maria; Malogorski, Davorin

    2014-01-01

    Sample type recommended by the manufacturer for the digoxin Abbott assay is either serum collected in glass tubes or plasma (sodium heparin, lithium heparin, citrate, EDTA or oxalate as anticoagulant) collected in plastic tubes. In our hospital samples are collected in plastic tubes. Our hypothesis was that the serum sample collected in plastic serum tube can be used interchangeably with plasma sample for measurement of digoxin concentration. Our aim was verification of plastic serum tubes for determination of digoxin concentration. Concentration of digoxin was determined simultaneously in 26 venous blood plasma (plastic Vacuette, LH Lithium heparin) and serum (plastic Vacuette, Z Serum Clot activator; both Greiner Bio-One GmbH, Kremsmünster, Austria) samples, on Abbott AxSYM analyzer using the original Abbott Digoxin III assay (Abbott, Wiesbaden, Germany). Tube comparability was assessed using the Passing Bablok regression and Bland-Altman plot. Serum and plasma digoxin concentrations are comparable. Passing Bablok intercept (0.08 [95% CI = -0.10 to 0.20]) and slope (0.99 [95% CI = 0.92 to 1.11]) showed there is no constant or proportional error. Blood samples drawn in plastic serum tubes and plastic plasma tubes can be interchangeably used for determination of digoxin concentration.

  13. Integrated hot-melt extrusion - injection molding continuous tablet manufacturing platform: Effects of critical process parameters and formulation attributes on product robustness and dimensional stability.

    Science.gov (United States)

    Desai, Parind M; Hogan, Rachael C; Brancazio, David; Puri, Vibha; Jensen, Keith D; Chun, Jung-Hoon; Myerson, Allan S; Trout, Bernhardt L

    2017-10-05

    This study provides a framework for robust tablet development using an integrated hot-melt extrusion-injection molding (IM) continuous manufacturing platform. Griseofulvin, maltodextrin, xylitol and lactose were employed as drug, carrier, plasticizer and reinforcing agent respectively. A pre-blended drug-excipient mixture was fed from a loss-in-weight feeder to a twin-screw extruder. The extrudate was subsequently injected directly into the integrated IM unit and molded into tablets. Tablets were stored in different storage conditions up to 20 weeks to monitor physical stability and were evaluated by polarized light microscopy, DSC, SEM, XRD and dissolution analysis. Optimized injection pressure provided robust tablet formulations. Tablets manufactured at low and high injection pressures exhibited the flaws of sink marks and flashing respectively. Higher solidification temperature during IM process reduced the thermal induced residual stress and prevented chipping and cracking issues. Polarized light microscopy revealed a homogeneous dispersion of crystalline griseofulvin in an amorphous matrix. DSC underpinned the effect of high tablet residual moisture on maltodextrin-xylitol phase separation that resulted in dimensional instability. Tablets with low residual moisture demonstrated long term dimensional stability. This study serves as a model for IM tablet formulations for mechanistic understanding of critical process parameters and formulation attributes required for optimal product performance. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. Documentation of pediatric drug safety in manufacturers' product monographs: a cross-sectional evaluation of the canadian compendium of pharmaceuticals and specialities.

    Science.gov (United States)

    Uppal, Navjeet K; Dupuis, Lee L; Parshuram, Christopher S

    2008-01-01

    To describe the provision of pediatric drug safety information in a national formulary of manufacturers' drug product monographs. We performed a cross-sectional evaluation of comprehensive product monographs contained in the 2005 Canadian Compendium of Pharmaceuticals and Specialities (CPS). We abstracted data describing indications for prescription, statements about pediatric safety, available preparations, and provision of dosing guidelines. For each monograph we classified pediatric safety data as either present, present but limited or absent. We then described the pediatric safety data in CPS monographs for drugs listed in the published formulary of the Hospital for Sick Children, Toronto, Ontario, Canada. A total of 2232 product monographs were screened; 684 were excluded and 1548 (66%) were further analyzed. 1462 (94%) had indications that did not exclude children. Pediatric safety information was present in 592 (38%), present but limited in 148 (10%), and absent in 808 (52%) drug monographs. Safety statements were absent in 224 (14%) drug monographs that provided both dosing guidelines and formulations suitable for administration to children, and in 214 (52%) of 411 drugs in the pediatric hospital formulary. We evaluated a widely available national source of pediatric prescribing information. Safety data for children was not mentioned in more than half of the product monographs. Moreover, the provision of safety data was discordant with indications for prescription, the availability of pediatric formulations, and dosing guidelines within the monographs, and with inclusion in a pediatric hospital formulary. Our study suggests that the presentation of pediatric safety data in drug product monographs can be improved to better inform prescribing and to optimize pharmacotherapy in children.

  15. 21 CFR 201.100 - Prescription drugs for human use.

    Science.gov (United States)

    2010-04-01

    ... which it is possible to determine the complete manufacturing history of the package of the drug. (7) A... which the manufacturer's original package is designed and intended to be dispensed to patients without..., or graphic matter containing no representation or suggestion relating to the drug product. If the...

  16. A high performance, high precision, low cost rapid prototyping and manufacturing technology

    OpenAIRE

    Viacheslav R. Shulunov

    2014-01-01

    A novel roll powder sintering (RPS) technology is proposed for processing real plastic, ceramic, metal and other 3-D objects 1m³ (or more) in volume directly from a CAD model within several hours. The breakthrough advantages of the technology are compared to the dominant rapid prototyping and manufacturing (RP&M) processes that are currently on the market.

  17. 78 FR 69133 - Drug Enforcement Administration

    Science.gov (United States)

    2013-11-18

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances..., California 94085, made application by renewal to the Drug Enforcement Administration (DEA) to be registered... Diversion Control, Drug Enforcement Administration. [FR Doc. 2013-27486 Filed 11-15-13; 8:45 am] BILLING...

  18. The generic drug user fee amendments: an economic perspective

    Science.gov (United States)

    Berndt, Ernst R; Murphy, Stephen J

    2018-01-01

    Abstract Since the vast majority of prescription drugs consumed by Americans are off patent (‘generic’), their regulation and supply is of wide interest. We describe events leading up to the US Congress's 2012 passage of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act (FDASIA). Under GDUFA I, generic manufacturers agreed to pay approximately $300 million in fees each year of the five-year program. In exchange, the US Food and Drug Administration (FDA) committed to performance goals. We describe GDUFA I’s FDA commitments, provisions, goals, and annual fee structure and compare it to that entailed in the authorization and implementation of GDUFA II on October 1, 2017. We explain how user fees required under GDUFA I erected barriers to entry and created scale and scope economies for incumbent manufacturers. Congress changed user fees under GDUFA II in part to lessen these incentives. In order to initiate and sustain user fees under GDUFA legislation, FDA requires the submission of self-reported data on generic manufacturers including domestic and foreign facilities. These data are public and our examination of them provides an unprecedented window into the recent organization of generic drug manufacturers supplying the US market. Our results suggest that generic drug manufacturing is increasingly concentrated and foreign. We discuss the implications of this observed market structure for GDUFA II’s implementation among other outcomes. PMID:29707218

  19. ENVIRONMENTAL RESEARCH BRIEF: WASTE MINIMIZATION ASSESSMENT FOR A MANUFACTURER OF PRINTED PLASTIC BAGS

    Science.gov (United States)

    The U.S. Environmental Protection Agency (EPA) has funded a pilot project to assist small- and medium-size manufacturers who want to minimize their generation of hazardous waste but who lack the expertise to do so. Waste Minimization Assessment Centers (WMACs) were established ...

  20. Bioprinting: an assessment based on manufacturing readiness levels.

    Science.gov (United States)

    Wu, Changsheng; Wang, Ben; Zhang, Chuck; Wysk, Richard A; Chen, Yi-Wen

    2017-05-01

    Over the last decade, bioprinting has emerged as a promising technology in the fields of tissue engineering and regenerative medicine. With recent advances in additive manufacturing, bioprinting is poised to provide patient-specific therapies and new approaches for tissue and organ studies, drug discoveries and even food manufacturing. Manufacturing Readiness Level (MRL) is a method that has been applied to assess manufacturing maturity and to identify risks and gaps in technology-manufacturing transitions. Technology Readiness Level (TRL) is used to evaluate the maturity of a technology. This paper reviews recent advances in bioprinting following the MRL scheme and addresses corresponding MRL levels of engineering challenges and gaps associated with the translation of bioprinting from lab-bench experiments to ultimate full-scale manufacturing of tissues and organs. According to our step-by-step TRL and MRL assessment, after years of rigorous investigation by the biotechnology community, bioprinting is on the cusp of entering the translational phase where laboratory research practices can be scaled up into manufacturing products specifically designed for individual patients.

  1. 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation. Final rule; further delay of effective date.

    Science.gov (United States)

    2017-05-19

    The Health Resources and Services Administration (HRSA) administers section 340B of the Public Health Service Act (PHSA), referred to as the "340B Drug Pricing Program" or the "340B Program." HRSA published a final rule on January 5, 2017, that set forth the calculation of the ceiling price and application of civil monetary penalties. The final rule applied to all drug manufacturers that are required to make their drugs available to covered entities under the 340B Program. In accordance with a January 20, 2017, memorandum from the Assistant to the President and Chief of Staff, entitled "Regulatory Freeze Pending Review," HRSA issued an interim final rule that delayed the effective date of the final rule published in the Federal Register (82 FR 1210, (January 5, 2017)) to May 22, 2017. HHS invited commenters to provide their views on whether a longer delay of the effective date to October 1, 2017, would be more appropriate. After consideration of the comments received on the interim final rule, HHS is delaying the effective date of the January 5, 2017 final rule, to October 1, 2017.

  2. Plasticity theory

    CERN Document Server

    Lubliner, Jacob

    2008-01-01

    The aim of Plasticity Theory is to provide a comprehensive introduction to the contemporary state of knowledge in basic plasticity theory and to its applications. It treats several areas not commonly found between the covers of a single book: the physics of plasticity, constitutive theory, dynamic plasticity, large-deformation plasticity, and numerical methods, in addition to a representative survey of problems treated by classical methods, such as elastic-plastic problems, plane plastic flow, and limit analysis; the problem discussed come from areas of interest to mechanical, structural, and

  3. The flow properties and presence of crystals in drug-polymer mixtures

    DEFF Research Database (Denmark)

    Aho, J; Van Renterghem, J; Arnfast, L

    2017-01-01

    and ibuprofen with polyethylene oxide and methacrylate copolymer (Eudragit(®) E PO) were observed by polarized microscopy simultaneously while measuring their rheological properties within temperature ranges relevant for melt processes, such as hot melt extrusion and fused deposition modeling 3D printing....... The dissolution of solid crystalline matter into the molten polymer and its effects on the rheological parameters showed that the plasticization effect of the drug was highly dependent on the temperature range, and at a temperature high enough, plasticization induced by the small-molecule drugs could enhance...... morphological changes in the drug-polymer and the flow behavior of the drug-polymer mixtures at different temperature ranges and deformation modes....

  4. Low temperature conversion of plastic waste into light hydrocarbons

    International Nuclear Information System (INIS)

    Shah, Sajid Hussain; Khan, Zahid Mahmood; Raja, Iftikhar Ahmad; Mahmood, Qaisar; Bhatti, Zulfiqar Ahmad; Khan, Jamil; Farooq, Ather; Rashid, Naim; Wu, Donglei

    2010-01-01

    Advance recycling through pyrolytic technology has the potential of being applied to the management of plastic waste (PW). For this purpose 1 l volume, energy efficient batch reactor was manufactured locally and tested for pyrolysis of waste plastic. The feedstock for reactor was 50 g waste polyethylene. The average yield of the pyrolytic oil, wax, pyrogas and char from pyrolysis of PW were 48.6, 40.7, 10.1 and 0.6%, respectively, at 275 deg. C with non-catalytic process. Using catalyst the average yields of pyrolytic oil, pyrogas, wax and residue (char) of 50 g of PW was 47.98, 35.43, 16.09 and 0.50%, respectively, at operating temperature of 250 deg. C. The designed reactor could work at low temperature in the absence of a catalyst to obtain similar products as for a catalytic process.

  5. Designing Business Solutions for Plastic Waste Management to Enhance Circular Transitions in Kenya

    Directory of Open Access Journals (Sweden)

    Balint Horvath

    2018-05-01

    Full Text Available Least-developed countries face many challenges regarding their plastic waste management systems. In 2017, Kenya imposed a selective ban targeting manufacturers and consumers of plastic carrier bags. However, this selectivity does not avoid the continuous use of other plastic products. The present paper states that circular priorities, which have been defined to advanced economies, would not be entirely valid for the rest of the world. While high-income countries face only the impacts of their own consumption, developing nations must endure the externalities of these developed economies. Thus, the focus of the least developed part of the world must not be on reducing its relatively normal (or even low consumption, but to manage its surplus material flow. According to the employed circular evaluation methodology (CEV—Circular Economic Value, the circularity level in Kenya’s plastic material flow stands on a rather low stage with 32.72%. This result outlines the linear deficiencies of the plastic waste management system and urges the prevention of further material leakage (such as energy use. Through the Business Model Canvas (BMC approach this study offers a holistic business solution which can improve the system’s sustainability.

  6. Photostability and Photostabilization of Drugs and Drug Products

    OpenAIRE

    Ahmad, Iqbal; Ahmed, Sofia; Anwar, Zubair; Sheraz, Muhammad Ali; Sikorski, Marek

    2016-01-01

    Photostability studies of drugs and drug products are an integral part of the product development process in the pharmaceutical industry. These studies are carried out to ensure quality, efficacy, and safety of the formulated products during manufacture, storage, and use. This review deals with the concept of photostability and related aspects and the literature available in the field. It highlights the role of the photochemistry in the photostability studies, describes the functional groups ...

  7. Mesoporous Silica Molecular Sieve based Nanocarriers: Transpiring Drug Dissolution Research.

    Science.gov (United States)

    Pattnaik, Satyanarayan; Pathak, Kamla

    2017-01-01

    Improvement of oral bioavailability through enhancement of dissolution for poorly soluble drugs has been a very promising approach. Recently, mesoporous silica based molecular sieves have demonstrated excellent properties to enhance the dissolution velocity of poorly water-soluble drugs. Current research in this area is focused on investigating the factors influencing the drug release from these carriers, the kinetics of drug release and manufacturing approaches to scale-up production for commercial manufacture. This comprehensive review provides an overview of different methods adopted for synthesis of mesoporous materials, influence of processing factors on properties of these materials and drug loading methods. The drug release kinetics from mesoporous silica systems, the manufacturability and stability of these formulations are reviewed. Finally, the safety and biocompatibility issues related to these silica based materials are discussed. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

  8. Nanosecond multi-pulse laser milling for certain area removal of metal coating on plastics surface

    Science.gov (United States)

    Zhao, Kai; Jia, Zhenyuan; Ma, Jianwei; Liu, Wei; Wang, Ling

    2014-12-01

    Metal coating with functional pattern on engineering plastics surface plays an important role in industry applications; it can be obtained by adding or removing certain area of metal coating on engineering plastics surface. However, the manufacturing requirements are improved continuously and the plastic substrate presents three-dimensional (3D) structure-many of these parts cannot be fabricated by conventional processing methods, and a new manufacturing method is urgently needed. As the laser-processing technology has many advantages like high machining accuracy and constraints free substrate structure, the machining of the parts is studied through removing certain area of metal coating based on the nanosecond multi-pulse laser milling. To improve the edge quality of the functional pattern, generation mechanism and corresponding avoidance strategy of the processing defects are studied. Additionally, a prediction model for the laser ablation depth is proposed, which can effectively avoid the existence of residual metal coating and reduces the damage of substrate. With the optimal machining parameters, an equiangular spiral pattern on copper-clad polyimide (CCPI) is machined based on the laser milling at last. The experimental results indicate that the edge of the pattern is smooth and consistent, the substrate is flat and without damage. The achievements in this study could be applied in industrial production.

  9. PVMaT improvements in the manufacturing of the PVI Powergrid{trademark}: Phase I annual technical report, 26 October 1995--25 October 1996

    Energy Technology Data Exchange (ETDEWEB)

    Kaminar, N; Curchod, D; Hobden, P [Photovoltaics International, LLC (PVI), Sunnyvale, CA (United States); and others

    1997-05-01

    The PVI Powergrid is a linear focus concentrator which uses low-cost components and manufacturing techniques that are intended to reduce the price of a photovoltaic system to a level required for broad level deployment of PV. The Powergrid uses a linear-focus Fresnel lens made by a plastic extrusion process, the lowest cost method of manufacturing. The plastic module sides are also extruded. The Powergrid uses solar cells manufactured using the low-cost methods used for one-sun cells. Twelve modules are mounted on a stationary panel frame to move in unison for single-axis tracking. The components for the Powergrid have been shown to be low cost. Reducing the cost of manufacturing the Powergrid, while increasing the output and reliability, are key to reaching the strategic goals of the company. During a project sponsored in part under contracts with Sandia National Laboratories and the California Energy Commission, PVI developed a pilot production facility. The company was able to demonstrate 830 KW/yr production capability, but several manufacturing areas were discovered that needed additional development. This resulted in the formulation of PVI`s PVMaT program.

  10. 77 FR 75670 - Manufacturer of Controlled Substances, Notice of Registration, AMRI Rensselaer, Inc.

    Science.gov (United States)

    2012-12-21

    ... bulk manufacturer of the following basic classes of controlled substances: Drug Schedule Marihuana... development and for distribution to its customers. In reference to drug code 7360 (Marihuana), the company...

  11. Cold surface treatments on fiber-reinforced plastics by pulsed laser

    OpenAIRE

    Gebauer, Jana; Franke, Volker; Klotzbach, Udo; Beyer, Eckhard

    2017-01-01

    The importance of lightweight materials increases in all aspects of manufacturing, e.g. automotive, sports equipment and aerospace [1]. Making fiber reinforced plastics suitable for use in mass production new technologies have to be developed to overcome existing challenges e.g. shorter cycle times or more efficient resource usage. Innovative laser systems are used for a full range of treatments for all materials, like structuring, drilling, joining and cutting [2] - [4]. This paper presents ...

  12. Emerging Applications of Bedside 3D Printing in Plastic Surgery

    OpenAIRE

    Chae, Michael P.; Rozen, Warren M.; McMenamin, Paul G.; Findlay, Michael W.; Spychal, Robert T.; Hunter-Smith, David J.

    2015-01-01

    Modern imaging techniques are an essential component of preoperative planning in plastic and reconstructive surgery. However, conventional modalities, including three-dimensional (3D) reconstructions, are limited by their representation on 2D workstations. 3D printing, also known as rapid prototyping or additive manufacturing, was once the province of industry to fabricate models from a computer-aided design (CAD) in a layer-by-layer manner. The early adopters in clinical practice have embrac...

  13. Trends in Non-prescription Drug Recalls in Japan.

    Science.gov (United States)

    Yamamoto, Chikoto; Ishida, Takuya; Osawa, Takashi; Naito, Takafumi; Kawakami, Junichi

    2016-01-01

    Recalls of non-prescription drugs can contribute to preventing harm to human health, however, they also interrupt the supply of medicines to the market. The aim of the present study was to investigate the trends in non-prescription drug recalls in Japan. Class I, II, and III recalls reported from April 2009 to March 2014 were obtained from the websites of the Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency. Each drug recall was classified according to year, dosage form, therapeutic category, and reasons for the recall. The trends over the 5 year period were assessed for each class. A total of 220 recalls were reported in the 5-year study period. The numbers of drug recalls were 21, 16, 80, 58, and 45 in 2009, 2010, 2011, 2012, and 2013, respectively. The drugs recalled consisted of 177 internal medications, 35 topical agents, and 8 others. Drug recalls were observed in 12 therapeutic categories of drug effects. The largest number of recalls was for Chinese herbal medicines and crude drugs. Of all the drug recalls in 2011, Chinese herbal medicines and crude drugs produced by one manufacturer accounted for 84%. Slightly more than half (54%) of drug recalls were due to a violation of the regulations. One manufacturer recalled many drugs because of non-compliance with the standard regulations for manufacturing drugs after 2011. In conclusion, non-prescription drug recalls can occur for any drug regardless of the dosage form and therapeutic category.

  14. Printed Proliferation: The Implications of Additive Manufacturing and Nuclear Weapons Proliferation

    Energy Technology Data Exchange (ETDEWEB)

    Lindsey, Nicholas C. [Pacific Northwest National Lab. (PNNL), Richland, WA (United States)

    2016-01-26

    The growth of additive manufacturing as a disruptive technology poses nuclear proliferation concerns worthy of serious consideration. Additive manufacturing began in the early 1980s with technological advances in polymer manipulation, computer capabilities, and computer-aided design (CAD) modeling. It was originally limited to rapid prototyping; however, it eventually developed into a complete means of production that has slowly penetrated the consumer market. Today, additive manufacturing machines can produce complex and unique items in a vast array of materials including plastics, metals, and ceramics. These capabilities have democratized the manufacturing industry, allowing almost anyone to produce items as simple as cup holders or as complex as jet fuel nozzles. Additive manufacturing, or three-dimensional (3D) printing as it is commonly called, relies on CAD files created or shared by individuals with additive manufacturing machines to produce a 3D object from a digital model. This sharing of files means that a 3D object can be scanned or rendered as a CAD model in one country, and then downloaded and printed in another country, allowing items to be shared globally without physically crossing borders. The sharing of CAD files online has been a challenging task for the export controls regime to manage over the years, and additive manufacturing could make these transfers more common. In this sense, additive manufacturing is a disruptive technology not only within the manufacturing industry but also within the nuclear nonproliferation world. This paper provides an overview of additive manufacturing concerns of proliferation.

  15. 77 FR 14022 - Guidance for Industry on Chemistry, Manufacturing, and Controls Information-Fermentation-Derived...

    Science.gov (United States)

    2012-03-08

    ...] Guidance for Industry on Chemistry, Manufacturing, and Controls Information--Fermentation-Derived... (CMC) Information-- Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products for... to submit to support the CMC information for fermentation-derived intermediates, drug substances, and...

