WorldWideScience

Sample records for biological product safety

  1. 75 FR 59935 - Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and...

    Science.gov (United States)

    2010-09-29

    ... ``E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting'' (60 FR 11284... 0910-AG13 Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products... safety reporting for human biological products: Laura Rich, Center for Biologics Evaluation and...

  2. Postmarketing safety reports for human drug and biological products; electronic submission requirements. Final rule.

    Science.gov (United States)

    2014-06-10

    The Food and Drug Administration (FDA or we) is amending its postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is taking this action to improve the Agency's systems for collecting and analyzing postmarketing safety reports. The change will help the Agency to more rapidly review postmarketing safety reports, identify emerging safety problems, and disseminate safety information in support of FDA's public health mission. In addition, the amendments will be a key element in harmonizing FDA's postmarketing safety reporting regulations with international standards for the electronic submission of safety information.

  3. A Product Safety Primer

    Science.gov (United States)

    Brown, Mary Anne Symons

    1975-01-01

    The article offers an overview of the product safety issue and offers ideas for helping students develop product safety awareness. The role of the Consumer Product Safety Commission and safety legislation are discussed. (MW)

  4. Robustness of nanofiltration for increasing the viral safety margin of biological products.

    Science.gov (United States)

    Caballero, Santiago; Diez, José M; Belda, Francisco J; Otegui, Magdalena; Herring, Steven; Roth, Nathan J; Lee, Douglas; Gajardo, Rodrigo; Jorquera, Juan I

    2014-03-01

    In this study, the virus-removal capacity of nanofiltration was assessed using validated laboratory scale models on a wide range of viruses (pseudorabies virus; human immunodeficiency virus; bovine viral diarrhea virus; West Nile virus; hepatitis A virus; murine encephalomyocarditis virus; and porcine parvovirus) with sizes from 18 nm to 200 nm and applying the different process conditions existing in a number of Grifols' plasma-derived manufacturing processes (thrombin, α1-proteinase inhibitor, Factor IX, antithrombin, plasmin, intravenous immunoglobulin, and fibrinogen). Spiking experiments (n = 133) were performed in process intermediate products, and removal was subsequently determined by infectivity titration. Reduction Factor (RF) was calculated by comparing the virus load before and after nanofiltration under each product purification condition. In all experiments, the RFs were close to or greater than 4 log10 (>99.99% of virus elimination). RF values were not significantly affected by the process conditions within the limits assayed (pH, ionic strength, temperature, filtration ratio, and protein concentration). The virus-removal capacity of nanofiltration correlated only with the size of the removed agent. In conclusion, nanofiltration, as used in the manufacturing of several Grifols' products, is consistent, robust, and not significantly affected by process conditions.

  5. Production, safety, exchange, and risk

    OpenAIRE

    Hausken, Kjell

    2011-01-01

    Two agents convert resources into safety investment and production while exchanging goods voluntarily. Safety investment ensures reduction of costly risk. High unit cost of safety effort reduces both productive effort and safety effort, which reduces income.

  6. Consumer Product Safety Bills.

    Science.gov (United States)

    American Enterprise Inst. for Public Policy Research, Washington, DC.

    This legislative analysis of the actions of the 92nd Congress concerning consumer product safety bills, current as of March 20, 1972, presents briefly the background of Congressional investigations in this area. Describing in detail four major bills which focus on the establishment of an independent government agency regulating consumer products…

  7. Production, safety, fighting, and risk

    OpenAIRE

    Hausken, Kjell

    2011-01-01

    Two agents make a trade off between production and safety investment, fighting for joint production. Ceteris paribus, if agent 1 has a higher unit cost of production, lower emphasis on safety causes more fighting and higher utility for agent 1, and less production and safety effort by agent 1.

  8. Biological hydrogen production

    Energy Technology Data Exchange (ETDEWEB)

    Benemann, J.R. [Univ. of California, Berkeley, CA (United States)

    1995-11-01

    Biological hydrogen production can be accomplished by either thermochemical (gasification) conversion of woody biomass and agricultural residues or by microbiological processes that yield hydrogen gas from organic wastes or water. Biomass gasification is a well established technology; however, the synthesis gas produced, a mixture of CO and H{sub 2}, requires a shift reaction to convert the CO to H{sub 2}. Microbiological processes can carry out this reaction more efficiently than conventional catalysts, and may be more appropriate for the relatively small-scale of biomass gasification processes. Development of a microbial shift reaction may be a near-term practical application of microbial hydrogen production.

  9. Exports reflect "safety of products"

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    Most of the made-in-China products are absolutely safe, and the steady increase in exports despite the recent widespread criticism reflects their safety standards, a Ministry of Commerce official said Thursday.

  10. Cell biology and EMF safety standards.

    Science.gov (United States)

    Blank, Martin

    2015-01-01

    Living cells react defensively and start to synthesize stress proteins when exposed to potentially harmful stimuli. Electromagnetic fields (EMF) are among the many different environmental stimuli that initiate stress protein synthesis. Although there is greater energy transfer and heating due to EMF at higher frequencies, there is no greater stress response. The cellular stress response is far more sensitive to EMF than to an increase in temperature. It should be obvious that an EMF safety standard should be based on the more sensitive, natural biological response.

  11. Biological Safety of Fish (Tilapia Collagen

    Directory of Open Access Journals (Sweden)

    Kohei Yamamoto

    2014-01-01

    Full Text Available Marine collagen derived from fish scales, skin, and bone has been widely investigated for application as a scaffold and carrier due to its bioactive properties, including excellent biocompatibility, low antigenicity, and high biodegradability and cell growth potential. Fish type I collagen is an effective material as a biodegradable scaffold or spacer replicating the natural extracellular matrix, which serves to spatially organize cells, providing them with environmental signals and directing site-specific cellular regulation. This study was conducted to confirm the safety of fish (tilapia atelocollagen for use in clinical application. We performed in vitro and in vivo biological studies of medical materials to investigate the safety of fish collagen. The extract of fish collagen gel was examined to clarify its sterility. All present sterility tests concerning bacteria and viruses (including endotoxin yielded negative results, and all evaluations of cell toxicity, sensitization, chromosomal aberrations, intracutaneous reactions, acute systemic toxicity, pyrogenic reactions, and hemolysis were negative according to the criteria of the ISO and the http://dx.doi.org/10.13039/501100003478 Ministry of Health, Labour and Welfare. The present study demonstrated that atelocollagen prepared from tilapia is a promising biomaterial for use as a scaffold in regenerative medicine.

  12. Biological safety of fish (tilapia) collagen.

    Science.gov (United States)

    Yamamoto, Kohei; Igawa, Kazunari; Sugimoto, Kouji; Yoshizawa, Yuu; Yanagiguchi, Kajiro; Ikeda, Takeshi; Yamada, Shizuka; Hayashi, Yoshihiko

    2014-01-01

    Marine collagen derived from fish scales, skin, and bone has been widely investigated for application as a scaffold and carrier due to its bioactive properties, including excellent biocompatibility, low antigenicity, and high biodegradability and cell growth potential. Fish type I collagen is an effective material as a biodegradable scaffold or spacer replicating the natural extracellular matrix, which serves to spatially organize cells, providing them with environmental signals and directing site-specific cellular regulation. This study was conducted to confirm the safety of fish (tilapia) atelocollagen for use in clinical application. We performed in vitro and in vivo biological studies of medical materials to investigate the safety of fish collagen. The extract of fish collagen gel was examined to clarify its sterility. All present sterility tests concerning bacteria and viruses (including endotoxin) yielded negative results, and all evaluations of cell toxicity, sensitization, chromosomal aberrations, intracutaneous reactions, acute systemic toxicity, pyrogenic reactions, and hemolysis were negative according to the criteria of the ISO and the Ministry of Health, Labour and Welfare of Japan. The present study demonstrated that atelocollagen prepared from tilapia is a promising biomaterial for use as a scaffold in regenerative medicine. PMID:24809058

  13. Monitoring product safety in the postmarketing environment.

    Science.gov (United States)

    Sharrar, Robert G; Dieck, Gretchen S

    2013-10-01

    The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.

  14. Synthetic Biology Guides Biofuel Production

    Directory of Open Access Journals (Sweden)

    Michael R. Connor

    2010-01-01

    Full Text Available The advancement of microbial processes for the production of renewable liquid fuels has increased with concerns about the current fuel economy. The development of advanced biofuels in particular has risen to address some of the shortcomings of ethanol. These advanced fuels have chemical properties similar to petroleum-based liquid fuels, thus removing the need for engine modification or infrastructure redesign. While the productivity and titers of each of these processes remains to be improved, progress in synthetic biology has provided tools to guide the engineering of these processes through present and future challenges.

  15. Biological hydrogen production from phytomass

    Energy Technology Data Exchange (ETDEWEB)

    Bartacek, J.; Zabranska, J. [Inst. of Chemical Technology, Prague (Czech Republic). Dept. of Water Technology and Environmental Engineering

    2004-07-01

    Renewable sources of energy have received wide attention lately. One candidate is hydrogen which has the added advantage of involving no greenhouse gases. Biological hydrogen production from wastewater or biowastes is a very attractive production technique. So far, most studies have concentrated on the use of photosynthetic bacteria. However, dark fermentation has recently become a popular topic of research as it has the advantage of not requiring light energy input, something that limits the performance of the photosynthetic method. While pure cultures have been used in most of the investigations to date, in industrial situations mixed cultures will probably be the norm because of unavoidable contamination. In this investigation the phytomass of amaranth (Amaranthus cruentus L) was used to produce hydrogen. Specific organic loading, organic loading, and pH were varied to study the effect on hydrogen production. 18 refs., 1 tab., 6 figs.

  16. Safety issues at the defense production reactors

    International Nuclear Information System (INIS)

    The United States produces plutonium and tritium for use in nuclear weapons at the defense production reactors - the N Reactor in Washington and the Savannah River reactors in South Carolina. This report reaches general conclusions about the management of those reactors and highlights a number of safety and technical issues that should be resolved. The report provides an assessment of the safety management, safety review, and safety methodology employed by the Department of Energy and the private contractors who operate the reactors for the federal government. This report examines the safety objective established by the Department of Energy for the production reactors and the process the Department of its contractors use to implement the objective; focuses on a variety of uncertainties concerning the production reactors, particularly those related to potential vulnerabilities to severe accidents; and identifies ways in which the DOE approach to management of the safety of the production reactors can be improved

  17. The Traceability and Safety of Fishery Products

    Directory of Open Access Journals (Sweden)

    Gheorghe Adrian ZUGRAVU

    2012-12-01

    Full Text Available The paper follows two main objectives: to understand consumers’ perception of safety trasability and quality of fishery products and to identify communication levers in order to improve the perceived image of fishery products. The present research is focused on the fishery products, regardless of their presentation – fresh, frozen or processed. This paper conducted a questionnaire survey of Romanian consumers’ perception toward fishery products. The empirical study with brands indicated that consumers are different awareness to domestic and foreign safety fish products. National fishery products got more attention from the consumers.

  18. Safety in the design of production lines

    DEFF Research Database (Denmark)

    Dyhrberg, Mette Bang; Broberg, Ole; Jacobsen, Peter

    2006-01-01

    This paper is a case study report on how safety considerations were handled in the process of redesigning a production line. The design process was characterized as a specification and negotiation process between engineers from the company and the supplier organization. The new production line...... became safer, but not as a result of any intentional plan to integrate safety aspects into the design process. Instead, the supplier’s design of a new piece of equipment had a higher built-in safety level. The engineering team in the company was aware of the importance of safety aspects neither...... a ‘history workshop’ with the engineering team. The workshop clarified the sequence of events and discussions that took place during the design process and opened for a discussion of the role of safety aspects. During the workshop new insights emerged into the question of how to integrate safety aspects...

  19. Safety in the redesigning of production lines

    DEFF Research Database (Denmark)

    Dyhrberg, Mette Bang; Broberg, Ole; Jacobsen, Peter

    2006-01-01

    This paper is a case study report on how safety considerations were handled in the process of redesigning a production line. The design process was characterized as a specification and negotiation process between engineers from the company and the supplier organization. The new production line...... became safer, but not as a result of any intentional plan to integrate safety aspects into the design process. Instead, the supplier’s design of a new piece of equipment had a higher built-in safety level. The engineering team in the company was aware of the importance of safety aspects neither...... a ‘history workshop’ with the engineering team. The workshop clarified the sequence of events and discussions that took place during the design process and opened for a discussion of the role of safety aspects. During the workshop new insights emerged into the question of how to integrate safety aspects...

  20. Microbial Safety of Fishery Products

    Digital Repository Service at National Institute of Oceanography (India)

    Karunasagar, Indrani; Karunasagar, Iddya; Parvathi, A.

    of microorganisms. Viruses, bacteria and parasites are the agents of human disease associated with seafoods. The products of microorganism such as bacterial toxins, algal toxins or products of bacterial metabolism such as histamine can cause intoxication when fish.... Nevertheless, very low numbers (1-100) of viruses are known to be capable of causing infections in humans making these organisms all the more important as agents of human illness. The transmission is through fecal-oral route with infected individuals becoming...

  1. Biological ensilage of fish - optimization of stability, safety and functionality

    NARCIS (Netherlands)

    Enes Dapkevicius, M.L.N.

    2002-01-01

    This thesis deals with stability, safety, and functionality aspects of biological fish silage (BFS) obtained by lactic acid fermentation. BFS may provide an economically viable, environment friendly way of upgrading fish waste.BFS has been found advantageous when compared to the so-called acid proce

  2. A comparison of the oral application and injection routes using the Onderstepoort Biological Products Fowl Typhoid vaccine, its safety, efficacy and duration of protection in commercial laying hens : article

    Directory of Open Access Journals (Sweden)

    C. Purchase

    2008-05-01

    Full Text Available This study was undertaken to establish whether the Onderstepoort Biological Products Fowl Typhoid (OBPft vaccine registered as an injectable vaccine was effective and safe when administered orally to commercial layers. Its efficacy and duration of protection were compared with application by intramuscular injection. Commercial brown layer hens were used as they were found to be highly susceptible to Salmonella gallinarum infections. In the vaccine safety trial birds were euthanased at timed intervals spanning 4 weeks post-vaccination. Necropsies were performed and samples were taken and tested. No clinical signs or mortalities could be attributed to the OBPft vaccine nor could active shedding of the vaccine strain be detected. Slight pathological changes were noted with both routes of vaccination; however, these changes were transient, returning to normal within the observation period. The injected groups showed a better serological response with the rapid serum plate agglutination (RSPA test than the orally vaccinated groups. In the duration of protection trial, birds were challenged at 3-8-week intervals post-vaccination. All unvaccinated birds died. Protection 8 and 16 weeks after vaccination was above 60 %, by 24 weeks after challenge, the vaccine protection was below 30 %. It was found that there was no significant difference (P < 0.05 in the protection offered by either the oral or injected route of vaccination with the OBPft vaccine.

  3. 16 CFR 1031.3 - Consumer Product Safety Act amendments.

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Consumer Product Safety Act amendments. 1031.3 Section 1031.3 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION GENERAL COMMISSION... Consumer Product Safety Act amendments. The Consumer Product Safety Act, as amended, contains...

  4. 16 CFR 1115.8 - Compliance with product safety standards.

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Compliance with product safety standards. 1115.8 Section 1115.8 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY... product safety standards. (a) Voluntary standards. The CPSA and other federal statutes administered by...

  5. Safety issues at the defense production reactors

    International Nuclear Information System (INIS)

    The United States produces plutonium and tritium for use in nuclear weapons at the defense production reactors endash the N Reactor in Washington and the Savannah River reactors in South Carolina. This report reaches general conclusions about the management of those reactors and highlights a number of safety and technical issues that should be resolved. The report provides an assessment of the safety management, safety review, and safety methodology employed by the Department of Energy and the private contractors who operate the reactors for the federal government. The report is necessarily based on a limited review of the defense production reactors. It does not address whether any of the reactors are ''safe,'' because such an analysis would involve a determination of acceptable risk endash a matter of obvious importance, but one that was beyond the purview of the committee. It also does not address whether the safety of the production reactors is comparable to that of commercial nuclear power stations, because even this narrower question extended beyond the charge to the committee and would have involved detailed analyses that the committee could not undertake

  6. Synthetic biology advances for pharmaceutical production

    OpenAIRE

    Breitling, Rainer; Takano, Eriko

    2015-01-01

    Synthetic biology enables a new generation of microbial engineering for the biotechnological production of pharmaceuticals and other high-value chemicals. This review presents an overview of recent advances in the field, describing new computational and experimental tools for the discovery, optimization and production of bioactive molecules, and outlining progress towards the application of these tools to pharmaceutical production systems.

  7. Synthetic Biology Guides Biofuel Production

    OpenAIRE

    2010-01-01

    The advancement of microbial processes for the production of renewable liquid fuels has increased with concerns about the current fuel economy. The development of advanced biofuels in particular has risen to address some of the shortcomings of ethanol. These advanced fuels have chemical properties similar to petroleum-based liquid fuels, thus removing the need for engine modification or infrastructure redesign. While the productivity and titers of each of these processes remains to be improve...

  8. The impact of organizational culture on Concurrent Engineering, Design-for-Safety, and product safety performance.

    OpenAIRE

    A. Zhu; von Zedtwitz, M.; Assimakopoulos, D.; Fernandes, K

    2016-01-01

    This paper empirically extends the research on the relationships between organizational culture, new product development (NPD) practices, and product safety performance (PSP). Using Schein's conceptualization of culture (i.e., underlying assumptions, espoused values, and artifacts), we build and test a model among five variables: top management commitment to safety (MCS), group level product safety culture (PSC) at NPD, Concurrent Engineering (CE), Design-for-Safety (DFS), and product safety ...

  9. Biologic Therapy in Inflammatory Immunomediated Systemic Diseases: Safety Profile.

    Science.gov (United States)

    Moroncini, Gianluca; Albani, Lisa; Nobili, Lorenzo; Gabrielli, Armando

    2016-01-01

    The discovery of some key molecular mechanisms underlying the dysregulation of the immune system responsible for inflammatory systemic diseases as severe as Systemic Lupus Erythematosus (SLE), Systemic Sclerosis (SSc), and Systemic Vasculitides, led to the development and subsequent introduction into clinical practice of biological drugs which are significantly improving the management of such complex disorders. This novel molecular targeted therapeutics represents in fact a valid alternative or complementary treatment to conventional immunosuppressive strategies, characterized by broad, unspecific actions and severe adverse effects. Main advantages of the use of biologic drugs reside in their steroid-sparing effect and in the ability of inducing remission of refractory disease states or curing specific organ involvements. Aim of this article is to review and briefly discuss the scientific evidence supporting the use of biologics in these diseases, with a particular emphasis on their efficacy and safety profile compared to the canonical drugs.

  10. 9 CFR 114.6 - Mixing biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Mixing biological products. 114.6... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS § 114.6 Mixing biological products. Each biological product, when in liquid form,...

  11. Biological production of organic compounds

    Energy Technology Data Exchange (ETDEWEB)

    Yu, Jianping; Paddock, Troy; Carrieri, Damian; Maness, Pin-Ching; Seibert, Michael

    2016-04-12

    Strains of cyanobacteria that produce high levels of alpha ketoglutarate (AKG) and pyruvate are disclosed herein. Methods of culturing these cyanobacteria to produce AKG or pyruvate and recover AKG or pyruvate from the culture are also described herein. Nucleic acid sequences encoding polypeptides that function as ethylene-forming enzymes and their use in the production of ethylene are further disclosed herein. These nucleic acids may be expressed in hosts such as cyanobacteria, which in turn may be cultured to produce ethylene.

  12. Product Safety, It's No Accident. A Consumer Product Safety Monthly Planning Guide for Community Organizations.

    Science.gov (United States)

    Consumer Product Safety Commission, Washington, DC.

    A consumer product safety monthly planning guide for community organizations is provided. The material is organized into suggested monthly topics with seasonal emphasis. Each section highlights selected information about how to identify potential hazards associated with categories of products. Each section also includes recommendaitons of ways to…

  13. Standardization for natural product synthetic biology.

    Science.gov (United States)

    Zhao, Huimin; Medema, Marnix H

    2016-08-27

    Standardization is one of the foundational features of modern-day engineering, and the use of standardized parts and processes is a key element that distinguishes bona fide synthetic biology from traditional genetic engineering. Here, we discuss the role of standardization in natural product synthetic biology, focusing on standardization of data on biosynthetic pathways and gene clusters, as well as the role of standardization in the process of biosynthetic gene cluster engineering. PMID:27313083

  14. Standardization for natural product synthetic biology

    OpenAIRE

    Zhao, Huimin; Medema, Marnix H.

    2016-01-01

    Standardization is one of the foundational features of modern-day engineering, and the use of standardized parts and processes is a key element that distinguishes bona fide synthetic biology from traditional genetic engineering. Here, we discuss the role of standardization in natural product synthetic biology, focusing on standardization of data on biosynthetic pathways and gene clusters, as well as the role of standardization in the process of biosynthetic gene cluster engineering.

  15. Chemical safety of meat and meat products.

    Science.gov (United States)

    Andrée, Sabine; Jira, W; Schwind, K-H; Wagner, H; Schwägele, F

    2010-09-01

    Since the Second World War the consumer behaviour in developed countries changed drastically. Primarily there existed the demand for sufficient food after a period of starvation, afterwards the desire for higher quality was arising, whereas today most people ask for safe and healthy food with high quality. Therefore a united approach comprising consistent standards, sound science and robust controls is required to ensure consumers' health and to maintain consumers' confidence and satisfaction. Chemical analysis along the whole food chain downstream (tracking) from primary production to the consumer and upstream (tracing) from the consumer to primary production is an important prerequisite to ensure food safety and quality. In this frame the focus of the following paper is the "chemical safety of meat and meat products" taking into account inorganic as well as organic residues and contaminants, the use of nitrite in meat products, the incidence of veterinary drugs, as well as a Failure Mode and Effect Analysis (FMEA) system assessing (prioritizing) vulnerable food chain steps to decrease or eliminate vulnerability.

  16. The Consumer Product Safety Commission: Benefit or Boondoggle?

    Science.gov (United States)

    Feldman, Laurence P.

    1977-01-01

    The Consumer Product Safety Commission has been subject to the criticism of all parties involved in the regulation of the safety of consumer products. Evaluates the Commission's performance, examining both the sources of the Commission's regulatory problems and the extent to which recent amendments to the Consumer Product Safety Act will solve…

  17. Design and Realization of the Safety Production Scheduling System

    Directory of Open Access Journals (Sweden)

    Qiang Fan

    2013-01-01

    Full Text Available In this study, we have a research of the design and realization of the Safety Production Scheduling System. Urged by the government departments as well as safety supervising institutions, many coal enterprises are embarking on designing and constructing an information system platform for safety production and scheduling. How to establish a systematic, comprehensive, standardized and scientific management platform for the safety production and scheduling has become a hot issue in the coal industry, which is also an important move to integrate various safety management measures in order to prevent major safety accidents and keep up with the international industry status. Taking a successful, large-scale safety production and scheduling system for example, this study elaborates on its overall design and construction. When the system is completed, it will play an important role in strengthening safety production of the coal mines, preventing accidents as well as increasing the overall safety level of the coal industry.

  18. Animal Drug Safety FAQs

    Science.gov (United States)

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Animal & Veterinary Home Animal & Veterinary Safety & Health Frequently Asked Questions Animal Drug Safety Frequently Asked Questions Share Tweet Linkedin ...

  19. Standardization for natural product synthetic biology

    NARCIS (Netherlands)

    Zhao, Huimin; Medema, Marnix H.

    2016-01-01

    Standardization is one of the foundational features of modern-day engineering, and the use of standardized parts and processes is a key element that distinguishes bona fide synthetic biology from traditional genetic engineering. Here, we discuss the role of standardization in natural product synt

  20. 9 CFR 114.17 - Rebottling of biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Rebottling of biological products. 114... OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS § 114.17 Rebottling of biological products. The Administrator...

  1. 9 CFR 114.18 - Reprocessing of biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Reprocessing of biological products..., DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS § 114.18 Reprocessing of biological products. The Administrator...

  2. 9 CFR 114.4 - Identification of biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Identification of biological products... OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PRODUCTION REQUIREMENTS FOR BIOLOGICAL PRODUCTS § 114.4 Identification of biological products. Suitable tags or labels...