  16. 75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-08-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...

  17. 78 FR 16824 - Tobacco Product Manufacturing Practice; Establishment of a Public Docket

    Science.gov (United States)

    2013-03-19

    ... manufacturing operations. DATES: Submit electronic or written comments on the tobacco companies' recommendations... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Chapter I [Docket No. FDA-2013-N-0227] Tobacco Product Manufacturing Practice; Establishment of a Public Docket AGENCY: Food...

  18. Examining the production costs of antiretroviral drugs.

    Science.gov (United States)

    Pinheiro, Eloan; Vasan, Ashwin; Kim, Jim Yong; Lee, Evan; Guimier, Jean Marc; Perriens, Joseph

    2006-08-22

    To present direct manufacturing costs and price calculations of individual antiretroviral drugs, enabling those responsible for their procurement to have a better understanding of the cost structure of their production, and to indicate the prices at which these antiretroviral drugs could be offered in developing country markets. Direct manufacturing costs and factory prices for selected first and second-line antiretroviral drugs were calculated based on cost structure data from a state-owned company in Brazil. Prices for the active pharmaceutical ingredients (API) were taken from a recent survey by the World Health Organization (WHO). The calculated prices for antiretroviral drugs are compared with quoted prices offered by privately-owned, for-profit manufacturers. The API represents the largest component of direct manufacturing costs (55-99%), while other inputs, such as salaries, equipment costs, and scale of production, have a minimal impact. The calculated prices for most of the antiretroviral drugs studied fall within the lower quartile of the range of quoted prices in developing country markets. The exceptions are those drugs, primarily for second-line therapy, for which the API is either under patent, in short supply, or in limited use in developing countries (e.g. abacavir, lopinavir/ritonavir, nelfinavir, saquinavir). The availability of data on the cost of antiretroviral drug production and calculation of factory prices under a sustainable business model provide benchmarks that bulk purchasers of antiretroviral drugs could use to negotiate lower prices. While truly significant price decreases for antiretroviral drugs will depend largely on the future evolution of API prices, the present study demonstrates that for several antiretroviral drugs price reduction is currently possible. Whether or not these reductions materialize will depend on the magnitude of indirect cost and profit added by each supplier over the direct production costs. The ability to

  19. Magical Engineering Plastic

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Gwang Ung

    1988-01-15

    This book introduces engineering plastic about advantage of engineering plastic, plastic material from processing method, plastic shock, plastic until now, background of making of engineering plastic, wonderful engineering plastic science such as a high molecule and molecule, classification of high molecule, difference between metal and high molecule, heat and high molecule materials, and property of surface, engineering plastic of dream like from linseed oil to aramid, small dictionary of engineering plastic.

  20. Magical Engineering Plastic

    International Nuclear Information System (INIS)

    Kim, Gwang Ung

    1988-01-01

    This book introduces engineering plastic about advantage of engineering plastic, plastic material from processing method, plastic shock, plastic until now, background of making of engineering plastic, wonderful engineering plastic science such as a high molecule and molecule, classification of high molecule, difference between metal and high molecule, heat and high molecule materials, and property of surface, engineering plastic of dream like from linseed oil to aramid, small dictionary of engineering plastic.

  1. Contour scanning of textile preforms using a light-section sensor for the automated manufacturing of fibre-reinforced plastics

    Science.gov (United States)

    Schmitt, R.; Niggemann, C.; Mersmann, C.

    2008-04-01

    Fibre-reinforced plastics (FRP) are particularly suitable for components where light-weight structures with advanced mechanical properties are required, e.g. for aerospace parts. Nevertheless, many manufacturing processes for FRP include manual production steps without an integrated quality control. A vital step in the process chain is the lay-up of the textile preform, as it greatly affects the geometry and the mechanical performance of the final part. In order to automate the FRP production, an inline machine vision system is needed for a closed-loop control of the preform lay-up. This work describes the development of a novel laser light-section sensor for optical inspection of textile preforms and its integration and validation in a machine vision prototype. The proposed method aims at the determination of the contour position of each textile layer through edge scanning. The scanning route is automatically derived by using texture analysis algorithms in a preliminary step. As sensor output a distinct stage profile is computed from the acquired greyscale image. The contour position is determined with sub-pixel accuracy using a novel algorithm based on a non-linear least-square fitting to a sigmoid function. The whole contour position is generated through data fusion of the measured edge points. The proposed method provides robust process automation for the FRP production improving the process quality and reducing the scrap quota. Hence, the range of economically feasible FRP products can be increased and new market segments with cost sensitive products can be addressed.

  2. 76 FR 13629 - Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information-Fermentation...

    Science.gov (United States)

    2011-03-14

    ...] Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Information--Fermentation-Derived... Controls (CMC) Information-- Fermentation-Derived Intermediates, Drug Substances, and Related Drug Products... documentation to submit to support the CMC information for fermentation-derived intermediates, drug substances...

  3. High drug load, stable, manufacturable and bioavailable fenofibrate formulations in mesoporous silica: a comparison of spray drying versus solvent impregnation methods.

    Science.gov (United States)

    Hong, Shiqi; Shen, Shoucang; Tan, David Cheng Thiam; Ng, Wai Kiong; Liu, Xueming; Chia, Leonard S O; Irwan, Anastasia W; Tan, Reginald; Nowak, Steven A; Marsh, Kennan; Gokhale, Rajeev

    2016-01-01

    Encapsulation of drugs in mesoporous silica using co-spray drying process has been recently explored as potential industrial method. However, the impact of spray drying on manufacturability, physiochemical stability and bioavailability in relation to conventional drug load processes are yet to be fully investigated. Using a 2(3) factorial design, this study aims to investigate the effect of drug-loading process (co-spray drying and solvent impregnation), mesoporous silica pore size (SBA-15, 6.5 nm and MCM-41, 2.5 nm) and percentage drug load (30% w/w and 50% w/w) on material properties, crystallinity, physicochemical stability, release profiles and bioavailability of fenofibrate (FEN) loaded into mesoporous silica. From the scanning electronic microscopy (SEM) images, powder X-ray diffraction and Differential scanning calorimetry measurements, it is indicated that the co-spray drying process was able to load up to 50% (w/w) FEN in amorphous form onto the mesoporous silica as compared to the 30% (w/w) for solvent impregnation. The in vitro dissolution rate of the co-spray dried formulations was also significantly (p = 0.044) better than solvent impregnated formulations at the same drug loading. Six-month accelerated stability test at 40 °C/75 RH in open dish indicated excellent physical and chemical stability of formulations prepared by both methods. The amorphous state of FEN and the enhanced dissolution profiles were well preserved, and very low levels of degradation were detected after storage. The dog data for the three selected co-spray-dried formulations revealed multiple fold increment in FEN bioavailability compared to the reference crystalline FEN. These results validate the viability of co-spray-dried mesoporous silica formulations with high amorphous drug load as potential drug delivery systems for poorly water soluble drugs.

  4. International policies to reduce plastic marine pollution from single-use plastics (plastic bags and microbeads): A review.

    Science.gov (United States)

    Xanthos, Dirk; Walker, Tony R

    2017-05-15

    Marine plastic pollution has been a growing concern for decades. Single-use plastics (plastic bags and microbeads) are a significant source of this pollution. Although research outlining environmental, social, and economic impacts of marine plastic pollution is growing, few studies have examined policy and legislative tools to reduce plastic pollution, particularly single-use plastics (plastic bags and microbeads). This paper reviews current international market-based strategies and policies to reduce plastic bags and microbeads. While policies to reduce microbeads began in 2014, interventions for plastic bags began much earlier in 1991. However, few studies have documented or measured the effectiveness of these reduction strategies. Recommendations to further reduce single-use plastic marine pollution include: (i) research to evaluate effectiveness of bans and levies to ensure policies are having positive impacts on marine environments; and (ii) education and outreach to reduce consumption of plastic bags and microbeads at source. Copyright © 2017 Elsevier Ltd. All rights reserved.

  5. 78 FR 16684 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-03-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  6. 77 FR 20642 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2012-04-05

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  7. 76 FR 14415 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-03-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  8. 76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

    Science.gov (United States)

    2011-10-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of... Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical...

  9. 76 FR 62419 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-10-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  10. 75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2010-08-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  11. 78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2013-05-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  12. 76 FR 39882 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

    Science.gov (United States)

    2011-07-07

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0478] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

  13. Flexible continuous manufacturing platforms for solid dispersion formulations

    Science.gov (United States)

    Karry-Rivera, Krizia Marie

    In 2013 16,000 people died in the US due to overdose from prescription drugs and synthetic narcotics. As of that same year, 90% of new molecular entities in the pharmaceutical drug pipeline are classified as poor water-soluble. The work in this dissertation aims to design, develop and validate platforms that solubilize weak acids and can potentially deter drug abuse. These platforms are based on processing solid dispersions via solvent-casting and hot-melt extrusion methods to produce oral transmucosal films and melt tablets. To develop these platforms, nanocrystalline suspensions and glassy solutions were solvent-casted in the form of films after physicochemical characterizations of drug-excipient interactions and design of experiment approaches. A second order model was fitted to the emulsion diffusion process to predict average nanoparticle size and for process optimization. To further validate the manufacturing flexibility of the formulations, glassy solutions were also extruded and molded into tablets. This process included a systematic quality-by-design (QbD) approach that served to identify the factors affecting the critical quality attributes (CQAs) of the melt tablets. These products, due to their novelty, lack discriminatory performance tests that serve as predictors to their compliance and stability. Consequently, Process Analytical Technology (PAT) tools were integrated into the continuous manufacturing platform for films. Near-infrared (NIR) spectroscopy, including chemical imaging, combined with deconvolution algorithms were utilized for a holistic assessment of the effect of formulation and process variables on the product's CQAs. Biorelevant dissolution protocols were then established to improve the in-vivo in-vitro correlation of the oral transmucosal films. In conclusion, the work in this dissertation supports the delivery of poor-water soluble drugs in products that may deter abuse. Drug nanocrystals ensured high bioavailability, while glassy

  14. Drug recall: An incubus for pharmaceutical companies and most serious drug recall of history.

    Science.gov (United States)

    Nagaich, Upendra; Sadhna, Divya

    2015-01-01

    There has been an increasing trend in the number of prescribed and over-the-counter drug recall over the last few years. The recall is usually due to company's discovery, customer's complaint or Food and Drug Administration (FDA) observation. The process of recall involves a planned specific course of action, which addresses the depth of recall, need for public warning, and the extent of effectiveness checks for the recall. The FDA review and/or recommend changes to the firm's recall strategy, as appropriate. The critical recall information list includes the identity of the product; summary of the failure; amount of product produced in the distribution chain and direct account. Product recalls clashes thousands of companies every year affecting: sales, testing customer relationships and disrupting supply chains. Drug recall is incubus for pharmaceutical companies. It effects the reputation of the company. The reason for the recall can be divided into two categories: manufacturing affined and safety/efficacy affined. It is essential to follow all the guidelines related to drug development and manufacturing procedure so as to minimize drug recall.

  15. Cortical plasticity as a new endpoint measurement for chronic pain

    Directory of Open Access Journals (Sweden)

    Zhuo Min

    2011-07-01

    Full Text Available Abstract Animal models of chronic pain are widely used to investigate basic mechanisms of chronic pain and to evaluate potential novel drugs for treating chronic pain. Among the different criteria used to measure chronic pain, behavioral responses are commonly used as the end point measurements. However, not all chronic pain conditions can be easily measured by behavioral responses such as the headache, phantom pain and pain related to spinal cord injury. Here I propose that cortical indexes, that indicate neuronal plastic changes in pain-related cortical areas, can be used as endpoint measurements for chronic pain. Such cortical indexes are not only useful for those chronic pain conditions where a suitable animal model is lacking, but also serve as additional screening methods for potential drugs to treat chronic pain in humans. These cortical indexes are activity-dependent immediate early genes, electrophysiological identified plastic changes and biochemical assays of signaling proteins. It can be used to evaluate novel analgesic compounds that may act at peripheral or spinal sites. I hope that these new cortical endpoint measurements will facilitate our search for new, and more effective, pain medicines, and help to reduce false lead drug targets.

  16. Manufacture and Drug Delivery Applications of Silk Nanoparticles.

    Science.gov (United States)

    Wongpinyochit, Thidarat; Johnston, Blair F; Seib, F Philipp

    2016-10-08

    Silk is a promising biopolymer for biomedical and pharmaceutical applications due to its outstanding mechanical properties, biocompatibility and biodegradability, as well its ability to protect and subsequently release its payload in response to a trigger. While silk can be formulated into various material formats, silk nanoparticles are emerging as promising drug delivery systems. Therefore, this article covers the procedures for reverse engineering silk cocoons to yield a regenerated silk solution that can be used to generate stable silk nanoparticles. These nanoparticles are subsequently characterized, drug loaded and explored as a potential anticancer drug delivery system. Briefly, silk cocoons are reverse engineered first by degumming the cocoons, followed by silk dissolution and clean up, to yield an aqueous silk solution. Next, the regenerated silk solution is subjected to nanoprecipitation to yield silk nanoparticles - a simple but powerful method that generates uniform nanoparticles. The silk nanoparticles are characterized according to their size, zeta potential, morphology and stability in aqueous media, as well as their ability to entrap a chemotherapeutic payload and kill human breast cancer cells. Overall, the described methodology yields uniform silk nanoparticles that can be readily explored for a myriad of applications, including their use as a potential nanomedicine.

  17. 75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

    Science.gov (United States)

    2010-01-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice...) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices...

  18. Stabilization of soil using plastic waste

    International Nuclear Information System (INIS)

    Khan, S.A.

    2005-01-01

    The economy in a soil stabilization project depends on the cost of the stabilizing material. Cheaper the stabilizing material, lesser will be the project cost. Specially manufactured geotextiles are successfully being used for soil stabilization, but the cost is higher. In this study, the cuttings of the waste polyethylene shopper bags have been used to stabilize the soil. The polyethylene shopper bags are transformed to cuttings for easy mixing with the soil by conventional methods. The plastic cuttings acted similar to the non-woven geotextile fibers. Different quantities of the shopper bag cuttings were mixed with the soil. The soil was compacted in the California Bearing Ratio (CBR) test molds according to the British Standards. CBR values of the soil with varying quantities of the plastic cuttings were determined both for the un-soaked and soaked conditions. The tests showed significant increase in the CBR values of the stabilized soil under un-soaked conditions. However, the improvement in the CBR values under the soaked condition was comparatively lesser than that of the un-soaked condition. This method of stabilization proved economical due to low cost of the waste shopper bags. (author)

  19. Market power and state costs of HIV/AIDS drugs.

    Science.gov (United States)

    Leibowitz, Arleen A; Sood, Neeraj

    2007-03-01

    We examine whether U.S. states can use their market power to reduce the costs of supplying prescription drugs to uninsured and underinsured persons with HIV through a public program, the AIDS Drug Assistance Program (ADAP). Among states that purchase drugs from manufacturers and distribute them directly to clients, those that purchase a greater volume pay lower average costs per prescription. Among states depending on retail pharmacies to distribute drugs and then claiming rebates from manufacturers, those that contract with smaller numbers of pharmacy networks have lower average costs. Average costs per prescription do not differ between the two purchase methods.

  20. COST ANALYSIS OF LONG ESTABLISHED AND NEWER ORAL ANTIEPILEPTIC DRUGS AVAILABLE IN THE INDIAN MARKET

    Directory of Open Access Journals (Sweden)

    Phatak Abhishek M, Hotwani Jitendra H, Deshmukhkiran R, Panchal Sagar S, Naik Madhura S

    2015-10-01

    Full Text Available Background: Large number of pharmaceutical companies manufactures antiepileptic drugs in India. The price variations among the marketed drugs are wide. Aims: The present study was aimed to find the cost of different oral antiepileptic drugs available in Indian market as monotherapy, combination therapy and number of manufacturing companies for each, to evaluate difference in cost of different brands of same dosage of same active drug by calculating percentage variation of cost. Methods and Materials: Cost of a drug being manufactured by different companies, in the same strength and dosage forms was obtained from “Indian Drug Review” Vol. XXI, Issue No.4, 2014 and “Current Index of Medical Specialties” July-October 2014. The difference in the maximum and minimum price of the same drug manufactured by different pharmaceutical companies and percentage variation in price was calculated. Results: The percentage price variation noted of long-established drugs was – Phenytoin (50mg: 140%, Carbamazepine (100mg: 1033%, Phenobarbital (30mg : 730%, Valproic acid (300mg : 420%. Newer drugs –Levetiracetam (250mg: 75%, Lamotrigine (25mg: 66%, Topiramate (50mg: 108%, Zonisamide (100mg: 19%. Combination drugs – Phenobarbital + Phenytoin (30+100 mg: 354.55%. Conclusion: The percentage price variation of different brands of the same commonly used long-established oral antiepileptic drug manufactured in India is very wide. The formulation or brand of Antiepileptic drugs (AED’s should preferably not be changed since variations in bioavailability or different pharmacokinetic profiles may increase the potential for reduced effect or excessive side effects. Hence, manufacturing companies should aim to decrease the price variation while maintaining the therapeutic efficacy.

  1. A treatment plant receiving waste water from multiple bulk drug manufacturers is a reservoir for highly multi-drug resistant integron-bearing bacteria.

    Directory of Open Access Journals (Sweden)

    Nachiket P Marathe

    Full Text Available The arenas and detailed mechanisms for transfer of antibiotic resistance genes between environmental bacteria and pathogens are largely unclear. Selection pressures from antibiotics in situations where environmental bacteria and human pathogens meet are expected to increase the risks for such gene transfer events. We hypothesize that waste-water treatment plants (WWTPs serving antibiotic manufacturing industries may provide such spawning grounds, given the high bacterial densities present there together with exceptionally strong and persistent selection pressures from the antibiotic-contaminated waste. Previous analyses of effluent from an Indian industrial WWTP that processes waste from bulk drug production revealed the presence of a range of drugs, including broad spectrum antibiotics at extremely high concentrations (mg/L range. In this study, we have characterized the antibiotic resistance profiles of 93 bacterial strains sampled at different stages of the treatment process from the WWTP against 39 antibiotics belonging to 12 different classes. A large majority (86% of the strains were resistant to 20 or more antibiotics. Although there were no classically-recognized human pathogens among the 93 isolated strains, opportunistic pathogens such as Ochrobactrum intermedium, Providencia rettgeri, vancomycin resistant Enterococci (VRE, Aerococcus sp. and Citrobacter freundii were found to be highly resistant. One of the O. intermedium strains (ER1 was resistant to 36 antibiotics, while P. rettgeri (OSR3 was resistant to 35 antibiotics. Class 1 and 2 integrons were detected in 74/93 (80% strains each, and 88/93 (95% strains harbored at least one type of integron. The qPCR analysis of community DNA also showed an unprecedented high prevalence of integrons, suggesting that the bacteria living under such high selective pressure have an appreciable potential for genetic exchange of resistance genes via mobile gene cassettes. The present study provides

  2. Injury to crops by gas as produced from plastic materials

    Energy Technology Data Exchange (ETDEWEB)

    Inden, T; Tachibana, S

    1971-01-01

    The effects of gas formations of phthalate and epoxy plasticizers on crops were studied at room temperature and 100 to 200 C. The materials were tested either alone Or as products including polyvinyl chloride and a stabilizer. At room temperature, dioctylphthalate (DOP) did not injure the cucumber leaves, whereas diisobutyl phthalate (DIBF) injured 74.1%, and dibutyl phthalate injured 36.5% of the surface of the leaves. Among many stabilizers tested, triphenyl phosphite injured 80% of the surface area of cucumber leaves. At 100 C to 200 C for 48 hours DIBP and CLP injured the Chinese cabbage leaves most, about 80% of the surface area. The following chemicals for the manufacturing of the plasticizers were also found to injure Chinese cabbage leaves, isobutanol 18.3%, 2-ethyl-hexanol 98.3%, isodecanol 98.5%, phthalic acid 40.0, and adipic acid 6.6%.

  3. Photostability and Photostabilization of Drugs and Drug Products

    Directory of Open Access Journals (Sweden)

    Iqbal Ahmad

    2016-01-01

    Full Text Available Photostability studies of drugs and drug products are an integral part of the product development process in the pharmaceutical industry. These studies are carried out to ensure quality, efficacy, and safety of the formulated products during manufacture, storage, and use. This review deals with the concept of photostability and related aspects and the literature available in the field. It highlights the role of the photochemistry in the photostability studies, describes the functional groups important for the photoreactivity of drugs, explains photophysical processes, and deals with the kinetics of photochemical reactions. The various modes of photodegradation of drugs with examples of selected compounds are presented. The biological consequences of the effect of light on the drug degradation are described. The photostability testing of drugs and drug products and the requirements under ICH guideline are discussed. Some information on the packaging requirements for the formulated products is provided. The various methods used for the photostabilization of solid and liquid dosage forms are also discussed.

  4. Design of conformal cooling for plastic injection moulding by heat transfer simulation

    Directory of Open Access Journals (Sweden)

    Sabrina Marques

    2015-12-01

    Full Text Available The cooling channels of a mold for plastic injection have to be as close as possible to the part geometry in order to ensure fast and homogeneous cooling. However, conventional methods to manufacture cooling channels (drilling can only produce linear holes. Selective laser melting (SLM is an additive manufacturing technique capable to manufacture complex cooling channels (known as conformal cooling. Nevertheless, because of the high costs of SLM the benefits of conformal collings are still not clear. The current work investigates two designs of conformal coolings: i parallel circuit; ii serial circuit. Both coolings are evaluated against to traditional cooling circuits (linear channels by CAE simulation to produce parts of polypropylene. The results show that if the conformal cooling is not properly designed it cannot provide reasonable results. The deformation of the product can be reduced significantly after injection but the cycle time reduced not more than 6%.