  3. 78 FR 57570 - Safety Zone; Motion Picture Production; Chicago, Illinois

    Science.gov (United States)

    2013-09-19

    ... Safety Zone; Motion Picture Production; Chicago, IL (78 FR 20241, August 20, 2013). This updated schedule... SECURITY Coast Guard 33 CFR Part 165 RIN 1625-AA00 Safety Zone; Motion Picture Production; Chicago... will enforce the temporary safety zone for motion picture filming in Calumet Harbor, Chicago, IL from...

  4. Expectations of safety: realising ergonomics and safety in product design

    OpenAIRE

    Norris, Beverley

    1998-01-01

    This research considers the role of ergonomics in consumer safety. The aim was to encourage and improve the input of ergonomics, and thus safety, into the design process. The research has resulted in a series of publications targeted specifically at designers and producers of consumer goods, with the aim of encouraging their adoption of ergonomics principles, data and methods. These publications have been produced and distributed to industry by the Department of Trade and Industry (DTI) Consu...

  5. Safety evaluation of asphalt products, (1)

    International Nuclear Information System (INIS)

    The safety of activity-containing asphalt products kept in enclosed storage was evaluated from considerations of radiolysis and hydrogen evolution. The samples examined were mainly homogeneous asphalt products containing 43w/0 of sludge produced in routine operation of the asphalt plant at the Japan Atomic Energy Research Institute (JAERI), the samples were irradiated with external 60Co γ-ray source to a dose of 109 R. The bulk of the gases evolving from the asphalt product is hydrogen, which constitutes 75 -- 95% of the total gas evolution. The total amount of gases generated during infinite time is proportional to the total exposure dose; hydrogen evolves at a rate of 5.5x10-3 cm3/g.MR. The amount of total gas evolution is governed solely by the quantity of asphalt, and is independent of the sludge contained therein. Nor do differences in the rate of dose appear to have any significant effect. In so far as concerns smallness of radiolysis, slightly better performance can be expected from straight than from blown asphalt. There is no danger of explosion of the asphalt products currently generated at JAERI (10-5 Ci/kg), which can be expected to accumulate in infinite time no more than about 3 cm3 from a 200 l product. Only asphalt products containing activity in concentrations exceeding 10-1 Ci/kg risk explosion when kept in enclosed storage, through accumulation of hydrogen in quantity exceeding the explosion limit in a relatively short time. (auth.)

  6. 9 CFR 106.1 - Biological products; exemption.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXEMPTION FOR BIOLOGICAL PRODUCTS USED IN DEPARTMENT PROGRAMS OR UNDER DEPARTMENT CONTROL OR SUPERVISION § 106.1 Biological products... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Biological products; exemption....

  7. Relevance of microbial finished product testing in food safety management

    DEFF Research Database (Denmark)

    Zwietering, Marcel H.; Jacxsens, Liesbeth; Membré, Jeanne Marie;

    2016-01-01

    Management of microbiological food safety is largely based on good design of processes, products and procedures. Finished product testing may be considered as a control measure at the end of the production process. However, testing gives only very limited information on the safety status of a food......-active way by implementing an effective food safety management system. For verification activities in a food safety management system, finished product testing may however be useful. For three cases studies; canned food, chocolate and cooked ham, the relevance of testing both of finished products...... assessment and epidemiological data....

  8. MedWatch Safety Alerts for Human Medical Products

    Data.gov (United States)

    U.S. Department of Health & Human Services — MedWatch alerts provide timely new safety information on human drugs, medical devices, vaccines and other biologics, dietary supplements, and cosmetics. The alerts...

  9. 9 CFR 112.6 - Packaging biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Packaging biological products. 112.6... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS PACKAGING AND LABELING § 112.6 Packaging biological products. (a) Each multiple-dose final container of a biological...

  10. A Biological Safety Cabinet Certification Program: Experiences in Southeast Asia

    Science.gov (United States)

    Whistler, Toni; Kaewpan, Anek; Blacksell, Stuart D.

    2016-01-01

    Biological safety cabinets (BSCs) are the primary means of containment used in laboratories worldwide for the safe handling of infectious microorganisms. They provide protection to the laboratory worker and the surrounding environment from pathogens. To ensure the correct functioning of BSCs, they need to be properly maintained beyond the daily care routines of the laboratory. This involves annual maintenance and certification by a qualified technician in accordance to the NSF/American National Standards Institute 49-2014 Biosafety Cabinetry: Design, Construction, Performance, and Field Certification. Service programs can be direct from the manufacturer or through third-party service companies, but in many instances, technicians are not accredited by international bodies, and these services are expensive. This means that a large number of BSCs may not be operating in a safe manner. In this article, we discuss our approach to addressing the lack of trained and qualified personnel in Thailand who can install, maintain, and certify BSCs in a cost-effective and practical manner. We initiated a program to create both local and regional capacity for repair, maintenance, and certification of BSCs and share our experiences with the reader.

  11. The Effect of Safety System on Production Indices

    Directory of Open Access Journals (Sweden)

    Manouchehr Omidvari

    2012-01-01

    Full Text Available Nowadays, in addition to implement the quality of management systems and environment management and due to the effects of safety and health issues on working processes, the organizations have also sought to acquire health and safety management systems. This descriptive –analytic and past reviewing study has been implemented based on five years (from 2006 to 2010 recorded documents and statistics information in food industrial. Information was collected based on the food industries checklists. The safety indices including risk evaluation, safety auditing, personnel safety training, investment in personal protection equipments, accident severity, accident frequency, accident frequency-severity and job decease repetition coefficient were used for determination of safety programs successfulness degree. Productivity indices such as human forces productivity, wastage amount, production per capita, personnel absence, personnel complaint and production exploitation were for organizational productivity measurements. The results showed that the safety programs implementation have positive impacts on mentioned productivity indices. So there was a direct relationship between safety rules respect and work condition optimization which arouse productivity development in the organizations. Indices definition could be helpful for the safety system effectiveness and system continuous performance optimization.

  12. Optimization of Safety Production Supervision Mode of Coalmining Enterprises

    Institute of Scientific and Technical Information of China (English)

    ZHOU Min; XIAO Zhong-hai

    2005-01-01

    In view of the fact that safety production supervision of coal mines in China features low efficacy, this paper applies principles of cybernetics to simulate the dynamic process of safety supervision, and proposes that institutional variables be controlled to support intermediate goals, which in turn contribute to the ultimate safety production objective. Rather than focusing all attention on safety issues of working faces, supervising departments of coalmines are advised to pay much more attention to institutional factors that may impact people's attitude and behavior, which are responsible for most coalmine accidents. It is believed that such a shift of attention can effectively reduce coalmining production accidents and greatly enhance supervision efficacy.

  13. Food Safety Detection Methods Applied to National Special Rectification of Product Quality and Food Safety

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ Afour-month period of national special rectification for product quality and food safety officially started on August 25, and was focused on eight fields, including those of agricultural products and processed foods.

  14. Edible agro-products quality and safety in China

    Institute of Scientific and Technical Information of China (English)

    LI Zhe-min; SU Nian-si; DONG Xiao-xia; YANG Yan-tao; WANG Yu-ting; XIAO Hong-li

    2015-01-01

    Ensuring an acceptable level of edible agro-products quality and safety is necessary to provide adequate protection for con-sumers. It is the ifrst time that we analyzed the edible agro-products quality and safety issues in the supply chain, including production, processing, circulation, and consumption. The results indicate that the agro-products quality and safety levels improves steadily, and the supervision system and standardization system are both enhanced signiifcantly, however, certain chalenges stil remain in each stage of the supply chain and the entire supervision process. Finaly, ifve recommendations regarding four aspects (production, processing, circulation, and consumption) are concluded.

  15. Product Engineering Class in the Software Safety Risk Taxonomy for Building Safety-Critical Systems

    Science.gov (United States)

    Hill, Janice; Victor, Daniel

    2008-01-01

    When software safety requirements are imposed on legacy safety-critical systems, retrospective safety cases need to be formulated as part of recertifying the systems for further use and risks must be documented and managed to give confidence for reusing the systems. The SEJ Software Development Risk Taxonomy [4] focuses on general software development issues. It does not, however, cover all the safety risks. The Software Safety Risk Taxonomy [8] was developed which provides a construct for eliciting and categorizing software safety risks in a straightforward manner. In this paper, we present extended work on the taxonomy for safety that incorporates the additional issues inherent in the development and maintenance of safety-critical systems with software. An instrument called a Software Safety Risk Taxonomy Based Questionnaire (TBQ) is generated containing questions addressing each safety attribute in the Software Safety Risk Taxonomy. Software safety risks are surfaced using the new TBQ and then analyzed. In this paper we give the definitions for the specialized Product Engineering Class within the Software Safety Risk Taxonomy. At the end of the paper, we present the tool known as the 'Legacy Systems Risk Database Tool' that is used to collect and analyze the data required to show traceability to a particular safety standard

  16. Analysis on safety production in coal mines Henan Province

    Institute of Scientific and Technical Information of China (English)

    KONG Liu-an; ZHANG Wen-yong

    2006-01-01

    Based on the rigorous situation of safety production in coal mines, the paper analyzed the statistical data of recent accidents indexes in Henan's coal mines. Using investigation and comparison analysis methods, a specified analysis on mining conditions, technical facility level, safety input and vocational quality of workers in Henan's coal mines was conducted. The result indicates that there have been existing such main safety production problems as weak safety management, low-level facilities, inadequate safety input and poor vocational quality and so on. Finally it proposes such reference solutions as to establish and perfect coal mining supervision and management system, to increase safety investment into techniques and facilities and to strengthen workers' safety education and introduction of more high-level professional talents.

  17. Postharvest intervention technologies for safety enhancement of meat and meat based products; a critical review.

    Science.gov (United States)

    Sohaib, Muhammad; Anjum, Faqir Muhammad; Arshad, Muhammad Sajid; Rahman, Ubaid Ur

    2016-01-01

    Globally, the demand for safe, healthy and nutritious meat and allied products possesses improved taste with extended shelf life is mounting. Microbial safety is among the imperative challenges that prevails in meat products because they provide an ideal medium for the growth of microorganisms particularly pathogenic bacteria. The incidence of these microbes can result quality deterioration of products leading towards food borne diseases when consumed by peoples. Several preservation technologies like chemical and biological interventions are effective to retard or inactivate the growth of micro-organisms most commonly related to food-borne diseases. Despite these, innovative approaches like hydrostatic pressure processing, active packaging, pulse electric field, hurdle approach and use of natural antimicrobials can be deployed to enhance the safety of meat and meat products. The objective of review is to describe the current approaches and developing technologies for enhancing safety of meat and allied meat products. PMID:26787929

  18. Systems biology of microbial exopolysaccharides production

    Directory of Open Access Journals (Sweden)

    Ozlem eAtes

    2015-12-01

    Full Text Available Exopolysaccharides (EPS produced by diverse group of microbial systems are rapidly emerging as new and industrially important biomaterials. Due to their unique and complex chemical structures and many interesting physicochemical and rheological properties with novel functionality, the microbial EPSs find wide range of commercial applications in various fields of the economy such as food, feed, packaging, chemical, textile, cosmetics and pharmaceutical industry, agriculture and medicine. EPSs are mainly associated with high-value applications and they have received considerable research attention over recent decades with their biocompatibility, biodegradability, and both environmental and human compatibility. However only a few microbial EPSs have achieved to be used commercially due to their high production costs. The emerging need to overcome economic hurdles and the increasing significance of microbial EPSs in industrial and medical biotechnology call for the elucidation of the interrelations between metabolic pathways and EPS biosynthesis mechanism in order to control and hence enhance its microbial productivity. Moreover a better understanding of biosynthesis mechanism is a significant issue for improvement of product quality and properties and also for the design of novel strains. Therefore a systems-based approach constitutes an important step towards understanding the interplay between metabolism and EPS biosynthesis and further enhances its metabolic performance for industrial application. In this review, primarily the microbial EPSs, their biosynthesis mechanism and important factors for their production will be discussed. After this brief introduction, recent literature on the application of omics technologies and systems biology tools for the improvement of production yields will be critically evaluated. Special focus will be given to EPSs with high market value such as xanthan, levan, pullulan and dextran.

  19. Biological production of ethanol from coal

    Energy Technology Data Exchange (ETDEWEB)

    1992-12-01

    Due to the abundant supply of coal in the United States, significant research efforts have occurred over the past 15 years concerning the conversion of coal to liquid fuels. Researchers at the University of Arkansas have concentrated on a biological approach to coal liquefaction, starting with coal-derived synthesis gas as the raw material. Synthesis gas, a mixture of CO, H[sub 2], CO[sub 2], CH[sub 4] and sulfur gases, is first produced using traditional gasification techniques. The CO, CO[sub 2] and H[sub 2] are then converted to ethanol using a bacterial culture of Clostridium 1jungdahlii. Ethanol is the desired product if the resultant product stream is to be used as a liquid fuel. However, under normal operating conditions, the wild strain'' produces acetate in favor of ethanol in conjunction with growth in a 20:1 molar ratio. Research was performed to determine the conditions necessary to maximize not only the ratio of ethanol to acetate, but also to maximize the concentration of ethanol resulting in the product stream.

  20. 9 CFR 103.1 - Preparation of experimental biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Preparation of experimental biological..., DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING § 103.1 Preparation...

  1. 9 CFR 103.3 - Shipment of experimental biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Shipment of experimental biological..., DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING § 103.3 Shipment...

  2. RESEARCH OF QUALITY, SAFETY AND CONTENT OF BIOLOGICALLY ACTIVE SUBSTANCES OF FOOD RED BEET

    Directory of Open Access Journals (Sweden)

    Gorash E. Y.

    2015-11-01

    Full Text Available The article presents results of research of quality, safety and content of biologically active substances of food red beet roots of Bordo 237 variety, grown in the Krasnodar region in 2014. On the basis of the research carried out it was established, that there are carbohydrates, proteins, organic acids and mineral substances in the food red beet roots of Bordo 237 variety. Food red beet roots are a source of dietary fibers (pectin, protopectin, hemicelluloses and cellulose, possessing antitoxic, antioxidant, radiation protective, cholesterol-lowering and lipid correcting qualities, and also a source of vitamins C, B9 (folic acid and P-active substances, possessing antioxidant properties. Due to high content in food red beet of a complex of microelements – iron, zinc, manganese and copper, and a complex of macro elements – potassium and magnesium, it can be recommended for prophylaxis and treatment of hypertension, atherosclerosis and other diseases of heart and vascular system, and for prophylaxis of iron-deficiency anemia. Thus, the research of quality, safety and content of biologically active substances showed that food red beet roots of Bordo 237 variety are a high quality component ingredient for creation of food products of specialized and functional purpose

  3. Consumer Product Safety Commission. Consumer Education Efforts for Revised Children's Sleepwear Safety Standard.

    Science.gov (United States)

    General Accounting Office, Washington, DC. Health, Education, and Human Services Div.

    A study examined the type and extent of consumer education that occurred since the Consumer Product Safety Commission (CPSC) amended the 1972 federal safety standards (effective January 1997) to permit marketing of snug-fitting, nonflame-resistant cotton garments as sleepwear. Three voluntary point-of-sale (POS) practices recognized as important…

  4. Safety assessment of smoke flavouring primary products by the European Food Safety Authority

    NARCIS (Netherlands)

    Theobald, A.; Arcella, D.; Carere, A.; Croera, C.; Engel, K.H.; Gott, D.; Gurtler, R.; Meier, D.; Pratt, I.; Rietjens, I.M.C.M.; Simon, R.; Walker, R.

    2012-01-01

    This paper summarises the safety assessments of eleven smoke flavouring primary products evaluated by the European Food Safety Authority (EFSA). Data on chemical composition, content of polyaromatic hydrocarbons and results of genotoxicity tests and subchronic toxicity studies are presented and disc

  5. Review of health safety aspects of nanotechnologies in food production.

    Science.gov (United States)

    Bouwmeester, Hans; Dekkers, Susan; Noordam, Maryvon Y; Hagens, Werner I; Bulder, Astrid S; de Heer, Cees; ten Voorde, Sandra E C G; Wijnhoven, Susan W P; Marvin, Hans J P; Sips, Adriënne J A M

    2009-02-01

    Due to new, previously unknown, properties attributed to engineered nanoparticles many new products are introduced in the agro-food area. Nanotechnologies cover many aspects, such as disease treatment, food security, new materials for pathogen detection, packaging materials and delivery systems. As with most new and evolving technologies, potential benefits are emphasized, while little is known on safety of the application of nanotechnologies in the agro-food sector. This review gives an overview of scientific issues that need to be addressed with priority in order to improve the risk assessment for nanoparticles in food. The following research topics are considered to contribute pivotally to risk assessment of nanotechnologies and nanoparticles in food products. Set a definition for NPs to facilitate regulatory discussions, prioritization of research and exchange of study results. Develop analytical tools for the characterization of nanoparticles in complex biological matrices like food. Establish relevant dose metrics for nanoparticles used for both interpretation of scientific studies as well as regulatory frameworks. Search for deviant behavior (kinetics) and novel effects (toxicity) of nanoparticles and assess the validity of currently used test systems following oral exposure. Estimate the consumer exposure to nanoparticles.

  6. Cost Benefit Analysis of Consumer Product Safety Standards

    Science.gov (United States)

    Smith, Betty F.; Dardis, Rachel

    1977-01-01

    This paper investigates the role of cost-benefit analysis in evaluating consumer product safety standards and applys such analysis to an evaluation of flammability standards for children's sleepwear. (Editor)

  7. Safety of biologics in rheumatoid arthritis: data from randomized controlled trials and registries.

    Science.gov (United States)

    Codreanu, Catalin; Damjanov, Nemanja

    2015-01-01

    Over the past decade, the use of biologics has significantly changed the management of rheumatoid arthritis (RA). Biologics selectively target components of the immune system, resulting in better disease control. However, the growing use of biologics in RA has increased safety concerns among rheumatologists. Randomized controlled trials (RCTs) and registries are the most reliable sources of clinical safety data. Although safety data from RCTs provide certain insights into the clinical safety profile of an agent, strict constraints in study design (eg, exclusion criteria and restrictive treatment protocols) often do not accurately reflect possible safety issues in the use of the agent, either in the clinical setting or over long-term treatment. Registries, on the other hand, are not restrictive regarding patient enrollment, making them more reliable in evaluating long-term safety. A number of registries have been established globally: in Europe, the United States, and Asia. However, the availability of registry data from Eastern Europe is lacking. The notable exceptions so far are registries from the Czech Republic (ATTRA, a registry of patients treated with anti-tumor necrosis factor-alpha drugs) and Serbia (National registry of patients with rheumatoid arthritis in Serbia [NARRAS]). The current report provides an overview of safety data with biologics in RA from RCTs and registries. Availability of regional safety data from Eastern Europe is of great importance to its clinicians for making evidence-based treatment decisions in RA. PMID:25670881

  8. The Current Situation of Quality Supervision and Production Safety of Aquatic Products in Nanjing City

    Institute of Scientific and Technical Information of China (English)

    Guoqin; ZHOU; Wenjie; LI

    2013-01-01

    In recent years, the work of quality supervision and production safety of aquatic products in Nanjing City has been carried out rapidly, and the system of "origin exit, market access, sign traceability, real-time monitoring" has been basically formed, initially realizing the whole-process monitoring on the quality safety of aquatic products from "pond to table". We take the current situation of quality supervision and production safety of aquatic products in Nanjing City as the study object, take the basic work of supervision on aquatic products in Nanjing City and advancing both in scope and in depth as breakthrough point, to sum up the results achieved in the work of quality supervision and production safety of aquatic products in Nanjing City in recent years; make initial exploration and research, in order to consolidate the existing achievements, and further enhance the level of supervision on quality safety of aquatic products in Nanjing City.

  9. Biological treatment of shrimp production wastewater.

    Science.gov (United States)

    Boopathy, Raj

    2009-07-01

    Over the last few decades, there has been an increase in consumer demand for shrimp, which has resulted in its worldwide aquaculture production. In the United States, the stringent enforcement of environmental regulations encourages shrimp farmers to develop new technologies, such as recirculating raceway systems. This is a zero-water exchange system capable of producing high-density shrimp yields. The system also produces wastewater characterized by high levels of ammonia, nitrate, nitrite, and organic carbon, which make waste management costs prohibitive. Shrimp farmers have a great need for a waste management method that is effective and economical. One such method is the sequencing batch reactor (SBR). A SBR is a variation of the activated sludge biological treatment process. This process uses multiple steps in the same reactor to take the place of multiple reactors in a conventional treatment system. The SBR accomplishes equalization, aeration, and clarification in a timed sequence in a single reactor system. This is achieved through reactor operation in sequences, which includes fill, react, settle, decant, and idle. A laboratory scale SBR was successfully operated using shrimp aquaculture wastewater. The wastewater contained high concentrations of carbon and nitrogen. By operating the reactors sequentially, namely, aerobic and anoxic modes, nitrification and denitrification were achieved as well as removal of carbon. Ammonia in the waste was nitrified within 4 days. The denitrification of nitrate was achieved by the anoxic process, and 100% removal of nitrate was observed within 15 days of reactor operation. PMID:19396482

  10. Evaluation of Safety, Quality and Productivity in Construction

    Science.gov (United States)

    Usmen, M. A.; Vilnitis, M.

    2015-11-01

    This paper examines the success indicators of construction projects, safety, quality and productivity, in terms of their implications and impacts during and after construction. First safety is considered during construction with a focus on hazard identification and the prevention of occupational accidents and injuries on worksites. The legislation mandating safety programs, training and compliance with safety standards is presented and discussed. Consideration of safety at the design stage is emphasized. Building safety and the roles of building codes in prevention of structural failures are also covered in the paper together with factors affecting building failures and methods for their prevention. Quality is introduced in the paper from the perspective of modern total quality management. Concepts of quality management, quality control, quality assurance and Six Sigma and how they relate to building quality and structural integrity are discussed with examples. Finally, productivity concepts are presented with emphasis on effective project management to minimize loss of productivity, complimented by lean construction and lean Six Sigma principles. The paper concludes by synthesizing the relationships between safety, quality and productivity.

  11. Danish initiatives to improve the safety of meat products

    DEFF Research Database (Denmark)

    Wegener, Henrik Caspar

    2010-01-01

    and Campylobacter, and to a lesser extent Yersinia, Escherichia coli O157 and Listeria. Danish initiatives to improve the safety of meat products have focused on the entire production chain from the farm to the consumer, with a special emphasis on the pre-harvest stage of production. The control of bacterial......During the last two decades the major food safety problems in Denmark, as determined by the number of human patients, has been associated with bacterial infections stemming from meat products and eggs. The bacterial pathogens causing the majority of human infections has been Salmonella...

  12. Biological hydrogen production using a membrane bioreactor.

    Science.gov (United States)

    Oh, Sang-Eun; Iyer, Prabha; Bruns, Mary Ann; Logan, Bruce E

    2004-07-01

    A cross-flow membrane was coupled to a chemostat to create an anaerobic membrane bioreactor (MBR) for biological hydrogen production. The reactor was fed glucose (10,000 mg/L) and inoculated with a soil inoculum heat-treated to kill non-spore-forming methanogens. Hydrogen gas was consistently produced at a concentration of 57-60% in the headspace under all conditions. When operated in chemostat mode (no flow through the membrane) at a hydraulic retention time (HRT) of 3.3 h, 90% of the glucose was removed, producing 2200 mg/L of cells and 500 mL/h of biogas. When operated in MBR mode, the solids retention time (SRT) was increased to SRT = 12 h producing a solids concentration in the reactor of 5800 mg/L. This SRT increased the overall glucose utilization (98%), the biogas production rate (640 mL/h), and the conversion efficiency of glucose-to-hydrogen from 22% (no MBR) to 25% (based on a maximum of 4 mol-H(2)/mol-glucose). When the SRT was increased from 5 h to 48 h, glucose utilization (99%) and biomass concentrations (8,800 +/- 600 mg/L) both increased. However, the biogas production decreased (310 +/- 40 mL/h) and the glucose-to-hydrogen conversion efficiency decreased from 37 +/- 4% to 18 +/- 3%. Sustained permeate flows through the membrane were in the range of 57 to 60 L/m(2) h for three different membrane pore sizes (0.3, 0.5, and 0.8 microm). Most (93.7% to 99.3%) of the membrane resistance was due to internal fouling and the reversible cake resistance, and not the membrane itself. Regular backpulsing was essential for maintaining permeate flux through the membrane. Analysis of DNA sequences using ribosomal intergenic spacer analysis indicated bacteria were most closely related to members of Clostridiaceae and Flexibacteraceae, including Clostridium acidisoli CAC237756 (97%), Linmingia china AF481148 (97%), and Cytophaga sp. MDA2507 AF238333 (99%). No PCR amplification of 16s rRNA genes was obtained when archaea-specific primers were used.

  13. Food Safety Practices in the Egg Products Industry.

    Science.gov (United States)

    Viator, Catherine L; Cates, Sheryl C; Karns, Shawn A; Muth, Mary K; Noyes, Gary

    2016-07-01

    We conducted a national census survey of egg product plants (n = 57) to obtain information on the technological and food safety practices of the egg products industry and to assess changes in these practices from 2004 to 2014. The questionnaire asked about operational and sanitation practices, microbiological testing practices, food safety training for employees, other food safety issues, and plant characteristics. The findings suggest that improvements were made in the industry's use of food safety technologies and practices between 2004 and 2014. The percentage of plants using advanced pasteurization technology and an integrated, computerized processing system increased by almost 30 percentage points. Over 90% of plants voluntarily use a written hazard analysis and critical control point (HACCP) plan to address food safety for at least one production step. Further, 90% of plants have management employees who are trained in a written HACCP plan. Most plants (93%) conduct voluntary microbiological testing. The percentage of plants conducting this testing on egg products before pasteurization has increased by almost 30 percentage points since 2004. The survey findings identify strengths and weaknesses in egg product plants' food safety practices and can be used to guide regulatory policymaking and to conduct required regulatory impact analysis of potential regulations.

  14. Biologically plausible and evidence-based risk intervals in immunization safety research.

    Science.gov (United States)

    Rowhani-Rahbar, Ali; Klein, Nicola P; Dekker, Cornelia L; Edwards, Kathryn M; Marchant, Colin D; Vellozzi, Claudia; Fireman, Bruce; Sejvar, James J; Halsey, Neal A; Baxter, Roger

    2012-12-17

    In immunization safety research, individuals are considered at risk for the development of certain adverse events following immunization (AEFI) within a specific period of time referred to as the risk interval. These intervals should ideally be determined based on biologic plausibility considering features of the AEFI, presumed or known pathologic mechanism, and the vaccine. Misspecification of the length and timing of these intervals may result in introducing bias in epidemiologic and clinical studies of immunization safety. To date, little work has been done to formally assess and determine biologically plausible and evidence-based risk intervals in immunization safety research. In this report, we present a systematic process to define biologically plausible and evidence-based risk interval estimates for two specific AEFIs, febrile seizures and acute disseminated encephalomyelitis. In addition, we review methodologic issues related to the determination of risk intervals for consideration in future studies of immunization safety.

  15. Methods for observational post-licensure medical product safety surveillance.

    Science.gov (United States)

    Nelson, Jennifer C; Cook, Andrea J; Yu, Onchee; Zhao, Shanshan; Jackson, Lisa A; Psaty, Bruce M

    2015-04-01

    Post-licensure medical product safety surveillance is important for detecting adverse events potentially not identified pre-licensure. Historically, post-licensure safety monitoring has been accomplished using passive reporting systems and by conducting formal Phase IV randomized trials or large epidemiological studies, also known as safety surveillance or pharmacovigilance studies. However, crucial gaps in the safety evidence base provided by these approaches have led to high profile product withdrawals and growing public concern about unknown health risks associated with licensed products. To address the limitations of existing surveillance systems and to facilitate more accurate and rapid detection of safety problems, new systems involving active surveillance of large, population-based cohorts using observational health care databases are being developed. In this article, we review common statistical methods that have been employed previously for post-licensure safety monitoring, including data mining and sequential hypothesis testing, and assess which methods may be promising for potential use within this newly proposed prospective observational cohort monitoring framework. We discuss gaps in existing approaches and identify areas where methodological development is needed to improve the success of safety surveillance efforts in this setting.

  16. Safety of biologics in rheumatoid arthritis: data from randomized controlled trials and registries

    OpenAIRE

    Codreanu C; Damjanov N

    2015-01-01

    Catalin O Codreanu,1 Nemanja Damjanov2 1Rheumatology Department, Center of Rheumatic Diseases, Bucharest, Romania; 2Institute of Rheumatology, School of Medicine, University of Belgrade, Belgrade, SerbiaAbstract: Over the past decade, the use of biologics has significantly changed the management of rheumatoid arthritis (RA). Biologics selectively target components of the immune system, resulting in better disease control. However, the growing use of biologics in RA has increased safety concer...

  17. Biological control and sustainable food production

    NARCIS (Netherlands)

    Bale, J.S.; Lenteren, van J.C.; Bigler, F.

    2008-01-01

    The use of biological control for the management of pest insects pre-dates the modern pesticide era. The first major successes in biological control occurred with exotic pests controlled by natural enemy species collected from the country or area of origin of the pest (classical control). Augmentati

  18. Safety of biologics in rheumatoid arthritis: data from randomized controlled trials and registries

    Directory of Open Access Journals (Sweden)

    Codreanu C

    2015-01-01

    Full Text Available Catalin O Codreanu,1 Nemanja Damjanov2 1Rheumatology Department, Center of Rheumatic Diseases, Bucharest, Romania; 2Institute of Rheumatology, School of Medicine, University of Belgrade, Belgrade, SerbiaAbstract: Over the past decade, the use of biologics has significantly changed the management of rheumatoid arthritis (RA. Biologics selectively target components of the immune system, resulting in better disease control. However, the growing use of biologics in RA has increased safety concerns among rheumatologists. Randomized controlled trials (RCTs and registries are the most reliable sources of clinical safety data. Although safety data from RCTs provide certain insights into the clinical safety profile of an agent, strict constraints in study design (eg, exclusion criteria and restrictive treatment protocols often do not accurately reflect possible safety issues in the use of the agent, either in the clinical setting or over long-term treatment. Registries, on the other hand, are not restrictive regarding patient enrollment, making them more reliable in evaluating long-term safety. A number of registries have been established globally: in Europe, the United States, and Asia. However, the availability of registry data from Eastern Europe is lacking. The notable exceptions so far are registries from the Czech Republic (ATTRA, a registry of patients treated with anti-tumor necrosis factor-alpha drugs and Serbia (National registry of patients with rheumatoid arthritis in Serbia [NARRAS]. The current report provides an overview of safety data with biologics in RA from RCTs and registries. Availability of regional safety data from Eastern Europe is of great importance to its clinicians for making evidence-based treatment decisions in RA. Keywords: biologic therapy, biologic drugs, adverse events, infections, pregnancy, malignancies

  19. Direct farm, production base, traceability and food safety in China

    Institute of Scientific and Technical Information of China (English)

    DING Ji-ping; HUANG Ji-kun; JIA Xiang-ping; BAI Jun-fei; Steve Boucher; Michael Carter

    2015-01-01

    With the rapid growth of China’s economy, rising demand for safety food has been accompanied by frequent food safety scandals. Given that China’s farming is dominated by milions of smal-scale farms, ensuring food safety is a major chalenge facing the public and private sectors. The direct farm (DF) program, initiated in 2008, represents one of the government’s major initiatives to modernize the distribution of fresh fruit and vegetables (FFV) and improve food safety. Under the DF program, participating national and international retailers are expected to establish more direct procurement relationships with farm communities. While it is often claimed that greater participation by retailers in the production and post-harvest processing implied the DF program wil lead to improved quality, safety and traceability, systematic evidence remains elu-sive as existing studies are largely narrative, based on case studies, or theoretical inference. Little empirical evidence is available for a broader evaluation of the DF program. This paper aims to ifl this gap by assessing the overal performance of a single retailer’s DF experience with respect to the procurement and food safety of FFV. We use data from a survey of production managers of 35 DF production bases (PBs) spread across 11 provinces, 3 cities and 1 autonomous region in China. The results show a mixture of opportunities and chalenges. On one hand, the DF program improves production practices and distribution channels of FFV produced on its PBs, thus facilitating the move of China’s food system towards improved food safety compliance. On the other hand, signiifcant heterogeneity in the traceability of food and the ability of DF to meet higher safety standards is evident both across major product categories and across household-operatedvs. ifrm-operated PBs. The paper concludes with policy implications.

  20. 75 FR 29155 - Publicly Available Consumer Product Safety Information Database

    Science.gov (United States)

    2010-05-24

    ... deposited into a central data warehouse for such information. We propose that product-related incident... certificates, consumer complaints, and hospital emergency rooms. In addition, the Commission receives... or incidents. The data that the Commission collects and maintains on product safety has not...

  1. Improving occupational safety and health by integration into product development

    DEFF Research Database (Denmark)

    Broberg, Ole

    1996-01-01

    A cross-sectional case study was performed in a large company producing electro-mechanical products for industrial application. The objectives were: (i) to study the product development process and the role of key actors', (ii) to identify current practice on integrating occupational safety and h...

  2. 77 FR 32146 - Safety Evaluation Report, International Isotopes Fluorine Products, Inc., Fluorine Extraction...

    Science.gov (United States)

    2012-05-31

    ... summary, radiation protection, nuclear criticality safety, chemical process safety, fire safety, emergency... COMMISSION Safety Evaluation Report, International Isotopes Fluorine Products, Inc., Fluorine Extraction Process and Depleted Uranium Deconversion Plan, Lea County, NM AGENCY: Nuclear Regulatory...

  3. 16 CFR Appendix A to Part 1212 - Findings Under the Consumer Product Safety Act

    Science.gov (United States)

    2010-01-01

    ... 16 Commercial Practices 2 2010-01-01 2010-01-01 false Findings Under the Consumer Product Safety Act A Appendix A to Part 1212 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT... 1212—Findings Under the Consumer Product Safety Act Section 9(f) of the Consumer Product Safety Act...

  4. Safety and Contamination Information to Consumers regarding Control of Quality and Safety in Organic Production Chains

    OpenAIRE

    Ogden, Iain; Rosa, Eduardo; Wyss, Gabriela; Brandt, Kirsten

    2005-01-01

    This leaflet provides a practical overview for consumers of what is done to secure the safety and purity of 7 types of organically pro-duced foods, and what the consumer can do to support those ef-forts and preserve the food safety after purchase. Other leaflets for consumers cover authenticity and fraud or taste, freshness & nu-trients, and separate leaflets aim at retailers or at production of specific commodities.

  5. Safety & Contamination Information to Retailers regarding Control of Quality and Safety in Organic Production Chains

    OpenAIRE

    Ogden, Iain; Rosa, Eduardo; Wyss, Gabriela; Brandt, Kirsten

    2005-01-01

    This leaflet provides a practical overview for retailers of what is done to secure the safety and purity of 7 types of organically pro-duced foods, and what the retailers can do to support those efforts and preserve the food safety until purchase. Other leaflets for re-tailers cover authenticity and fraud or taste, freshness & nutrients, and separate leaflets aim at consumers or at production of specific commodities.

  6. Efficacy and Safety of Pomegranate Medicinal Products for Cancer

    OpenAIRE

    Christian Vlachojannis; Zimmermann, Benno F.; Sigrun Chrubasik-Hausmann

    2015-01-01

    Preclinical in vitro and in vivo studies demonstrate potent effects of pomegranate preparations in cancer cell lines and animal models with chemically induced cancers. We have carried out one systematic review of the effectiveness of pomegranate products in the treatment of cancer and another on their safety. The PubMed search provided 162 references for pomegranate and cancer and 122 references for pomegranate and safety/toxicity. We identified 4 clinical studies investigating 3 pomegranate ...

  7. Quality and safety of bovine clones and their products.

    Science.gov (United States)

    Heyman, Y; Chavatte-Palmer, P; Fromentin, G; Berthelot, V; Jurie, C; Bas, P; Dubarry, M; Mialot, J P; Remy, D; Richard, C; Martignat, L; Vignon, X; Renard, J P

    2007-08-01

    cattle derived from somatic nuclear transfer than in cattle born from conventional reproduction. Our results confirm that the quality and safety of products (milk and meat) from adult and clinically healthy cloned cattle is globally similar to normal animals. However, from a strictly biological point of view, the slightly delayed maturation we observed in the muscle of clones together with some marginal differences identified in FA composition of both muscle and milk, point to the need for more refined analysis to totally exclude any risks from the consumption of those products.

  8. Long-term safety of biologics in the treatment of psoriasis

    Directory of Open Access Journals (Sweden)

    Panchal MR

    2013-12-01

    Full Text Available Manisha R Panchal,1 Helen Coope,2 D John McKenna,3 Anton B Alexandroff31Department of Dermatology, Sherwood Forest Hospitals, Kingsmill Hospital, Nottinghamshire, 2Novartis Pharmaceuticals UK Ltd, West Sussex, 3Department of Dermatology, University Hospitals of Leicester, Leicester Royal Infirmary, Leicester, UKAbstract: Biologics are novel and important agents in the treatment of severe psoriasis. These agents block specific molecular steps in the inflammatory cascade, thereby reducing activation and proliferation of keratinocytes. Prescreening for biologic agents and careful monitoring of patients is important. There are four biologics currently licensed and used in the treatment of psoriasis in the European Union. This is an evidence-based review examining clinical trials and focusing on the long-term safety data for four biologic agents. Current British Association of Dermatology guidance for the use of biologics in psoriasis and guidelines on the management of psoriasis from the National Institute for Health and Clinical Excellence have been used. Advances on safety information since 2009 in clinical trials are reviewed. The results show that overall there is no statistical significance in the incidence of adverse effects of biologics versus placebo. However, there are serious adverse effects that are reported for biologics that need to be assessed for and addressed promptly. Results of studies discussing major adverse cardiovascular events are also reviewed.Keywords: psoriasis, biologic agents, safety profile, major cardiovascular events

  9. Safety and efficacy of health supplement (Pegaga based product)

    OpenAIRE

    Firdaus Abd Rahman; Chua Say Tiong; Kah Seng Lee; Amir Heberd Abdullah; Long Chiau Ming

    2016-01-01

    Purpose: The aim of this review is to evaluate the safety and efficacy of a product containing Pegaga and to understand the related marketing issues. Methodology: A review regarding registration of product was conducted by examining the registration in National Pharmaceutical Control Bureau (NPCB), Ministry of Health (MOH) of Malaysia and the profile of product was evaluated by assessing the online MIMS, Micromedex, and www.globinmed.com. Besides that, an electronic search was conducted th...

  10. Support for the revocation of general safety test regulations in biologics license applications.

    Science.gov (United States)

    Evans, Dana M; Thorn, Jennifer M; Arch-Douglas, Katherine; Sperry, Justin B; Thompson, Bruce; Davis, Heather L; McCluskie, Michael J

    2016-05-01

    The United States Food and Drug Administration recently removed the requirement for a General Safety Test (GST) for biologics in the Code of Federal Regulations (21 CFR 610.11). The GST, as well as abnormal toxicity (European Pharmacopeia) and innocuity tests (World Health Organization), were designed to test for extraneous toxic contaminants on each product lot intended for human use. Tests require one-week observations for general health and weight following injection of specified volumes of product batches into guinea pigs and mice. At the volumes specified, dose-related toxicity may result when the product is pharmacologically active in rodents. With vaccines, required doses may be > 3 logs higher than intended human dose on a weight-adjusted basis and if an immune modulatory adjuvant is included, systemic immune hyperactivation may cause toxicity. Herein, using the CpG/alum adjuvant combination we evaluated the different test protocols and showed their unsuitability for this adjuvant combination. PMID:26996102

  11. Design of Traceability System for Pork Safety Production

    Institute of Scientific and Technical Information of China (English)

    2009-01-01

    With the development of society and the improvement of living standards,consumers’demand for high quality meat products is constantly increasing.Traceability for livestock products is widely recognized to be an effective measure for any modern and integrated food safety control system.The quality tracing and traceability system of production’s entire processes is an important technology tool to protect pork safety.This paper proposes a RFID-enabled traceability system for pork supply chain.By adopting SQL Server 2000 databases and intelligent identification technology,a tracing system suitable to Chinese situation for monitoring and controlling quality of pork is constructed,and it manages to realize information traceability for entire pork production.The study indicates that the traceability system is valuable for practical reference and feasible.It can help consumers to confide in pork safety and encourage the pork industry developing.

  12. 9 CFR 115.2 - Inspections of biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Inspections of biological products. 115.2 Section 115.2 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS...

  13. Management present situation and countermeasures of coal mines safety in production

    Institute of Scientific and Technical Information of China (English)

    ZHANG Shu-dong; YU Chang-wu

    2008-01-01

    Analyzed of the present situation of Chinese coal mines safety in production and the reasons for coal mining accident, and realized the coal mines safety in production,which should increase the legal safeguards of coal mine safety in production, and safety input, established the comprehensive coal mine safety evaluation system, comprehensively enhance quality of coal mine workers, established and improved early warning mechanism of safety production of coal mine.

  14. Product safety and human reliability; Seihin anzen to ningen shinraisei

    Energy Technology Data Exchange (ETDEWEB)

    Miyamura, T. [Chuo University, Tokyo (Japan). Faculty of Science and Engineering

    1997-10-15

    Described herein are cognitive psychological studies for product safety management and user interfaces. Easiness of handling products has two facets; one is easiness of realizing their basic functions and the other easiness of handling them safely, the latter being more important in product safety. For products to be used by the general public, it is necessary to take into account errors by the users who are not trained beforehand to handle them. In the design of products to be handled easily, problems must be found and solved from the overall viewpoints of human factors and machine systems. It is accepted that cognitive studies on the interfaces need various considerations, including those for sending information while taking human memory systems into account, for visualization of the processing steps, and for alignment between mental models of makers and users. Designs of user interfaces must include the elements related to functionality, interactions and metacommunication. 10 refs., 8 figs., 8 tabs.

  15. 30 CFR 6.20 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Science.gov (United States)

    2010-07-01

    ... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.20 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as equivalent... intent to review any non-MSHA product safety standard for equivalency in the Federal Register for...

  16. Safety assessment of cosmetic products, with emphasis on the ocular area: regulatory aspects and validation processes

    Directory of Open Access Journals (Sweden)

    Maythê de Lima Cancian

    2014-12-01

    Full Text Available Before marketing a cosmetic product, a series of biological assays, such as ocular irritation tests, must be conducted in order to prove that the product is safe. However, a few scientific articles mention the discussion and evolution of cosmetic products testing performed in the eyes area. The aim of this study was to review the available literature on the evolution of tests carried out with cosmetics, in the ocular area, as well as to describe the methodologies that have been used and that are currently accepted. In Brazil, tests performed on animals are still allowed. However, the international laws strongly recommend the use of alternative methods for evaluating the risk of cosmetic ingredients and products. Regulatory requirements involving the registration of these products also request safety support of them in human beings. To perform ocular tests in human beings, it is necessary to involve an ophthalmologist for conducting clinical protocols. These protocols signed by the expert physician are sent to the National Health Surveillance Agency in order to endorse the product manufacturer concerning its safety. The safety support of a cosmetic product is very important, taking into account that the consumer has free access to these products of widespread use in today's society.

  17. A biological safety evaluation on reclaimed water reused as scenic water using a bioassay battery

    Institute of Scientific and Technical Information of China (English)

    Dongbin Wei; Zhuowei Tan; Yuguo Du

    2011-01-01

    An assessment method based on three toxicity tests (algae growth inhibition,daphnia immobilization and larval fish toxicity) was used to screen the biological safety of reclaimed water which was reused as sole replenishment for scenic water system in a park (SOF Park) in northern China.A total of 24 water samples were collected from six sites of water system in the SOF Park in four different seasons.The results indicated that:(1) the reclaimed water directly discharged from a reclamation treatment plant near the SOF Park as influent of park had relatively low biological safety (all samples were ranked as C or D); (2) the biological safety of reclaimed water was improved greatly with the ecological reclamation treatment processes composing of artificial wetland system and followed oxidation pond system; (3) the biological safety of reclaimed water in the main lake of SOF Park kept at a health status during different seasons (all samples were ranked as A); (4) there was some certain correlation (R2 =0.5737) between the sum of toxicity scores and dissolved organic carbon for the studied water samples.It was concluded that the assessment method was reliable to screen the safety of reclaimed water reused as scenic water,and the reclaimed water with further ecological purification processes such as artificial wetland and oxidation pond system can be safely reused as scenic water in park.

  18. Analysis of safety and economics for cobalt-60 production

    Energy Technology Data Exchange (ETDEWEB)

    Suh, D. S.; Jun, H. S. [Korea Electric Power Corporation, Seoul (Korea)

    2000-06-01

    The feasibility of Co-60 production in Wolsong Unit 1,2,3,4 was studied by reviewing its impact on plant safety and conformance to licensing basis, and by analyzing impact of Co-60 production on plant operation, initial investment capital, and operating costs and revenue. Design changes, equipment and tools needed for Co-60 production in Wolsong reactors and safety concerns in using cobalt adjuster rods were reviewed. There are several safety concerns in using cobalt adjuster rods are change in nuclear characteristics due to change in material in adjuster rods, deflagration potential in moderator cover gas and radiation control, however, it was estimated that the reactor conversion would not impose adverse impact on plant safety. In the economical aspect, although there is a relatively large uncertainty in estimating plant conversion cost, it was verified that, since Co-60 can be produced without any adverse impact on electricity production, in principal Co-60 production is an economically feasible business. 25 figs. (Author)

  19. Biological safety evaluation of the modified urinary catheter

    Energy Technology Data Exchange (ETDEWEB)

    Kowalczuk, Dorota, E-mail: dorota.kowalczuk@umlub.pl [Department of Medicinal Chemistry, Medical University of Lublin, Jaczewskiego 4, 20-090 Lublin (Poland); Przekora, Agata; Ginalska, Grazyna [Department of Biochemistry and Biotechnology, Medical University of Lublin, Chodzki 1, 20-093 Lublin (Poland)

    2015-04-01

    The purpose of this study was to evaluate in vitro safety of the novel tosufloxacin (TOS)-treated catheters with the prolonged antimicrobial activity. The test samples of silicone latex catheter were prepared by the immobilization of TOS on chitosan (CHIT)-coated catheter by means of covalent bonds and non-covalent interactions. Each step of the modification process of catheter surface was observed using ATR–Fourier transform infrared spectroscopy. In vitro cytotoxicity of the modified and unmodified catheters was assessed by direct and indirect tests in accordance with ISO standards using green monkey kidney (GMK) cell line. The MTT, lactate dehydrogenase activity (LDH), WST-8, Sulforhodamine B (SRB) test results and microscopic observation clearly indicated that unmodified silicone latex catheters decrease cell metabolic activity, act as a cytotoxic agent causing cell lysis and induce cell death through necrotic or apoptotic process. We suggest that chitosan coat with TOS immobilized limits leaching of harmful agents from silicone latex material, which significantly enhances survivability of GMK cells and therefore is quite a good protection against the cytotoxic effect of this material. - Highlights: • Characterization of the novel antimicrobial urinary catheters • Monitoring of the catheter modification by FTIR analysis • Confirmation of high cytotoxicity of latex-based catheter used in urological practice • Chitosan-coated and tosufloxacin-treated catheter is less toxic than the untreated one. • The proposed surface modification protects cells against latex-induced death.

  20. Cholesterol oxidation products and their biological importance.

    Science.gov (United States)

    Kulig, Waldemar; Cwiklik, Lukasz; Jurkiewicz, Piotr; Rog, Tomasz; Vattulainen, Ilpo

    2016-09-01

    The main biological cause of oxysterols is the oxidation of cholesterol. They differ from cholesterol by the presence of additional polar groups that are typically hydroxyl, keto, hydroperoxy, epoxy, or carboxyl moieties. Under typical conditions, oxysterol concentration is maintained at a very low and precisely regulated level, with an excess of cholesterol. Like cholesterol, many oxysterols are hydrophobic and hence confined to cell membranes. However, small chemical differences between the sterols can significantly affect how they interact with other membrane components, and this in turn can have a substantial effect on membrane properties. In this spirit, this review describes the biological importance and the roles of oxysterols in the human body. We focus primarily on the effect of oxysterols on lipid membranes, but we also consider other issues such as enzymatic and nonenzymatic synthesis processes of oxysterols as well as pathological conditions induced by oxysterols. PMID:26956952

  1. COTTAGE CHEESE PRODUCTS ENRICHED BIOLOGICALLY ACTIVE ADDITIVES

    OpenAIRE

    Салкинбаева Г. Т.; Байбалинова Г. М.; Смаилова М. Н.