  5. Mechanisms of Neuroplasticity and Ethanol’s Effects on Plasticity in the Striatum and Bed Nucleus of the Stria Terminalis

    Science.gov (United States)

    Lovinger, David M.; Kash, Thomas L.

    2015-01-01

    Long-lasting changes in synaptic function (i.e., synaptic plasticity) have long been thought to contribute to information storage in the nervous system. Although synaptic plasticity mainly has adaptive functions that allow the organism to function in complex environments, it is now clear that certain events or exposure to various substances can produce plasticity that has negative consequences for organisms. Exposure to drugs of abuse, in particular ethanol, is a life experience that can activate or alter synaptic plasticity, often resulting in increased drug seeking and taking and in many cases addiction. Two brain regions subject to alcohol’s effects on synaptic plasticity are the striatum and bed nucleus of the stria terminalis (BNST), both of which have key roles in alcohol’s actions and control of intake. The specific effects depend on both the brain region analyzed (e.g., specific subregions of the striatum and BNST) and the duration of ethanol exposure (i.e., acute vs. chronic). Plastic changes in synaptic transmission in these two brain regions following prolonged ethanol exposure are thought to contribute to excessive alcohol drinking and relapse to drinking. Understanding the mechanisms underlying this plasticity may lead to new therapies for treatment of these and other aspects of alcohol use disorder. PMID:26259092

  6. Affordability and availability of off-patent drugs in the United States—the case for importing from abroad: observational study

    Science.gov (United States)

    Gupta, Ravi; Bollyky, Thomas J; Cohen, Matthew; Ross, Joseph S

    2018-01-01

    Abstract Objectives To evaluate whether off-patent prescription drugs at risk of sudden price increases or shortages in the United States are available from independent manufacturers approved in other well regulated settings around the world. Design Observational study. Setting Off-patent drugs in the USA and approved by the Food and Drug Administration, up to 10 April 2017. Study cohort Novel tablet or capsule prescription drugs approved by the FDA since 1939 that were no longer protected by patents or other market exclusivity and had up to three generic versions. Main outcome measures Number of additional manufacturers that had obtained approval from any of seven non-US regulators with similar standards (European Medicines Agency (European Union), HealthCanada (Canada), Therapeutic Goods Association (Australia), Medsafe (New Zealand), Swissmedic (Switzerland), Medicines Control Council (South Africa), and the Israel Health Ministry). Association with drug characteristics including US orphan drug designation for drugs treating rare diseases, World Health Organization essential medicine designation, treatment area, drug product complexity (that is, with attributes that could complicate establishing bioequivalence or manufacturing), and total Medicaid spending in 2015. Results Of 170 eligible study drugs, more than half (109, 64%) had at least one manufacturer approved by a non-US regulator and 32 (19%) had four or more. Among 44 (26%) drugs with no FDA approved generic versions, 21 (48%) were available from at least one manufacturer approved by one of the seven non-US regulators, and two (5%) by four or more manufacturers. Across all drugs and regulators (including the FDA), 66 (39%) drugs were available from four or more total manufacturers. Of 109 drugs with at least one non-US regulator approved manufacturer, 12 (11%) were approved for patients with rare diseases and 29 (27%) were WHO designated essential medicines; only 12 (11%) were complex products that might

  7. Drug promotion practices: A review.

    Science.gov (United States)

    Jacob, Nilan T

    2018-01-18

    Over the years, the pharmaceutical industry has been at the forefront of research and innovation in drug discovery and development. The process of drug discovery extending from preclinical studies to multicentric clinical trials and postmarketing phase is a costly affair running into billions of dollars. On the flip side, not all investigational molecules clear the trial phases and get approved, which puts pressure on the manufacturers to maximize the profit from approved drugs. It is in this key area that the practice of drug promotion plays its role. The World Health Organization defines drug promotion as "all informational and persuasive activities by manufacturers and distributors, the effect of which is to influence the prescription, supply, purchase or use of medicinal drugs". With its humble intent of creating awareness among healthcare professionals and updating their knowledge on recent advances in treatment options, drug promotion has been an important tool, but gradually it has evolved to embrace aggressive marketing strategies and sometimes unethical business and scientific practices where the need for profit-making eclipses commitment to patient care and scientific exploration. In this review, we discuss the evolution of drug promotion practices, the various types, its merits and demerits, the influence of drug promotion on physician prescribing behaviour, the role of regulatory bodies, unethical promotional practices and finally summarize with future directions. © 2018 The British Pharmacological Society.

  8. Dropwise additive manufacturing of pharmaceutical products for melt-based dosage forms.

    Science.gov (United States)

    Içten, Elçin; Giridhar, Arun; Taylor, Lynne S; Nagy, Zoltan K; Reklaitis, Gintaras V

    2015-05-01

    The US Food and Drug Administration introduced the quality by design approach and process analytical technology guidance to encourage innovation and efficiency in pharmaceutical development, manufacturing, and quality assurance. As part of this renewed emphasis on the improvement of manufacturing, the pharmaceutical industry has begun to develop more efficient production processes with more intensive use of online measurement and sensing, real-time quality control, and process control tools. Here, we present dropwise additive manufacturing of pharmaceutical products (DAMPP) as an alternative to conventional pharmaceutical manufacturing methods. This mini-manufacturing process for the production of pharmaceuticals utilizes drop on demand printing technology for automated and controlled deposition of melt-based formulations onto edible substrates. The advantages of drop-on-demand technology, including reproducible production of small droplets, adjustable drop sizing, high placement accuracy, and flexible use of different formulations, enable production of individualized dosing even for low-dose and high-potency drugs. In this work, DAMPP is used to produce solid oral dosage forms from hot melts of an active pharmaceutical ingredient and a polymer. The dosage forms are analyzed to show the reproducibility of dosing and the dissolution behavior of different formulations. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

  9. 77 FR 47115 - Manufacturer of Controlled Substances; Notice of Application; Cayman Chemical Company

    Science.gov (United States)

    2012-08-07

    ...)-propylthiophenethylamine I (7348). Marihuana (7360) I Tetrahydrocannabinols (7370) I Mescaline (7381) I 3,4,5... (1205) II The company plans to manufacture small quantities of marihuana derivatives for research purposes. In reference to drug code 7360 (Marihuana), the company plans to bulk manufacture cannabidiol. In...

  10. Formulation and Optimization of Multiparticulate Drug Delivery System Approach for High Drug Loading.

    Science.gov (United States)

    Shah, Neha; Mehta, Tejal; Gohel, Mukesh

    2017-08-01

    The aim of the present work was to develop and optimize multiparticulate formulation viz. pellets of naproxen by employing QbD and risk assessment approach. Mixture design with extreme vertices was applied to the formulation with high loading of drug (about 90%) and extrusion-spheronization as a process for manufacturing pellets. Independent variables chosen were level of microcrystalline cellulose (MCC)-X 1 , polyvinylpyrrolidone K-90 (PVP K-90)-X 2 , croscarmellose sodium (CCS)-X 3 , and polacrilin potassium (PP)-X 4 . Dependent variables considered were disintegration time (DT)-Y 1 , sphericity-Y 2 , and percent drug release-Y 3 . The formulation was optimized based on the batches generated by MiniTab 17 software. The batch with maximum composite desirability (0.98) proved to be optimum. From the evaluation of design batches, it was observed that, even in low variation, the excipients affect the pelletization property of the blend and also the final drug release. In conclusion, pellets with high drug loading can be effectively manufactured and optimized systematically using QbD approach.

  11. 78 FR 9928 - Food and Drug Administration Drug Shortages Task Force and Strategic Plan; Request for Comments

    Science.gov (United States)

    2013-02-12

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0124... metrics. With that in mind, FDA would like input on the following issues: What metrics do manufacturers... been suggested as a potentially useful approach to expanding manufacturing capacity and preventing...

  12. A Comparison of Protein Stability in Prefillable Syringes Made of Glass and Plastic.

    Science.gov (United States)

    Waxman, Lloyd; Vilivalam, Vinod D

    2017-01-01

    The development of protein therapeutics requires stabilization of these labile molecules during shipment and storage. Biologics, particularly monoclonal antibodies, are frequently packaged at high concentration in prefillable syringes traditionally made of glass. However, some biologics are unstable in glass due to sensitivity to silicone oil, tungsten, glue, or metal ions. Syringes made from the plastic cyclic olefin polymer, Daikyo Crystal Zenith® (CZ), with a Flurotec-laminated piston, have none of these issues. This study compared the stability of several proteins including biotherapeutics when stored up to 14 months at 5 °C and 25 °C in prefillable siliconized syringes made of glass or silicone oil-free CZ syringes, and when subjected to mild agitation by end-over-end rotation at room temperature. At each time point, proteins were analyzed by several techniques including turbidity, size exclusion high-performance liquid chromatography, reversed phase high-performance liquid chromatography, ion-exchange chromatography, electrophoresis, and light scattering to monitor changes in aggregation and degradation. The results show that proteins have comparable stability when stored in glass syringes or in syringes made of CZ sterilized by E-beam or autoclave. In addition, proteins stressed by agitation were generally more stable and aggregated less in syringes made of CZ than in ones made of glass. LAY ABSTRACT: Biotherapeutic protein drugs such as monoclonal antibodies are frequently packaged at high concentration in prefillable syringes, which allows the drug to be directly administered by the patient or caregiver. Protein drugs, or biologics, can be unstable, and may aggregate, particularly when shaken. These aggregates can be immunogenic, stimulating the body's immune system to produce antibodies that can reduce the drug's efficacy. Although prefillable syringes are traditionally made of glass, some biologics are unstable in glass syringes due to the presence of

  13. A new technology for automatic identification and sorting of plastics for recycling.

    Science.gov (United States)

    Ahmad, S R

    2004-10-01

    A new technology for automatic sorting of plastics, based upon optical identification of fluorescence signatures of dyes, incorporated in such materials in trace concentrations prior to product manufacturing, is described. Three commercial tracers were selected primarily on the basis of their good absorbency in the 310-370 nm spectral band and their identifiable narrow-band fluorescence signatures in the visible band of the spectrum when present in binary combinations. This absorption band was selected because of the availability of strong emission lines in this band from a commercial Hg-arc lamp and high fluorescence quantum yields of the tracers at this excitation wavelength band. The plastics chosen for tracing and identification are HDPE, LDPE, PP, EVA, PVC and PET and the tracers were compatible and chemically non-reactive with the host matrices and did not affect the transparency of the plastics. The design of a monochromatic and collimated excitation source, the sensor system are described and their performances in identifying and sorting plastics doped with tracers at a few parts per million concentration levels are evaluated. In an industrial sorting system, the sensor was able to sort 300 mm long plastic bottles at a conveyor belt speed of 3.5 m.sec(-1) with a sorting purity of -95%. The limitation was imposed due to mechanical singulation irregularities at high speed and the limited processing speed of the computer used.

  14. Energy Storage Criteria Handbook.

    Science.gov (United States)

    1982-10-01

    Incorporated ( Fenton , Missouri) manufacture plastic pipes filled with calcium chloride hexahydrate and stabilizing ingredients, which have a melting...higher than that of ethylene and propylene glycol. 1 The U.S. Food, Drug and Cosmetic Act of 1938, a step in the formation of the U.S. Food and Drug

  15. 78 FR 22553 - Generic Drug Facilities, Sites, and Organizations

    Science.gov (United States)

    2013-04-16

    ...] Generic Drug Facilities, Sites, and Organizations AGENCY: Food and Drug Administration, HHS. ACTION.... Generic drug facilities, certain sites, and organizations identified in a generic drug submission are... active pharmaceutical ingredients and certain other sites and organizations that support the manufacture...

  16. Plasticity-Related Gene Expression During Eszopiclone-Induced Sleep.

    Science.gov (United States)

    Gerashchenko, Dmitry; Pasumarthi, Ravi K; Kilduff, Thomas S

    2017-07-01

    Experimental evidence suggests that restorative processes depend on synaptic plasticity changes in the brain during sleep. We used the expression of plasticity-related genes to assess synaptic plasticity changes during drug-induced sleep. We first characterized sleep induced by eszopiclone in mice during baseline conditions and during the recovery from sleep deprivation. We then compared the expression of 18 genes and two miRNAs critically involved in synaptic plasticity in these mice. Gene expression was assessed in the cerebral cortex and hippocampus by the TaqMan reverse transcription polymerase chain reaction and correlated with sleep parameters. Eszopiclone reduced the latency to nonrapid eye movement (NREM) sleep and increased NREM sleep amounts. Eszopiclone had no effect on slow wave activity (SWA) during baseline conditions but reduced the SWA increase during recovery sleep (RS) after sleep deprivation. Gene expression analyses revealed three distinct patterns: (1) four genes had higher expression either in the cortex or hippocampus in the group of mice with increased amounts of wakefulness; (2) a large proportion of plasticity-related genes (7 out of 18 genes) had higher expression during RS in the cortex but not in the hippocampus; and (3) six genes and the two miRNAs showed no significant changes across conditions. Even at a relatively high dose (20 mg/kg), eszopiclone did not reduce the expression of plasticity-related genes during RS period in the cortex. These results indicate that gene expression associated with synaptic plasticity occurs in the cortex in the presence of a hypnotic medication. © Sleep Research Society 2017. Published by Oxford University Press on behalf of the Sleep Research Society. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

  17. Estimating preferences for modes of drug administration: The case of US healthcare professionals.

    Science.gov (United States)

    Tetteh, Ebenezer K; Morris, Steve; Titchener-Hooker, Nigel

    2018-01-01

    There are hidden drug administration costs that arise from a mismatch between end-user preferences and how manufacturers choose to formulate their drug products for delivery to patients. The corollary of this is: there are "intangible benefits" from considering end-user preferences in manufacturing patient-friendly medicines. It is important then to have some idea of what pharmaceutical manufacturers should consider in making patient-friendly medicines and of the magnitude of the indirect benefits from doing so. This study aimed to evaluate preferences of healthcare professionals in the US for the non-monetary attributes of different modes of drug administration. It uses these preference orderings to compute a monetary valuation of the indirect benefits from making patient-friendly medicines. A survey collected choice preferences of a sample of 210 healthcare professionals in the US for two unlabelled drug options. These drugs were identical except in the levels of attributes of drug administration. Using the choice data collected, statistical models were estimated to compute gross welfare benefits, measured by the expected compensating variation, from making drugs in a more patient-friendly manner. The monetary value of end-user benefits from developing patient-friendly drug delivery systems is: (1) as large as the annual acquisition costs per full treatment episode for some biologic drugs; and (2) likely to fall in the "high end" of the distribution of the direct monetary costs of drug administration. An examination of end-user preferences should help manufacturers make more effective and efficient use of limited resources for innovations in drug delivery system, or manufacturing research in general. Copyright © 2017 Elsevier Inc. All rights reserved.

  18. Plastic litter from shotgun ammunition on Danish coastlines - Amounts and provenance.

    Science.gov (United States)

    Kanstrup, Niels; Balsby, Thorsten J S

    2018-06-01

    Plastic litter in the marine environment is a major global issue. Discarded plastic shotgun ammunition shells and discharged wads are an unwelcome addition and feature among the top ten litter items found on reference beaches in Denmark. To understand this problem, its scale and origins, collections were made by volunteers along Danish coastal shorelines. In all 3669 plastic ammunition items were collected at 68 sites along 44.6 km of shoreline. The collected items were scored for characteristic variables such as gauge and length, shot type, and the legibility of text, the erosion, and the presence of metallic components. Scores for characteristics were related to the site, area, and season and possible influences discussed. The prevalence of collected plastic shotgun litter ranges from zero to 41 items per 100 m with an average of 3.7 items per 100 m. Most ammunition litter on Danish coasts originates from hunting on Danish coastal waterbodies, but a small amount may come from further afield. North Sea coasts are the most distinctive suggesting the possible contribution of long distance drift as well as the likelihood that such litter can persist in marine habitats for decades. The pathway from initial discard to eventual wash-up and collection depends on the physical properties of plastic components, marine tides and currents, coastal topography and shoreline vegetation. Judging from the disintegration of the cartridge and the wear and decomposition of components, we conclude that there is a substantial supply of polluting plastic ammunition materials that has and will accumulate. These plastic items pose a hazard to marine ecosystems and wash up on coasts for many years to come. We recommend that responsible managers, hunters and ammunition manufacturers will take action now to reduce the problem and, thereby, protect ecosystems, wildlife and the sustainability of hunting. Copyright © 2018 Elsevier Ltd. All rights reserved.

  19. A Lower Temperature FDM 3D Printing for the Manufacture of Patient-Specific Immediate Release Tablets.

    Science.gov (United States)

    Okwuosa, Tochukwu C; Stefaniak, Dominika; Arafat, Basel; Isreb, Abdullah; Wan, Ka-Wai; Alhnan, Mohamed A

    2016-11-01

    The fabrication of ready-to-use immediate release tablets via 3D printing provides a powerful tool to on-demand individualization of dosage form. This work aims to adapt a widely used pharmaceutical grade polymer, polyvinylpyrrolidone (PVP), for instant on-demand production of immediate release tablets via FDM 3D printing. Dipyridamole or theophylline loaded filaments were produced via processing a physical mixture of API (10%) and PVP in the presence of plasticizer through hot-melt extrusion (HME). Computer software was utilized to design a caplet-shaped tablet. The surface morphology of the printed tablet was assessed using scanning electron microscopy (SEM). The physical form of the drugs and its integrity following an FDM 3D printing were assessed using x-ray powder diffractometry (XRPD), thermal analysis and HPLC. In vitro drug release studies for all 3D printed tablets were conducted in a USP II dissolution apparatus. Bridging 3D printing process with HME in the presence of a thermostable filler, talc, enabled the fabrication of immediate release tablets at temperatures as low as 110°C. The integrity of two model drugs was maintained following HME and FDM 3D printing. XRPD indicated that a portion of the loaded theophylline remained crystalline in the tablet. The fabricated tablets demonstrated excellent mechanical properties, acceptable in-batch variability and an immediate in vitro release pattern. Combining the advantages of PVP as an impeding polymer with FDM 3D printing at low temperatures, this approach holds a potential in expanding the spectrum of drugs that could be used in FDM 3D printing for on demand manufacturing of individualised dosage forms.

  20. 75 FR 6062 - Manufacturer of Controlled Substances Notice of Registration

    Science.gov (United States)

    2010-02-05

    ... controlled substances listed in schedules I and II: Drug Schedule Marihuana (7360) I Tetrahydrocannabinols (7370) I Cocaine (9041) I The Institute will manufacture small quantities of cocaine and marihuana...

  1. Properties of plastic filtration material

    Energy Technology Data Exchange (ETDEWEB)

    Paluch, W.

    1988-01-01

    Discusses properties of filters made of thermoplastic granulated material. The granulated plastic has a specific density of 10.3-10.6 kN/m/sup 3/ and a bulk density of about 6 kN/m/sup 3/. Its chemical resistance to acids, bases and salts is high but is it soluble in organic solvents. Filters made of this material are characterized by a porosity coefficient of 36.5% and a bulk density of 5.7-6.8 kN/m/sup 3/. Physical and mechanical properties of filter samples made of thermoplastic granulated material (50x50x50 mm) were investigated under laboratory conditions. Compression strength and influencing factors were analyzed (ambient temperature, manufacturing technology). Tests show that this filtration material developed by Poltegor is superior to other filtration materials used in Poland.

  2. Utilization of portable effluent wastewater in brick manufacturing

    International Nuclear Information System (INIS)

    EI-Mahllawy, M.S.; El-Sokkary, T.M.

    2005-01-01

    Portable wastewater is produced from sedimentation and filtration tanks in portable water treatment plants. Usually, this useless wastewater is drained into River Nile Canal and not to the sewer system causing a potential pollution. Wastewater has been taken from Portable Treatment Plant located at Qalubia Province, Delta, Egypt. Evaluation of raw materials was carried out by using X-ray diffraction (XRD), X-ray fluorescence (XRF), thermal analyses (DTA and TGA) as well as plasticity and drying sensitivity coefficient (DSC) measurements. Technological properties of fired bricks were investigated according to Egyptian and American Specifications. The obtained experimental results encourage substitution of the drained portable wastewater for the tap water in bricks manufacturing. Thus, utilization of the studied portable effluent wastewater in such industry is possible and fulfills the double target of saving drinking water used in clay bricks manufacturing, rather than its environmental pollution prevention. Keywords: Portable wastewater, tap water, clay building bricks, physicomechanical properties

  3. Comparative manufacture and cell-based delivery of antiretroviral nanoformulations

    Directory of Open Access Journals (Sweden)

    Balkundi S

    2011-12-01

    Full Text Available Shantanu Balkundi1, Ari S Nowacek1, Ram S Veerubhotla1, Han Chen2, Andrea Martinez-Skinner1, Upal Roy1, R Lee Mosley1,3, Georgette Kanmogne1, Xinming Liu1,3,4, Alexander V Kabanov3,4, Tatiana Bronich3,4, JoEllyn McMillan1, Howard E Gendelman1,31Department of Pharmacology and Experimental Neuroscience, University of Nebraska Medical Center, Omaha, NE, USA; 2Center for Biotechnology, University of Nebraska-Lincoln, Lincoln, NE, USA; 3Center for Drug Delivery and Nanomedicine, University of Nebraska Medical Center, Omaha, NE, USA; 4Department of Pharmaceutical Sciences, College of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USAAbstract: Nanoformulations of crystalline indinavir, ritonavir, atazanavir, and efavirenz were manufactured by wet milling, homogenization or sonication with a variety of excipients. The chemical, biological, immune, virological, and toxicological properties of these formulations were compared using an established monocyte-derived macrophage scoring indicator system. Measurements of drug uptake, retention, release, and antiretroviral activity demonstrated differences amongst preparation methods. Interestingly, for drug cell targeting and antiretroviral responses the most significant difference among the particles was the drug itself. We posit that the choice of drug and formulation composition may ultimately affect clinical utility.Keywords: human immunodeficiency virus type one, nanotoxicology, monocyte-derived macrophage, nanoformulated antiretroviral therapy, manufacturing techniques

  4. 76 FR 66994 - Manufacturer of Controlled Substances; Notice of Application

    Science.gov (United States)

    2011-10-28

    ... following basic classes of controlled substances: Drug Schedule Marihuana (7360) I Cocaine (9041) II The Institute will manufacture marihuana, and cocaine derivatives for use by their customers in analytical kits...