    2015-01-01

    This article deals with a reliable means of improving the structure of supply and optimum balance of the diet of the population, is the use of biologically active additives in a daily diet of the people to food dietary supplements. Supplements such advantages as an expression of food oriented, high nutritional density, homogeneity, easy preparation and forms of transport, good taste allow us to use them successfully in catering.

  2. BIOLOGICALLY ACTIVE SUBSTANCES OF SPIRIT PRODUCTION WASTE

    OpenAIRE

    A. S. Kayshev; N. S. Kaysheva

    2014-01-01

    A content of biologically active compounds (BAC) with signified pharmacological activity in distillers grains was proved. It is prospective for applications of these grains as a raw material resource of pharmaceuticals. A composition of BAC distillers grains received from wheat, corn, barley, millet at different spirit enterprises which use hydro fermentative grain processing. Considering polydispersity of distillers grains they were separated on solid and liquid phases preliminary. Physical ...

  3. [Important aspects of virus safety of advanced therapy medicinal products].

    Science.gov (United States)

    Blümel, J; Stühler, A

    2010-01-01

    Virus safety of advanced therapy medicinal products is a particular challenge. These products may consist of whole cells and the manufacture of these is performed using various human or animal-derived starting materials and reagents. Therefore, extensive testing of donors and of established cell banks is required. Furthermore, the virus safety of reagents such as bovine sera, porcine trypsin, and growth factors needs to be considered. Whenever possible, manufacturing steps for inactivation or removal of viruses should be introduced. However, it is not possible to introduce such steps for cell-based medicinal products as the activity and viability of cells will be compromised. Only in the production of small and stable non-enveloped viral gene vectors is it conceivable to implement steps to selectively inactivate or remove potential contaminating enveloped viruses.

  4. Safety in the Marketplace: A Program for the Improvement of Consumer Product Safety.

    Science.gov (United States)

    National Business Council for Consumer Affairs, Washington, DC.

    Prepared under the auspices of the National Business Council for Consumer Affairs by its Sub-Council on Product Safety, this report is part of a program to advise the federal government on voluntary activities by the business community which would help consumers. Contents include analysis, conclusions and recommendations relating to manufacturers,…

  5. Sustainability, environmental, and safety aspects in the production of biocomposites

    DEFF Research Database (Denmark)

    Markert, Frank

    Future product design requires sustainbale processes and may with great benefit prtially be based on composites made from agricultural by-products. the EU project Biocomp addressed the manufacturing and the parallel assessment of the world wide sustainability of such an approach as well as the en......Future product design requires sustainbale processes and may with great benefit prtially be based on composites made from agricultural by-products. the EU project Biocomp addressed the manufacturing and the parallel assessment of the world wide sustainability of such an approach as well...... as the environmental and safety issues for each of the life cycle phases....

  6. Decisions about Product Safety. A Multidisciplinary Teaching Unit.

    Science.gov (United States)

    Procter and Gamble Educational Services, Cincinnati, OH.

    A multidisciplinary educational unit featuring product safety decisions made by businesses and consumers is presented. teach critical thinking and decision making while supplementing the science, home economics, social studies, and economics curricula. The activities rely extensively, though not exclusively, on Procter & Gamble's experiences in…

  7. Hurdle technology to ensure the safety of seafood products

    OpenAIRE

    Leroi, Francoise; Amarita, Felix; Arboleya, Juan Carlos; Bjørkevoll, Ingebright; Cruz, Ziortza; Dousset, Xavier; Izurieta, E; Joffraud, Jean-Jacques; Lasagabaster, Amaïa; Lauzon, Hélène-liette; Lorentzen, G.; Martínez De Marañón, Iñigo; Matamoros, Sébastien; Miranda, I.; Nuin, Maider

    2008-01-01

    The microbial safety and stability of most food, are based on an application of preservative factors called hurdles. Each hurdle implies putting microorganisms in a hostile environment, which inhibits their growth or causes their death (Leistner, 2000). Some of those hurdles have been empirically used for years to stabilize meat, fish, milk and vegetables. This sometimes leads to completely different product with its own new taste characteristics. Examples of hurdles in marine products are sa...

  8. Production and consumption of biological particles in temperate tidal estuaries

    NARCIS (Netherlands)

    Heip, C.H.R.; Goosen, N.K.; Herman, P.M.J.; Kromkamp, J.C.; Middelburg, J.J.; Soetaert, K.E.R.

    1995-01-01

    The question is reviewed whether a balance exists between production and consumption of biological particles in temperate tidal estuaries and what the relationships are between the magnitude of production and consumption processes and system carbon metabolism. The production terms considered are pri

  9. The aspect of personnel metal attitude in the production safety

    International Nuclear Information System (INIS)

    The occurrence of an accident could always be traced to component/system failures and/or human error. The two factors are closely related to competency of the personnel's involved, in which mental attitude is a decisive factor. Furthermore mental attitude could be viewed as an element of Safety (S) Culture. Consequently, S. Culture could might created or at lea ts, be enhanced by the introduction of appropriate values, norms, as well as attitudes. The ABC and TBC of safety norm have been discussed briefly. Whereas mental attitude has been defined and discussed in detail and graded into six levels, namely: attending, responding, complying, accepting, preferring, and integrating. To assure highest level of safety, personnel must achieve integrating level of attitude, in the sense that he would merely do an action on the basis of safety values and/or norms prevailing in the system, not due to external pressure. Furthermore, considering the work as a physical and an emotional activity resulting in stress and strain on the body, Karate exercises have been promoted as an alternative for enhancing mental attitude by means of reducing personnel vulnerability to strain and stress. This method is accomplished by exploiting Roux's Low of conditioning effect and by implementation of an in-depth understanding on the spiritual aspect of Karate. It is concluded that in the field of production safety, there is a positive correlation between Karate, mental attitude, competence, performance, quality, and safety

  10. The potential of plants as a system for the development and production of human biologics

    OpenAIRE

    Qiang Chen; Davis, Keith R.

    2016-01-01

    The growing promise of plant-made biologics is highlighted by the success story of ZMapp™ as a potentially life-saving drug during the Ebola outbreak of 2014-2016. Current plant expression platforms offer features beyond the traditional advantages of low cost, high scalability, increased safety, and eukaryotic protein modification. Novel transient expression vectors have been developed that allow the production of vaccines and therapeutics at unprecedented speed to control potential pandemics...

  11. Biological hydrogen production from industrial wastewaters

    Energy Technology Data Exchange (ETDEWEB)

    Peixoto, Guilherme; Pantoja Filho, Jorge Luis Rodrigues; Zaiat, Marcelo [Universidade de Sao Paulo (EESC/USP), Sao Carlos, SP (Brazil). School of Engineering. Dept. Hydraulics and Sanitation], Email: peixoto@sc.usp.br

    2010-07-01

    This research evaluates the potential for producing hydrogen in anaerobic reactors using industrial wastewaters (glycerol from bio diesel production, wastewater from the parboilization of rice, and vinasse from ethanol production). In a complementary experiment the soluble products formed during hydrogen production were evaluated for methane generation. The assays were performed in batch reactors with 2 liters volume, and sucrose was used as a control substrate. The acidogenic inoculum was taken from a packed-bed reactor used to produce hydrogen from a sucrose-based synthetic substrate. The methanogenic inoculum was taken from an upflow anaerobic sludge blanket reactor treating poultry slaughterhouse wastewater. Hydrogen was produced from rice parboilization wastewater (24.27 ml H{sub 2} g{sup -1} COD) vinasse (22.75 ml H{sub 2} g{sup -1} COD) and sucrose (25.60 ml H{sub 2} g{sup -1} COD), while glycerol only showed potential for methane generation. (author)

  12. The future trends for research on quality and safety of animal products

    Directory of Open Access Journals (Sweden)

    Nigel D. Scollan

    2010-01-01

    Full Text Available Quality must now be considered as a convergence between consumers' wishes and needs and the intrinsic and extrinsic quality attributes of food products. The increasing number of quality attributes which must be considered, increasing globalisation and the heterogeneity in consumption habits between countries are making this convergence progressively more difficult. In parallel, science is rapidly evolving (with the advent of genomics for instance, and a growing number of applications is thus expected for the improvement of food safety and quality. Among the meat and fish quality attributes, colour is very important because it determines, at least in part, consumer choice. The key targets to ensure a satisfactory colour are animal nutrition and management for fish, processing and product conditioning for meat. Tenderness and flavour continue to be important issues for the consumer because eating remains a pleasure. They both determine quality experience which itself influences repetitive purchase. Meat tenderness is a very complex problem which can be solved only by a holistic approach involving all the factors from conception, animal breeding and production, muscle biology and slaughter practice to carcass processing and meat preparation at the consumer end. Today, safety and healthiness are among the most important issues. Unfortunately, animal products can potentially be a source of biological and chemical contamination for consumers. The introduction of both control strategies along the food chain and the development of a food safety management system, from primary production to the domestic environment, are key issues that must be achieved. Despite a high dietary supply of saturated fats by dairy and meat products, it is imperative that professionals involved in animal research and in the associated industry convey the positive nutritional contributions of animal products to both consumers and health professionals. The latter include protein

  13. Dust control products at Hagerman National Wildlife Refuge, Texas: environmental safety and performance

    Science.gov (United States)

    Kunz, Bethany K.; Little, Edward E.

    2015-01-01

    Controlling fugitive dust while protecting natural resources is a challenge faced by all managers of unpaved roads. Unfortunately, road managers choosing between dust control products often have little objective environmental information to aid their decisions. To address this information gap, the U.S. Geological Survey and the U.S. Fish and Wildlife Service collaborated on a field test of three dust control products with the objectives of (a) evaluating product performance under real-world conditions, (b) verifying the environmental safety of products identified as practically nontoxic in laboratory tests, and (c) testing the feasibility of several environmental monitoring techniques for use in dust control tests. In cooperation with refuge staff and product vendors, three products (one magnesium chloride plus binder, one cellulose, and one synthetic fluid plus binder) were applied in July 2012 to replicated road sections at the Hagerman National Wildlife Refuge in Texas. These sections were monitored periodically for 12 months after application. Product performance was assessed by mobile-mounted particulate-matter meters measuring production of fugitive dust and by observations of road conditions. Environmental safety was evaluated through on-site biological observations and leaching tests with samples of treated aggregate. All products reduced dust and improved surface condition during those 12 months. Planned environmental measurements were not always compatible with day-to-day refuge management actions; this incompatibility highlighted the need for flexible biological monitoring plans. As one of the first field tests of dust suppressants that explicitly incorporated biological endpoints, this effort provides valuable information for improving field tests and for developing laboratory or semifield alternatives.

  14. Chemical Compositional, Biological, and Safety Studies of a Novel Maple Syrup Derived Extract for Nutraceutical Applications

    OpenAIRE

    Zhang, Yan; Yuan, Tao; Li, Liya; Nahar, Pragati; Slitt, Angela; Seeram, Navindra P.

    2014-01-01

    Maple syrup has nutraceutical potential given the macronutrients (carbohydrates, primarily sucrose), micronutrients (minerals and vitamins), and phytochemicals (primarily phenolics) found in this natural sweetener. We conducted compositional (ash, fiber, carbohydrates, minerals, amino acids, organic acids, vitamins, phytochemicals), in vitro biological, and in vivo safety (animal toxicity) studies on maple syrup extracts (MSX-1 and MSX-2) derived from two declassified maple syrup samples. Alo...

  15. National Standard of "General Request on Biological Safety" Was Officially Issued

    Institute of Scientific and Technical Information of China (English)

    2004-01-01

    @@ May 28 2004, sponsored by Standardization Administration of P.R. China ( SAC ) and Certification and Accreditation Administration of P.R. China (CNCA), China National Accreditation Board For Laboratories (CNAL) organized the press conference on National Standard of "General Request on Biological Safety" in Beijing.

  16. Innovation of Supervision System for Quality and Safety of Edible Agricultural Products

    Institute of Scientific and Technical Information of China (English)

    Xingxing; MEI; Zhongchao; FENG

    2014-01-01

    This paper elaborated multidimensional characteristics of quality and safety of agricultural products,introduced current situation of quality and safety supervision of edible agricultural products in China,analyzed existing problems of quality and safety supervision system and corresponding reasons,and finally came up with recommendations for innovation of supervision system for quality and safety of agricultural products.

  17. [Safety monitoring of cell-based medicinal products (CBMPs)].

    Science.gov (United States)

    Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

    2015-11-01

    Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.

  18. [Safety monitoring of cell-based medicinal products (CBMPs)].

    Science.gov (United States)

    Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte

    2015-11-01

    Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved. PMID:26391098

  19. Efficacy and Safety of Pomegranate Medicinal Products for Cancer

    Directory of Open Access Journals (Sweden)

    Christian Vlachojannis

    2015-01-01

    Full Text Available Preclinical in vitro and in vivo studies demonstrate potent effects of pomegranate preparations in cancer cell lines and animal models with chemically induced cancers. We have carried out one systematic review of the effectiveness of pomegranate products in the treatment of cancer and another on their safety. The PubMed search provided 162 references for pomegranate and cancer and 122 references for pomegranate and safety/toxicity. We identified 4 clinical studies investigating 3 pomegranate products, of which one was inappropriate because of the low polyphenol content. The evidence of clinical effectiveness was poor because the quality of the studies was poor. Although there is no concern over safety with the doses used in the clinical studies, pomegranate preparations may be harmful by inducing synthetic drug metabolism through activation of liver enzymes. We have analysed various pomegranate products for their content of anthocyanins, punicalagin, and ellagic acid in order to compare them with the benchmark doses from published data. If the amount of coactive constituents is not declared, patients risk not benefiting from the putative pomegranate effects. Moreover, pomegranate end products are affected by many determinants. Their declaration should be incorporated into the regulatory guidance and controlled before pomegranate products enter the market.

  20. Efficacy and safety of pomegranate medicinal products for cancer.

    Science.gov (United States)

    Vlachojannis, Christian; Zimmermann, Benno F; Chrubasik-Hausmann, Sigrun

    2015-01-01

    Preclinical in vitro and in vivo studies demonstrate potent effects of pomegranate preparations in cancer cell lines and animal models with chemically induced cancers. We have carried out one systematic review of the effectiveness of pomegranate products in the treatment of cancer and another on their safety. The PubMed search provided 162 references for pomegranate and cancer and 122 references for pomegranate and safety/toxicity. We identified 4 clinical studies investigating 3 pomegranate products, of which one was inappropriate because of the low polyphenol content. The evidence of clinical effectiveness was poor because the quality of the studies was poor. Although there is no concern over safety with the doses used in the clinical studies, pomegranate preparations may be harmful by inducing synthetic drug metabolism through activation of liver enzymes. We have analysed various pomegranate products for their content of anthocyanins, punicalagin, and ellagic acid in order to compare them with the benchmark doses from published data. If the amount of coactive constituents is not declared, patients risk not benefiting from the putative pomegranate effects. Moreover, pomegranate end products are affected by many determinants. Their declaration should be incorporated into the regulatory guidance and controlled before pomegranate products enter the market. PMID:25815026

  1. Recent Developments in Biological Hydrogen Production Processes

    Directory of Open Access Journals (Sweden)

    DEBABRATA DAS

    2008-07-01

    Full Text Available Biohydrogen production technology can utilize renewable energy sources like biomass for the generation of hydrogen, the cleanest form of energy for the use of mankind. However, major constraints to the commercialization of these processes include lower hydrogen yields and rates of hydrogen production. To overcome these bottlenecks intensive research work has already been carried out on the advancement of these processes such as the development of genetically modified microorganisms, the improvement of the bioreactor design, molecular engineering of the key enzyme hydrogenases, the development of two stage processes, etc. The present paper explores the recent advancements that have been made till date and also presents the state of the art in molecular strategies to improve the hydrogen production.

  2. Safety and efficacy of personal care products containing colloidal oatmeal

    Directory of Open Access Journals (Sweden)

    Criquet M

    2012-11-01

    Full Text Available Maryline Criquet,1 Romain Roure,1 Liliane Dayan,2 Virginie Nollent,1 Christiane Bertin11Johnson & Johnson Santé Beauté France, Issy les Moulineaux, 2Independent consultant dermatologist, Paris, FranceBackground: Colloidal oatmeal is a natural ingredient used in the formulation of a range of personal care products for relief of skin dryness and itchiness. It is also used as an adjunctive product in atopic dermatitis. The safety of personal care products used on vulnerable skin is of particular importance and the risk of developing further skin irritations and/or allergies should be minimized.Methods: In a series of studies, we tested the safety of personal care products containing oatmeal (creams, cleansers, lotions by assessing their irritant/allergenic potential on repeat insult patch testing, in safety-in-use and ocular studies using subjects with nonsensitive and sensitive skin. We also tested the skin moisturizing and repair properties of an oatmeal-containing skin care product for dry skin.Results: We found that oatmeal-containing personal care products had very low irritant potential as well as a very low allergenic sensitization potential. Low-level reactions were documented in 1.0% of subjects during the induction phase of repeat insult patch testing; one of 2291 subjects developed a persistent but doubtful low-level reaction involving edema during the challenge phase in repeat insult patch testing. No allergies were reported by 80 subjects after patch testing after in-use application. Sustained skin moisturizing was documented in subjects with dry skin that lasted up to 2 weeks after product discontinuation.Conclusion: Our results demonstrate that colloidal oatmeal is a safe and effective ingredient in personal care products. No allergies were reported by consumers of 445,820 products sold during a 3-year period.Keywords: Avena sativa, colloids, protective agents, atopic dermatitis, irritant dermatitis, allergenic dermatitis, skin

  3. Product safety and security in the global supply chain: Issues, challenges and research opportunities

    OpenAIRE

    Marucheck, Ann; Greis, Noel; Mena, Carlos; Cai, Linning

    2011-01-01

    A number of high profile product safety events and recalls have heightened public attention to the safety and security of the products that people consume and use. While product safety isn’t a new topic, the effect of the global supply chain in creating or exacerbating safety risks and vulnerabilities is both timely and relevant. In this essay we focus on how the field of operations management can provide fresh perspectives and insights in addressing the challenges of product safety and secur...

  4. Present situation and countermeasures for managing expenses of safety in production in enterprise

    International Nuclear Information System (INIS)

    The paper introduces the evolutions concerning accountant accounting for the capital of safety in production over the recent years, and analyses the present situation and reasons for the problems existed in enterprise as for gathering expenses of safety in production, and propose the countermeasures to reinforce the management of enterprise expenses of safety in production, in order to improve the management of enterprise expenses of safety in production and to enhance the level of the management in safety for the enterprise. (author)

  5. Electricity-mediated biological hydrogen production

    NARCIS (Netherlands)

    Geelhoed, J.S.; Hamelers, H.V.M.; Stams, A.J.M.

    2010-01-01

    Anaerobic bacteria have the ability to produce electricity from the oxidation of organic substrates. They also may use electricity to support chemical reactions that are energetically unfavorable. In the fermentation of sugars, hydrogen can be formed as one of the main products. However, a yield of

  6. Models of risk assessments for biologicals or related products in the European Union.

    Science.gov (United States)

    Moos, M

    1995-12-01

    In the context of veterinary biologicals, environmental risk assessment means the evaluation of the risk to human health and the environment (which includes plants and animals) connected with the release of such products. The following categories or types of veterinary biologicals can be distinguished: non-genetically modified organisms (non-GMOs) (inactivated/live) GMOs (inactivated/live) carrier products related products (e.g. non-specific "inducers'). Suitable models used in risk assessment for these products should aim to identify all possible adverse effects. A good working model should lead, at least, to a qualitative judgement on the environmental risk of the biological product (e.g. negligible, low, medium, severe, unacceptable). Quantifiable outcomes are rare; therefore, the producer of a biological product and the European control authorities should accept only models which are based on testable points and which are relevant to the type of product and its instructions for use. In view of animal welfare aspects, models working without animals should be preferred. In recent years, some of these methods have been integrated into safety tests described in European Union Directives and in monographs of the European Pharmacopoeia. By reviewing vaccine/registration problems (e.g. Aujeszky's disease live vaccine for pigs, and vaccinia-vectored rabies vaccine), several models used in risk assessment are demonstrated and discussed. PMID:8639943

  7. Biologic, environmental, radiation protection, health and safety norms adopted during the production of Rx (single dosage) and Dx (multidosage) forms of 131I-mIBG in a non-dedicated hospital facility

    International Nuclear Information System (INIS)

    Full text: Manufacture of 131I-mIBG involves working with large amounts of a strong β-, γ emitter, a relatively volatile and toxic radionuclide, a potent molecule in trace amounts radiolabelled only a high temperature and one which is required as an i.v. injectable dosage form. In the absence of the requisite infrastructure, we were constrained to use the available limited facilities:lead shields, tongs and ingenuity. A production run involved: cleaning, fumigation, disinfection of the non- dedicated multi-user locale (+fume cupboard) along with the microplant and accessories positioned in place, checking the exhaust system, monitoring the basal value of thyroid counts of operators, checking the operational status of instruments. The high radiation field was controlled using 30 mm lead pot and a cut-to size 30 mm lead pot enveloped with a heating coil + lid for the reactor. Transfer of reactants and reagents, sealing the reactor, heating the reactor were effected using extra-long handled gadgets - spatula, sealer, while the micro-condenser was positioned using a trigger operated gun; the chemical control exercised remotely. Special remote devices were improvised to carry out leaching and sampling operations. Transfer of solutions was effected using extra-long grip tongs or low vacuum/pressure pumps. Special custom designed lead shields were fabricated for chemical purification and pharmaceutical terminal filtration assemblies. Formulation of the dosage forms were also remotely performed under vacuum. The final dosage form(s) were stored in lead shielded vials. The impurity as waste (ion exchanger) was allowed to decay in specially fabricated lead housing devices. Thus far, we have safely made 17 and 89 batches of Rx and Dx dosage forms totaling 111 GBq

  8. Biological production of liquid fuels from biomass

    Energy Technology Data Exchange (ETDEWEB)

    None

    1982-01-01

    A scheme for the production of liquid fuels from renewable resources such as poplar wood and lignocellulosic wastes from a refuse hydropulper was investigated. The particular scheme being studied involves the conversion of a cellulosic residue, resulting from a solvent delignified lignocellulosic feed, into either high concentration sugar syrups or into ethyl and/or butyl alcohol. The construction of a pilot apparatus for solvent delignifying 150 g samples of lignocellulosic feeds was completed. Also, an analysis method for characterizing the delignified product has been selected and tested. This is a method recommended in the Forage Fiber Handbook. Delignified samples are now being prepared and tested for their extent of delignification and susceptibility to enzyme hydrolysis. Work is continuing on characterizing the cellulase and cellobiase enzyme systems derived from the YX strain of Thermomonospora.

  9. Validation of cross-contamination control in biological safety cabinet for biotech/pharmaceutical manufacturing process.

    Science.gov (United States)

    Hu, Shih-Cheng; Shiue, Angus; Tu, Jin-Xin; Liu, Han-Yang; Chiu, Rong-Ben

    2015-12-01

    For class II, type A2 biological safety cabinets (BSC), NSF/ANSI Standard 49 should be conformed in cabinet airflow velocity derivation, particle contamination, and aerodynamic flow properties. However, there exists a potential problem. It has been built that the cabinet air flow stabilize is influenced by the quantity of downflow of air and the height above the cabinet exhaust opening. Three air downflow quantities were compared as an operating apparatus was placed from 20 to 40 cm above the bench of the cabinet. The results show that the BSC air downflow velocity is a function of increased sampling height, displaying that containment is improvingly permitted over product protection as the sampling height decreases. This study investigated the concentration gradient of particles at various heights and downflow air quantity from the bench of the BSC. Experiment results indicate that performance near the bench was better than in the rest of the BSC. In terms of height, the best cleanliness was measured at a height of 10 cm over the bench; it reduced actually with add in height. The empirical curves accommodate, founded on the concentration gradient of particle created was elaborated for evaluating the particle concentration at different heights and downflow air quantity from the source of the bench of the BSC. The particle image velocimetry system applied for BSC airflow research to fix amount of airflow patterns and air distribution measurement and results of measurements show how obstructions can greatly influence the airflow and contaminant transportation in a BSC.

  10. Packaging Evaluation Approach to Improve Cosmetic Product Safety

    Directory of Open Access Journals (Sweden)

    Benedetta Briasco

    2016-09-01

    Full Text Available In the Regulation 1223/2009, evaluation of packaging has become mandatory to assure cosmetic product safety. In fact, the safety assessment of a cosmetic product can be successfully carried out only if the hazard deriving from the use of the designed packaging for the specific product is correctly evaluated. Despite the law requirement, there is too little information about the chemical-physical characteristics of finished packaging and the possible interactions between formulation and packaging; furthermore, different from food packaging, the cosmetic packaging is not regulated and, to date, appropriate guidelines are still missing. The aim of this work was to propose a practical approach to investigate commercial polymeric containers used in cosmetic field, especially through mechanical properties’ evaluation, from a safety point of view. First of all, it is essential to obtain complete information about raw materials. Subsequently, using an appropriate full factorial experimental design, it is possible to investigate the variables, like polymeric density, treatment, or type of formulation involved in changes to packaging properties or in formulation-packaging interaction. The variation of these properties can greatly affect cosmetic safety. In particular, mechanical properties can be used as an indicator of pack performances and safety. As an example, containers made of two types of polyethylene with different density, low-density polyethylene (LDPE and high-density polyethylene (HDPE, are investigated. Regarding the substances potentially extractable from the packaging, in this work the headspace solid-phase microextraction method (HSSPME was used because this technique was reported in the literature as suitable to detect extractables from the polymeric material here employed.

  11. Adjusting the Passing Scores for Gearing up for Safety: Production Agriculture Safety Training for Youth Curriculum Test Instruments

    Science.gov (United States)

    Hoover, William Brian; French, Brian F.; Field, William E.; Tormoehlen, Roger L.

    2012-01-01

    Minimum passing scores for the Gearing Up for Safety: Production Agriculture Safety Training for Youth curriculum (Gearing Up for Safety) were set in 2006 with widely used and established procedures by efforts of subject matter experts (French, Breidenbach et al., 2007; French, Field, and Tormoehlen, 2006, 2007). While providing a research-based…

  12. Synthetic biology and microbioreactor platforms for programmable production of biologics at the point-of-care

    Science.gov (United States)

    Perez-Pinera, Pablo; Han, Ningren; Cleto, Sara; Cao, Jicong; Purcell, Oliver; Shah, Kartik A.; Lee, Kevin; Ram, Rajeev; Lu, Timothy K.

    2016-01-01

    Current biopharmaceutical manufacturing systems are not compatible with portable or distributed production of biologics, as they typically require the development of single biologic-producing cell lines followed by their cultivation at very large scales. Therefore, it remains challenging to treat patients in short time frames, especially in remote locations with limited infrastructure. To overcome these barriers, we developed a platform using genetically engineered Pichia pastoris strains designed to secrete multiple proteins on programmable cues in an integrated, benchtop, millilitre-scale microfluidic device. We use this platform for rapid and switchable production of two biologics from a single yeast strain as specified by the operator. Our results demonstrate selectable and near-single-dose production of these biologics in system with analytical, purification and polishing technologies could lead to a small-scale, portable and fully integrated personal biomanufacturing platform that could advance disease treatment at point-of-care. PMID:27470089

  13. BIOLOGICALLY ACTIVE SUBSTANCES OF SPIRIT PRODUCTION WASTE

    Directory of Open Access Journals (Sweden)

    A. S. Kayshev

    2014-01-01

    Full Text Available A content of biologically active compounds (BAC with signified pharmacological activity in distillers grains was proved. It is prospective for applications of these grains as a raw material resource of pharmaceuticals. A composition of BAC distillers grains received from wheat, corn, barley, millet at different spirit enterprises which use hydro fermentative grain processing. Considering polydispersity of distillers grains they were separated on solid and liquid phases preliminary. Physical and chemical characteristics of distillers grains' liquid base were identified. Elementary composition of distillers grains is signified by active accumulation of biogenic elements (phosphorus, potassium, magnesium, calcium, sodium, iron and low content of heavy metals. The solid phase of distillers grains accumulates carbon, hydrogen and nitrogen in high concentration. The liquid phase of distillers grains contains: proteins and amino acids (20-46%, reducing sugars (5,6%-17,5%, galacturonides (0,8-1,4%, ascorbic acid (6,2-11,4 mg%. The solid base of distillers grains contains: galacturonides (3,4-5,3%, fatty oil (8,4-11,1% with predomination of essential fatty acids, proteins and amino acids (2,1-2,5%, flavonoids (0,4-0,9%, tocopherols (3,4-7,7 mg%. A method of complex processing of distillers grains based on application of membrane filtering of liquid phase and liquid extraction by inorganic and organic solvents of solid phase, which allows almost full extraction of the sum of biologically active compounds (BAC from liquid phase (Biobardin BM and solid phase (Biobardin UL. Biobardin BM comprises the following elements: proteins and amino acids (41-69%, reducing sugars (3,5-15,6%, fatty oil (0,2-0,3%, flavonoids (0,2-0,7%, ascorbic acid (17-37 mg%. Biobardin UL includes: oligouronids (16,4-19,5%, proteins and amino acids (11-21%, fatty oil (3,2-4,9% which includes essential acids; flavonoids (0,6-1,5%, tocopherols (6,6-10,2 mg%, carotinoids (0,13-0,21 mg

  14. Safety and efficacy of Labisia pumila containing products

    Directory of Open Access Journals (Sweden)

    Muhammad Syafiq Saleh

    2016-01-01

    Full Text Available Labisia pumila is a traditional medicinal plant which has wide therapeutic application including induction of labor and treatment of dysentery, dysmenorrhea and gonorrhea. We aimed for systematic review of the efficacy andsafety of L. pumila extract or its other commercial products availabe in Malaysian market. The marketed 500 mg capsule is composed of 40 mg L. pumila, 10 mg C. caudatum extract and 450 mg excipient. The commercial products did not follow the registration guidelines of Malaysian National Pharmaceutical Control Bureau (NPCB and advertisement guidelines of Malaysian Advertisement Board. Randomized, placebo controlled clinical trials reported the safe consumpotion of L. pumila water extract on postmanoposal women. Information on the efficacy and safety of commercial products are not sufficiently available. Many unregistered products (mostly capsule form are flooded in Malaysian market without having scientific information. Consumption of those products may seriously impair the health of the people.

  15. Safety of botanical ingredients in personal care products/cosmetics.

    Science.gov (United States)

    Antignac, Eric; Nohynek, Gerhard J; Re, Thomas; Clouzeau, Jacques; Toutain, Hervé

    2011-02-01

    The key issue of the safety assessment of botanical ingredients in personal care products (PCP) is the phytochemical characterisation of the plant source, data on contamination, adulteration and hazardous residues. The comparative approach used in the safety assessment of GM-plants may be applied to novel botanical PCP ingredients. Comparator(s) are the parent plant or varieties of the same species. Chemical grouping includes definition of chemical groups suitable for a read-across approach; it allows the estimation of toxicological endpoints on the basis of data from related substances (congeneric groups) with physical/chemical properties producing similar toxicities. The Threshold of Toxicological Concern (TTC) and Dermal Sensitisation Threshold (DST) are tools for the assessment of trace substances or minor ingredients. The evaluation of skin penetration of substances present in human food is unnecessary, whereas mixtures may be assessed on the basis of physical/chemical properties of individual substances. Adverse dermal effects of botanicals include irritation, sensitisation, phototoxicity and immediate-type allergy. The experience from dietary supplements or herbal medicines showed that being natural is not equivalent to being safe. Pragmatic approaches for quality and safety standards of botanical ingredients are needed; consumer safety should be the first objective of conventional and botanical PCP ingredients.

  16. Efficacy and safety of biological agents for systemic juvenile idiopathic arthritis

    DEFF Research Database (Denmark)

    Tarp, Simon; Amarilyo, Gil; Foeldvari, Ivan;

    2016-01-01

    % improvement according to the modified American College of Rheumatology Paediatric 30 response criteria (JIA ACR30). The primary safety outcome was defined as serious adverse events (SAEs). Outcomes were analysed by pairwise and network meta-analyses. The quality of evidence between biologic agents......% CI 0.03, 0.44), P = 0.001]. Risks of SAEs were similar among the biologic agents (supported by very low-quality evidence) and not different from placebo. CONCLUSION: Despite heterogeneous eligibility criteria and study designs across the five studies and different modified JIA ACR30 criteria...

  17. MILK KEFIR: COMPOSITION, MICROBIAL CULTURES, BIOLOGICAL ACTIVITIES AND RELATED PRODUCTS

    Directory of Open Access Journals (Sweden)

    Maria Rosa Prado

    2015-10-01

    Full Text Available In recent years, there has been a strong focus on beneficial foods with probiotic microorganisms and functional organic substances. In this context, there is an increasing interest in the commercial use of kefir, since it can be marketed as a natural beverage that has health promoting bacteria. There are numerous commercially available kefir based-products. Kefir may act as a matrix in the effective delivery of probiotic microorganisms in different types of products. Also, the presence of kefir’s exopolysaccharides, known as kefiran, which has biological activity, certainly adds value to products. Kefiran can also be used separately in other food products and as a coating film for various food and pharmaceutical products. This article aims to update the information about kefir and its microbiological composition, biological activity of the kefir’s microflora and the importance of kefiran as a beneficial health substance.

  18. Ionizing radiation for sterilization of medical products and biological tissues

    International Nuclear Information System (INIS)

    The article reviews the deliberations of the International Symposium on Ionizing Radiation for Sterilization of Medical Products and Biological Tissues which was held during 9-13 December 1974 under the auspices of the IAEA at the Bhabha Atomic Research Centre, Bombay. 42 papers were presented in the following broad subject areas: (1) Microbiological Control aspects of radiation sterilization, (2) Dosimetry aspects of radiation sterilization practices, (3) Effects of sterilizing radiation dose on the constituents of medical products, (4) Application of radiation sterilization of medical products of biological origin, (5) Technological aspects of radiation sterilization facilities, (6) Radiation sterilization of pharmaceutical substances, (7) Reports on current status of radiation sterilization of medical products in IAEA member states and (8) Working group discussion on the revision of the IAEA recommended code of practice for radiation sterilization of medical products. (S.K.K.)

  19. Assessment of biological Hydrogen production processes: A review

    Science.gov (United States)

    Najafpour, G. D.; Shahavi, M. H.; Neshat, S. A.

    2016-06-01

    Energy crisis created a special attention on renewable energy sources. Among these sources; hydrogen through biological processes is well-known as the most suitable and renewable energy sources. In terms of process yield, hydrogen production from various sources was evaluated. A summary of microorganisms as potential hydrogen producers discussed along with advantages and disadvantages of several bioprocesses. The pathway of photo-synthetic and dark fermentative organisms was discussed. In fact, the active enzymes involved in performance of biological processes for hydrogen generation were identified and their special functionalities were discussed. The influential factors affecting on hydrogen production were known as enzymes assisting liberation specific enzymes such as nitrogenase, hydrogenase and uptake hydrogenase. These enzymes were quite effective in reduction of proton and form active molecular hydrogen. Several types of photosynthetic systems were evaluated with intension of maximum hydrogen productivities. In addition dark fermentative and light intensities on hydrogen productions were evaluated. The hydrogen productivities of efficient hydrogen producing strains were evaluated.

  20. European legal developments in product liability and product safety and the Total Quality Management approach

    NARCIS (Netherlands)

    Brack, A.; Gieskes, J.F.B.

    1990-01-01

    The purpose of this paper is to show that Product Liability (PL) and Product Safety (PS) are relevant categories in terms of the Total Quality Management literature. From a societal point of view PL and PS are two sides of a coin. The effects of the PL and PS regulation on companies are described an

  1. RESEARCH OF QUALITY, SAFETY AND CONTENT OF BIOLOGICALLY ACTIVE SUBSTANCES OF FOOD RED BEET

    OpenAIRE

    Gorash E. Y.; Victorova E. P.; Kupin G. A.; Aleshin V. N.; Lisovoy V. V.

    2015-01-01

    The article presents results of research of quality, safety and content of biologically active substances of food red beet roots of Bordo 237 variety, grown in the Krasnodar region in 2014. On the basis of the research carried out it was established, that there are carbohydrates, proteins, organic acids and mineral substances in the food red beet roots of Bordo 237 variety. Food red beet roots are a source of dietary fibers (pectin, protopectin, hemicelluloses and cellulose), possessing antit...

  2. Expert forecast on emerging biological risks related to occupational safety and health

    OpenAIRE

    Brun, Emmanuelle

    2007-01-01

    This report contains a forecast of emerging biological risks related to occupational safety and health (OSH) based on an expert survey and a literature review. The Agency also worked on forecasts and literature reviews on physical, chemical, and psychosocial risks in order to paint as full a picture as possible of the potential emerging risks in the world of work. These results are linked to other Risk Observatory work and aims to examine OSH trends in Europe and to anticipa...

  3. Application of Mixed Group Decision Making to Safety Evaluation of Agricultural Products

    OpenAIRE

    Zhao, Xiao-hong

    2012-01-01

    In view of the gravity of issues concerning safety of agricultural products and urgency of resolving these issues, after analyzing the problems existing in safety of agricultural products, this article offers a method for evaluating safety of agricultural products on the basis of mixed group decision making. First of all, it introduces the factors influencing safety evaluation of agricultural products; subsequently, given that the judgment matrices offered by the group of experts contain both...

  4. Natural product synthesis at the interface of chemistry and biology.

    Science.gov (United States)

    Hong, Jiyong

    2014-08-11

    Nature has evolved to produce unique and diverse natural products that possess high target affinity and specificity. Natural products have been the richest sources for novel modulators of biomolecular function. Since the chemical synthesis of urea by Wöhler, organic chemists have been intrigued by natural products, leading to the evolution of the field of natural product synthesis over the past two centuries. Natural product synthesis has enabled natural products to play an essential role in drug discovery and chemical biology. With the introduction of novel, innovative concepts and strategies for synthetic efficiency, natural product synthesis in the 21st century is well poised to address the challenges and complexities faced by natural product chemistry and will remain essential to progress in biomedical sciences.

  5. 30 CFR 6.30 - MSHA listing of equivalent non-MSHA product safety standards.

    Science.gov (United States)

    2010-07-01

    ... LABORATORIES AND NON-MSHA PRODUCT SAFETY STANDARDS § 6.30 MSHA listing of equivalent non-MSHA product safety standards. MSHA evaluated the following non-MSHA product safety standards and determined that they provide... 30 Mineral Resources 1 2010-07-01 2010-07-01 false MSHA listing of equivalent non-MSHA...

  6. Do biological medicinal products pose a risk to the environment?: a current view on ecopharmacovigilance.

    Science.gov (United States)

    Kühler, Thomas C; Andersson, Mikael; Carlin, Gunnar; Johnsson, Ann; Akerblom, Lennart

    2009-01-01

    The occurrence of active pharmaceutical substances in the environment is of growing concern. The vast majority of the compounds in question are of low molecular weight, intended for oral use and designed to tolerate, for example, the digestive enzymes in the upper alimentary tract, the harsh milieus found in the acidic stomach, or the microbe rich intestine. Accordingly, these xenobiotic compounds may, due to their inherent biological activity, constitute a risk to the environment. Biological medicinal products, for example recombinant human insulin or monoclonal antibodies, however, are different. They are primarily made up of oligomers or polymers of amino acids, sugars or nucleotides and are thus readily metabolized. They are therefore generally not considered to pose any risk to the environment. Certain classes of biological medicinal products, however, are associated with specific safety issues. Genetically modified organisms as vectors in vaccines or in gene therapy products have attracted much attention in this regard. Issues include the degree of attenuation of the live recombinant vaccine, replication restrictions of the vaccine vector, alteration of the host and tissue tropism of the vector, the possibility of reversion to virulence, and risk to the ecosystem. In this review we discuss the fate and the potential environmental impact of biological medicinal products following clinical use from an ecopharmacovigilance point of view, and review relevant policy documents and regulatory statements. PMID:19810773

  7. The Biological Safety of Stainless Steel Needles Used in Warm-Needling

    Directory of Open Access Journals (Sweden)

    Sabina Lim

    2010-01-01

    Full Text Available Warm-needling (also called thermo-acupuncture is a combination of acupuncture and moxibustion. Due to the intense heat involved, there have been concerns over the biological safety of the acuneedles used in the treatment. This paper reports two phases of a safety test. For a preliminary test, we compared the temperature change patterns of stainless steel (SS304 needles and traditional gold alloy needles, which have been increasingly replaced by the former. To verify the effects of the presence of coating materials, the main test involved three different kinds of SS304: silicone-coated, salicylic acid-coated and non-coated needles. Each group of needles was tested for pH level, heavy metals and UV absorbance spectrum along with biological tests on the cytotoxicity and hemolysis of the needle. All the tests on the extractants from the needles were negative. In the biological tests, each test result showed a significant difference from the positive control samples, while no significant difference was observed compared with the negative control samples. In the hemolysis tests, all samples satisfied the Korean Government Standards. All the results suggest that SS304 needles are biologically safe to be used in warm-needling, though they can be improved to perform as well as the gold alloy needles in terms of temperature fluctuations.

  8. A review on safety and efficacy of products containing Longifolia

    Directory of Open Access Journals (Sweden)

    Abdul Hafeez Ahmad Hamdi

    2016-01-01

    Full Text Available Eurycoma longifolia (commonly called tongkat ali is a flowering plant in the family Simaroubaceae, native to Indonesia, Malaysia, and, to a lesser extent, Thailand, Vietnam and also Laos. The roots extract of E. longifolia, is a well-known traditional herbal medicine in Asia used for many purposes such as sexual dysfunction, aging, malaria, cancer, diabetes, anxiety, aches, constipation, exercise recovery, fever, increased energy, increased strength, leukemia, osteoporosis, stress, syphilis and glandular swelling. The roots are also used as an aphrodisiac, antibiotic, appetite stimulant and health supplement. It is very important to conserve this valuable medicinal plant for the health benefit of future generations. The purpose of this review article is to evaluate and summarize the existing literatures regarding the efficacy and safety of products which contain E. longifolia as its main ingredient. In summary, based on the literature evaluated in this review article, products which contain tongkat ali showed a clinical benefit on improving erectile dysfunction as well as a good safety profile. We recommend consumers to check the level of the bioactive compound “eurycomanone” as their guide before choosing any E. longifolia product.

  9. Combining biologic and phototherapy treatments for psoriasis: safety, efficacy, and patient acceptability

    Directory of Open Access Journals (Sweden)

    Farahnik B

    2016-07-01

    Full Text Available Benjamin Farahnik,1 Viraat Patel,2 Kourosh Beroukhim,3 Tian Hao Zhu,4 Michael Abrouk,2 Mio Nakamura,5 Rasnik Singh,3 Kristina Lee,5 Tina Bhutani,5 John Koo5 1University of Vermont College of Medicine, Burlington, VT; 2School of Medicine, University of California, Irvine, 3David Geffen School of Medicine, University of California, Los Angeles, 4University of Southern California Keck School of Medicine, Los Angeles, 5Department of Dermatology, Psoriasis and Skin Treatment Center, University of California, San Francisco, CA, USA Background: The efficacy and safety of biologic and phototherapy in treating moderate-to-severe psoriasis is well known. However, some patients may not respond well to biologic agents or phototherapy on their own and may require combination therapy. Skillfully combining a biologic agent and phototherapy may provide an additive improvement without much increase in risks.Objective: To summarize the current state of evidence for the efficacy and safety of combining biologics with phototherapy in the treatment of moderate-to-severe plaque psoriasis.Methods: We conducted an extensive search on Pubmed database for English language literature that evaluated the use of a combination of biologic and phototherapy for the treatment of moderate-to-severe psoriasis through January 2016. The search included the following keywords: psoriasis, etanercept, adalimumab, infliximab, ustekinumab, biologics, phototherapy, and combination therapy.Results: The primary literature included randomized controlled trials, a head-to-head study, open-label controlled and uncontrolled trials, case series, and case reports. Etanercept was used in over half of the reported cases, but other biologic agents used included ustekinumab, adalimumab, and infliximab. The vast majority of phototherapy was narrowband ultraviolet B (NBUVB radiation. Most cases reported enhanced improvement with combination therapy. Serious adverse events throughout the study duration

  10. Technical suitability mapping of feedstocks for biological hydrogen production

    NARCIS (Netherlands)

    Panagiotopoulos, I.A.; Karaoglanoglou, L.S.; Koullas, D.P.; Bakker, R.R.; Claassen, P.A.M.; Koukios, E.G.

    2015-01-01

    The objective of this work was to map and compare the technical suitability of different raw materials for biological hydrogen production. Our model was based on hydrogen yield potential, sugar mobilization efficiency, fermentability and coproduct yield and value. The suitability of the studied r

  11. Theoretical Application of Supervision over Quality and Safety of Agricultural Products

    Institute of Scientific and Technical Information of China (English)

    Xin; CHENG; Ying; ZHANG

    2013-01-01

    Supervision over quality and safety of agricultural products has received high attention of management department.Competent authorities have formulated and issued many measures to strengthen supervision over quality and safety of agricultural products and improve China’s agricultural product quality and safety level.From the perspective of management science,this paper elaborates basic contents of two basic management theories,Broken Windows Effect and Effect of Heat Furnace.Then,it analyzes influence of Broken Windows Effect and Effect of Heat Furnace on supervision over quality and safety of agricultural products.Finally,it comes up with recommendations for supervision over quality and safety of agricultural products.

  12. Irradiation of advanced health care products – Tissues and biologics

    International Nuclear Information System (INIS)

    Radiation sterilization of tissues and biologics has become more common in recent years. As a result it has become critical to understand how to adapt the typical test methods and validation approaches to a tissue or biological product scenario. Also data evaluation sometimes becomes more critical than with traditional medical devices because for many tissues and biologics a low radiation dose is required. It is the intent behind this paper to provide information on adapting bioburden tests used in radiation validations such that the data can be most effectively used on tissues and biologics. In addition challenges with data evaluation are discussed, particularly the use of less-than values for bioburden results in radiation validation studies. - Highlights: • MPN testing can provide good bioburden results for tissue/biologics. • There are appropriate situations to pool products for bioburden testing. • Options on dealing with bioburden results of “less-than” the limit of detection. • Underestimation and overestimation of bioburden and the dangers of both

  13. Capturing Biological Activity in Natural Product Fragments by Chemical Synthesis.

    Science.gov (United States)

    Crane, Erika A; Gademann, Karl

    2016-03-14

    Natural products have had an immense influence on science and have directly led to the introduction of many drugs. Organic chemistry, and its unique ability to tailor natural products through synthesis, provides an extraordinary approach to unlock the full potential of natural products. In this Review, an approach based on natural product derived fragments is presented that can successfully address some of the current challenges in drug discovery. These fragments often display significantly reduced molecular weights, reduced structural complexity, a reduced number of synthetic steps, while retaining or even improving key biological parameters such as potency or selectivity. Examples from various stages of the drug development process up to the clinic are presented. In addition, this process can be leveraged by recent developments such as genome mining, antibody-drug conjugates, and computational approaches. All these concepts have the potential to identify the next generation of drug candidates inspired by natural products.

  14. 9 CFR 102.5 - U.S. Veterinary Biological Product License.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false U.S. Veterinary Biological Product..., DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS LICENSES FOR BIOLOGICAL PRODUCTS § 102.5 U.S. Veterinary Biological Product License. (a) Authorization to produce...