  5. Progress of alternative sintering approaches of inkjet-printed metal inks and their application for manufacturing of flexible electronic devices

    NARCIS (Netherlands)

    Wünscher, S.; Abbel, R.; Perelaer, J.; Schubert, U.S.

    2014-01-01

    Well-defined high resolution structures with excellent electrical conductivities are key components of almost every electronic device. Producing these by printing metal based conductive inks on polymer foils represents an important step forward towards the manufacturing of plastic electronic

  6. Study of flow stress and spall strength of additively manufactured Ti-6-4 alloy

    Science.gov (United States)

    Cohen, Amitay; Paris, Vitaly; Yosef-Hai, Arnon; Gudinetsky, Eli; Tiferet, Eitan

    2017-06-01

    The use of additive manufacturing (AM) by Electron Beam Melting (EBM) or Selective Laser Melting (SLM) has extensively grown in the past few years. A major goal in AM is to manufacture materials with mechanical properties at least as good as traditionally manufactured materials. In this work we present results of planar impact tests and Split Hopkinson Pressure Bar tests (SHPB) on Ti-6-4 manufactured by EBM and SLM processes. Results of planar impact tests on SLM samples display slightly higher spall strength compared to EBM while the stress at Hugoniot elastic limit (HEL) is practically the same. Stress strain curves based on SHPB measurements at two different strain rates present similar plastic flow stresses for SLM and EBM processed Ti-6-4 alloy, while the flow stress is about 20% higher than reported for commercial reference material. The strain to failure of both materials shows considerable strain rate sensitivity. The results of post-mortem analysis of spall fracture will also be presented.

  7. Analysis of phthalate migration to food simulants in plastic containers during microwave operations.

    Science.gov (United States)

    Moreira, Miriany A; André, Leiliane C; Cardeal, Zenilda L

    2013-12-30

    Phthalates used as plasticizers in the manufacture of household containers can potentially be transferred to foods that are stored or heated in these plastic containers. Phthalates are endocrine disruptor compounds (EDC) and are found in very low concentrations in foods, thus, highly sensitive analytical techniques are required for their quantification. This study describes the application of a new method developed for analyzing the migration of dibutylphthalate (DBP) and benzylbutylphthalate (BBP) from plastic food containers into liquid food simulants. This new method employs the technique of solid phase microextraction cooled with liquid nitrogen. The analysis was conducted by gas chromatography/mass spectrometry (GC/MS) using a polyacrylate fiber. Ultrapure water was used as a simulant for liquids foods, and both new and used plastic containers were placed in a domestic microwave oven for different periods of time at different power levels. The limits of detection for DBP and BBP were 0.08 µg/L and 0.31 µg/L, respectively. BBP was not found in the samples that were analyzed. DBP was found in concentrations ranging from containers that were used for a prolonged time, which correlated with increasing heating time.

  8. Rapid manufacturing for microfluidics

    CSIR Research Space (South Africa)

    Land, K

    2012-10-01

    Full Text Available for microfluidics K. LAND, S. HUGO, M MBANJWA, L FOURIE CSIR Materials Science and Manufacturing P O Box 395, Pretoria 0001, SOUTH AFRICA Email: kland@csir.co.za INTRODUCTION Microfluidics refers to the manipulation of very small volumes of fluid.... Microfluidics is at the forefront of developing solutions for drug discovery, diagnostics (from glucose tests to malaria and TB testing) and environmental diagnostics (E-coli monitoring of drinking water). In order to quickly implement new designs, a rapid...

  9. Affordability and availability of off-patent drugs in the United States-the case for importing from abroad: observational study.

    Science.gov (United States)

    Gupta, Ravi; Bollyky, Thomas J; Cohen, Matthew; Ross, Joseph S; Kesselheim, Aaron S

    2018-03-19

    To evaluate whether off-patent prescription drugs at risk of sudden price increases or shortages in the United States are available from independent manufacturers approved in other well regulated settings around the world. Observational study. Off-patent drugs in the USA and approved by the Food and Drug Administration, up to 10 April 2017. Novel tablet or capsule prescription drugs approved by the FDA since 1939 that were no longer protected by patents or other market exclusivity and had up to three generic versions. Number of additional manufacturers that had obtained approval from any of seven non-US regulators with similar standards (European Medicines Agency (European Union), HealthCanada (Canada), Therapeutic Goods Association (Australia), Medsafe (New Zealand), Swissmedic (Switzerland), Medicines Control Council (South Africa), and the Israel Health Ministry). Association with drug characteristics including US orphan drug designation for drugs treating rare diseases, World Health Organization essential medicine designation, treatment area, drug product complexity (that is, with attributes that could complicate establishing bioequivalence or manufacturing), and total Medicaid spending in 2015. Of 170 eligible study drugs, more than half (109, 64%) had at least one manufacturer approved by a non-US regulator and 32 (19%) had four or more. Among 44 (26%) drugs with no FDA approved generic versions, 21 (48%) were available from at least one manufacturer approved by one of the seven non-US regulators, and two (5%) by four or more manufacturers. Across all drugs and regulators (including the FDA), 66 (39%) drugs were available from four or more total manufacturers. Of 109 drugs with at least one non-US regulator approved manufacturer, 12 (11%) were approved for patients with rare diseases and 29 (27%) were WHO designated essential medicines; only 12 (11%) were complex products that might be more complicated to import. The highest numbers of drugs were indicated

  10. 21 CFR 101.5 - Food; name and place of business of manufacturer, packer, or distributor.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Food; name and place of business of manufacturer... Food; name and place of business of manufacturer, packer, or distributor. (a) The label of a food in... business in lieu of the actual place where such food was manufactured or packed or is to be distributed...

  11. Manufacture of rings of 08Kh18N10T sheet for internal structures of WWER type reactors

    International Nuclear Information System (INIS)

    Fojta, A.; Nitka, B.

    1984-01-01

    Technology is presented of the manufacture of rings for the jacket, shaft, core catcher and shaft bottom of WWER-440 reactors produced by Vitkovice Steel Works. The rings are manufactured from sheets of austenitic steel 08Kh18N10T. The materials and technology problems are discussed of sheet production, ring welding technology and annealing following welding. The plastic properties are assessed of the welded joints and problems are outlined of ring production for WWER-1000 reactors. (B.S.)

  12. Environmental pollution with antimicrobial agents from bulk drug manufacturing industries in Hyderabad, South India, is associated with dissemination of extended-spectrum beta-lactamase and carbapenemase-producing pathogens.

    Science.gov (United States)

    Lübbert, Christoph; Baars, Christian; Dayakar, Anil; Lippmann, Norman; Rodloff, Arne C; Kinzig, Martina; Sörgel, Fritz

    2017-08-01

    High antibiotic and antifungal concentrations in wastewater from anti-infective drug production may exert selection pressure for multidrug-resistant (MDR) pathogens. We investigated the environmental presence of active pharmaceutical ingredients and their association with MDR Gram-negative bacteria in Hyderabad, South India, a major production area for the global bulk drug market. From Nov 19 to 28, 2016, water samples were collected from the direct environment of bulk drug manufacturing facilities, the vicinity of two sewage treatment plants, the Musi River, and habitats in Hyderabad and nearby villages. Samples were analyzed for 25 anti-infective pharmaceuticals with liquid chromatography-tandem mass spectrometry and for MDR Gram-negative bacteria using chromogenic culture media. In addition, specimens were screened with PCR for bla VIM , bla KPC , bla NDM , bla IMP-1 , and bla OXA-48 resistance genes. All environmental specimens from 28 different sampling sites were contaminated with antimicrobials. High concentrations of moxifloxacin, voriconazole, and fluconazole (up to 694.1, 2500, and 236,950 µg/L, respectively) as well as increased concentrations of eight other antibiotics were found in sewers in the Patancheru-Bollaram industrial area. Corresponding microbiological analyses revealed an extensive presence of extended-spectrum beta-lactamase and carbapenemase-producing Enterobacteriaceae and non-fermenters (carrying mainly bla OXA-48 , bla NDM , and bla KPC ) in more than 95% of the samples. Insufficient wastewater management by bulk drug manufacturing facilities leads to unprecedented contamination of water resources with antimicrobial pharmaceuticals, which seems to be associated with the selection and dissemination of carbapenemase-producing pathogens. The development and global spread of antimicrobial resistance present a major challenge for pharmaceutical producers and regulatory agencies.

  13. Utilization of mango seed starch in manufacture of bioplastic reinforced with microparticle clay using glycerol as plasticizer

    Science.gov (United States)

    Maulida; Kartika, T.; Harahap, M. B.; Ginting, M. H. S.

    2018-02-01

    Bioplastics are plastics that can be used just like conventional plastics but will disintegrate by the activity of microorganisms into water and carbon dioxide. Starch is a natural polymer material that can used for bioplastic production. The addition of reinforcing particles has been shown to improve the mechanical properties of bioplastics. The aim of this research is to know the potency of mango seed starch and microparticle clay as filler and glycerol concentration as plasticizer on tensile strength and elongation at break, functional group (FTIR) and surface morphology (SEM). In this study used mango seed starch size of 5 grams, with the variation of clay filler mass of 0; 3; 6 and nine wt%, while the mass of glycerol with a variation of 0; 20; 25; 30; And 35% wt. The heating temperature of the bioplastics solution used was 80.53 °C. The resulting bioplastics was analyzed for their physical and chemical properties, including FTIR, SEM, tensile strength, elongation at break. The FTIR analysis shows that no new functional groups was formed. From the analysis of mango starch content obtained 62.82%, 44.0% amylopectin content, amylose content 14.82%, and water content 12.65%. In this study obtained bioplastics with the best conditions on the use of 6% clay and 25% glycerol, with a tensile strength of 5.657MPa, percent elongation at breakup 43.431%.

  14. Plastic substrates for active matrix liquid crystal display incapable of withstanding processing temperature of over 200 C and method of fabrication

    Energy Technology Data Exchange (ETDEWEB)

    Carey, P.G.; Smith, P.M.; Havens, J.H.; Jones, P.

    1999-01-05

    Bright-polarizer-free, active-matrix liquid crystal displays (AMLCDs) are formed on plastic substrates. The primary components of the display are a pixel circuit fabricated on one plastic substrate, an intervening liquid-crystal material, and a counter electrode on a second plastic substrate. The-pixel circuit contains one or more thin-film transistors (TFTs) and either a transparent or reflective pixel electrode manufactured at sufficiently low temperatures to avoid damage to the plastic substrate. Fabrication of the TFTs can be carried out at temperatures less than 100 C. The liquid crystal material is a commercially made nematic curvilinear aligned phase (NCAP) film. The counter electrode is comprised of a plastic substrate coated with a transparent conductor, such as indium-doped tin oxide (ITO). By coupling the active matrix with NCAP, a high-information content can be provided in a bright, fully plastic package. Applications include any low cost portable electronics containing flat displays where ruggedization of the display is desired. 12 figs.

  15. Sensitivity of stock market indices to oil prices: Evidence from manufacturing sub-sectors in Turkey

    Directory of Open Access Journals (Sweden)

    Eksi Halil Ibrahim

    2012-01-01

    Full Text Available Crude oil price is a critical cost factor for manufacturing industries that are of vital importance for economic growth. This study examines the relationship between crude oil prices and the indices of seven Turkish manufacturing sub-sectors over the period 1997:01-2009:12. The error correction model results reveal the long term causality from crude oil prices to chemical petroleum-plastic and basic metal sub-sectors indicating that these sub-sectors are highly sensitive to crude oil prices. We find no causal relationship for other sector indices for short or long time periods.

  16. Biomedical applications of additive manufacturing: present and future

    NARCIS (Netherlands)

    Singh, Sunpreet; Ramakrishna, Seeram; Bouten, Carlijn V.C.; Narayan, Roger

    2017-01-01

    Three dimensional printing (3DP) or additive manufacturing (AM) of medical devices and scaffolds for tissue engineering, regenerative medicine, ex-vivo tissues and drug delivery is of intense interest in recent years. A few medical devices namely, ZipDose ® , Pharmacoprinting, powder bed fusion,

  17. Plastic Surgery

    Science.gov (United States)

    ... Staying Safe Videos for Educators Search English Español Plastic Surgery KidsHealth / For Teens / Plastic Surgery What's in ... her forehead lightened with a laser? What Is Plastic Surgery? Just because the name includes the word " ...

  18. Exercise in Experimental Plastics Technology: Hot Embossing of Polymers with surface microstructure

    DEFF Research Database (Denmark)

    Eriksson, Torbjörn Gerhard; Rasmussen, Henrik Koblitz

    2004-01-01

    Hot Embossing of polymers with surface microstructure Polymer materials have proven to be good materials for manufacturing nano/ and microstructure. There are three major processing techniques: hot embossing, injection moulding and casting. Hot embossing provides several advantages such as relati......Hot Embossing of polymers with surface microstructure Polymer materials have proven to be good materials for manufacturing nano/ and microstructure. There are three major processing techniques: hot embossing, injection moulding and casting. Hot embossing provides several advantages...... such as relatively low cost for embossing tools, simple operation and high replication accuracy for small features. Two different plastic materials will be used to replicate surface microstructures by hot embossing. The hot embossing will be done in a hydraulic press where it is easy to control temperature...

  19. Drug procurement and management.

    Science.gov (United States)

    Salhotra, V S

    2003-03-01

    A strong drug procurement and management system under the RNTCP is critical to programme success. Significant improvements in manufacturing, inspection, supply, storage and quality control practices and procedures have been achieved due to an intensive RNTCP network. Drugs used in RNTCP are rifampicin, isoniazid, ethambutol, pyrazinamide and streptomycin. Patients of TB are categorised into I, II and III and each category has a different standarised treatment. Procurement, distribution system and quality assurance of drugs are narrated in brief in this article.

  20. Plastic dosimeter

    International Nuclear Information System (INIS)

    Nagai, Shiro; Matsuda, Kohji.

    1988-01-01

    The report outlines major features and applications of plastic dosimeters. Some plastic dosimeters, including the CTA and PVC types, detect the response of the plastic material itself to radiations while others, such as pigment-added plastic dosimeters, contain additives as radiation detecting material. Most of these dosimeters make use of color centers produced in the dosimeter by radiations. The PMMA dosimeter is widely used in the field of radiation sterilization of food, feed and medical apparatus. The blue cellophane dosimeter is easy to handle if calibrated appropriately. The rad-color dosimeter serves to determine whether products have been irradiated appropriately. The CTA dosimeter has better damp proofing properties than the blue cellophane type. The pigment-added plastic dosimeter consists of a resin such as nylon, CTA or PVC that contains a dye. Some other plastic dosimeters are also described briefly. Though having many advantages, these plastic dosimeter have disadvantages as well. Some of their major disadvantages, including fading as well as large dependence on dose, temperature, humidity and anviroment, are discussed. (Nogami, K.)

  1. Oscillatory Shear Rheology in Examining the Drug-Polymer Interactions Relevant in Hot Melt Extrusion

    DEFF Research Database (Denmark)

    Aho, Johanna; Edinger, Magnus; Botker, Johan

    2016-01-01

    The flow properties of drug-polymer mixtures have a significant influence on their processability when using techniques such as hot melt extrusion (HME). Suitable extrusion temperature and screw speed to be used in laboratory scale HME were evaluated for mixtures containing 30% of paracetamol (PRC...... of the drug substances. Consecutively, the mixtures were extruded, and the maximum plasticizing weight fraction of each drug was determined by means of rheological measurements. IBU was found to have an efficient plasticizing functionality, decreasing the viscosity of the mixtures even above its apparent...

  2. Processing and characterization of plasticized PLA/PHB blends for biodegradable multiphase systems

    Directory of Open Access Journals (Sweden)

    I. Armentano

    2015-07-01

    Full Text Available Blends of poly(lactic acid (PLA and poly(3-hydroxybutyrate (PHB plasticized with a lactic acid oligomer (OLA added at three different concentrations (15, 20 and 30 wt% by weight, were prepared by an optimized extrusion process to improve the processability and mechanical properties of these biopolymers for flexible film manufacturing. Morphological, chemical, thermal, mechanical, barrier and migration properties were investigated and formulations with desired performance in eco-friendly films were selected. The efficiency of OLA as plasticizer for PLA_PHB blends was demonstrated by the significant decrease of their glass transition temperatures and a considerable improvement of their ductile properties. The measured improvements in the barrier properties are related to the higher crystallinity of the plasticized PLA_PHB blends, while the overall migration test underlined that all the proposed formulations maintained migration levels below admitted levels. The PLA_PHB blend with 30 wt% OLA was selected as the optimum formulation for food packaging, since it offered the best compromise between ductility and oxygen and water vapor barrier properties with practically no migration.

  3. 76 FR 6143 - Draft Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug...

    Science.gov (United States)

    2011-02-03

    ...; formerly Docket No. 00D-0892] Draft Guidance on Positron Emission Tomography Drug Applications--Content and... Applications for Certain Positron Emission Tomography Drug Products; Availability,'' issued on March 10, 2000... and ANDAs.'' The draft guidance is intended to assist manufacturers of certain positron emission...

  4. The Daniel K. Inouye College of Pharmacy Scripts: Prescription Drug Pricing.

    Science.gov (United States)

    Sumida, Wesley K; Taniguchi, Ronald; Juarez, Deborah Taira

    2016-01-01

    Prescription drugs have reduced morbidity and mortality and improved the quality of life of millions of Americans. Yet, concerns over drug price increases loom. Drug spending has risen relatively slowly over the past decade because many of the most popular brand-name medicines lost patent protection. In the near future, there will be fewer low-cost generics coming into the market to offset the rising prices of brand-name drugs. Drug expenditures are influenced by both volume and price. This article focuses on how drug prices are set in the United States and current trends. Drug prices are determined through an extremely complicated set of interactions between pharmaceutical manufacturers, wholesalers, retailers, insurers, pharmacy benefit managers (PBMs), managed care organizations, hospitals, chain stores, and consumers. The process differs depending on the type of drug and place of delivery. Rising drug prices have come under increased scrutiny due to increased cost inflation and because many price increases come as a result of mergers and acquisitions of generic drug companies or changes in ownership of brand name drug manufacturers. Other countries have reigned in drug prices by negotiating with or regulating pharmaceutical manufacturers. The best long-term solution to rising drug prices is yet to be determined but the United States will continue to debate this issue and the discussions will get more heated if drug expenditures continue to rise at a rapid rate (ie, increasing 13% in 2014 from the previous year).

  5. Recent development of a CEC'S elasto-plastic-creep cyclic benchmark programme relevant to LMFBR structural integrity

    International Nuclear Information System (INIS)

    Corsi, F.; Terzaghi, A.

    1984-01-01

    It's presented the programme of elasto-plastic benchmark calculations relevant to LMFBr, which started in 1977 with the support and coordination of the Commission of the European Communities (CEC) and the participation of nuclear engineering and manufacturing companies as well as nuclear research centers of France, Germany, Italy and the United Kingdom. (E.G.) [pt

  6. Airborne emissions of carcinogens and respiratory sensitizers during thermal processing of plastics.

    Science.gov (United States)

    Unwin, John; Coldwell, Matthew R; Keen, Chris; McAlinden, John J

    2013-04-01

    Thermoplastics may contain a wide range of additives and free monomers, which themselves may be hazardous substances. Laboratory studies have shown that the thermal decomposition products of common plastics can include a number of carcinogens and respiratory sensitizers, but very little information exists on the airborne contaminants generated during actual industrial processing. The aim of this work was to identify airborne emissions during thermal processing of plastics in real-life, practical applications. Static air sampling was conducted at 10 industrial premises carrying out compounding or a range of processes such as extrusion, blown film manufacture, vacuum thermoforming, injection moulding, blow moulding, and hot wire cutting. Plastics being processed included polyvinyl chloride, polythene, polypropylene, polyethylene terephthalate, and acrylonitrile-butadiene-styrene. At each site, static sampling for a wide range of contaminants was carried out at locations immediately adjacent to the prominent fume-generating processes. The monitoring data indicated the presence of few carcinogens at extremely low concentrations, all less than 1% of their respective WEL (Workplace Exposure Limit). No respiratory sensitizers were detected at any sites. The low levels of process-related fume detected show that the control strategies, which employed mainly forced mechanical general ventilation and good process temperature control, were adequate to control the risks associated with exposure to process-related fume. This substantiates the advice given in the Health and Safety Executive's information sheet No 13, 'Controlling Fume During Plastics Processing', and its broad applicability in plastics processing in general.

  7. Manufacture and characterization of mucoadhesive buccal films.

    Science.gov (United States)

    Morales, Javier O; McConville, Jason T

    2011-02-01

    The buccal route of administration has a number of advantages including bypassing the gastrointestinal tract and the hepatic first pass effect. Mucoadhesive films are retentive dosage forms and release drug directly into a biological substrate. Furthermore, films have improved patient compliance due to their small size and reduced thickness, compared for example to lozenges and tablets. The development of mucoadhesive buccal films has increased dramatically over the past decade because it is a promising delivery alternative to various therapeutic classes including peptides, vaccines, and nanoparticles. The "film casting process" involves casting of aqueous solutions and/or organic solvents to yield films suitable for this administration route. Over the last decade, hot-melt extrusion has been explored as an alternative manufacturing process and has yielded promising results. Characterization of critical properties such as the mucoadhesive strength, drug content uniformity, and permeation rate represent the major research areas in the design of buccal films. This review will consider the literature that describes the manufacture and characterization of mucoadhesive buccal films. Copyright © 2010 Elsevier B.V. All rights reserved.