  15. Systems Biology Approaches to Understand Natural Products Biosynthesis

    Science.gov (United States)

    Licona-Cassani, Cuauhtemoc; Cruz-Morales, Pablo; Manteca, Angel; Barona-Gomez, Francisco; Nielsen, Lars K.; Marcellin, Esteban

    2015-01-01

    Actinomycetes populate soils and aquatic sediments that impose biotic and abiotic challenges for their survival. As a result, actinomycetes metabolism and genomes have evolved to produce an overwhelming diversity of specialized molecules. Polyketides, non-ribosomal peptides, post-translationally modified peptides, lactams, and terpenes are well-known bioactive natural products with enormous industrial potential. Accessing such biological diversity has proven difficult due to the complex regulation of cellular metabolism in actinomycetes and to the sparse knowledge of their physiology. The past decade, however, has seen the development of omics technologies that have significantly contributed to our better understanding of their biology. Key observations have contributed toward a shift in the exploitation of actinomycete’s biology, such as using their full genomic potential, activating entire pathways through key metabolic elicitors and pathway engineering to improve biosynthesis. Here, we review recent efforts devoted to achieving enhanced discovery, activation, and manipulation of natural product biosynthetic pathways in model actinomycetes using genome-scale biological datasets. PMID:26697425

  16. Systems biology approaches to understand natural products biosynthesis

    Directory of Open Access Journals (Sweden)

    Cuauhtemoc eLicona-Cassani

    2015-12-01

    Full Text Available Actinomycetes populate soils and aquatic sediments which impose biotic and abiotic challenges for their survival. As a result, actinomycetes metabolism and genomes have evolved to produce an overwhelming diversity of specialized molecules. Polyketides, non-ribosomal peptides, post-translationally modified peptides, lactams and terpenes are well known bioactive natural products with enormous industrial potential. Accessing such biological diversity has proven difficult due to the complex regulation of cellular metabolism in actinomycetes and to the sparse knowledge of their physiology. The past decade, however, has seen the development of omics technologies that have significantly contributed to our better understanding of their biology. Key observations have contributed towards a shift in the exploitation of actinomycetes biology, such as using their full genomic potential, activating entire pathways through key metabolic elicitors and pathway engineering to improve biosynthesis. Here, we review recent efforts devoted to achieving enhanced discovery, activation and manipulation of natural product biosynthetic pathways in model actinomycetes using genome-scale biological datasets.

  17. Frozen, Fully-Cooked Products and Botulism--Food Safety Advisory

    Science.gov (United States)

    ... Standard Forms FSIS United States Department of Agriculture Food Safety and Inspection Service About FSIS District Offices Careers ... Actions ${title} Loading... Frozen, Fully-Cooked Products & Botulism - Food Safety Advisory In August and September 2001, several cases ...

  18. Westinghouse independent safety review of Savannah River production reactors

    International Nuclear Information System (INIS)

    Westinghouse Electric Corporation has performed a safety assessment of the Savannah River production reactors (K, L, and P) as requested by the US Department of Energy. This assessment was performed between November 1, 1988, and April 1, 1989, under the transition contract for the Westinghouse Savannah River Company's preparations to succeed E.I. du Pont de Nemours ampersand Company as the US Department of Energy contractor for the Savannah River Project. The reviewers were drawn from several Westinghouse nuclear energy organizations, embody a combination of commercial and government reactor experience, and have backgrounds covering the range of technologies relevant to assessing nuclear safety. The report presents the rationale from which the overall judgment was drawn and the basis for the committee's opinion on the phased restart strategy proposed by E.I. du Pont de Nemours ampersand Company, Westinghouse, and the US Department of Energy-Savannah River. The committee concluded that it could recommend restart of one reactor at partial power upon completion of a list of recommended upgrades both to systems and their supporting analyses and after demonstration that the organization had assimilated the massive changes it will have undergone. 37 refs., 1 fig., 3 tabs

  19. Westinghouse independent safety review of Savannah River production reactors

    Energy Technology Data Exchange (ETDEWEB)

    Leggett, W.D.; McShane, W.J. (Westinghouse Hanford Co., Richland, WA (USA)); Liparulo, N.J.; McAdoo, J.D.; Strawbridge, L.E. (Westinghouse Electric Corp., Pittsburgh, PA (USA). Nuclear and Advanced Technology Div.); Toto, G. (Westinghouse Electric Corp., Pittsburgh, PA (USA). Nuclear Services Div.); Fauske, H.K. (Fauske and Associates, Inc., Burr Ridge, IL (USA)); Call, D.W. (Westinghouse Savannah R

    1989-04-01

    Westinghouse Electric Corporation has performed a safety assessment of the Savannah River production reactors (K,L, and P) as requested by the US Department of Energy. This assessment was performed between November 1, 1988, and April 1, 1989, under the transition contract for the Westinghouse Savannah River Company's preparations to succeed E.I. du Pont de Nemours Company as the US Department of Energy contractor for the Savannah River Project. The reviewers were drawn from several Westinghouse nuclear energy organizations, embody a combination of commercial and government reactor experience, and have backgrounds covering the range of technologies relevant to assessing nuclear safety. The report presents the rationale from which the overall judgment was drawn and the basis for the committee's opinion on the phased restart strategy proposed by E.I. du Pont de Nemours Company, Westinghouse, and the US Department of Energy-Savannah River. The committee concluded that it could recommend restart of one reactor at partial power upon completion of a list of recommended upgrades both to systems and their supporting analyses and after demonstration that the organization had assimilated the massive changes it will have undergone.

  20. [Special considerations for the regulation of biological medicinal products in individualised medicine. More than stratified medicine].

    Science.gov (United States)

    Müller-Berghaus, J; Volkers, P; Scherer, J; Cichutek, K

    2013-11-01

    The term individualised medicine, also called personalised medicine, is commonly used as an equivalent to stratified medicine. However, this is erroneous since quite often it is forgotten that especially biological medicinal products have other aspects of individualization that go beyond mere stratification. The principles of stratified medicine have been applied for biological medicinal products for many years. A historical example is diphtheria antitoxin made from horse serum, while current examples are transfusion of red blood cells and the administration of factor VIII in haemophilia A. The stratifying aspects of these medicinal products are given by the following considerations: diphtheria antitoxin is only administered after a diagnosis of diphtheria and not in other forms of tonsillitis, red blood cells should only be transfused once blood group compatibility as been established and factor VIII replacement is only administered in haemophilia A as opposed to other acquired or hereditary disease of the coagulation system. The peculiarities of biological medicinal products, in particular the inherent variability of the drug, are especially important for autologous cellular medicinal products. In addition to the expected variability of the biological source material there is interindividual variability of patients as cell donors, which make definition of specifications and determination of criteria for pharmaceutical quality and potency tests difficult. Therapy with modified autologous cells, a common and important application of advanced therapy medicinal products, is exemplary for the special considerations that must be made when evaluating pharmaceutical quality, mode of action and toxicological properties of the biological medicine. The clinical investigation of advanced therapy medicinal products with the intent of demonstrating safety and efficacy is particularly challenging because of the complexity of therapy, which often involves invasive interventions

  1. [Special considerations for the regulation of biological medicinal products in individualised medicine. More than stratified medicine].

    Science.gov (United States)

    Müller-Berghaus, J; Volkers, P; Scherer, J; Cichutek, K

    2013-11-01

    The term individualised medicine, also called personalised medicine, is commonly used as an equivalent to stratified medicine. However, this is erroneous since quite often it is forgotten that especially biological medicinal products have other aspects of individualization that go beyond mere stratification. The principles of stratified medicine have been applied for biological medicinal products for many years. A historical example is diphtheria antitoxin made from horse serum, while current examples are transfusion of red blood cells and the administration of factor VIII in haemophilia A. The stratifying aspects of these medicinal products are given by the following considerations: diphtheria antitoxin is only administered after a diagnosis of diphtheria and not in other forms of tonsillitis, red blood cells should only be transfused once blood group compatibility as been established and factor VIII replacement is only administered in haemophilia A as opposed to other acquired or hereditary disease of the coagulation system. The peculiarities of biological medicinal products, in particular the inherent variability of the drug, are especially important for autologous cellular medicinal products. In addition to the expected variability of the biological source material there is interindividual variability of patients as cell donors, which make definition of specifications and determination of criteria for pharmaceutical quality and potency tests difficult. Therapy with modified autologous cells, a common and important application of advanced therapy medicinal products, is exemplary for the special considerations that must be made when evaluating pharmaceutical quality, mode of action and toxicological properties of the biological medicine. The clinical investigation of advanced therapy medicinal products with the intent of demonstrating safety and efficacy is particularly challenging because of the complexity of therapy, which often involves invasive interventions

  2. Systems Biology Approaches to Understand Natural Products Biosynthesis

    OpenAIRE

    Licona-Cassani, Cuauhtemoc; Cruz-Morales, Pablo; Manteca, Angel; Barona-Gomez, Francisco; Nielsen, Lars K; Marcellin, Esteban

    2015-01-01

    Actinomycetes populate soils and aquatic sediments that impose biotic and abiotic challenges for their survival. As a result, actinomycetes metabolism and genomes have evolved to produce an overwhelming diversity of specialized molecules. Polyketides, non-ribosomal peptides, post-translationally modified peptides, lactams, and terpenes are well-known bioactive natural products with enormous industrial potential. Accessing such biological diversity has proven difficult due to the complex regul...

  3. Systems biology approaches to understand natural products biosynthesis

    OpenAIRE

    Cuauhtemoc eLicona-Cassani; Pablo Cruz Morales; Angel eManteca; Francisco eBarona-Gomez; Lars Keld Nielsen; Esteban eMarcellin

    2015-01-01

    Actinomycetes populate soils and aquatic sediments which impose biotic and abiotic challenges for their survival. As a result, actinomycetes metabolism and genomes have evolved to produce an overwhelming diversity of specialized molecules. Polyketides, non-ribosomal peptides, post-translationally modified peptides, lactams and terpenes are well known bioactive natural products with enormous industrial potential. Accessing such biological diversity has proven difficult due to the complex regul...

  4. Polycyclic Xanthone Natural Products: Structure, Biological Activity and Chemical Synthesis

    OpenAIRE

    Winter, Dana K.; Sloman, David L.; Porco, John A.

    2013-01-01

    Polycyclic xanthone natural products are a family of polyketides which are characterized by highly oxygenated, angular hexacyclic frameworks. In the last decade, this novel class of molecules has attracted noticeable attention from the synthetic and biological communities due to emerging reports of their potential use as antitumour agents. The aim of this article is to highlight the most recent developments of this subset of the xanthone family by detailing the innate challenges of the constr...

  5. Research on coal mine safety production management decision system based on VB

    Institute of Scientific and Technical Information of China (English)

    ZHAO Zhong-ling; FENG Xi-wen; FANG Heng-fu; YUAN Qing-he

    2007-01-01

    Based on safety management appraisal theory, the decision system was divided into 5 function menu module, including system control module, mining coal and the tunneling working surface security evaluation module, the entire ore safety production condition appraisal module, the safety management level appraisal module of main production work area, the withdrawal system module and so on. The system operates through the constitutive procedure, outputs the main operation results by graph and form,and realizes the main function of safety evaluation.

  6. Vector Design for Improved DNA Vaccine Efficacy, Safety and Production

    Directory of Open Access Journals (Sweden)

    James A. Williams

    2013-06-01

    Full Text Available DNA vaccination is a disruptive technology that offers the promise of a new rapidly deployed vaccination platform to treat human and animal disease with gene-based materials. Innovations such as electroporation, needle free jet delivery and lipid-based carriers increase transgene expression and immunogenicity through more effective gene delivery. This review summarizes complementary vector design innovations that, when combined with leading delivery platforms, further enhance DNA vaccine performance. These next generation vectors also address potential safety issues such as antibiotic selection, and increase plasmid manufacturing quality and yield in exemplary fermentation production processes. Application of optimized constructs in combination with improved delivery platforms tangibly improves the prospect of successful application of DNA vaccination as prophylactic vaccines for diverse human infectious disease targets or as therapeutic vaccines for cancer and allergy.

  7. Product-based Safety Certification for Medical Devices Embedded Software.

    Science.gov (United States)

    Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

    2015-01-01

    Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

  8. Reproductive biology traits affecting productivity of sour cherry

    Directory of Open Access Journals (Sweden)

    Milica Fotiric Aksic

    2013-01-01

    Full Text Available The objective of this work was to evaluate variability in reproductive biology traits and the correlation between them in genotypes of 'Oblačinska' sour cherry (Prunus cerasus. High genetic diversity was found in the 41 evaluated genotypes, and significant differences were observed among them for all studied traits: flowering time, pollen germination, number of fruiting branches, production of flower and fruit, number of flowers per bud, fruit set, and limb yield efficiency. The number of fruiting branches significantly influenced the number of flower and fruit, fruit set, and yield efficiency. In addition to number of fruiting branches, yield efficiency was positively correlated with fruit set and production of flower and fruit. Results from principal component analysis suggested a reduction of the reproductive biology factors affecting yield to four main characters: number and structure of fruiting branches, flowering time, and pollen germination. Knowledge of the reproductive biology of the 'Oblačinska' genotypes can be used to select the appropriate ones to be grown or used as parents in breeding programs. In this sense, genotypes II/2, III/9, III/13, and III/14 have very good flower production and satisfactory pollen germination.

  9. Formate Formation and Formate Conversion in Biological Fuels Production

    Directory of Open Access Journals (Sweden)

    Bryan R. Crable

    2011-01-01

    Full Text Available Biomethanation is a mature technology for fuel production. Fourth generation biofuels research will focus on sequestering CO2 and providing carbon-neutral or carbon-negative strategies to cope with dwindling fossil fuel supplies and environmental impact. Formate is an important intermediate in the methanogenic breakdown of complex organic material and serves as an important precursor for biological fuels production in the form of methane, hydrogen, and potentially methanol. Formate is produced by either CoA-dependent cleavage of pyruvate or enzymatic reduction of CO2 in an NADH- or ferredoxin-dependent manner. Formate is consumed through oxidation to CO2 and H2 or can be further reduced via the Wood-Ljungdahl pathway for carbon fixation or industrially for the production of methanol. Here, we review the enzymes involved in the interconversion of formate and discuss potential applications for biofuels production.

  10. An Overview of Trials´Accreditation and Recognition of Brazilian Tests Used for the Safety Evaluation of Cosmetic Products

    Directory of Open Access Journals (Sweden)

    Luciana dos Santos Almeida

    2016-06-01

    Full Text Available For some time, Brazil has been appointed as one of the greatest consumers of cosmetic products in the world. Although cosmetics may seem harmless, destined exclusively to enhance personal appearance or to clean and protect the skin, hair and nails, new studies and events are highlighting the need to evaluate the safety of such products. The present work interrelated the lifecycle of a cosmetic product with the safety trials and tests applicable to some cycle phases. From this information, a survey was made of accredited Conformity Assessment Bodies (CAB and test facilities recognized by the General Coordination for Accreditation (CGCRE which are competent respectively to carry out safety trials and tests of cosmetics. Twenty five competent laboratories were identified to carry out chemical and/or biological trials of cosmetics, according to the legislation ABNT ISO IEC 17025:2005, and 10 test facilities recognized by the Compliance Monitoring Program that can carry out tests of the development of a product for register purposes, aiming at human health and safety. It is interesting to notice that Brazil has accredited laboratories to carry out trials that are critical for the health of the population, such as the levels of heavy metals and the presence of pathogens. On the other hand, CGCRE does not have a program to recognize safety clinical trials. The importance of this kind of study is understood, considering the world history of adverse reactions and the great consumption of cosmetics in the country.

  11. Off-Label Biologic Regimens in Psoriasis: A Systematic Review of Efficacy and Safety of Dose Escalation, Reduction, and Interrupted Biologic Therapy

    OpenAIRE

    Elizabeth A. Brezinski; Armstrong, April W.

    2012-01-01

    OBJECTIVES: While off-label dosing of biologic treatments may be necessary in selected psoriasis patients, no systematic review exists to date that synthesizes the efficacy and safety of these off-label dosing regimens. The aim of this systematic review is to evaluate efficacy and safety of off-label dosing regimens (dose escalation, dose reduction, and interrupted treatment) with etanercept, adalimumab, infliximab, ustekinumab, and alefacept for psoriasis treatment. DATA SOURCES AND STUDY SE...

  12. Chemical safety of cassava products in regions adopting cassava production and processing - experience from Southern Africa

    DEFF Research Database (Denmark)

    Nyirenda, D.B.; Chiwona-Karltun, L.; Chitundu, M.;

    2011-01-01

    The cassava belt area in Southern Africa is experiencing an unforeseen surge in cassava production, processing and consumption. Little documentation exists on the effects of this surge on processing procedures, the prevailing levels of cyanogenic glucosides of products consumed and the levels...... and perceptions concerning cassava and chemical food safety. Chips, mixed biscuits and flour, procured from households and markets in three regions of Zambia (Luapula-North, Western and Southern) as well as products from the Northern, Central and Southern regions of Malawi, were analyzed for total cyanogenic...

  13. Safety Evaluation of CNS Administered Biologics-Study Design, Data Interpretation, and Translation to the Clinic.

    Science.gov (United States)

    Vuillemenot, Brian R; Korte, Sven; Wright, Teresa L; Adams, Eric L; Boyd, Robert B; Butt, Mark T

    2016-07-01

    Many central nervous system (CNS) diseases are inadequately treated by systemically administered therapies due to the blood brain barrier (BBB), which prevents achieving adequate drug concentrations at sites of action. Due to the increasing prevalence of neurodegenerative diseases and the inability of most systemically administered therapies to cross the BBB, direct CNS delivery will likely play an increasing role in treatment. Administration of large molecules, cells, viral vectors, oligonucleotides, and other novel therapies directly to the CNS via the subarachnoid space, ventricular system, or parenchyma overcomes this obstacle. Clinical experience with direct CNS administration of small molecule therapies suggests that this approach may be efficacious for the treatment of neurodegenerative disorders using biological therapies. Risks of administration into the brain tissue or cerebrospinal fluid include local damage from implantation of the delivery system and/or administration of the therapeutic and reactions affecting the CNS. Preclinical safety studies on CNS administered compounds must differentiate between the effects of the test article, the delivery device, and/or the vehicle, and assess exacerbations of reactions due to combinations of effects. Animal models characterized for safety assessment of CNS administered therapeutics have enabled human trials, but interpretation can be challenging. This manuscript outlines the challenges of preclinical intrathecal/intracerebroventricular/intraparenchymal studies, evaluation of results, considerations for special endpoints, and translation of preclinical findings to enable first-in-human trials. Recommendations will be made based on the authors' collective experience with conducting these studies to enable clinical development of CNS-administered biologics. PMID:27354708

  14. The potential of plants as a system for the development and production of human biologics.

    Science.gov (United States)

    Chen, Qiang; Davis, Keith R

    2016-01-01

    The growing promise of plant-made biologics is highlighted by the success story of ZMapp™ as a potentially life-saving drug during the Ebola outbreak of 2014-2016. Current plant expression platforms offer features beyond the traditional advantages of low cost, high scalability, increased safety, and eukaryotic protein modification. Novel transient expression vectors have been developed that allow the production of vaccines and therapeutics at unprecedented speed to control potential pandemics or bioterrorism attacks. Plant-host engineering provides a method for producing proteins with unique and uniform mammalian post-translational modifications, providing opportunities to develop biologics with increased efficacy relative to their mammalian cell-produced counterparts. Recent demonstrations that plant-made proteins can function as biocontrol agents of foodborne pathogens further exemplify the potential utility of plant-based protein production. However, resolving the technical and regulatory challenges of commercial-scale production, garnering acceptance from large pharmaceutical companies, and obtaining U.S. Food and Drug Administration approval for several major classes of biologics are essential steps to fulfilling the untapped potential of this technology. PMID:27274814

  15. The potential of plants as a system for the development and production of human biologics

    Science.gov (United States)

    Chen, Qiang; Davis, Keith R.

    2016-01-01

    The growing promise of plant-made biologics is highlighted by the success story of ZMapp™ as a potentially life-saving drug during the Ebola outbreak of 2014-2016. Current plant expression platforms offer features beyond the traditional advantages of low cost, high scalability, increased safety, and eukaryotic protein modification. Novel transient expression vectors have been developed that allow the production of vaccines and therapeutics at unprecedented speed to control potential pandemics or bioterrorism attacks. Plant-host engineering provides a method for producing proteins with unique and uniform mammalian post-translational modifications, providing opportunities to develop biologics with increased efficacy relative to their mammalian cell-produced counterparts. Recent demonstrations that plant-made proteins can function as biocontrol agents of foodborne pathogens further exemplify the potential utility of plant-based protein production. However, resolving the technical and regulatory challenges of commercial-scale production, garnering acceptance from large pharmaceutical companies, and obtaining U.S. Food and Drug Administration approval for several major classes of biologics are essential steps to fulfilling the untapped potential of this technology. PMID:27274814

  16. The potential of plants as a system for the development and production of human biologics.

    Science.gov (United States)

    Chen, Qiang; Davis, Keith R

    2016-01-01

    The growing promise of plant-made biologics is highlighted by the success story of ZMapp™ as a potentially life-saving drug during the Ebola outbreak of 2014-2016. Current plant expression platforms offer features beyond the traditional advantages of low cost, high scalability, increased safety, and eukaryotic protein modification. Novel transient expression vectors have been developed that allow the production of vaccines and therapeutics at unprecedented speed to control potential pandemics or bioterrorism attacks. Plant-host engineering provides a method for producing proteins with unique and uniform mammalian post-translational modifications, providing opportunities to develop biologics with increased efficacy relative to their mammalian cell-produced counterparts. Recent demonstrations that plant-made proteins can function as biocontrol agents of foodborne pathogens further exemplify the potential utility of plant-based protein production. However, resolving the technical and regulatory challenges of commercial-scale production, garnering acceptance from large pharmaceutical companies, and obtaining U.S. Food and Drug Administration approval for several major classes of biologics are essential steps to fulfilling the untapped potential of this technology.

  17. Potential of chicken by-products as sources of useful biological resources

    International Nuclear Information System (INIS)

    By-products from different animal sources are currently being utilised for beneficial purposes. Chicken processing plants all over the world generate large amount of solid by-products in form of heads, legs, bones, viscera and feather. These wastes are often processed into livestock feed, fertilizers and pet foods or totally discarded. Inappropriate disposal of these wastes causes environmental pollution, diseases and loss of useful biological resources like protein, enzymes and lipids. Utilisation methods that make use of these biological components for producing value added products rather than the direct use of the actual waste material might be another viable option for dealing with these wastes. This line of thought has consequently led to researches on these wastes as sources of protein hydrolysates, enzymes and polyunsaturated fatty acids. Due to the multi-applications of protein hydrolysates in various branches of science and industry, and the large body of literature reporting the conversion of animal wastes to hydrolysates, a large section of this review was devoted to this subject. Thus, this review reports the known functional and bioactive properties of hydrolysates derived from chicken by-products as well their utilisation as source of peptone in microbiological media. Methods of producing these hydrolysates including their microbiological safety are discussed. Based on the few references available in the literature, the potential of some chicken by-product as sources of proteases and polyunsaturated fatty acids are pointed out along with some other future applications

  18. Potential of chicken by-products as sources of useful biological resources

    Energy Technology Data Exchange (ETDEWEB)

    Lasekan, Adeseye [Faculty of Food Science and Technology, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor (Malaysia); Abu Bakar, Fatimah, E-mail: fatim@putra.upm.edu.my [Faculty of Food Science and Technology, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor (Malaysia); Halal Products Research Institute, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor (Malaysia); Hashim, Dzulkifly [Faculty of Food Science and Technology, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor (Malaysia); Halal Products Research Institute, Universiti Putra Malaysia, 43400 UPM Serdang, Selangor (Malaysia)

    2013-03-15

    By-products from different animal sources are currently being utilised for beneficial purposes. Chicken processing plants all over the world generate large amount of solid by-products in form of heads, legs, bones, viscera and feather. These wastes are often processed into livestock feed, fertilizers and pet foods or totally discarded. Inappropriate disposal of these wastes causes environmental pollution, diseases and loss of useful biological resources like protein, enzymes and lipids. Utilisation methods that make use of these biological components for producing value added products rather than the direct use of the actual waste material might be another viable option for dealing with these wastes. This line of thought has consequently led to researches on these wastes as sources of protein hydrolysates, enzymes and polyunsaturated fatty acids. Due to the multi-applications of protein hydrolysates in various branches of science and industry, and the large body of literature reporting the conversion of animal wastes to hydrolysates, a large section of this review was devoted to this subject. Thus, this review reports the known functional and bioactive properties of hydrolysates derived from chicken by-products as well their utilisation as source of peptone in microbiological media. Methods of producing these hydrolysates including their microbiological safety are discussed. Based on the few references available in the literature, the potential of some chicken by-product as sources of proteases and polyunsaturated fatty acids are pointed out along with some other future applications.

  19. Biological treatment of chicken feather waste for improved biogas production

    Institute of Scientific and Technical Information of China (English)

    Gergely Forgács; Saeid Alinezhad; Amir Mirabdollah; Elisabeth Feuk-Lagerstedt; Ilona Sárvári Horwáth

    2011-01-01

    A two-stage system was developed which combines the biological degradation of keratin-rich waste with the production of biogas.Chicken feather waste was treated biologically with a recombinant Bacillus megaterium strain showing keratinase activity prior to biogas production.Chopped,autoclaved chicken feathers (4%,W/V) were completely degraded,resulting in a yellowish fermentation broth with a level of 0.51 mg/mL soluble proteins after 8 days of cultivation of the recombinant strain.During the subsequent anaerobic batch digestion experiments,methane production of 0.35 Nm3/kg dry feathers (i.e.,0.4 Nm3/kg volatile solids of feathers),corresponding to 80% of the theoretical value on proteins,was achieved from the feather hydrolyzates,independently of the prehydrolysis time period of 1,2 or 8 days.Cultivation with a native keratinase producing strain,Bacillus licheniformis resulted in only 0.25 mg/mL soluble proteins in the feather hydrolyzate,which then was digested achieving a maximum accumulated methane production of 0.31 Nm3/kg dry feathers.Feather hydrolyzates treated with the wild type B.megaterium produced 0.21 Nm3 CH4/kg dry feathers as maximum yield.

  20. 16 CFR 1115.5 - Reporting of failures to comply with a voluntary consumer product safety standard relied upon by...

    Science.gov (United States)

    2010-01-01

    ... voluntary consumer product safety standard relied upon by the Commission under section 9 of the CPSA. 1115.5 Section 1115.5 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT... with a voluntary consumer product safety standard relied upon by the Commission under section 9 of...

  1. 30 CFR 7.10 - MSHA acceptance of equivalent non-MSHA product safety standards.

    Science.gov (United States)

    2010-07-01

    ... General § 7.10 MSHA acceptance of equivalent non-MSHA product safety standards. (a) MSHA will accept non-MSHA product safety standards, or groups of standards, as equivalent after determining that they: (1... protection as those MSHA requirements. (b) MSHA will publish its intent to review any non-MSHA product...

  2. Incentives for the Quality and Safety Traceability System of Agricultural Products

    Institute of Scientific and Technical Information of China (English)

    Shizhen; BAI; Meng; LI

    2014-01-01

    The quality and safety traceability system of agricultural products is an important measure to protect the quality and safety of agricultural products. Farmers and food enterprises are main operators of the traceability system. If they are effectively encouraged to practice traceability system,food safety can be guaranteed from the source. This paper studies the incentive problem of agricultural product traceability system from two aspects- vertical contract coordination and government external incentive.

  3. The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals : A simulation study

    NARCIS (Netherlands)

    Vermeer, Niels S.; Ebbers, Hans C.; Straus, Sabine M J M; Leufkens, Hubert G M; Egberts, Toine C G; De Bruin, Marie L.

    2016-01-01

    Background and Objective: The availability of accurate product-specific exposure information is essential in the pharmacovigilance of biologicals, because differences in the safety profile may emerge between products containing the same active substance. In spontaneous adverse drug reaction (ADR) re

  4. Study on cooperative development of safety and production in coal mines

    Institute of Scientific and Technical Information of China (English)

    YUAN Qing-he; HOU Yan-hui; HAO Min; YUAN Qing-wen

    2007-01-01

    Based on cooperative theories and analysis of characters of safety and production in coal mines, discussed the relationship and function of cooperative development between safety and production and established a basic cooperative development model.At the same time, a systemic expatiation of the basic principle, the core conception and the contents of the model was given. In the end, the guarantee measures for realization were proposed. The result of the research may have some leading meaning to ensure safety and production in coal enterprises and to achieve synchronous exaltation of production efficiency and the safety degree.

  5. Removal of Review and Reclassification Procedures for Biological Products Licensed Prior to July 1, 1972. Final rule.

    Science.gov (United States)

    2016-02-12

    The Food and Drug Administration (FDA, the Agency, or we) is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. In addition, other statutory and regulatory authorities authorize FDA to revoke a license for biological products because they are not safe and effective, or are misbranded. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation. PMID:26878738

  6. Evaluation of the efficiency and safety in cosmetic products.

    Science.gov (United States)

    Uckaya, Meryem; Uckaya, Fatih; Demir, Nazan; Demir, Yasar

    2016-02-29

    Chemicals used in cosmetics have to interact with enzymes for beneficial or destroy purpose after they enter in our body. Active sections of enzymes that catalyze reactions have three dimensions and they are active optically. When these limitations of catalytic sections are considered, it may be considered that defining geometric specifications of chemical materials and functional groups they contain may contribute on safety evaluations of cosmetic products. In this study, defining similarities and differences of geometric structures of chemicals that are prohibited to be used in cosmetic products and chemical that are allowed to be used by using group theory and analyze of functional groups that are often encountered in these chemicals are aimed. Molecule formulas related to chemical material of, 276 pieces chemicals that are prohibited to be used in cosmetic products and 65 pieces chemicals that are allowed, are used as the material. Two and three-dimension structures of these formulas are drawn and types and quantity of functional groups they contain are defined. And as a method, freeware (Free Trial) version of "Chem-BioOffice Ultra 13.0 Suite" chemical drawing program to draw two and three-dimension of formulas, "Campus-Licensed" version that are provided for use by our university of "Autodesk 3DS Max" for three-dimension drawings are used. In order to analyze geometric specifications of drawn molecules according to Group Theory and define type and quantity of available functional groups, Excel applications developed by Prof. Dr. Yaşar Demir are used. PMID:26773597

  7. 77 FR 24722 - Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability

    Science.gov (United States)

    2012-04-25

    ... HUMAN SERVICES Food and Drug Administration Draft Guidance for Industry: Safety of Nanomaterials in... ``Guidance for Industry: Safety of Nanomaterials in Cosmetic Products.'' The draft guidance, when finalized, will represent FDA's current thinking on the safety assessment of nanomaterials in cosmetic...

  8. Molecular biology in studies of oceanic primary production

    International Nuclear Information System (INIS)

    Remote sensing and the use of moored in situ instrumentation has greatly improved our ability to measure phytoplankton chlorophyll and photosynthesis on global scales with high temporal resolution. However, the interpretation of these measurements and their significance with respect to the biogeochemical cycling of carbon relies on their relationship with physiological and biochemical processes in phytoplankton. For example, the use of satellite images of surface chlorophyll to estimate primary production is often based on the functional relationship between photosynthesis and irradiance. A variety of environmental factors such as light, temperature, nutrient availability affect the photosynthesis/irradiance (P vs I) relationship in phytoplankton. We present three examples showing how molecular biology can be used to provide basic insight into the factors controlling primary productivity at three different levels of complexity: 1. Studies of light intensity regulation in unicellular alga show how molecular biology can help understand the processing of environmental cues leading to the regulation of photosynthetic gene expression. 2. Probing of the photosynthetic apparatus using molecular techniques can be used to test existing mechanistic models derived from the interpretation of physiological and biophysical measurements. 3. Exploratory work on the expression of specific proteins during nutrient-limited growth of phytoplankton may lead to the identification and production of molecular probes for field studies

  9. 生物安全柜的质量控制%Quality Control of Biological Safety Cabinet

    Institute of Scientific and Technical Information of China (English)

    马飞; 武文军; 熊陆平; 赵鹏

    2012-01-01

    Objective To ensure the safety and reliability of using biological safety cabinet(BSC) based on analyzing the quality and performance of BSC. Methods According to the correlative domestic and international criteria, the BSC performance testing content and key projects were analyzed and compared. Results Physical and biological performance tests of BSC included at least leak-tightness of carcass, integrity of high efficiency particulate air(HEPA) filter, airflow velocity of down -flow, airflow velocity of in -flow, airflow pattern, person protection, product protection and cross contamination protection. Conclusion The government should institute laws to regulate quality control of BSC. The laboratory should establish quality management system for periodic checking of BSC.[Chinese Medical Equipment Journal,2012,33(5):113-115]%目的:分析生物安全柜的质量和性能,保障实验室人员安全、可靠地使用生物安全柜.方法:根据国内外相关标准,分析和比较了生物安全柜性能检测的内容和关键项目.结果:生物安全柜的物理和生物性能检测至少包括柜体防泄漏,高效过滤器完整性,下降气流流速,流入气流流速,气流模式,人员、产品与交叉污染保护.结论:国家应制定强制性法规,规定生物安全柜的质量控制;实验室应建立质量管理制度,对生物安全柜进行周期检测.

  10. Analysis on Pollution Factors in Asparagus Production and Research on Safety Production Technology

    Institute of Scientific and Technical Information of China (English)

    Liping; MA; Bianqing; HAO; Xiongwu; QIAO

    2013-01-01

    Based on the analysis on the infection degree,infection law and influencing factors of the main diseases on asparagus and the analysis on the pollution factors in asparagus production such as blind pesticide use,atmospheric pollution and acid rain,the pollution of soil and fertilizer,this article proposes asparagus safety production technologies which include the selection of disease-resistant variety and suitable planting field,scientific and reasonable disease control,balanced fertilization,rational irrigation,making a good job of field management, etc.,to reduce pathogenic factors.

  11. Assessment of nitrogen and sulphur cycle bacteria and shrimp production in ponds treated with biological products

    Institute of Scientific and Technical Information of China (English)

    Thangapalam Jawahar Abraham; Shubhadeep Ghosh; Debasis Sasmal

    2015-01-01

    Objective:To study the influence of biological products on the levels of nitrogen and sulphur cycle bacteria in shrimp culture systems of West Bengal, India. Methods: The pond water and sediment samples were analyzed for physico-chemical parameters as per standard methods. The bacteria involved in ammonification, nitrification, denitrification, sulphate reduction and sulphur oxidation were enumerated by most probable number technique. Results:The semi-intensive and modified extensive shrimp farms used a variety of biological products during various stages of production. No biological products were used in traditional farms. The water and sediment samples of modified extensive system recorded significantly higher mean heterotrophic bacterial counts. The counts of ammonia, nitrite and sulphur oxidizers, and nitrate and sulphate reducers varied among the systems. The cycling of nitrogen and sulphur appeared to be affected with the intensification of culture practices. Conclusions:The application of biological products in certain systems helped to maintain the bacteria involved in nitrogen and sulphur cycles and safe levels of ammonia, nitrite and nitrate. An assessment of these metabolically active bacteria in shrimp culture ponds and the application of right kind microbial products would help ameliorate the organic pollution in shrimp aquaculture.

  12. Role of Public Standards in the Safety and Efficacy of Biologic Medicines

    OpenAIRE

    Williams, Roger L.; Bristow, Adrian F.; Hauck, Walter W.; Srinivasan, V. Srini; Morris, Tina; Atouf, Fouad; Ambrose, Michael; Surendranath, Koduru V.; Chakrabarty, Ranjan; Menon, Krishna

    2014-01-01

    In this report, we emphasize the importance of public monographs with reference materials, coupled with careful process and change control and attention to GMPs, as a means of advancing access to good quality, safe, and effective medicines, with emphasis on available and incoming biologic medicines. With adequate control of articles covered by a monograph, these public standards can form the basis for a global public quality platform that covers reference products, non-interchangeable referen...

  13. Biological hydrogen production from biomass by thermophilic bacteria

    Energy Technology Data Exchange (ETDEWEB)

    Claassen, P.A.M.; Mars, A.E.; Budde, M.A.W.; Lai, M.; de Vrije, T. [Wageningen UR, Agrotechnology and Food Sciences Group (AFSG), Business Unit Biobased Products, P.O. Box 17, 6700 AA Wageningen, (Netherlands); van Niel, E.W.J. [Lund University, Applied microbiology, P.O. Box 124, 221 000 Lund, (Sweden)

    2006-07-01

    To meet the reduction of the emission of CO{sub 2} imposed by the Kyoto protocol, hydrogen should be produced from renewable primary energy. Besides the indirect production of hydrogen by electrolysis using electricity from renewable resources, such as sunlight, wind and hydropower, hydrogen can be directly produced from biomass. At present, there are two strategies for the production of hydrogen from biomass: the thermochemical technology, such as gasification, and the biotechnological approach using micro-organisms. Biological hydrogen production delivers clean hydrogen with an environmental-friendly technology and is very suitable for the conversion of wet biomass in small-scale applications, thus having a high chance of becoming an economically feasible technology. Many micro-organisms are able to produce hydrogen from mono- and disaccharides, starch and (hemi)cellulose under anaerobic conditions. The anaerobic production of hydrogen is a common phenomenon, occurring during the process of anaerobic digestion. Here, hydrogen producing micro-organisms are in syn-trophy with methanogenic bacteria which consume the hydrogen as soon as it is produced. In this way, hydrogen production remains obscure and methane is the end-product. By uncoupling hydrogen production from methane production, hydrogen becomes available for recovery and exploitation. This study describes the use of extreme thermophilic bacteria, selected because of a higher hydrogen production efficiency as compared to mesophilic bacteria, for the production of hydrogen from renewable resources. As feedstock energy crops like Miscanthus and Sorghum bicolor and waste streams like domestic organic waste, paper sludge and potato steam peels were used. The feedstock was pretreated and/or enzymatically hydrolyzed prior to fermentation to make a fermentable substrate. Hydrogen production by Caldicellulosiruptor saccharolyticus, Thermotoga elfii and T. neapolitana on all substrates was observed. Nutrient

  14. Biological hydrogen production from biomass by thermophilic bacteria

    International Nuclear Information System (INIS)

    To meet the reduction of the emission of CO2 imposed by the Kyoto protocol, hydrogen should be produced from renewable primary energy. Besides the indirect production of hydrogen by electrolysis using electricity from renewable resources, such as sunlight, wind and hydropower, hydrogen can be directly produced from biomass. At present, there are two strategies for the production of hydrogen from biomass: the thermochemical technology, such as gasification, and the biotechnological approach using micro-organisms. Biological hydrogen production delivers clean hydrogen with an environmental-friendly technology and is very suitable for the conversion of wet biomass in small-scale applications, thus having a high chance of becoming an economically feasible technology. Many micro-organisms are able to produce hydrogen from mono- and disaccharides, starch and (hemi)cellulose under anaerobic conditions. The anaerobic production of hydrogen is a common phenomenon, occurring during the process of anaerobic digestion. Here, hydrogen producing micro-organisms are in syn-trophy with methanogenic bacteria which consume the hydrogen as soon as it is produced. In this way, hydrogen production remains obscure and methane is the end-product. By uncoupling hydrogen production from methane production, hydrogen becomes available for recovery and exploitation. This study describes the use of extreme thermophilic bacteria, selected because of a higher hydrogen production efficiency as compared to mesophilic bacteria, for the production of hydrogen from renewable resources. As feedstock energy crops like Miscanthus and Sorghum bicolor and waste streams like domestic organic waste, paper sludge and potato steam peels were used. The feedstock was pretreated and/or enzymatically hydrolyzed prior to fermentation to make a fermentable substrate. Hydrogen production by Caldicellulosiruptor saccharolyticus, Thermotoga elfii and T. neapolitana on all substrates was observed. Nutrient requirements

  15. Building a safety case for a small sized product line of Fuel Level Display Systems

    OpenAIRE

    Gallucci, Antonio

    2013-01-01

    ISO 26262 is an international standard valid for the automotive domain. It regulates all the activities to perform for developing safety critical systems in such domain. To be compliant with ISO 26262, all the required activities have to be performed and all the required work products have to be provided. Furthermore, in addition to develop a system in a safe way, following the safety standard guidelines, the achieved safety has also to be demonstrated. This is done through a safety case, a s...

  16. [Ecological and food safety considerations about products of vegetable origin].

    Science.gov (United States)

    Tapia de Daza, M S; Díaz, R V

    1994-12-01

    Media have paid much attention in recent years to emerging microbiological problems in foods of plant origin. The potential for contamination of fruits and vegetables is high because of the wide variety of conditions to which produce is exposed during growth, harvest, processing and distribution. These considerations acquire great significance in the current scenario of the new processing techniques that offer attributes of convenience and fresh-likeness in response to changes in consumption patterns and increased demand of fresh and minimally processed fruits and vegetables. Thus, reliance on low temperature storage and on improved packaging materials/techniques have increased. Even if produce had not been considered a major vector for foodborne diseases, technologies that extend shelf-life by decreasing the rate of product deterioration might increase the risks associated with pathogenic microorganisms, especially of psychotropic nature, by allowing sufficient time for their growth when retarding the development of competitive spoilage organisms. Processing steps that modify the food microenvironment open new possibilities to support pathogens that, for ecological reason, would have never been naturally present in produce. Ecological and safety aspects related to fruits and vegetables as well as foodborne disease outbreaks traceable to produce and reportedly due to Salmonella and Shigella spp., Listeria monocytogenes, Clostridium botulinum, Aeromonas hydrophila, Campylobacter jejuni are reviewed. PMID:8984963

  17. Current studies on physiological functions and biological production of lactosucrose.

    Science.gov (United States)

    Mu, Wanmeng; Chen, Qiuming; Wang, Xiao; Zhang, Tao; Jiang, Bo

    2013-08-01

    Lactosucrose (O-β-D-galactopyranosyl-(1,4)-O-α-D-glucopyranosyl-(1,2)-β-D-fructofuranoside) is a trisaccharide formed from lactose and sucrose by enzymatic transglycosylation. This rare trisaccharide is a kind of indigestible carbohydrate, has good prebiotic effect, and promotes intestinal mineral absorption. It has been used as a functional ingredient in a range of food products which are approved as foods for specified health uses in Japan. Using lactose and sucrose as substrates, lactosucrose can be produced through transfructosylation by β-fructofuranosidase from Arthrobacter sp. K-1 or a range of levansucrases, or through transgalactosylation by β-galactosidase from Bacillus circulans. This article presented a review of recent studies on the physiological functions of lactosucrose and the biological production from lactose and sucrose by different enzymes.

  18. Current studies on physiological functions and biological production of lactosucrose.

    Science.gov (United States)

    Mu, Wanmeng; Chen, Qiuming; Wang, Xiao; Zhang, Tao; Jiang, Bo

    2013-08-01

    Lactosucrose (O-β-D-galactopyranosyl-(1,4)-O-α-D-glucopyranosyl-(1,2)-β-D-fructofuranoside) is a trisaccharide formed from lactose and sucrose by enzymatic transglycosylation. This rare trisaccharide is a kind of indigestible carbohydrate, has good prebiotic effect, and promotes intestinal mineral absorption. It has been used as a functional ingredient in a range of food products which are approved as foods for specified health uses in Japan. Using lactose and sucrose as substrates, lactosucrose can be produced through transfructosylation by β-fructofuranosidase from Arthrobacter sp. K-1 or a range of levansucrases, or through transgalactosylation by β-galactosidase from Bacillus circulans. This article presented a review of recent studies on the physiological functions of lactosucrose and the biological production from lactose and sucrose by different enzymes. PMID:23828605

  19. Food Safety for Seniors

    Science.gov (United States)

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Food Home Food Foodborne Illness & Contaminants People at Risk of Foodborne Illness To Your Health! Food Safety for Seniors Share Tweet Linkedin Pin it ...

  20. [Current concept for the microbiological safety of cell-based medicinal products].

    Science.gov (United States)

    Schurig, Utta; Karo, Jan-Oliver; Sicker, U; Spindler-Raffel, E; Häckel, L; Spreitzer, I; Bekeredjian-Ding, I

    2015-11-01

    Ensuring microbiological safety in advanced-therapy medicinal products is still a big challenge for manufacturers. There are fundamental problems, especially in cell-based medicinal products, regarding sterility of source materials, short shelf-life of final products, and the selection of suitable microbiological methods. Different from classical medicinal products, there is the need to evaluate a large number of possible risks and to calculate the risk-benefit balance. Depending on the source material, the presence of micro-organisms with specific growth requirements has to be considered. They cannot be detected by conventional testing methods, but may replicate after the application of the preparation in the recipient. Mycoplasmas are the primary representatives of these contaminants and specific testing procedures are required. Additionally, depending on the source and processing of the biological material, specific testing methods for mycobacteria and other contaminants should be included. Alternative microbiological methods (e.g. NAT, flow cytometry) should be applied in order to reduce the time to detection and to provide reliable results before application of a preparation, but should be also assessed for their possible use for the detection of conventionally undetectable micro-organisms.

  1. [Current concept for the microbiological safety of cell-based medicinal products].

    Science.gov (United States)

    Schurig, Utta; Karo, Jan-Oliver; Sicker, U; Spindler-Raffel, E; Häckel, L; Spreitzer, I; Bekeredjian-Ding, I

    2015-11-01

    Ensuring microbiological safety in advanced-therapy medicinal products is still a big challenge for manufacturers. There are fundamental problems, especially in cell-based medicinal products, regarding sterility of source materials, short shelf-life of final products, and the selection of suitable microbiological methods. Different from classical medicinal products, there is the need to evaluate a large number of possible risks and to calculate the risk-benefit balance. Depending on the source material, the presence of micro-organisms with specific growth requirements has to be considered. They cannot be detected by conventional testing methods, but may replicate after the application of the preparation in the recipient. Mycoplasmas are the primary representatives of these contaminants and specific testing procedures are required. Additionally, depending on the source and processing of the biological material, specific testing methods for mycobacteria and other contaminants should be included. Alternative microbiological methods (e.g. NAT, flow cytometry) should be applied in order to reduce the time to detection and to provide reliable results before application of a preparation, but should be also assessed for their possible use for the detection of conventionally undetectable micro-organisms. PMID:26369764

  2. The application of transcriptomics in the comparative safety assessment of (GMO-derived) plant products

    NARCIS (Netherlands)

    Kok, E.J.

    2008-01-01

    National and international organizations have discussed current approaches to the safety assessment of complex (plant) food products in general and the safety assessment of GMO-derived food products in particular. One of the recommendations of different expert meetings was that the new analytical te

  3. 30 CFR 250.804 - Production safety-system testing and records.

    Science.gov (United States)

    2010-07-01

    ... OFFSHORE OIL AND GAS AND SULPHUR OPERATIONS IN THE OUTER CONTINENTAL SHELF Oil and Gas Production Safety... methane-air mixture shall not be used. All combustible gas-detection systems shall be calibrated every 3... 30 Mineral Resources 2 2010-07-01 2010-07-01 false Production safety-system testing and...

  4. 75 FR 18825 - Advantage Electronic Product Development Incorporated/Utility Crew Safety LLC

    Science.gov (United States)

    2010-04-13

    ... Advantage Electronic Product Development Incorporated/Utility Crew Safety LLC AGENCY: Department of Energy... intent to grant to: Advantage Electronic Product Development Incorporated/Utility Crew Safety LLC, of... whether the interests of the Federal Government or the United States industry in foreign commerce will...

  5. Biological evaluation of nanosilver incorporated cellulose pulp for hygiene products.

    Science.gov (United States)

    Kavitha Sankar, P C; Ramakrishnan, Reshmi; Rosemary, M J

    2016-04-01

    Cellulose pulp has a visible market share in personal hygiene products such as sanitary napkins and baby diapers. However it offers good surface for growth of microorganisms. Huge amount of research is going on in developing hygiene products that do not initiate microbial growth. The objective of the present work is to produce antibacterial cellulose pulp by depositing silver nanopowder on the cellulose fiber. The silver nanoparticles used were of less than 100 nm in size and were characterised using transmission electron microscopy and X-ray powder diffraction studies. Antibacterial activity of the functionalized cellulose pulp was proved by JIS L 1902 method. The in-vitro cytotoxicity, in-vivo vaginal irritation and intracutaneous reactivity studies were done with silver nanopowder incorporated cellulose pulp for introducing a new value added product to the market. Cytotoxicity evaluation suggested that the silver nanoparticle incorporated cellulose pulp is non-cytotoxic. No irritation and skin sensitization were identified in animals tested with specific extracts prepared from the test material in the in-vivo experiments. The results indicated that the silver nanopowder incorporated cellulose pulp meets the requirements of the standard practices recommended for evaluating the biological reactivity and has good biocompatibility, hence can be classified as a safe hygiene product. PMID:26838891

  6. Biological productivity and carbon cycling in the Arctic Ocean

    Institute of Scientific and Technical Information of China (English)

    2002-01-01

    Primary production, bacterial production, particulate organic carbon fluxes and organic carbon burial rates were quantified during the summer period of 1999 in the Arctic Ocean via 14C uptake, 3H uptake, 234Th/238U disequilibrium and 210Pbex dating, respectively. The integrated primary production in the water column was as high as 197 mmolC/(m2@d) in the Chukchi shelf and was 3.8 mmolC/(m2@d) in the Canada Basin. These rates are higher than those reported previously. The ratios of bacterial production to primary production in the study region were higher than 0.5, indicating that microbial activity is not depressed but important in cold Arctic waters. 234Th/238U disequilibria were evident at the station in the Canada Basin. The presence of significant 234Th deficiency suggested that scavenging and removal processes are also important to biogeochemical cycles of trace elements in the Arctic Ocean. Particulate organic carbon export flux was estimated to be 1.0 mmolC/(m2@d). Measurements of sediment excess 210Pb profile in the Chukchi shelf allowed us to estimate the amount of organic carbon buried in the bottom sediment, which ranged from 25 to 35 mmolC/(m2@d) and represented about 59%-82% of the mean primary production in the euphotic zone. Overall, our results indicated that the Arctic Ocean has active carbon cycling and is not a biological desert as previously believed. Therefore, the Arctic Ocean may play an important role in the global carbon cycle and climate change.