  8. plastic waste recycling

    African Journals Online (AJOL)

    Dr Ahmed

    incinerators is increasing around the world. Discarded plastic products ... Agency (EPA) estimated that the amount of plastics throw away is. 50 % greater in the ... The waste plastics were identified using the Society of the Plastic. Industry (SPI) ...

  9. Neutron Detection with Large Plastic Scintillators for RPM Applications

    International Nuclear Information System (INIS)

    Corre, G.; Boudergui, K.; Sannie, G.; Kondrasovs, V.

    2015-01-01

    Homeland security requests the use Radiation Portal Monitor (RPM). They must be able to detect and differentiate gamma and neutron radiation. Gamma detection is required for illicit transportation of radioactive matter detection. Neutron detection is important to control nonproliferation of enriched material. Manufacturers worldwide propose sensors based on 3 He which give the actual state of art in term of neutron detection. The imminent shortage of 3 He forces manufacturers to find viable alternative. From 10 years sensors providers have the challenge to replace previous 3 He detectors that are known to be the most commonly deployed neutron sensor. As 3 He detectors can only detect neutron, they must be completed with gamma detector. The proposed approach is based on pulse time correlation between adjacent sensors from signal collected by EJ200 plastic scintillators. Results obtained during FP7 Scintilla project test campaigns show the system relevance for replacement of today's 3 He detectors. (authors)

  10. Decay Time Measurement for Different Energy Depositions of Plastic Scintillator Fabricated by High Temperature Polymerization Reaction

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Cheol Ho; Son, Jaebum; Lee, Sangmin; Kim, Tae Hoon; Kim, Yong-Kyun [Hanyang University, Seoul (Korea, Republic of)

    2016-10-15

    Plastic scintillators are based on organic fluorite. They have many advantages such as fast rise and decay time, high optical transmission, ease of manufacturing, low cost, and large available size. For these reasons they are widely used for particle identification. Also, protection of people against a variety of threats (such as nuclear, radiological, and explosive) represents a true challenge along with the continuing development of science and technology. The plastic scintillator is widely used in various devise, which serves for nuclear, photonics, quantum, and high-energy physics. The plastic scintillator is probably the most widely used organic detector, and polystyrene is one of the most widely used materials in the making of the plastic scintillator detector. Thus, a styrene monomer as a solvent was used to fabricate the plastic scintillator by using high temperature polymerization reaction, and then the emission wavelength and the decay times for different energy depositions were measured by using the fabricated plastic scintillator. A plastic scintillator was fabricated to measure decay time for different energy depositions using the high temperature polymerization. Emission wavelength was measured of 426.05 nm to confirm a scintillator property using the spectrophotometer. Four gamma-ray sources (Cs-137, Co-60, Na-22, and Ba-133) were used to evaluate effect for decay time of different energy depositions. The average decay time of the fabricated plastic scintillator was measured to approximately 4.72 ns slightly higher more than commercial plastic scintillator. In future, light output and linearity will be measured to evaluate other property compared with the commercial scintillator.

  11. Decay Time Measurement for Different Energy Depositions of Plastic Scintillator Fabricated by High Temperature Polymerization Reaction

    International Nuclear Information System (INIS)

    Lee, Cheol Ho; Son, Jaebum; Lee, Sangmin; Kim, Tae Hoon; Kim, Yong-Kyun

    2016-01-01

    Plastic scintillators are based on organic fluorite. They have many advantages such as fast rise and decay time, high optical transmission, ease of manufacturing, low cost, and large available size. For these reasons they are widely used for particle identification. Also, protection of people against a variety of threats (such as nuclear, radiological, and explosive) represents a true challenge along with the continuing development of science and technology. The plastic scintillator is widely used in various devise, which serves for nuclear, photonics, quantum, and high-energy physics. The plastic scintillator is probably the most widely used organic detector, and polystyrene is one of the most widely used materials in the making of the plastic scintillator detector. Thus, a styrene monomer as a solvent was used to fabricate the plastic scintillator by using high temperature polymerization reaction, and then the emission wavelength and the decay times for different energy depositions were measured by using the fabricated plastic scintillator. A plastic scintillator was fabricated to measure decay time for different energy depositions using the high temperature polymerization. Emission wavelength was measured of 426.05 nm to confirm a scintillator property using the spectrophotometer. Four gamma-ray sources (Cs-137, Co-60, Na-22, and Ba-133) were used to evaluate effect for decay time of different energy depositions. The average decay time of the fabricated plastic scintillator was measured to approximately 4.72 ns slightly higher more than commercial plastic scintillator. In future, light output and linearity will be measured to evaluate other property compared with the commercial scintillator

  12. Plastic substrates for active matrix liquid crystal display incapable of withstanding processing temperature of over 200.degree. C and method of fabrication

    Energy Technology Data Exchange (ETDEWEB)

    Carey, Paul G. (Mountain View, CA); Smith, Patrick M. (San Ramon, CA); Havens, John (San Diego, CA); Jones, Phil (Marlborough, GB)

    1999-01-01

    Bright-polarizer-free, active-matrix liquid crystal displays (AMLCDs) are formed on plastic substrates. The primary components of the display are a pixel circuit fabricated on one plastic substrate, an intervening liquid-crystal material, and a counter electrode on a second plastic substrate. The-pixel circuit contains one or more thin-film transistors (TFTs) and either a transparent or reflective pixel electrode manufactured at sufficiently low temperatures to avoid damage to the plastic substrate. Fabrication of the TFTs can be carried out at temperatures less than 100.degree. C. The liquid crystal material is a commercially made nematic curvilinear aligned phase (NCAP) film. The counter electrode is comprised of a plastic substrate coated with a transparent conductor, such as indium-doped tin oxide (ITO). By coupling the active matrix with NCAP, a high-information content can be provided in a bright, fully plastic package. Applications include any low cost portable electronics containing flat displays where ruggedization of the display is desired.

  13. GENERIC DRUG IN GLOBAL MARKET AND REGULATORY ENVIRONMENT

    OpenAIRE

    Pankaj Kumar*, Bharti Mangla2, Satbir Singh, Arapna Rana

    2017-01-01

    Different regulatory authorities regulate the drug development in various countries of the world. Various Regulatory authority for generic drug application Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceutical and Medical Devices Agency (PMDA), Health Product and Food Branch (HPFB) Central Drug Standard of Organization (CDSO). Generic manufacturers may file an abbreviated New Drug Application (ANDA) that incorporates the safety/effectiveness data submitted by ori...

  14. Direct liquefaction of plastics and coprocessing of coal with plastics

    Energy Technology Data Exchange (ETDEWEB)

    Huffman, G.P.; Feng, Z.; Mahajan, V. [Univ. of Kentucky, Lexington, KY (United States)

    1995-12-31

    The objectives of this work were to optimize reaction conditions for the direct liquefaction of waste plastics and the coprocessing of coal with waste plastics. In previous work, the direct liquefaction of medium and high density polyethylene (PE), polypropylene (PPE), poly(ethylene terephthalate) (PET), and a mixed plastic waste, and the coliquefaction of these plastics with coals of three different ranks was studied. The results established that a solid acid catalyst (HZSM-5 zeolite) was highly active for the liquefaction of the plastics alone, typically giving oil yields of 80-95% and total conversions of 90-100% at temperatures of 430-450 {degrees}C. In the coliquefaction experiments, 50:50 mixtures of plastic and coal were used with a tetralin solvent (tetralin:solid = 3:2). Using approximately 1% of the HZSM-5 catalyst and a nanoscale iron catalyst, oil yields of 50-70% and total conversion of 80-90% were typical. In the current year, further investigations were conducted of the liquefaction of PE, PPE, and a commingled waste plastic obtained from the American Plastics Council (APC), and the coprocessing of PE, PPE and the APC plastic with Black Thunder subbituminous coal. Several different catalysts were used in these studies.

  15. Designing an in-situ ultrasonic nondestructive evaluation system for ultrasonic additive manufacturing

    Science.gov (United States)

    Nadimpalli, Venkata K.; Nagy, Peter B.

    2018-04-01

    Ultrasonic Additive Manufacturing (UAM) is a solid-state layer by layer manufacturing process that utilizes vibration induced plastic deformation to form a metallurgical bond between a thin layer and an existing base structure. Due to the vibration based bonding mechanism, the quality of components at each layer depends on the geometry of the structure. In-situ monitoring during and between UAM manufacturing steps offers the potential for closed-loop control to optimize process parameters and to repair existing defects. One interface that is most prone to delamination is the base/build interface and often UAM component height and quality are limited by failure at the base/build interface. Low manufacturing temperatures and favorable orientation of typical interface defects in UAM make ultrasonic NDE an attractive candidate for online monitoring. Two approaches for in-situ NDE are discussed and the design of the monitoring system optimized so that the quality of UAM components is not affected by the addition of the NDE setup. Preliminary results from in-situ ultrasonic NDE indicate the potential to be utilized for online qualification, closed-loop control and offline certification of UAM components.

  16. Preferred supplier contracts in post-patent prescription drug markets.

    Science.gov (United States)

    Blankart, Carl Rudolf; Stargardt, Tom

    2016-02-22

    In recent years, the expiration of patents for large drug classes has increased the importance of post-patent drug markets. However, previous research has focused solely on patent drug markets. In this study, the authors evaluate the influence of preferred supplier contracts, the German approach to tendering, in post-patent drug markets using a hierarchical market share attraction model. The authors find that preferred supplier contracts are a powerful strategic instrument for generic manufacturers in a highly competitive environment. They quantify the effects of signing a preferred supplier contract and show that brand-name manufacturers are vulnerable to tendering. Therefore, brand-name manufacturers should readjust their strategies and consider including preferred supplier contracts in their marketing mix. In addition, the authors employ a simulation to demonstrate that a first-mover advantage might be gained from signing a preferred supplier contract. Furthermore, their results can be used as a blueprint for decision makers in the pharmaceutical industry to assess the market share effects of different contracting strategies regarding preferred supplier contracts.

  17. 21 CFR 510.305 - Maintenance of copies of approved medicated feed mill licenses to manufacture animal feed bearing...

    Science.gov (United States)

    2010-04-01

    ... mill licenses to manufacture animal feed bearing or containing new animal drugs. 510.305 Section 510... copies of approved medicated feed mill licenses to manufacture animal feed bearing or containing new... medicated feed mill license (Form FDA 3448) on the premises of the manufacturing establishment; and (b...

  18. COMPARISON OF POLYJET PRINTING AND SILICON MOULDING AS RAPID PLASTIC MOULDING SOLUTIONS

    Directory of Open Access Journals (Sweden)

    R. Singh

    2012-12-01

    Full Text Available The aim of the present investigation is to compare two rapid molding (RM solutions, namely polyjet printing (PP and silicon molding (SM, for the manufacture of plastic components. The comparison has been made on the basis of dimensional accuracy (as per IT grades, mechanical properties (namely surface hardness, surface roughness and production cost. The comparison of the experimental results will serve as a yard stick for the further selection of processes for industrial applications.

  19. Cost effective manufacturing of the SEA 10X concentrator array. Final subcontract report, 9 January 1991--April 1991

    Energy Technology Data Exchange (ETDEWEB)

    Kaminar, N.; McEntee, J.; Curchod, D. [Solar Engineering Applications Corp., San Jose, CA (US)

    1991-11-01

    This report describes a low-cost, mass-producible 10X concentrator system that has been claimed to produce electricity at $0.04/kWh. It details changes in manufacturing techniques that could produce a concentrator system at a selling price of $0.71/W. (A simple design and a minimum number of parts and manufacturing steps reduced production costs.) Present production techniques, changes to improve these techniques, impediments to changes, and solutions to the impediments are described. This 10X concentrator system uses available components and manufacturing processes and one-sun solar cells in conjunction with inexpensive plastic lenses to generate about eight times the amount of electricity normally produced by these cells.

  20. 76 FR 51310 - Branded Prescription Drug Fee

    Science.gov (United States)

    2011-08-18

    ... Branded Prescription Drug Fee AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice of proposed... issue of the Federal Register, the IRS is issuing temporary regulations relating to the branded... business of manufacturing or importing certain branded prescription drugs. The text of the temporary...

  1. Association of contextual cues with morphine reward increases neural and synaptic plasticity in the ventral hippocampus of rats

    NARCIS (Netherlands)

    Alvandi, M.S.; Bourmpoula, M.; Homberg, J.R.; Fathollahi, Y.

    2017-01-01

    Drug addiction is associated with aberrant memory and permanent functional changes in neural circuits. It is known that exposure to drugs like morphine is associated with positive emotional states and reward-related memory. However, the underlying mechanisms in terms of neural plasticity in the

  2. Recycling of Plastic

    DEFF Research Database (Denmark)

    Christensen, Thomas Højlund; Fruergaard, Thilde

    2011-01-01

    Plastic is produced from fossil oil. Plastic is used for many different products. Some plastic products like, for example, wrapping foil, bags and disposable containers for food and beverage have very short lifetimes and thus constitute a major fraction of most waste. Other plastic products like...

  3. Latest developments in innovative manufacturing to combine nanotechnology with healthcare

    OpenAIRE

    Parhizkar, M.; Mahalingam, S.; Homer-Vanniasinkam, S.; Edirisinghe, M.

    2017-01-01

    Nanotechnology has become increasingly important in advancing the frontiers of many key areas of healthcare, for example, drug delivery and tissue engineering. To fully harness the many benefits of nanotechnology in healthcare, innovative manufacturing is necessary to mass produce nanoparticles and nanofibers, the two major types of nanofeatures currently sought after and of immense utilitarian value in healthcare. For example, nanoparticles are a key drug delivery enabler, the structural and...

  4. Opportunities and challenges of real-time release testing in biopharmaceutical manufacturing.

    Science.gov (United States)

    Jiang, Mo; Severson, Kristen A; Love, John Christopher; Madden, Helena; Swann, Patrick; Zang, Li; Braatz, Richard D

    2017-11-01

    Real-time release testing (RTRT) is defined as "the ability to evaluate and ensure the quality of in-process and/or final drug product based on process data, which typically includes a valid combination of measured material attributes and process controls" (ICH Q8[R2]). This article discusses sensors (process analytical technology, PAT) and control strategies that enable RTRT for the spectrum of critical quality attributes (CQAs) in biopharmaceutical manufacturing. Case studies from the small-molecule and biologic pharmaceutical industry are described to demonstrate how RTRT can be facilitated by integrated manufacturing and multivariable control strategies to ensure the quality of products. RTRT can enable increased assurance of product safety, efficacy, and quality-with improved productivity including faster release and potentially decreased costs-all of which improve the value to patients. To implement a complete RTRT solution, biologic drug manufacturers need to consider the special attributes of their industry, particularly sterility and the measurement of viral and microbial contamination. Continued advances in on-line and in-line sensor technologies are key for the biopharmaceutical manufacturing industry to achieve the potential of RTRT. Related article: http://onlinelibrary.wiley.com/doi/10.1002/bit.26378/full. © 2017 Wiley Periodicals, Inc.

  5. Elastic-plastic analysis of tube expansion in tubesheets

    International Nuclear Information System (INIS)

    Kasraie, B.; O'Donnell, W.J.; Porowski, J.S.; Selz, A.

    1983-01-01

    Conditions for expansion of tubes in tubesheets are often determined by the test. The tightness of the joint and pull out force are used as criteria for evaluation of the results. For closely spaced tubes, it is also necessary to control development of the plastic regions in the ligaments surrounding the tube being expanded. High local strains may occur and excessive distortion may result if the expansion of the tube is continued beyond the admissible limits. Elastic-plastic finite element analyses are performed herein in order to establish conditions for rolling of the tubes in tubesheets of low ligament efficiency. Such penetration patterns are often required in the design of tubular reactors for catalytic processes. The model considered includes individual tube expansion in tubesheets with triangular penetration patterns. The effect of prior expansion of the neighboring tubes is also evaluated. Gap elements are used to model the initial clearance of the tube in the hole. Development of the plastic zones and distortion of the ligaments is monitored during radial expansion of the tube diameter. The residual stresses between the tube and the hole surface and the history of gap closing after removal of the expansion tool are determined. The effect of axial extension of the tube on the tube thinning is determined. Tube thinning is often used as a measure of tube expansion in manufacturing processes. For the analyzed ligament efficiency, reliable joints are obtained for a thinning range within 2% to 3%

  6. A plastic surgeon's guide to applying smartphone technology in patient care.

    Science.gov (United States)

    Workman, Adrienne D; Gupta, Subhas C

    2013-02-01

    The vast array of information technology available to plastic surgeons continues to expand. With the recent introduction of smartphone application ("app") technology to the market, the potential for incorporating both social media and app technology into daily practice exists. The authors describe and evaluate the smartphone applications most pertinent to plastic surgery. Smartphone apps from all available markets were analyzed for various factors, including popularity among general consumers, ease of use, and functionality. Using various advertising guidelines from plastic surgery societies as well as the US Food and Drug Administration, each app's content was further analyzed within the context of ethical obligations. The apps with the highest number of ratings were those offering the option to upload photos and morph each photo according to the user's own preference. The title of apps also appears to play a role in popularity. A majority of apps demonstrated the same features available on websites. The applicability of social media marketing via smartphone apps has the potential to change future patient-surgeon interactions by offering more personalized and user-friendly encounters. The role of smartphone apps is important to the future of plastic surgery as long as plastic surgeons maintain an active role in the development of these apps to ensure their value.

  7. 21 CFR 1301.91 - Employee responsibility to report drug diversion.

    Science.gov (United States)

    2010-04-01

    ... REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES Employee Screening-Non-Practitioners § 1301.91 Employee responsibility to report drug diversion. Reports of drug diversion by fellow... 21 Food and Drugs 9 2010-04-01 2010-04-01 false Employee responsibility to report drug diversion...

  8. Analysis of Phthalate Migration to Food Simulants in Plastic Containers during Microwave Operations

    Directory of Open Access Journals (Sweden)

    Miriany A. Moreira

    2013-12-01

    Full Text Available Phthalates used as plasticizers in the manufacture of household containers can potentially be transferred to foods that are stored or heated in these plastic containers. Phthalates are endocrine disruptor compounds (EDC and are found in very low concentrations in foods, thus, highly sensitive analytical techniques are required for their quantification. This study describes the application of a new method developed for analyzing the migration of dibutylphthalate (DBP and benzylbutylphthalate (BBP from plastic food containers into liquid food simulants. This new method employs the technique of solid phase microextraction cooled with liquid nitrogen. The analysis was conducted by gas chromatography/mass spectrometry (GC/MS using a polyacrylate fiber. Ultrapure water was used as a simulant for liquids foods, and both new and used plastic containers were placed in a domestic microwave oven for different periods of time at different power levels. The limits of detection for DBP and BBP were 0.08 µg/L and 0.31 µg/L, respectively. BBP was not found in the samples that were analyzed. DBP was found in concentrations ranging from

  9. Development of modified release 3D printed tablets (printlets) with pharmaceutical excipients using additive manufacturing.

    Science.gov (United States)

    Goyanes, Alvaro; Fina, Fabrizio; Martorana, Annalisa; Sedough, Daniel; Gaisford, Simon; Basit, Abdul W

    2017-07-15

    The aim of this study was to manufacture 3D printed tablets (printlets) from enteric polymers by single filament fused deposition modeling (FDM) 3D printing (3DP). Hot melt extrusion was used to generate paracetamol-loaded filaments from three different grades of the pharmaceutical excipient hypromellose acetate succinate (HPMCAS), grades LG, MG and HG. One-step 3DP was used to process these filaments into enteric printlets incorporating up to 50% drug loading with two different infill percentages (20 and 100%). X-ray Micro Computed Tomography (Micro-CT) analysis revealed that printlets with 20% infill had cavities in the core compared to 100% infill, and that the density of the 50% drug loading printlets was higher than the equivalent formulations loaded with 5% drug. In biorelevant bicarbonate dissolution media, drug release from the printlets was dependent on the polymer composition, drug loading and the internal structure of the formulations. All HPMCAS-based printlets showed delayed drug release properties, and in the intestinal conditions, drug release was faster from the printlets prepared with polymers with a lower pH-threshold: HPMCAS LG > HPMCAS MG > HPMCAS HG. These results confirm that FDM 3D printing makes it possible not only to manufacture delayed release printlets without the need for an outer enteric coating, but it is also feasible to adapt the release profile in response to the personal characteristics of the patient, realizing the full potential of additive manufacturing in the development of personalised dose medicines. Copyright © 2017 Elsevier B.V. All rights reserved.

  10. A primer of drug safety surveillance: an industry perspective. Part I: Information flow, new drug development, and federal regulations.

    Science.gov (United States)

    Allan, M C

    1992-01-01

    To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part I of this series provides a background for the discussion of drug safety by defining the basic terms and showing the flow of safety information through a pharmaceutical company. The customers for adverse drug event data are identified to provide a basis for providing quality service. The development of a drug product is briefly reviewed to show the evolution of safety data. Drug development and safety are defined by federal regulations. These regulations are developed by the FDA with information from pharmaceutical manufacturers. The intent of the regulations and the accompanying guidelines is described. An illustration from the news media is cited to show an alternative, positive approach to handling an adverse event report. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text and additional readings are presented in an appendix. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction ;of the components

  11. [Smuggling of illegal drugs by body suffers].

    Science.gov (United States)

    Aksnes, Tonje Amb; Jacobsen, Dag

    2004-07-01

    Body packers are persons who smuggle illegal drugs by swallowing condoms or plastic cylinders containing such substances. Body stuffers are drug dealers or drug abusers who swallow illegal drugs in an effort to conceal evidence during an arrest or in fear of being arrested. We report four cases and discuss management. Asymptomatic body packers may be managed conservatively with laxatives and water-soluble contrast medium. This method allows an accurate follow-up with abdominal radiography. If patients develop abdominal pain or signs and symptoms of intoxication, surgical intervention should be considered. Both types of patients should be monitored carefully.

  12. PREDIKSI SHRINKAGE UNTUK MENGHINDARI CACAT PRODUK PADA PLASTIC INJECTION

    Directory of Open Access Journals (Sweden)

    Agus Dwi Anggono

    2015-05-01

    Full Text Available Plastic injection merupakan proses manufactur untuk membuat produk dengan bahan dasar plastic atau dalam kesempatan ini polypropylene. Pada proses tersebut seringkali terjadi cacat produk seperti pengerutan, retak, dimensi tidak sesuai dan kerusakan saat produk keluar dari mould, sehingga banyak material yang terbuang percuma. Meskipun cacat produk tersebut dipengaruhi banyak factor, tetapi yang paling utama adalah masalah shrinkage, atau penyusutan material setelah terjadi pendinginan. Sangat penting untuk melakukan prediksi lebih awal terjadinya penyusutan setelah pendinginan untuk menghindari cacat produk. Dalam penelitian ini akan dilakukan prediksi shrinkage yang akan digunakan untuk material polypropylene dengan cara perhitungan standar. Pembuatan modeling dalam bentuk 3D (tiga dimensi injection molding baik cavity maupun corenya dengan menggunakan CATIA, kemudian dilakukan analisis dengan software MoldFlow untuk pembuatan mesh dan memberikan batasan panas pada komponen sehingga dapat diketahui mode penyusutannya. Analisis ini akan memberikan gambaran tentang distribusi panas pada mould dan memberikan tentang gambaran aliran fluida. Pada analisis tersebut dapat dilihat gejala terjadinya cacat produk, jika hal itu terjadi maka perlu dilakukan perubahan shrinkage, sampai diperoleh hasil analisis yang baik.

  13. 21 CFR 1310.21 - Sale by Federal departments or agencies of chemicals which could be used to manufacture...

    Science.gov (United States)

    2010-04-01

    ... chemicals which could be used to manufacture controlled substances. 1310.21 Section 1310.21 Food and Drugs... manufacture controlled substances. (a) A Federal department or agency may not sell from the stocks of the... Administration, could be used in the manufacture of a controlled substance, unless the Administrator certifies in...

  14. Patient Drug Safety Reporting: Diabetes Patients' Perceptions of Drug Safety and How to Improve Reporting of Adverse Events and Product Complaints.

    Science.gov (United States)

    Patel, Puja; Spears, David; Eriksen, Betina Østergaard; Lollike, Karsten; Sacco, Michael

    2018-03-01

    Global health care manufacturer Novo Nordisk commissioned research regarding awareness of drug safety department activities and potential to increase patient feedback. Objectives were to examine patients' knowledge of pharmaceutical manufacturers' responsibilities and efforts regarding drug safety, their perceptions and experiences related to these efforts, and how these factors influence their thoughts and behaviors. Data were collected before and after respondents read a description of a drug safety department and its practices. We conducted quantitative survey research across 608 health care consumers receiving treatment for diabetes in the United States, Germany, United Kingdom, and Italy. This research validated initial, exploratory qualitative research (across 40 comparable consumers from the same countries) which served to guide design of the larger study. Before reading a drug safety department description, 55% of respondents were unaware these departments collect safety information on products and patients. After reading the description, 34% reported the department does more than they expected to ensure drug safety, and 56% reported "more confidence" in the industry as a whole. Further, 66% reported themselves more likely to report an adverse event or product complaint, and 60% reported that they were more likely to contact a drug safety department with questions. The most preferred communication methods were websites/online forums (39%), email (27%), and telephone (25%). Learning about drug safety departments elevates consumers' confidence in manufacturers' safety efforts and establishes potential for patients to engage in increased self-monitoring and reporting. Study results reveal potentially actionable insights for the industry across patient and physician programs and communications.

  15. Rheological characterization of plasticized corn proteins for fused deposition modeling

    Science.gov (United States)

    Chaunier, Laurent; Dalgalarrondo, Michèle; Della Valle, Guy; Lourdin, Denis; Marion, Didier; Leroy, Eric

    2017-10-01

    Additive Manufacturing (AM) of tailored natural biopolymer-based objects by Fused Deposition Modeling (FDM) opens new perspectives for applications such as biomedical temporary devices, or pharmaceutical tablets. This exploits the biocompatibility, resorbability and edibility properties of biopolymers. When adequately plasticized, zeins, storage proteins from endosperm of maize kernels, displayed thermomechanical properties possibly matching FDM processing requirements at a convenient temperature Tprinting=130°C. Indeed, with 20% glycerol added (Tg=42°C), plasticized zeins present a high modulus, E'>1GPa, at ambient conditions, which drops below 0.6 MPa at the processing temperature T=130°C, before flowing in the molten state. The rheological characterization shows that the processing window is limited by a progressive increase of viscosity linked to proteins aggregation and crosslinking by S-S bonding between cysteine amino acid residues, which can lead to gelation. However, for short residence time typical of FDM, the viscosity of plasticized zeins is comparable to the one of standard polymers, like ABS or PLA in their FDM processing conditions: indeed, in presence of glycerol, the molten zeins show a shear-thinning behavior with |η*|≈3kPa.s at 1s-1, decreasing to |η*|≈0.3kPa.s at 100s-1, at 130°C. Moreover, zeins presenting both hydrophilic and hydrophobic domains, amphiphilic plasticizers can be used supplementary to tune their rheological behavior. With 20% oleic acid added to the previous composition, the viscosity is divided down to a ratio about 1/2 at 100s-1 at 130°C, below the value of a standard polymer as PLA at its printing temperature. These results show the possible enhancement of the printability of zein-based materials in the molten state, by combining polar and amphiphilic plasticizers.

  16. Mixed WTO ruling on generic drug development.

    Science.gov (United States)

    Elliott, R

    2000-01-01

    On 17 March 2000, the World Trade Organization upheld the provision in Canada's patent laws that allows generic drug manufacturers to develop (but not sell) their cheaper versions of patented medicines before the 20-year patients expire. The decision prevents pharmaceutical companies from enjoying market monopolies beyond their patent terms, avoiding what would otherwise be even lengthier delays in the sale of cheaper, generic drugs in Canada. This decision is of significance not only to Canada, but also to other WTO member countries and to all individuals who use pharmaceutical products. However, the decision is not all positive: the WTO also ruled that Canada is violating international agreements by letting generic manufacturers stockpile their versions of patented drugs before patents expire. This article explains the issues, the arguments, and the decision.

  17. Drug quality in South Africa: perceptions of key players involved in medicines distribution.

    Science.gov (United States)

    Patel, Aarti; Norris, Pauline; Gauld, Robin; Rades, Thomas

    2009-01-01

    Substandard medicines contribute to poor public health and affect development, especially in the developing world. However knowledge of how manufacturers, distributors and providers understand the concept of drug quality and what strategies they adopt to ensure drug quality is limited, particularly in the developing world. The purpose of this paper is to explore pharmaceutical manufacturers', distributors' and providers' perceptions of drug quality in South Africa and how they ensure the quality of drugs during the distribution process. The approach taken was qualitative data collection through key informant interviews using a semi-structured interview guide. Transcripts were analysed thematically in Johannesburg, Pretoria and Durban, South Africa. Participants were recruited purposefully from a South African pharmaceutical manufacturer, SA subsidiaries of international manufacturers, national distribution companies, national wholesaler, public and private sector pharmacists, and a dispensing doctor. In total, ten interviews were conducted. Participants described drug quality in terms of the product and the processes involved in manufacturing and handling the product. Participants identified purchasing registered medicines from licensed suppliers, use of standard operating procedures, and audits between manufacturer and distributor and/or provider as key strategies employed to protect medicine quality. Effective communication amongst all stakeholders, especially in terms of providing feedback regarding complaints about medicine quality, appears as a potential area of concern, which would benefit from further research. The paper hightlights that ensuring medicine quality should be a shared responsibility amongst all involved in the distribution process to prevent medicines moving from one distribution system (public) into another (private).

  18. 21 CFR 878.4810 - Laser surgical instrument for use in general and plastic surgery and in dermatology.

    Science.gov (United States)

    2010-04-01

    ... plastic surgery and in dermatology. 878.4810 Section 878.4810 Food and Drugs FOOD AND DRUG ADMINISTRATION... dermatology. (a) Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a...) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by...

  19. Plastic value chains

    DEFF Research Database (Denmark)

    Baxter, John; Wahlstrom, Margareta; Zu Castell-Rüdenhausen, Malin

    2014-01-01

    Optimizing plastic value chains is regarded as an important measure in order to increase recycling of plastics in an efficient way. This can also lead to improved awareness of the hazardous substances contained in plastic waste, and how to avoid that these substances are recycled. As an example......, plastics from WEEE is chosen as a Nordic case study. The project aims to propose a number of improvements for this value chain together with representatives from Nordic stakeholders. Based on the experiences made, a guide for other plastic value chains shall be developed....

  20. Retempering of Concrete made by using Manufactured Sand

    Science.gov (United States)

    Pethkar, A. R.; Deshmukh, G.

    2014-06-01

    Retempering is defined as, " Addition of water and remixing of concrete or mortar which has lost enough workability to become unplaceable". Retempering inevitably results in some loss of strength compared with the original concrete [1]. Adding water to a plastic mix to increase slump is an extremely common practice, even though it is not recommended because it increases the porosity of concrete. Concrete often arrives on site more than half an hour after initial mixing. Placement operations can take anywhere from 10 to 60 min, depending on the field conditions and the size of the load. When the slump decreases to an unacceptable level during the operations, water is added to the mix [1]. In this work, an attempt is made to study the strength characteristics of retempered concrete made by using manufactured sand. Usually the retempering process is there with normal and ready mixed concrete; hence an attempt is made to check the compressive and flexural strength of normal retempered concrete with an addition of retarder 0.2, 0.4 and 0.6 % at retempering time from 15 to 90 min. There is scarcity of natural sand due to various factors, which is replaced by the manufactured sand. The concept of manufactured sand is nothing but breaking stone into smaller and smaller particles in such way that the gradation of particle will match with zone-II of I.S.

  1. Our plastic age.

    Science.gov (United States)

    Thompson, Richard C; Swan, Shanna H; Moore, Charles J; vom Saal, Frederick S

    2009-07-27

    Within the last few decades, plastics have revolutionized our daily lives. Globally we use in excess of 260 million tonnes of plastic per annum, accounting for approximately 8 per cent of world oil production. In this Theme Issue of Philosophical Transactions of the Royal Society, we describe current and future trends in usage, together with the many benefits that plastics bring to society. At the same time, we examine the environmental consequences resulting from the accumulation of waste plastic, the effects of plastic debris on wildlife and concerns for human health that arise from the production, usage and disposal of plastics. Finally, we consider some possible solutions to these problems together with the research and policy priorities necessary for their implementation.

  2. Our plastic age

    Science.gov (United States)

    Thompson, Richard C.; Swan, Shanna H.; Moore, Charles J.; vom Saal, Frederick S.

    2009-01-01

    Within the last few decades, plastics have revolutionized our daily lives. Globally we use in excess of 260 million tonnes of plastic per annum, accounting for approximately 8 per cent of world oil production. In this Theme Issue of Philosophical Transactions of the Royal Society, we describe current and future trends in usage, together with the many benefits that plastics bring to society. At the same time, we examine the environmental consequences resulting from the accumulation of waste plastic, the effects of plastic debris on wildlife and concerns for human health that arise from the production, usage and disposal of plastics. Finally, we consider some possible solutions to these problems together with the research and policy priorities necessary for their implementation. PMID:19528049

  3. 3D printed drug delivery and testing systems - a passing fad or the future?

    Science.gov (United States)

    Lim, Seng Han; Kathuria, Himanshu; Tan, Justin Jia Yao; Kang, Lifeng

    2018-05-18

    The US Food and Drug Administration approval of the first 3D printed tablet in 2015 has ignited growing interest in 3D printing, or additive manufacturing (AM), for drug delivery and testing systems. Beyond just a novel method for rapid prototyping, AM provides key advantages over traditional manufacturing of drug delivery and testing systems. These includes the ability to fabricate complex geometries to achieve variable drug release kinetics; ease of personalising pharmacotherapy for patient and lowering the cost for fabricating personalised dosages. Furthermore, AM allows fabrication of complex and micron-sized tissue scaffolds and models for drug testing systems that closely resemble in vivo conditions. However, there are several limitations such as regulatory concerns that may impede the progression to market. Here, we provide an overview of the advantages of AM drug delivery and testing, as compared to traditional manufacturing techniques. Also, we discuss the key challenges and future directions for AM enabled pharmaceutical applications. Copyright © 2018 Elsevier B.V. All rights reserved.

  4. Improved Properties of Medium-Density Particleboard Manufactured from Saline Creeping Wild Rye and HDPE Plastic

    Science.gov (United States)

    Creeping Wild Rye (CWR), Leymus triticoides, is a salt-tolerant perennial grass used for mitigating the problems of saltilization and alkalization in drainage irrigation water and soil to minimize potential pollution of water streams. In this study, CWR was used as a raw material to manufacture med...

  5. Molecular and Neuronal Plasticity Mechanisms in the Amygdala-Prefrontal Cortical Circuit: Implications for Opiate Addiction Memory Formation

    Directory of Open Access Journals (Sweden)

    Laura G Rosen

    2015-11-01

    Full Text Available The persistence of associative memories linked to the rewarding properties of drugs of abuse is a core underlying feature of the addiction process. Opiate class drugs in particular, possess potent euphorigenic effects which, when linked to environmental cues, can produce drug-related ‘trigger’ memories that may persist for lengthy periods of time, even during abstinence, in both humans and other animals. Furthermore, the transitional switch from the drug-naïve, non-dependent state to states of dependence and withdrawal, represents a critical boundary between distinct neuronal and molecular substrates associated with opiate-reward memory formation. Identifying the functional molecular and neuronal mechanisms related to the acquisition, consolidation, recall and extinction phases of opiate-related reward memories is critical for understanding, and potentially reversing, addiction-related memory plasticity characteristic of compulsive drug-seeking behaviors. The mammalian prefrontal cortex (PFC and basolateral nucleus of the amygdala (BLA share important functional and anatomical connections that are involved importantly in the processing of associative memories linked to drug reward. In addition, both regions share interconnections with the mesolimbic pathway’s ventral tegmental area (VTA and nucleus accumbens (NAc and can modulate dopamine (DA transmission and neuronal activity associated with drug-related DAergic signaling dynamics. In this review, we will summarize research from both human and animal modelling studies highlighting the importance of neuronal and molecular plasticity mechanisms within this circuitry during critical phases of opiate addiction-related learning and memory processing. Specifically, we will focus on two molecular signaling pathways known to be involved in both drug-related neuroadaptations and in memory-related plasticity mechanisms; the extracellular-signal-regulated kinase system (ERK and the Ca2+/calmodulin

  6. Transportation fuel from plastic: Two cases of study.

    Science.gov (United States)

    Faussone, Gian Claudio

    2018-03-01

    Synthesis of liquid fuels from waste is a promising pathway for reducing the carbon footprint of transportation industry and optimizing waste management towards zero landfilling. The study of commercial plants that conduct pyrolysis of plastics from post-consumer recycled materials and directly mine from old landfills without any pre-treatment has revealed two cases that show the feasibility of manufacturing transportation fuels via these methods. Pyrolysis oil, consisting of almost 26% hydrocarbons within the gasoline range and almost 70% within the diesel range, is upgraded to transportation fuel in the existing refinery. A batch operating plant is able to deliver relatively good quality pyrolysis oil from post-consumer plastic waste, owing to the catalyst employed. Simple distillation was also evaluated as an alternative and cheaper upgrading process into transportation fuels, meeting EN590 diesel and ISO8217 marine fuel standards. Even though the two installations are outside the European Union, they represent good examples of the "circular economy" concept envisaged by the European Union via its ambitious "Circular Economy Package [1]", providing real world data for comparison with other experimental and lab results. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. Circuit design on plastic foils

    CERN Document Server

    Raiteri, Daniele; Roermund, Arthur H M

    2015-01-01

    This book illustrates a variety of circuit designs on plastic foils and provides all the information needed to undertake successful designs in large-area electronics.  The authors demonstrate architectural, circuit, layout, and device solutions and explain the reasons and the creative process behind each. Readers will learn how to keep under control large-area technologies and achieve robust, reliable circuit designs that can face the challenges imposed by low-cost low-temperature high-throughput manufacturing.   • Discusses implications of problems associated with large-area electronics and compares them to standard silicon; • Provides the basis for understanding physics and modeling of disordered material; • Includes guidelines to quickly setup the basic CAD tools enabling efficient and reliable designs; • Illustrates practical solutions to cope with hard/soft faults, variability, mismatch, aging and bias stress at architecture, circuit, layout, and device levels.

  8. 14 CFR 61.15 - Offenses involving alcohol or drugs.

    Science.gov (United States)

    2010-01-01

    ... the growing, processing, manufacture, sale, disposition, possession, transportation, or importation of... influence of alcohol or a drug; (2) The cancellation, suspension, or revocation of a license to operate a... intoxicated by alcohol or a drug, while impaired by alcohol or a drug, or while under the influence of alcohol...

  9. Impact of Bio-Based Plastics on Current Recycling of Plastics

    Directory of Open Access Journals (Sweden)

    Luc Alaerts

    2018-05-01

    Full Text Available Bio-based plastics are increasingly appearing in a range of consumption products, and after use they often end up in technical recycling chains. Bio-based plastics are different from fossil-based ones and could disturb the current recycling of plastics and hence inhibit the closure of plastic cycles, which is undesirable given the current focus on a transition towards a circular economy. In this paper, this risk has been assessed via three elaborated case studies using data and information retrieved through an extended literature search. No overall risks were revealed for bio-based plastics as a group; rather, every bio-based plastic is to be considered as a potential separate source of contamination in current recycling practices. For PLA (polylactic acid, a severe incompatibility with PET (polyethylene terephthalate recycling is known; hence, future risks are assessed by measuring amounts of PLA ending up in PET waste streams. For PHA (polyhydroxy alkanoate there is no risk currently, but it will be crucial to monitor future application development. For PEF (polyethylene furanoate, a particular approach for contamination-related issues has been included in the upcoming market introduction. With respect to developing policy, it is important that any introduction of novel plastics is well guided from a system perspective and with a particular eye on incompatibilities with current and upcoming practices in the recycling of plastics.

  10. The cutting of metals via plastic buckling

    Science.gov (United States)

    Udupa, Anirudh; Viswanathan, Koushik; Ho, Yeung; Chandrasekar, Srinivasan

    2017-06-01

    The cutting of metals has long been described as occurring by laminar plastic flow. Here we show that for metals with large strain-hardening capacity, laminar flow mode is unstable and cutting instead occurs by plastic buckling of a thin surface layer. High speed in situ imaging confirms that the buckling results in a small bump on the surface which then evolves into a fold of large amplitude by rotation and stretching. The repeated occurrence of buckling and folding manifests itself at the mesoscopic scale as a new flow mode with significant vortex-like components-sinuous flow. The buckling model is validated by phenomenological observations of flow at the continuum level and microstructural characteristics of grain deformation and measurements of the folding. In addition to predicting the conditions for surface buckling, the model suggests various geometric flow control strategies that can be effectively implemented to promote laminar flow, and suppress sinuous flow in cutting, with implications for industrial manufacturing processes. The observations impinge on the foundations of metal cutting by pointing to the key role of stability of laminar flow in determining the mechanism of material removal, and the need to re-examine long-held notions of large strain deformation at surfaces.

  11. Analysis of field usage failure rate data for plastic encapsulated solid state devices

    Science.gov (United States)

    1981-01-01

    Survey and questionnaire techniques were used to gather data from users and manufacturers on the failure rates in the field of plastic encapsulated semiconductors. It was found that such solid state devices are being successfully used by commercial companies which impose certain screening and qualification procedures. The reliability of these semiconductors is now adequate to support their consideration in NASA systems, particularly in low cost systems. The cost of performing necessary screening for NASA applications was assessed.

  12. Biodegradability of plastics.

    Science.gov (United States)

    Tokiwa, Yutaka; Calabia, Buenaventurada P; Ugwu, Charles U; Aiba, Seiichi

    2009-08-26

    Plastic is a broad name given to different polymers with high molecular weight, which can be degraded by various processes. However, considering their abundance in the environment and their specificity in attacking plastics, biodegradation of plastics by microorganisms and enzymes seems to be the most effective process. When plastics are used as substrates for microorganisms, evaluation of their biodegradability should not only be based on their chemical structure, but also on their physical properties (melting point, glass transition temperature, crystallinity, storage modulus etc.). In this review, microbial and enzymatic biodegradation of plastics and some factors that affect their biodegradability are discussed.

  13. Development of metallic molds for the large volume plastic scintillator fabrication

    International Nuclear Information System (INIS)

    Calvo, Wilson A.P.; Vieira, Jose M.; Rela, Paulo R.; Bruzinga, Wilson A.; Araujo, Eduardo P.; Costa Junior, Nelson P.; Hamada, Margarida M.

    1997-01-01

    The plastic scintillators are radiation detectors made of organic fluorescent compounds dissolved in a solidified polymer matrix. The manufacturing process of large volume detectors (55 liters) at low cost, by polymerization of the styrene monomer plus PPO and POPOP scintillators, was studied in this paper. Metallic molds of ASTM 1200 aluminum and AISI 304 stainless steel were produced by TIG welding process since the polymerization reaction is very exothermic. The measurements of transmittance, luminescence, X-ray fluorescence and light output were carried out in the plastic scintillators made using different metallic molds. The characterization results of the detectors produced in an open system using ASTM 1200 aluminum mold show that there is not quality change in the scintillator, even with aluminum being considered as unstable for styrene monomer. Therefore, the ASTM 1200 aluminum was found to be the best alternative to produce the detector by an open system polymerization. (author). 11 refs., 8 figs., 1 tab

  14. The Economic Side Effects of Dangerous Drug Announcements.

    OpenAIRE

    Dranove, David; Olsen, Chris

    1994-01-01

    Immediately prior to the passage of the 1962 Food and Drug Administration Amendments, there were a number of drugs recalled from markets worldwide. Announcements about the dangerous side effects of these drugs were associated with lower-share prices for their manufacturers and the industry as a whole. We perform several analyses to sort out alternative explanations for the observed declines. We find that dangerous drug announcements had no effect on the sales of other drugs and didn't affect ...

  15. Characterization of plastic blends made from mixed plastics waste of different sources.

    Science.gov (United States)

    Turku, Irina; Kärki, Timo; Rinne, Kimmo; Puurtinen, Ari

    2017-02-01

    This paper studies the recyclability of construction and household plastic waste collected from local landfills. Samples were processed from mixed plastic waste by injection moulding. In addition, blends of pure plastics, polypropylene and polyethylene were processed as a reference set. Reference samples with known plastic ratio were used as the calibration set for quantitative analysis of plastic fractions in recycled blends. The samples were tested for the tensile properties; scanning electron microscope-energy-dispersive X-ray spectroscopy was used for elemental analysis of the blend surfaces and Fourier transform infrared (FTIR) analysis was used for the quantification of plastics contents.

  16. The strategic relevance of manufacturing technology: An overall quality concept to promote innovation preventing drug shortage.

    Science.gov (United States)

    Panzitta, Michele; Ponti, Mauro; Bruno, Giorgio; Cois, Giancarlo; D'Arpino, Alessandro; Minghetti, Paola; Mendicino, Francesca Romana; Perioli, Luana; Ricci, Maurizio

    2017-01-10

    Manufacturing is the bridge between research and patient: without product, there is no clinical outcome. Shortage has a variety of causes, in this paper we analyse only causes related to manufacturing technology and we use shortage as a paradigm highliting the relevance of Pharmaceutical Technology. Product and process complexity and capacity issues are the main challenge for the Pharmaceutical Industry Supply chain. Manufacturing Technology should be acknowledged as a R&D step and as a very important matter during University degree in Pharmacy and related disciplines, promoting collaboration between Academia and Industry, measured during HTA step and rewarded in terms of price and reimbursement. The above elements are not yet properly recognised, and manufacturing technology is taken in to consideration only when a shortage is in place. In a previous work, Panzitta et al. proposed to perform a full technology assessment at the Health Technological Assessment stage, evaluating three main technical aspects of a medicine: manufacturing process, physicochemical properties, and formulation characteristics. In this paper, we develop the concept of manufacturing appraisal, providing a technical overview of upcoming challenges, a risk based approach and an economic picture of shortage costs. We develop also an overall quality concept, not limited to GMP factors but broaden to all elements leading to a robust supply and promoting technical innovation. Copyright © 2016 Elsevier B.V. All rights reserved.

  17. 21 CFR 181.22 - Certain substances employed in the manufacture of food-packaging materials.

    Science.gov (United States)

    2010-04-01

    ... food-packaging materials. 181.22 Section 181.22 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT... of food-packaging materials. Prior to the enactment of the food additives amendment to the Federal... manufacturing practice for food-packaging materials includes the restriction that the quantity of any of these...

  18. 76 FR 17969 - Manufacturer of Controlled Substances; Notice of Registration

    Science.gov (United States)

    2011-03-31

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated November 1, 2010, and published in the Federal Register on November 12, 2010, 75 FR 69464, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665...

  19. 75 FR 10314 - Manufacturer of Controlled Substances; Notice of Registration

    Science.gov (United States)

    2010-03-05

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Registration By Notice dated September 17, 2009, and published in the Federal Register on September 25, 2009, (74 FR 49020), Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas...

  20. The Prevalence of Cosmetic Facial Plastic Procedures among Facial Plastic Surgeons.

    Science.gov (United States)

    Moayer, Roxana; Sand, Jordan P; Han, Albert; Nabili, Vishad; Keller, Gregory S

    2018-04-01

    This is the first study to report on the prevalence of cosmetic facial plastic surgery use among facial plastic surgeons. The aim of this study is to determine the frequency with which facial plastic surgeons have cosmetic procedures themselves. A secondary aim is to determine whether trends in usage of cosmetic facial procedures among facial plastic surgeons are similar to that of nonsurgeons. The study design was an anonymous, five-question, Internet survey distributed via email set in a single academic institution. Board-certified members of the American Academy of Facial Plastic and Reconstructive Surgery (AAFPRS) were included in this study. Self-reported history of cosmetic facial plastic surgery or minimally invasive procedures were recorded. The survey also queried participants for demographic data. A total of 216 members of the AAFPRS responded to the questionnaire. Ninety percent of respondents were male ( n  = 192) and 10.3% were female ( n  = 22). Thirty-three percent of respondents were aged 31 to 40 years ( n  = 70), 25% were aged 41 to 50 years ( n  = 53), 21.4% were aged 51 to 60 years ( n  = 46), and 20.5% were older than 60 years ( n  = 44). Thirty-six percent of respondents had a surgical cosmetic facial procedure and 75% has at least one minimally invasive cosmetic facial procedure. Facial plastic surgeons are frequent users of cosmetic facial plastic surgery. This finding may be due to access, knowledge base, values, or attitudes. By better understanding surgeon attitudes toward facial plastic surgery, we can improve communication with patients and delivery of care. This study is a first step in understanding use of facial plastic procedures among facial plastic surgeons. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

  1. Conformational plasticity of the Ebola virus matrix protein.

    Science.gov (United States)

    Radzimanowski, Jens; Effantin, Gregory; Weissenhorn, Winfried

    2014-11-01

    Filoviruses are the causative agents of a severe and often fatal hemorrhagic fever with repeated outbreaks in Africa. They are negative sense single stranded enveloped viruses that can cross species barriers from its natural host bats to primates including humans. The small size of the genome poses limits to viral adaption, which may be partially overcome by conformational plasticity. Here we review the different conformational states of the Ebola virus (EBOV) matrix protein VP40 that range from monomers, to dimers, hexamers, and RNA-bound octamers. This conformational plasticity that is required for the viral life cycle poses a unique opportunity for development of VP40 specific drugs. Furthermore, we compare the structure to homologous matrix protein structures from Paramyxoviruses and Bornaviruses and we predict that they do not only share the fold but also the conformational flexibility of EBOV VP40. © 2014 The Protein Society.

  2. A study on the development of engineering plastic piston used in the shock absorber

    Science.gov (United States)

    Kim, Young-Ho; Bae, Won-Byong; Lim, Dong-Ju; Suh, Yun-Soo

    1998-08-01

    A piston is an important component of the shock absorber which determines comfortable riding and handling. Conventional piston is made of metal powder that is pressed in a mold, and then sintered at high temperatures below the melting point before machining processes such as drilling, sizing and teflon banding. This study aims at cutting down cost and weight, and improving the process by replacing the traditional sintering process used for manufacturing the shock absorber with the injection molding process adopting engineering plastics as raw material. To analyze the injection molding process, we used the commercial program, MOLDFLOW, and obtained an optimal combination of the process parameters. In addition, by comparing the engineering plastic piston with the metal powder piston through the formability and the performance experiments, we confirmed the availability of this alternative process suggested.

  3. Evaluating the administration costs of biologic drugs: development of a cost algorithm.

    Science.gov (United States)

    Tetteh, Ebenezer K; Morris, Stephen

    2014-12-01

    Biologic drugs, as with all other medical technologies, are subject to a number of regulatory, marketing, reimbursement (financing) and other demand-restricting hurdles applied by healthcare payers. One example is the routine use of cost-effectiveness analyses or health technology assessments to determine which medical technologies offer value-for-money. The manner in which these assessments are conducted suggests that, holding all else equal, the economic value of biologic drugs may be determined by how much is spent on administering these drugs or trade-offs between drug acquisition and administration costs. Yet, on the supply-side, it seems very little attention is given to how manufacturing and formulation choices affect healthcare delivery costs. This paper evaluates variations in the administration costs of biologic drugs, taking care to ensure consistent inclusion of all relevant cost resources. From this, it develops a regression-based algorithm with which manufacturers could possibly predict, during process development, how their manufacturing and formulation choices may impact on the healthcare delivery costs of their products.

  4. Biodegradability of Plastics

    Directory of Open Access Journals (Sweden)

    Yutaka Tokiwa

    2009-08-01

    Full Text Available Plastic is a broad name given to different polymers with high molecular weight, which can be degraded by various processes. However, considering their abundance in the environment and their specificity in attacking plastics, biodegradation of plastics by microorganisms and enzymes seems to be the most effective process. When plastics are used as substrates for microorganisms, evaluation of their biodegradability should not only be based on their chemical structure, but also on their physical properties (melting point, glass transition temperature, crystallinity, storage modulus etc.. In this review, microbial and enzymatic biodegradation of plastics and some factors that affect their biodegradability are discussed.

  5. The impact of fit manufacturing on green manufacturing: A review

    Science.gov (United States)

    Qi, Ang Nian; Sin, Tan Chan; Fathullah, M.; Lee, C. C.

    2017-09-01

    Fit manufacturing and Green manufacturing are a new trend principle and concept. They are getting popular in industrial. This paper is identifying the impact between Fit manufacturing and Green manufacturing. Besides Fit manufacturing, Lean manufacturing, Agile manufacturing and Sustainable manufacturing gives big impacts to Green Manufacturing. On top of that, this paper also discuss the benefits of applying Fit manufacturing and Green manufacturing in industrial as well as environment. Hence, applications of Fit manufacturing and Green Manufacturing are increasing year by year.

  6. Microneedles for drug and vaccine delivery

    Science.gov (United States)

    Kim, Yeu-Chun; Park, Jung-Hwan; Prausnitz, Mark R.

    2012-01-01

    Microneedles were first conceptualized for drug delivery many decades ago, but only became the subject of significant research starting in the mid-1990’s when microfabrication technology enabled their manufacture as (i) solid microneedles for skin pretreatment to increase skin permeability, (ii) microneedles coated with drug that dissolves off in the skin, (iii) polymer microneedles that encapsulate drug and fully dissolve in the skin and (iv) hollow microneedles for drug infusion into the skin. As shown in more than 350 papers now published in the field, microneedles have been used to deliver a broad range of different low molecular weight drugs, biotherapeutics and vaccines, including published human studies with a number of small-molecule and protein drugs and vaccines. Influenza vaccination using a hollow microneedle is in widespread clinical use and a number of solid microneedle products are sold for cosmetic purposes. In addition to applications in the skin, microneedles have also been adapted for delivery of bioactives into the eye and into cells. Successful application of microneedles depends on device function that facilitates microneedle insertion and possible infusion into skin, skin recovery after microneedle removal, and drug stability during manufacturing, storage and delivery, and on patient outcomes, including lack of pain, skin irritation and skin infection, in addition to drug efficacy and safety. Building off a strong technology base and multiple demonstrations of successful drug delivery, microneedles are poised to advance further into clinical practice to enable better pharmaceutical therapies, vaccination and other applications. PMID:22575858

  7. Elastic-plastic behaviour of thick-walled containers considering plastic compressibility

    International Nuclear Information System (INIS)

    Betten, J.; Frosch, H.G.

    1983-01-01

    In this paper the elastic-plastic behaviour of thick-walled pressure vessels with internal and external pressure is studied. To describe the mechanical behaviour of isotropic, plastic compressible materials we use a plastic potential which is a single-valued function of the principle stresses. For cylinders and spheres an analytic expression for the computation of stresses and residual stresses is specified. Afterwards the strains are calculated by using the finite difference method. Some examples will high-light the influence of the plastic compressibility on the behaviour of pressure vessels. (orig.) [de

  8. Conceptual design for muon detectors using resistive plastic tubes. Final technical report

    International Nuclear Information System (INIS)

    Border, P.; Courant, H.; Heller, K.; Jones, A.; Lin, J.; Maxam, D.; Ruddick, K.

    1998-01-01

    Reliable low cost detectors which can be built in quantity require a simple design consisting of as few separate pieces as possible using inexpensive materials. For example, ordinary insulating plastics with good structural strength, such as polyethylene or polystyrene, have about 1/3 the cost of aluminum per unit weight. Since plastic is also about 1/3 the density of aluminum, the material cost for a drift tube would be reduced by an order of magnitude. This substitution of plastic for aluminum alone would save the muon system for the SDC more than $2M. Additional savings of greater magnitude can be expected since an entire drift tube, including a field shaping electrode structure, can be manufactured as a single piece by the technique of co-extrusion. A symmetric design with all walls far from the wire will also eliminate critical tolerances in the relative position of the electrodes with respect to the wire. Furthermore, module assembly and mounting costs will surely be reduced if the muon detectors were light weight and, as far as possible, had the same shape and size. With the 8 cm diameter plastic tube of the design, the electric drift field is nearly uniform as shown. This field is determined by a simple symmetric electrode structure, so that the necessary drift/position relationship can be achieved without precisely controlling the position of the electrode structure with respect to the wire. If the positioning of the electrode structure relative to the wire is not a critical dimension, the structural support for the tube need not be maintained to a high tolerance reducing the cost of the structure. Using a resistive plastic to shape the potential gives a simple electrode structure that will require a minimum number of electronic connections. The basic element of this design is the cylindrical plastic drift tube constructed from co-extruded plastics of different conductivity

  9. Process analytical technology in continuous manufacturing of a commercial pharmaceutical product.

    Science.gov (United States)

    Vargas, Jenny M; Nielsen, Sarah; Cárdenas, Vanessa; Gonzalez, Anthony; Aymat, Efrain Y; Almodovar, Elvin; Classe, Gustavo; Colón, Yleana; Sanchez, Eric; Romañach, Rodolfo J

    2018-03-01

    The implementation of process analytical technology and continuous manufacturing at an FDA approved commercial manufacturing site is described. In this direct compaction process the blends produced were monitored with a Near Infrared (NIR) spectroscopic calibration model developed with partial least squares (PLS) regression. The authors understand that this is the first study where the continuous manufacturing (CM) equipment was used as a gravimetric reference method for the calibration model. A principal component analysis (PCA) model was also developed to identify the powder blend, and determine whether it was similar to the calibration blends. An air diagnostic test was developed to assure that powder was present within the interface when the NIR spectra were obtained. The air diagnostic test as well the PCA and PLS calibration model were integrated into an industrial software platform that collects the real time NIR spectra and applies the calibration models. The PCA test successfully detected an equipment malfunction. Variographic analysis was also performed to estimate the sampling analytical errors that affect the results from the NIR spectroscopic method during commercial production. The system was used to monitor and control a 28 h continuous manufacturing run, where the average drug concentration determined by the NIR method was 101.17% of label claim with a standard deviation of 2.17%, based on 12,633 spectra collected. The average drug concentration for the tablets produced from these blends was 100.86% of label claim with a standard deviation of 0.4%, for 500 tablets analyzed by Fourier Transform Near Infrared (FT-NIR) transmission spectroscopy. The excellent agreement between the mean drug concentration values in the blends and tablets produced provides further evidence of the suitability of the validation strategy that was followed. Copyright © 2018 Elsevier B.V. All rights reserved.

  10. Substandard/counterfeit antimicrobial drugs.

    Science.gov (United States)

    Kelesidis, Theodoros; Falagas, Matthew E

    2015-04-01

    Substandard/counterfeit antimicrobial drugs are a growing global problem. The most common substandard/counterfeit antimicrobials include beta-lactams (among antibiotics) and chloroquine and artemisin derivatives (among antimalarials). The most common type of substandard/counterfeit antimicrobial drugs have a reduced amount of the active drug, and the majority of them are manufactured in Southeast Asia and Africa. Counterfeit antimicrobial drugs may cause increased mortality and morbidity and pose a danger to patients. Here we review the literature with regard to the issue of substandard/counterfeit antimicrobials and describe the prevalence of this problem, the different types of substandard/counterfeit antimicrobial drugs, and the consequences for the individuals and global public health. Local, national, and international initiatives are required to combat this very important public health issue. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

  11. Decreasing of the manufacturing time for a thermoforming mold by applying the DFM principles

    Directory of Open Access Journals (Sweden)

    Păcurar Ancuţa

    2017-01-01

    Full Text Available In this paper it is analyzed a product machined at the S.C. ULMA PACKAGING S.A. company, which is a “Thermoforming mold” used in order to obtain plastic containers in which the food or non-food product is packed, making part of a thermoforming machine called TFS 200. The aims of this paper are to determine the optimal technological parameters and to study the effects of the DFM principles and the optimal tool path strategy usage on manufacturing time of the “Thermoforming mold”. A redesign of the thermoforming mold is presented based on the failed rules and recommendations given by the DFM program and followed by the analysis of the DFM’s benefic effect on the manufacturing time.

  12. Effect of Drug Loading Method and Drug Physicochemical Properties on the Material and Drug Release Properties of Poly (Ethylene Oxide Hydrogels for Transdermal Delivery

    Directory of Open Access Journals (Sweden)

    Rachel Shet Hui Wong

    2017-07-01

    Full Text Available Novel poly (ethylene oxide (PEO hydrogel films were synthesized via UV cross-linking with pentaerythritol tetra-acrylate (PETRA as cross-linking agent. The purpose of this work was to develop a novel hydrogel film suitable for passive transdermal drug delivery via skin application. Hydrogels were loaded with model drugs (lidocaine hydrochloride (LID, diclofenac sodium (DIC and ibuprofen (IBU via post-loading and in situ loading methods. The effect of loading method and drug physicochemical properties on the material and drug release properties of medicated film samples were characterized using scanning electron microscopy (SEM, swelling studies, differential scanning calorimetry (DSC, fourier transform infrared spectroscopy (FT-IR, tensile testing, rheometry, and drug release studies. In situ loaded films showed better drug entrapment within the hydrogel network and also better polymer crystallinity. High drug release was observed from all studied formulations. In situ loaded LID had a plasticizing effect on PEO hydrogel, and films showed excellent mechanical properties and prolonged drug release. The drug release mechanism for the majority of medicated PEO hydrogel formulations was determined as both drug diffusion and polymer chain relaxation, which is highly desirable for controlled release formulations.

  13. Perspective for the reproduction of antimalarial drugs in Brazil

    Directory of Open Access Journals (Sweden)

    Benjamin Gilbert

    1992-01-01

    Full Text Available The appears to be no chemical manufacture of antimalarial drugs is Brazil. Technology at laboratory process level has been developed for chloroquine, mefloquine, pyrimethamine and cycloquanil, but not perfected nor scaled-up, largely for economic reasons and market uncertainty. Development of primaquine has been contracted but it will run into the same difficulty. Manufacturing capacity for sulfadoxine was registred in the SDI by Roche. A project to produce artemisinine and its derivates is under way at UNICAMP-CPQBA but is hampered by low content in the plant. Proguanil could be produced easily, but apparently no attempt has been made to do so. Quinine is imported on a large scale mostly for softdrink production. Since malarial treatment falls largely within responsability of the Government health authorities, manufacture of drugs in Brazil will depend on an assured medium-term purchase order made to a potential local manufacturer, since competition in the world market is scarcelyviable at the present moment.

  14. Mechanically equivalent elastic-plastic deformations and the problem of plastic spin

    Directory of Open Access Journals (Sweden)

    Steigmann David J.

    2011-01-01

    Full Text Available The problem of plastic spin is phrased in terms of a notion of mechanical equivalence among local intermediate configurations of an elastic/ plastic crystalline solid. This idea is used to show that, without further qualification, the plastic spin may be suppressed at the constitutive level. However, the spin is closely tied to an underlying undistorted crystal lattice which, once specified, eliminates the freedom afforded by mechanical equivalence. As a practical matter a constitutive specification of plastic spin is therefore required. Suppression of plastic spin thus emerges as merely one such specification among many. Restrictions on these are derived in the case of rate-independent response.

  15. 77 FR 47078 - 2012 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference...

    Science.gov (United States)

    2012-08-07

    ... foundations, emerging technologies and innovations in regulatory science, as well as the current quality and... of today's leading pharmaceutical companies present case studies on how they employ global strategies... Contract Manufacturing Organizations Contract Agreements Drug Safety Emerging Active Pharmaceutical...

  16. 75 FR 69464 - Manufacturer of Controlled Substances; Notice of Application

    Science.gov (United States)

    2010-11-12

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on July 16, 2009, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock...

  17. 77 FR 2321 - Manufacturer of Controlled Substances; Notice of Application

    Science.gov (United States)

    2012-01-17

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on June 28, 2011, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock...

  18. 76 FR 36577 - Manufacturer of Controlled Substances; Notice of Application

    Science.gov (United States)

    2011-06-22

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to Sec. 1301.33(a), Title 21 of the Code of Federal Regulations (CFR), this is notice that on May 4, 2011, Boehringer Ingelheim Chemicals Inc., 2820 N. Normandy Drive...

  19. 75 FR 32506 - Manufacturer of Controlled Substances; Notice of Application

    Science.gov (United States)

    2010-06-08

    ... DEPARTMENT OF JUSTICE Drug Enforcement Administration Manufacturer of Controlled Substances; Notice of Application Pursuant to Sec. 1301.33(a) of Title 21 of the Code of Federal Regulations (CFR), this is notice that on April 12, 2010, Boehringer Ingelheim Chemicals Inc., 2820 N. Normandy Drive...

  20. Prefrontal cortex plasticity mechanisms in drug seeking and relapse

    NARCIS (Netherlands)

    van den Oever, M.C.; Spijker, S.; Smit, A.B.; de Vries, T.J.

    2010-01-01

    Development of pharmacotherapy to reduce relapse rates is one of the biggest challenges in drug addiction research. The enduring nature of relapse suggests that it is maintained by long-lasting molecular and cellular adaptations in the neuronal circuitry that mediates learning and processing of

  1. Calculation of cracking under pulsed heat loads in tungsten manufactured according to ITER specifications

    International Nuclear Information System (INIS)

    Arakcheev, A.S.; Skovorodin, D.I.; Burdakov, A.V.; Shoshin, A.A.; Polosatkin, S.V.; Vasilyev, A.A.; Postupaev, V.V.; Vyacheslavov, L.N.; Kasatov, A.A.; Huber, A.; Mertens, Ph; Wirtz, M.; Linsmeier, Ch; Kreter, A.; Löwenhoff, Th; Begrambekov, L.; Grunin, A.; Sadovskiy, Ya

    2015-01-01

    A mathematical model of surface cracking under pulsed heat load was developed. The model correctly describes a smooth brittle–ductile transition. The elastic deformation is described in a thin-heated-layer approximation. The plastic deformation is described with the Hollomon equation. The time dependence of the deformation and stresses is described for one heating–cooling cycle for a material without initial plastic deformation. The model can be applied to tungsten manufactured according to ITER specifications. The model shows that the stability of stress-relieved tungsten deteriorates when the base temperature increases. This proved to be a result of the close ultimate tensile and yield strengths. For a heat load of arbitrary magnitude a stability criterion was obtained in the form of condition on the relation of the ultimate tensile and yield strengths.

  2. Motor cortex plasticity can indicate vulnerability to motor fluctuation and high L-DOPA need in drug-naïve Parkinson's disease.

    Science.gov (United States)

    Kishore, Asha; James, Praveen; Krishnan, Syam; Yahia-Cherif, Lydia; Meunier, Sabine; Popa, Traian

    2017-02-01

    Motor cortex plasticity is reported to be decreased in Parkinson's disease in studies which pooled patients in various stages of the disease. Whether the early decrease in plasticity is related to the motor signs or is linked to the future development of motor complications of treatment is unclear. The aim of the study was to test if motor cortex plasticity and its cerebellar modulation are impaired in treatment-naïve Parkinson's disease, are related to the motor signs of the disease and predict occurrence of motor complications of treatment. Twenty-nine denovo patients with Parkinson's disease were longitudinally assessed for motor complications for four years. Using transcranial magnetic stimulation, the plasticity of the motor cortex and its cerebellar modulation were measured (response to paired-associative stimulation alone or preceded by 2 active cerebellar stimulation protocols), both in the untreated state and after a single dose of L-DOPA. Twenty-six matched, healthy volunteers were tested, only without L-DOPA. Patients and healthy controls had similar proportions of responders and non-responders to plasticity induction. In the untreated state, the more efficient was the cerebellar modulation of motor cortex plasticity, the lower were the bradykinesia and rigidity scores. The extent of the individual plastic response to paired associative stimulation could indicate a vulnerability to develop early motor fluctuation but not dyskinesia. Measuring motor cortex plasticity in denovo Parkinson's disease could be a neurophysiological parameter that may help identify patients with greater propensity for early motor fluctuations. Copyright © 2016 Elsevier Ltd. All rights reserved.

  3. Validation of ATR FT-IR to identify polymers of plastic marine debris, including those ingested by marine organisms

    Science.gov (United States)

    Jung, Melissa R.; Horgen, F. David; Orski, Sara V.; Rodriguez, Viviana; Beers, Kathryn L.; Balazs, George H.; Jones, T. Todd; Work, Thierry M.; Brignac, Kayla C.; Royer, Sarah-Jeanne; Hyrenbach, David K.; Jensen, Brenda A.; Lynch, Jennifer M.

    2018-01-01

    Polymer identification of plastic marine debris can help identify its sources, degradation, and fate. We optimized and validated a fast, simple, and accessible technique, attenuated total reflectance Fourier transform infrared spectroscopy (ATR FT-IR), to identify polymers contained in plastic ingested by sea turtles. Spectra of consumer good items with known resin identification codes #1–6 and several #7 plastics were compared to standard and raw manufactured polymers. High temperature size exclusion chromatography measurements confirmed ATR FT-IR could differentiate these polymers. High-density (HDPE) and low-density polyethylene (LDPE) discrimination is challenging but a clear step-by-step guide is provided that identified 78% of ingested PE samples. The optimal cleaning methods consisted of wiping ingested pieces with water or cutting. Of 828 ingested plastics pieces from 50 Pacific sea turtles, 96% were identified by ATR FT-IR as HDPE, LDPE, unknown PE, polypropylene (PP), PE and PP mixtures, polystyrene, polyvinyl chloride, and nylon.

  4. 21 CFR 178.3790 - Polymer modifiers in semirigid and rigid vinyl chloride plastics.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 3 2010-04-01 2009-04-01 true Polymer modifiers in semirigid and rigid vinyl...: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS Certain Adjuvants and Production Aids § 178.3790 Polymer modifiers in semirigid and rigid vinyl chloride plastics. The polymers identified in paragraph (a) of this...

  5. 75 FR 57230 - 340B Drug Pricing Program Manufacturer Civil Monetary Penalties

    Science.gov (United States)

    2010-09-20

    ... Civil Monetary Penalties AGENCY: Health Resources and Services Administration, HHS. ACTION: Advance notice of proposed rulemaking and request for comments. SUMMARY: Section 602 of Public Law 102-585, the... of civil monetary penalties for manufacturers that knowingly and intentionally overcharge a covered...

  6. A comparative study between hot-melt extrusion and spray-drying for the manufacture of anti-hypertension compatible monolithic fixed-dose combination products.

    Science.gov (United States)

    Kelleher, J F; Gilvary, G C; Madi, A M; Jones, D S; Li, S; Tian, Y; Almajaan, A; Senta-Loys, Z; Andrews, G P; Healy, A M

    2018-07-10

    The purpose of this work was to investigate the application of different advanced continuous processing techniques (hot melt extrusion and spray drying) to the production of fixed-dose combination (FDC) monolithic systems comprising of hydrochlorothiazide and ramipril for the treatment of hypertension. Identical FDC formulations were manufactured by the two different methods and were characterised using powder X-ray diffraction (PXRD) and modulated differential scanning calorimetry (mDSC). Drug dissolution rates were investigated using a Wood's apparatus, while physical stability was assessed on storage under controlled temperature and humidity conditions. Interestingly both drugs were transformed into their amorphous forms when spray dried, however, hydrochlorothiazide was determined, by PXRD, to be partially crystalline when hot melt extruded with either polymer carrier (Kollidon® VA 64 or Soluplus®). Hot melt extrusion was found to result in significant degradation of ramipril, however, this could be mitigated by the inclusion of the plasticizer, polyethylene glycol 3350, in the formulation and appropriate adjustment of processing temperature. The results of intrinsic dissolution rate studies showed that hot-melt extruded samples were found to release both drugs faster than identical formulations produced via spray drying. However, the differences were attributable to the surface roughness of the compressed discs in the Wood's apparatus, rather than solid state differences between samples. After a 60-day stability study spray dried samples exhibited a greater physical stability than the equivalent hot melt extruded samples. Copyright © 2018 Elsevier B.V. All rights reserved.

  7. 77 FR 30327 - Manufacturer of Controlled Substances; Notice Of Application; Research Triangle Institute

    Science.gov (United States)

    2012-05-22

    ... the following basic classes of controlled substances: Drug Schedule Marihuana (7360) I Cocaine (9041) II The Institute will manufacture marihuana, and cocaine derivatives for use by their customers in...

  8. Trial manufacture of flame retardant and radiation resistant cables

    Energy Technology Data Exchange (ETDEWEB)

    Oshima, Yunosuke; Hagiwara, Miyuki (Japan Atomic Energy Research Inst., Takasaki, Gunma. Takasaki Radiation Chemistry Research Establishment); Oda, Eisuke

    1983-04-01

    High radiation resistance as well as incombustibility is required for the wires and cables used for nuclear facilities such as nuclear power stations. In order to give such performance to general purpose insulation materials such as ethylene-propylene copolymerized rubber, acenaphthylene bromide condensation product was developed anew. Moreover, by the use of this agent, the new flame retardant and radiation resistant cables were manufactured for trial, which are not different from ordinary plastic rubber cables in the handling such as flexibility, and withstand the radiation nearly up to 1000 Mrad. The requirement for the agent giving flame retardant and radiation resistant properties is explained. The synthesis of acenaphthylene bromide and its condensation product and the effect of giving flame retardant and radiation resistant properties are described. The test resultd of the prevention of spread of flame, the endurance in LOCA-simulating environment, and radiation resistance for the cables manufactured for trial are reported. It was confirmed that the cables of this type are suitable to the use in which the maintenance of mechanical properties after radiation exposure is required.

  9. The use of plasticizing additives based on recycled raw materials in the petrochemical rubber mixtures

    Directory of Open Access Journals (Sweden)

    Z. S. Shashok

    2016-01-01

    Full Text Available At present, the development of alternative products for elastomers based on recycling petrochemical raw materials is a new trend of the rubber industry progress. Petrochemical raw materials include spent lubricants and motor oils are among such recycling products. In this context, the influence of the products of recycling waste engine oil (DVCH and RA in comparison with industrial oil (I-20 on the technological properties of filled elastomeric compositions was investigated. The elastomeric compositions were based on poly isoprene and divinyl rubbers. The plasticizing components were manufactured by IOOO “DVCH-Menedzhment”. They are mixture of hydro-carbons, C16–C20 and differ from each other in the content of linear and branched paraffin. Plastic-elastic properties of rubber compounds on the shear disk viscometer MV2000 in accordance with GOST 10722–76 was carried out. Kinetics of vulcanization on the rheometer ODR2000 according to GOST 12535–84 was defined. It is shown that the introduction of RA test plasticizing component provides a significant effect on Mooney viscosity, as compared to elastomeric compositions containing a plasticizer and I-20 and plasticizing additive DVCH. It revealed that the administration of all components in the studied plasticizing elastomer compositions based on a combination poly isoprene and divinyl rubbers has no significant effect on the rate of relaxation of stress of rubber compounds. It is found that elastomeric compositions containing as additives investigated processing waste oil products (DVCH and RA are characterized by a slightly smaller value of time to reach an optimal degree of vulcanization.

  10. Monitoring system for the quality assessment in additive manufacturing

    Energy Technology Data Exchange (ETDEWEB)

    Carl, Volker, E-mail: carl@t-zfp.de [Carl Messtechnik, Thyssenstrasse 183a, 46535 Dinslaken (Germany)

    2015-03-31

    Additive Manufacturing (AM) refers to a process by which a set of digital data -representing a certain complex 3dim design - is used to grow the respective 3dim real structure equal to the corresponding design. For the powder-based EOS manufacturing process a variety of plastic and metal materials can be used. Thereby, AM is in many aspects a very powerful tool as it can help to overcome particular limitations in conventional manufacturing. AM enables more freedom of design, complex, hollow and/or lightweight structures as well as product individualisation and functional integration. As such it is a promising approach with respect to the future design and manufacturing of complex 3dim structures. On the other hand, it certainly calls for new methods and standards in view of quality assessment. In particular, when utilizing AM for the design of complex parts used in aviation and aerospace technologies, appropriate monitoring systems are mandatory. In this respect, recently, sustainable progress has been accomplished by joining the common efforts and concerns of a manufacturer Additive Manufacturing systems and respective materials (EOS), along with those of an operator of such systems (MTU Aero Engines) and experienced application engineers (Carl Metrology), using decent know how in the field of optical and infrared methods regarding non-destructive-examination (NDE). The newly developed technology is best described by a high-resolution layer by layer inspection technique, which allows for a 3D tomography-analysis of the complex part at any time during the manufacturing process. Thereby, inspection costs are kept rather low by using smart image-processing methods as well as CMOS sensors instead of infrared detectors. Moreover, results from conventional physical metallurgy may easily be correlated with the predictive results of the monitoring system which not only allows for improvements of the AM monitoring system, but finally leads to an optimisation of the quality

  11. Neural Mechanisms of Reproduction in Females as a Predisposing Factor for Drug Addiction

    Science.gov (United States)

    Hedges, Valerie L.; Staffend, Nancy A.; Meisel, Robert L.

    2010-01-01

    There is an increasing awareness that adolescent females differ from males in their response to drugs of abuse and consequently in their vulnerability to addiction. One possible component of this vulnerability to drug addiction is the neurobiological impact that reproductive physiology and behaviors have on the mesolimbic dopamine system, a key neural pathway mediating drug addiction. In this review, we examine animal models that address the impact of ovarian cyclicity, sexual affiliation, sexual behavior, and maternal care on the long-term plasticity of the mesolimbic dopamine system. The thesis is that this plasticity in synaptic neurotransmission stemming from an individual’s normal life history contributes to the pathological impact of drugs of abuse on the neurobiology of this system. Hormones released during reproductive cycles have only transient effects on these dopamine systems, whereas reproductive behaviors produce a persistent sensitization of dopamine release and postsynaptic neuronal responsiveness. Puberty itself may not represent a neurobiological risk factor for drug abuse, but attendant behavioral experiences may have a negative impact on females engaging in drug use. PMID:20176045

  12. 21 CFR 207.25 - Information required in registration and drug listing.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 4 2010-04-01 2010-04-01 false Information required in registration and drug listing. 207.25 Section 207.25 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... manufactured by a registered blood bank, a copy of all current labeling (except that only one representative...

  13. 77 FR 55504 - Manufacturer of Controlled Substances; Notice of Registration; Research Triangle Institute

    Science.gov (United States)

    2012-09-10

    ... classes of controlled substances: Drug Schedule Marihuana (7360) I Cocaine (9041) II The Institute will manufacture marihuana, and cocaine derivatives for use by their customers in analytical kits, reagents, and...

  14. Challenges in plastics recycling

    DEFF Research Database (Denmark)

    Pivnenko, Kostyantyn; Jakobsen, L. G.; Eriksen, Marie Kampmann

    2015-01-01

    Recycling of waste plastics still remains a challenging area in the waste management sector. The current and potential goals proposed on EU or regional levels are difficult to achieve, and even to partially fullfil them the improvements in collection and sorting should be considerable. A study...... was undertaken to investigate the factors affecting quality in plastics recycling. The preliminary results showed factors primarily influencing quality of plastics recycling to be polymer cross contamination, presence of additives, non-polymer impurities, and polymer degradation. Deprivation of plastics quality......, with respect to recycling, has been shown to happen throughout the plastics value chain, but steps where improvements may happen have been preliminary identified. Example of Cr in plastic samples analysed showed potential spreading and accumulation of chemicals ending up in the waste plastics. In order...

  15. Accelerant-related burns and drug abuse: Challenging combination.

    Science.gov (United States)

    Leung, Leslie T F; Papp, Anthony

    2018-05-01

    Accelerants are flammable substances that may cause explosion when added to existing fires. The relationships between drug abuse and accelerant-related burns are not well elucidated in the literature. Of these burns, a portion is related to drug manufacturing, which have been shown to be associated with increased burn complications. 1) To evaluate the demographics and clinical outcomes of accelerant-related burns in a Provincial Burn Centre. 2) To compare the clinical outcomes with a control group of non-accelerant related burns. 3) To analyze a subgroup of patients with history of drug abuse and drug manufacturing. Retrospective case control study. Patient data associated with accelerant-related burns from 2009 to 2014 were obtained from the British Columbia Burn Registry. These patients were compared with a control group of non-accelerant related burns. Clinical outcomes that were evaluated include inhalational injury, ICU length of stay, ventilator support, surgeries needed, and burn complications. Chi-square test was used to evaluate categorical data and Student's t-test was used to evaluate mean quantitative data with the p value set at 0.05. A logistic regression model was used to evaluate factors affecting burn complications. Accelerant-related burns represented 28.2% of all burn admissions (N=532) from 2009 to 2014. The accelerant group had higher percentage of patients with history of drug abuse and was associated with higher TBSA burns, ventilator support, ICU stay and pneumonia rates compared to the non-accelerant group. Within the accelerant group, there was no difference in clinical outcomes amongst people with or without history of drug abuse. Four cases were associated with methamphetamine manufacturing, all of which underwent ICU stay and ventilator support. Accelerant-related burns cause significant burden to the burn center. A significant proportion of these patients have history of drug abuse. Copyright © 2017 Elsevier Ltd and ISBI. All rights

  16. Manufacturing of biodrugs: need for harmonization in regulatory standards.

    Science.gov (United States)

    Sahoo, Niharika; Choudhury, Koel; Manchikanti, Padmavati

    2009-01-01

    Biodrugs (biologics) are much more complex than chemically synthesized drugs because of their structural heterogeneity and interactions within a given biologic system. The manufacturing process in the biodrug industry varies with each type of molecule and is far more elaborate and stringent due to the use of living organisms and complex substrates. Product purity and altered structural characteristics leading to potential immunogenicity have often been of concern when establishing quality and safety in the use of biodrugs. Regulatory compliance in manufacturing and commercialization of biodrugs involves quality control, quality assurance, and batch documentation. Many factors such as host cell development, cell bank establishment, cell culture, protein production, purification, analysis, formulation, storage, and handling are critical for ensuring the purity, activity, and safety of the finished product. Good Manufacturing Practice (GMP) for biodrugs has been developed in certain regions such as the EU, US, and Japan. Due to differences in manufacturing methods and systems, product-specific GMP guidelines are evolving. In general, there are variations in GMP guidelines between countries, which lead to difficulty for the manufacturers in conforming to different standards, thus entailing delays in the commercialization of biodrugs. There is a need to develop a unified regulatory guideline for biodrug manufacturing across various countries, which would be helpful in the marketing of products and trade. This review deals with the comparative framework and analysis of GMP regulation of biodrugs.

  17. Individual differences in behavioural plasticities.

    Science.gov (United States)

    Stamps, Judy A

    2016-05-01

    Interest in individual differences in animal behavioural plasticities has surged in recent years, but research in this area has been hampered by semantic confusion as different investigators use the same terms (e.g. plasticity, flexibility, responsiveness) to refer to different phenomena. The first goal of this review is to suggest a framework for categorizing the many different types of behavioural plasticities, describe examples of each, and indicate why using reversibility as a criterion for categorizing behavioural plasticities is problematic. This framework is then used to address a number of timely questions about individual differences in behavioural plasticities. One set of questions concerns the experimental designs that can be used to study individual differences in various types of behavioural plasticities. Although within-individual designs are the default option for empirical studies of many types of behavioural plasticities, in some situations (e.g. when experience at an early age affects the behaviour expressed at subsequent ages), 'replicate individual' designs can provide useful insights into individual differences in behavioural plasticities. To date, researchers using within-individual and replicate individual designs have documented individual differences in all of the major categories of behavioural plasticities described herein. Another important question is whether and how different types of behavioural plasticities are related to one another. Currently there is empirical evidence that many behavioural plasticities [e.g. contextual plasticity, learning rates, IIV (intra-individual variability), endogenous plasticities, ontogenetic plasticities) can themselves vary as a function of experiences earlier in life, that is, many types of behavioural plasticity are themselves developmentally plastic. These findings support the assumption that differences among individuals in prior experiences may contribute to individual differences in behavioural

  18. Chemical recycling of mixed waste plastics by selective pyrolysis

    Energy Technology Data Exchange (ETDEWEB)

    Tatsumoto, K.; Meglen, R.; Evans, R. [National Renewable Energy Laboratory, Golden, CO (United States)

    1995-05-01

    The goal of this work is to use selective pyrolysis to produce high-value chemicals from waste plastics mixtures. Selectivity is achieved by exploiting differences in reaction rates, catalysis, and coreactants. Target wastes are molecular mixtures such as; blends or composites, or mixtures from manufactured products such as; carpets and post-consumer mixed-plastic wastes. The experimental approach has been to use small-scale experiments using molecular beam mass spectrometry (MBMS), which provides rapid analysis of reaction products and permits rapid screening of process parameters. Rapid screening experiments permit exploration of many potential waste stream applications for the selective pyrolysis process. After initial screening, small-scale, fixed-bed and fluidized-bed reactors are used to provide products for conventional chemical analysis, to determine material balances, and to test the concept under conditions that will be used at a larger scale. Computer assisted data interpretation and intelligent chemical processing are used to extract process-relevant information from these experiments. An important element of this project employs technoeconomic assessments and market analyses of durables, the availability of other wastes, and end-product uses to identify target applications that have the potential for economic success.

  19. Regulatory challenges in manufacturing of pancreatic islets.

    Science.gov (United States)

    Linetsky, E; Ricordi, C

    2008-03-01

    At the present time, transplantation of pancreatic islet cells is considered an experimental therapy for a selected cohort of patients with type 1 diabetes, and is conducted under an Investigational New Drug (IND) application. Encouraging results of the Edmonton Protocol published in the year 2000 sparked a renewed interest in clinical transplantation of allogeneic islets, triggering a large number of IND applications for phase I clinical trials. Promising results reported by a number of centers since then prompted the Food and Drug Administration (FDA) to consider the possibility of licensing allogeneic islets as a therapeutic treatment for patients with type 1 diabetes. However, prior to licensure, issues such as safety, purity, efficacy, and potency of the islet product must be addressed. This is complicated by the intricate nature of pancreatic islets and limited characterization prior to transplantation. In this context, control of the manufacturing process plays a critical role in the definition of the final product. Despite significant progress made in standardization of the donor organ preservation methods, reagents used, and characterization assays performed to qualify an islet cell product, control of the isolation process remains a challenge. Within the scope of the FDA regulations, islet cells meet the definition of a biologic product, somatic cell therapy, and a drug. In addition, AABB standards that address cellular therapy products apply to manufacturing facilities accredited by this organization. Control of the source material, isolation process, and final product are critical issues that must be addressed in the context of FDA and other relevant regulations applicable to islet cell products.

  20. Phenotypic plasticity, costs of phenotypes, and costs of plasticity

    DEFF Research Database (Denmark)

    Callahan, Hilary S; Maughan, Heather; Steiner, Uli

    2008-01-01

    Why are some traits constitutive and others inducible? The term costs often appears in work addressing this issue but may be ambiguously defined. This review distinguishes two conceptually distinct types of costs: phenotypic costs and plasticity costs. Phenotypic costs are assessed from patterns...... of covariation, typically between a focal trait and a separate trait relevant to fitness. Plasticity costs, separable from phenotypic costs, are gauged by comparing the fitness of genotypes with equivalent phenotypes within two environments but differing in plasticity and fitness. Subtleties associated with both...... types of costs are illustrated by a body of work addressing predator-induced plasticity. Such subtleties, and potential interplay between the two types of costs, have also been addressed, often in studies involving genetic model organisms. In some instances, investigators have pinpointed the mechanistic...