  7. Application of Mixed Group Decision Making to Safety Evaluation of Agricultural Products

    Institute of Scientific and Technical Information of China (English)

    2012-01-01

    In view of the gravity of issues concerning safety of agricultural products and urgency of resolving these issues,after analyzing the problems existing in safety of agricultural products,this article offers a method for evaluating safety of agricultural products on the basis of mixed group decision making.First of all,it introduces the factors influencing safety evaluation of agricultural products;subsequently,given that the judgment matrices offered by the group of experts contain both reciprocal and complementary judgment matrices in the process of jointly participating in evaluation arising from personal preference,it proposes to assemble expert information in order to obtain indicator weight using the OWA operator;finally,the process of evaluating safety of agricultural products is given.

  8. Suitability of Gray Water for Hydroponic Crop Production Following Biological and Physical Chemical and Biological Subsystems

    Science.gov (United States)

    Bubenheim, David L.; Harper, Lynn D.; Wignarajah, Kanapathipillai; Greene, Catherine

    1994-01-01

    The water present in waste streams from a human habitat must be recycled in Controlled Ecological Life Support Systems (CELSS) to limit resupply needs and attain self-sufficiency. Plants play an important role in providing food, regenerating air, and producing purified water via transpiration. However, we have shown that the surfactants present in hygiene waste water have acute toxic effects on plant growth (Bubenheim et al. 1994; Greene et al., 1994). These phytotoxic affects can be mitigated by allowing the microbial population on the root surface to degrade the surfactant, however, a significant suppression (several days) in crop performance is experienced prior to reaching sub-toxic surfactant levels and plant recovery. An effective alternative is to stabilize the microbial population responsible for degradation of the surfactant on an aerobic bioreactor and process the waste water prior to utilization in the hydroponic solution (Wisniewski and Bubenheim, 1993). A sensitive bioassay indicates that the surfactant phytotoxicity is suppressed by more than 90% within 5 hours of introduction of the gray water to the bioreactor; processing for more than 12 hours degrades more than 99% of the phytotoxin. Vapor Compression Distillation (VCD) is a physical / chemical method for water purification which employees sequential distillation steps to separate water from solids and to volatilize contaminants. The solids from the waste water are concentrated in a brine and the pure product water (70 - 90% of the total waste water volume depending on operating conditions) retains non of the phytotoxic effects. Results of the bioassay were used to guide evaluations of the suitability of recovered gray water following biological and VCD processing for hydroponic lettuce production in controlled environments. Lettuce crops were grown for 28 days with 100% of the input water supplied with recovered water from the biological processor or VCD. When compared with the growth of plants

  9. Biological preservation of plant derived animal feed with antifungal microorganisms: safety and formulation aspects.

    Science.gov (United States)

    Melin, Petter; Sundh, Ingvar; Håkansson, Sebastian; Schnürer, Johan

    2007-08-01

    During storage of moist animal feed, growth of detrimental fungi causing spoilage, or being mycotoxigenic or pathogenic, is a severe problem. Addition of biopreservative yeasts or lactic acid bacteria can significantly reduce this problem. However, their use requires several careful considerations. One is the safety to the animal, humans and the environment, tightly connected to legal aspects and the need for pre-market authorisation when supplementing feed with microorganisms. Although both yeasts and lactic acid bacteria are considered comparatively safe organisms due to low production of toxic metabolites, it is of great importance to understand the mechanisms behind the biopreservative abilities. Another important issue concerns practical aspects, such as the economic production of large amounts of the organisms and the development of a suitable formulation giving the organisms a long shelf life. These aspects are discussed and a recommendation of this review is that both safety and formulation aspects of a specific microbe should be considered at an early stage in the selection of new organisms with biopreservation potential.

  10. A regulatory perspective of clinical trial applications for biological products with particular emphasis on Advanced Therapy Medicinal Products (ATMPs).

    Science.gov (United States)

    Jones, David R; McBlane, James W; McNaughton, Graham; Rajakumaraswamy, Nishanthan; Wydenbach, Kirsty

    2013-08-01

    The safety of trial subjects is the tenet that guides the regulatory assessment of a Clinical Trial Authorization application and applies equally to trials involving small molecules and those with biological/biotechnological products, including Advanced Therapy Medicinal Products. The objective of a regulator is to ensure that the potential risk faced by a trial subject is outweighed by the potential benefit to them from taking part in the trial. The focus of the application review is to assess whether risks have been identified and appropriate steps taken to alleviate these as much as possible. Other factors are also taken into account during a review, such as regulatory requirements, and emerging non-clinical and clinical data from other trials on the same or similar products. This paper examines the regulatory review process of a Clinical Trial Authorization application from the perspectives of Quality, Non-Clinical and Clinical Regulatory Assessors at the Medicines and Healthcare products Regulatory Agency. It should be noted that each perspective has highlighted specific issues from their individual competence and that these can be different between the disciplines.

  11. Biological production of ethanol from coal. Final report

    Energy Technology Data Exchange (ETDEWEB)

    1992-12-01

    Due to the abundant supply of coal in the United States, significant research efforts have occurred over the past 15 years concerning the conversion of coal to liquid fuels. Researchers at the University of Arkansas have concentrated on a biological approach to coal liquefaction, starting with coal-derived synthesis gas as the raw material. Synthesis gas, a mixture of CO, H{sub 2}, CO{sub 2}, CH{sub 4} and sulfur gases, is first produced using traditional gasification techniques. The CO, CO{sub 2} and H{sub 2} are then converted to ethanol using a bacterial culture of Clostridium 1jungdahlii. Ethanol is the desired product if the resultant product stream is to be used as a liquid fuel. However, under normal operating conditions, the ``wild strain`` produces acetate in favor of ethanol in conjunction with growth in a 20:1 molar ratio. Research was performed to determine the conditions necessary to maximize not only the ratio of ethanol to acetate, but also to maximize the concentration of ethanol resulting in the product stream.

  12. Systems biology of recombinant protein production using Bacillus megaterium.

    Science.gov (United States)

    Biedendieck, Rebekka; Borgmeier, Claudia; Bunk, Boyke; Stammen, Simon; Scherling, Christian; Meinhardt, Friedhelm; Wittmann, Christoph; Jahn, Dieter

    2011-01-01

    The Gram-negative bacterium Escherichia coli is the most widely used production host for recombinant proteins in both academia and industry. The Gram-positive bacterium Bacillus megaterium represents an increasingly used alternative for high yield intra- and extracellular protein synthesis. During the past two decades, multiple tools including gene expression plasmids and production strains have been developed. Introduction of free replicating and integrative plasmids into B. megaterium is possible via protoplasts transformation or transconjugation. Using His(6)- and StrepII affinity tags, the intra- or extracellular produced proteins can easily be purified in one-step procedures. Different gene expression systems based on the xylose controlled promoter P(xylA) and various phage RNA polymerase (T7, SP6, K1E) driven systems enable B. megaterium to produce up to 1.25g of recombinant protein per liter. Biomass concentrations of up to 80g/l can be achieved by high cell density cultivations in bioreactors. Gene knockouts and gene replacements in B. megaterium are possible via an optimized gene disruption system. For a safe application in industry, sporulation and protease-deficient as well as UV-sensitive mutants are available. With the help of the recently published B. megaterium genome sequence, it is possible to characterize bottle necks in the protein production process via systems biology approaches based on transcriptome, proteome, metabolome, and fluxome data. The bioinformatical platform (Megabac, http://www.megabac.tu-bs.de) integrates obtained theoretical and experimental data. PMID:21943898

  13. Assessing quality and safety of food and beverage products in Albanian processing enterprises

    OpenAIRE

    Kapaj, Ilir

    2012-01-01

    It is apparent that the consumers, for many reasons, do not have the ability to control directly the product they are purchasing. It is the FBE who have the ability to control and manage the quality and the safety of the products keeping in mind the customers? expectations of a product in terms of quality and safety. The mechanism that realizes this demand today is certification, a process that every product and system of quality and safety management in an enterprise should undergo. The mana...

  14. Enhanced saccharification of biologically pretreated wheat straw for ethanol production.

    Science.gov (United States)

    López-Abelairas, M; Lu-Chau, T A; Lema, J M

    2013-02-01

    The biological pretreatment of lignocellulosic biomass with white-rot fungi for the production of bioethanol is an alternative to the most used physico-chemical processes. After biological treatment, a solid composed of cellulose, hemicellulose, and lignin-this latter is with a composition lower than that found in the initial substrate-is obtained. On the contrary, after applying physico-chemical methods, most of the hemicellulose fraction is solubilized, while cellulose and lignin fractions remain in the solid. The optimization of the combination of cellulases and hemicellulases required to saccharify wheat straw pretreated with the white-rot fungus Irpex lacteus was carried out in this work. The application of the optimal dosage made possible the increase of the sugar yield from 33 to 54 %, and at the same time the reduction of the quantity of enzymatic mixture in 40 %, with respect to the initial dosage. The application of a pre-hydrolysis step with xylanases was also studied. PMID:23306886

  15. The Effect of Safety System on Production Indices

    OpenAIRE

    Manouchehr Omidvari; Naser Javaheri; Masoud Davudi

    2012-01-01

    Nowadays, in addition to implement the quality of management systems and environment management and due to the effects of safety and health issues on working processes, the organizations have also sought to acquire health and safety management systems. This descriptive –analytic and past reviewing study has been implemented based on five years (from 2006 to 2010) recorded documents and statistics information in food industrial. Information was collected based on the food industries checklists...

  16. Production and biological activities of yellow pigments from Monascus fungi.

    Science.gov (United States)

    Chen, Gong; Wu, Zhenqiang

    2016-08-01

    Monascus yellow pigments (MYPs), are azaphilone compounds and one of the three main components of total Monascus pigments (MPs). Thirty-five hydrophilic or hydrophobic MYPs have been identified, with the majority being hydrophobic. Apart from screening special Monascus strains, some advanced approaches, such as extractive and high-cell-density fermentations, have been applied for developing or producing new MYPs, especially extracellular hydrophilic MYPs. The outstanding performance of MYPs in terms of resistance to photodegradation, as well as tolerance for temperature and pH, give natural MYPs reasonable prospects, compared with the orange and red MPs, for practical use in the present and future. Meanwhile, MYPs have shown promising potential for applications in the food and pharmaceutical industries based on their described bioactivities. This review briefly summarizes the reports to date on chemical structures, biological activities, biosynthetic pathways, production technologies, and physicochemical performances of MYPs. The existing problems for MYPs are discussed and research prospects proposed. PMID:27357404

  17. SAFETY

    CERN Multimedia

    Niels Dupont

    2013-01-01

    CERN Safety rules and Radiation Protection at CMS The CERN Safety rules are defined by the Occupational Health & Safety and Environmental Protection Unit (HSE Unit), CERN’s institutional authority and central Safety organ attached to the Director General. In particular the Radiation Protection group (DGS-RP1) ensures that personnel on the CERN sites and the public are protected from potentially harmful effects of ionising radiation linked to CERN activities. The RP Group fulfils its mandate in collaboration with the CERN departments owning or operating sources of ionising radiation and having the responsibility for Radiation Safety of these sources. The specific responsibilities concerning "Radiation Safety" and "Radiation Protection" are delegated as follows: Radiation Safety is the responsibility of every CERN Department owning radiation sources or using radiation sources put at its disposition. These Departments are in charge of implementing the requi...

  18. 77 FR 45242 - Revisions to Safety Standards for Durable Infant or Toddler Products: Infant Bath Seats and Full...

    Science.gov (United States)

    2012-07-31

    ... promulgate consumer product safety standards for durable infant or toddler products. The law requires that... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY...: Infant Bath Seats and Full-Size Cribs AGENCY: Consumer Product Safety Commission. ACTION: Direct...

  19. Synthetic Biology in the FDA Realm: Toward Productive Oversight Assessment.

    Science.gov (United States)

    Fatehi, Leili; Hall, Ralph F

    2015-01-01

    Synthetic biology (SB) is expected to create tremendous opportunities in a wide range of areas, including in foods, therapeutics, and diagnostics subject to regulatory oversight by the United States Food and Drug Administration. At the same time, there is substantial basis for concern about the uncertainties of accurately assessing the human health and environmental risks of such SB products. As such, SB is the latest in a string of emerging technologies that is the subject of calls for new approaches to regulation and oversight that involve "thinking ahead" to anticipate governance challenges upstream of technological development and adopting oversight mechanisms that are both adaptive to new information about risks and reflexive to performance data and feedback on policy outcomes over time. These new approaches constitute a marked departure from the status quo, and their development and implementation will require considerable time, resources, and reallocation of responsibilities. Furthermore, in order to develop an appropriate oversight response, adaptive or otherwise, there is first a need to identify the specific types and natures of applications, uncertainties, and regulatory issues that are likely to pose oversight challenges. This article presents our vision for a Productive Oversight Assessment (POA) approach in which the abilities and deficits of an oversight system are evaluated with the aim of enabling productive decisions (i.e., timely, feasible, effective for achieving desired policy outcomes) about oversight while also building capacity to facilitate broader governance efforts. The value ofPOA is two-fold. First, it will advance the development of a generalizable approach for making productive planning and decision-making about the oversight of any given new technology that presents challenges and uncertainties for any given oversight system whose policy goals are implicated by that technology. Second, this effort can enhance the very processes

  20. 78 FR 59632 - Oil and Gas and Sulphur Operations on the Outer Continental Shelf-Oil and Gas Production Safety...

    Science.gov (United States)

    2013-09-27

    ... proposed rulemaking on production safety systems on August 22, 2013 (78 FR 52240). The proposed rule would... Bureau of Safety and Environmental Enforcement 30 CFR Part 250 RIN 1014-AA10 Oil and Gas and Sulphur Operations on the Outer Continental Shelf--Oil and Gas Production Safety Systems AGENCY: Bureau of Safety...

  1. 77 FR 3780 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2012-01-25

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related Biological..., Parasitic and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics...

  2. Flow and performance of an air-curtain biological safety cabinet.

    Science.gov (United States)

    Huang, Rong Fung; Chou, Chun I

    2009-06-01

    Using laser-assisted smoke flow visualization and tracer gas concentration detection techniques, this study examines aerodynamic flow properties and the characteristics of escape from containment, inward dispersion, and cross-cabinet contamination of a biological safety cabinet installed with an air curtain across the front aperture. The experimental method partially simulates the NSF/ANSI 49 standards with the difference that the biological tracer recommended by these standards is replaced by a mixture of 10% SF(6) in N(2). The air curtain is set up across the cabinet aperture plane by means of a narrow planar jet issued from the lower edge of the sash and a suction flow going through a suction slot installed at the front edge of the work surface. Varying the combination of jet velocity, suction flow velocity, and descending flow velocity reveals three types of characteristic flow modes: 'straight curtain', 'slightly concave curtain', and 'severely concave curtain'. Operating the cabinet in the straight curtain mode causes the air curtain to impinge on the doorsill and therefore induces serious escape from containment. In the severely concave curtain mode, drastically large inward dispersion and cross-cabinet contamination were observed because environmental air entered into the cabinet and a three-dimensional vortical flow structure formed in the cabinet. The slightly concave curtain mode presents a smooth and two-dimensional flow pattern with an air curtain separating the outside atmosphere from the inside space of the cabinet, and therefore exhibited negligibly small escape from containment, inward dispersion, and cross-cabinet contamination.

  3. Biological conversion of pyrolytic products to ethanol and lipids

    Science.gov (United States)

    Lian, Jieni

    Pyrolysis is a promising technology that can convert up to 75 % of lignocellulosic biomass into crude bio-oil. However, due to the complex chemical compositions of bio-oil, its further refining into fuels and high value chemicals faces great challenges. This dissertation research proposed new technologies for biological conversion of pyrolytic products derived from cellulose and hemicellulose, such as anhydrosugars and carbolic acids to fuels and chemicals. First, the pyrolytic anhydrosugars (chiefly levoglucosan (LG)) were hydrolysed into glucose followed by neutralization, detoxification and fermentation to produce ethanol by ethanogenetic yeast and lipids by oleaginous yeasts. Second, a novel process for the conversion of C1-C4 pyrolytic products to lipid with oleaginous yeasts was investigated. Third, oleaginous yeasts that can directly convert LG to lipids were studied and a recombined yeast with LG kinase was constructed for the direct convertion of LG into lipids. This allowed a reduction of existing process for LG fermentation from four steps into two steps and eliminated the need for acids and bases as well as the disposal of chemicals. The development of genetic modified organisms with LG kinase opens a promising avenue for the direct LG fermentation to produce a wide range of fuels and chemicals. The simplification of LG utilization process would enhance the economic viability of this technology.

  4. Competency development in antibody production in cancer cell biology

    Energy Technology Data Exchange (ETDEWEB)

    Park, M.S.

    1998-12-01

    This is the final report of a three-year, Laboratory Directed Research and Development (LDRD) project at Los Alamos National Laboratory (LANL). The main objective of this project was to develop a rapid recombinant antibody production technology. To achieve the objective, the authors employed (1) production of recombinant antigens that are important for cell cycle regulation and DNA repair, (2) immunization and specific selection of antibody-producing lymphocytes using the flow cytometry and magnetic bead capturing procedure, (3) construction of single chain antibody library, (4) development of recombinant vectors that target, express, and regulate the expression of intracellular antibodies, and (5) specific inhibition of tumor cell growth in tissue culture. The authors have accomplished (1) optimization of a selection procedure to isolate antigen-specific lymphocytes, (2) optimization of the construction of a single-chain antibody library, and (3) development of a new antibody expression vector for intracellular immunization. The future direction of this research is to continue to test the potential use of the intracellular immunization procedure as a tool to study functions of biological molecules and as an immuno-cancer therapy procedure to inhibit the growth of cancer cells.

  5. Biological hydrogen production measured in batch anaerobic respirometers.

    Science.gov (United States)

    Logan, Bruce E; Oh, Sang-Eun; Kim, In S; Van Ginkel, Steven

    2002-06-01

    The biological production of hydrogen from the fermentation of different substrates was examined in batch tests using heat-shocked mixed cultures with two techniques: an intermittent pressure release method (Owen method) and a continuous gas release method using a bubble measurement device (respirometric method). Under otherwise identical conditions, the respirometric method resulted in the production of 43% more hydrogen gas from glucose than the Owen method. The lower conversion of glucose to hydrogen using the Owen protocol may have been produced by repression of hydrogenase activity from high partial pressures in the gastight bottles, but this could not be proven using a thermodynamic/rate inhibition analysis. In the respirometric method, total pressure in the headspace never exceeded ambient pressure, and hydrogen typically composed as much as 62% of the headspace gas. High conversion efficiencies were consistently obtained with heat-shocked soils taken at different times and those stored for up to a month. Hydrogen gas composition was consistently in the range of 60-64% for glucose-grown cultures during logarithmic growth but declined in stationary cultures. Overall, hydrogen conversion efficiencies for glucose cultures were 23% based on the assumption of a maximum of 4 mol of hydrogen/ mol of glucose. Hydrogen conversion efficiencies were similar for sucrose (23%) and somewhat lower for molasses (15%) but were much lower for lactate (0.50%) and cellulose (0.075%).

  6. Safety

    CERN Multimedia

    2003-01-01

    Please note that the safety codes A9, A10 AND A11 (ex annexes of SAPOCO/42) entitled respectively "Safety responsibilities in the divisions" "The safety policy committee (SAPOCO) and safety officers' committees" and "Administrative procedure following a serious accident or incident" are available on the web at the following URLs: Code A9: http://edms.cern.ch/document/337016/LAST_RELEASED Code A10: http://edms.cern.ch/document/337019/LAST_RELEASED Code A11: http://edms.cern.ch/document/337026/LAST_RELEASED Paper copies can also be obtained from the TIS divisional secretariat, e-mail: tis.secretariat@cern.ch. TIS Secretariat

  7. Study on the Problems and Countermeasure in the Animal Products Quality and Safety

    Institute of Scientific and Technical Information of China (English)

    Shishan; WANG

    2013-01-01

    As the supply chain of animal products is long,there are many factors which would influence the quality safety of animal production.Therefore,by focusing on the present and having a vision for future,Jiaozuo government promulgated Ten Polices on the Food Safety in Jiaozuo City,which pushed forward the technological development,intensified measures to monitor the quality of animal products,set up a series of mechanism,and provided reference for the food quality and safety monitoring.

  8. Management of Rheumatoid Arthritis Patients with Interstitial Lung Disease: Safety of Biological Antirheumatic Drugs and Assessment of Pulmonary Fibrosis.

    Science.gov (United States)

    Mori, Shunsuke

    2015-01-01

    Interstitial lung disease (ILD) is one of the major causes of morbidity and mortality of patients with rheumatoid arthritis (RA). Accompanying the increased number of reports on the development or exacerbation of ILD in RA patients following therapy with biological disease-modifying antirheumatic drugs (DMARDs), RA-associated ILD (RA-ILD) has aroused renewed interest. Although such cases have been reported mainly in association with the use of tumor necrosis factor inhibitors, the use of other biological DMARDs has also become a matter of concern. Nevertheless, it is difficult to establish a causative relationship between the use of biological DMARDs and either the development or exacerbation of ILD. Such pulmonary complications may occur in the natural course of RA regardless of the use of biological DMARDs. Since rheumatologists currently aim to achieve remission in RA patients, the administration of biological DMARDs is increasing, even for those with RA-ILD. However, there are no reliable, evidence-based guidelines for deciding whether biological DMARDs can be safely introduced and continued in RA-ILD patients. A standardized staging system for pulmonary conditions of RA-ILD patients is needed when making therapeutic decisions at baseline and monitoring during biological DMARD therapy. Based on the available information regarding the safety of biological DMARDs and the predictive factors for a worse prognosis, this review discusses candidate parameters for risk evaluation of ILD in RA patients who are scheduled to receive biological antirheumatic therapy.

  9. Chemical compositional, biological, and safety studies of a novel maple syrup derived extract for nutraceutical applications.

    Science.gov (United States)

    Zhang, Yan; Yuan, Tao; Li, Liya; Nahar, Pragati; Slitt, Angela; Seeram, Navindra P

    2014-07-16

    Maple syrup has nutraceutical potential given the macronutrients (carbohydrates, primarily sucrose), micronutrients (minerals and vitamins), and phytochemicals (primarily phenolics) found in this natural sweetener. We conducted compositional (ash, fiber, carbohydrates, minerals, amino acids, organic acids, vitamins, phytochemicals), in vitro biological, and in vivo safety (animal toxicity) studies on maple syrup extracts (MSX-1 and MSX-2) derived from two declassified maple syrup samples. Along with macronutrient and micronutrient quantification, thirty-three phytochemicals were identified (by HPLC-DAD), and nine phytochemicals, including two new compounds, were isolated and identified (by NMR) from MSX. At doses of up to 1000 mg/kg/day, MSX was well tolerated with no signs of overt toxicity in rats. MSX showed antioxidant (2,2-diphenyl-1-picrylhydrazyl (DPPH) assay) and anti-inflammatory (in RAW 264.7 macrophages) effects and inhibited glucose consumption (by HepG2 cells) in vitro. Thus, MSX should be further investigated for potential nutraceutical applications given its similarity in chemical composition to pure maple syrup.

  10. IT safety in production data networks (PDN). Tracking, evaluation and elimination of safety threats; IT-Sicherheit in Produktionsnetzen (PDN). Aufspueren, einschaetzen und beseitigen von Sicherheitsbedrohungen

    Energy Technology Data Exchange (ETDEWEB)

    Neider, Ulrich [DETACK GmbH, Ludwigsburg (Germany)

    2013-03-01

    This contribution reports on the threats of production data networks. Within the context of the IT security, the risks of production data networks are not only based on a possible contamination by computer viruses. The author of this contribution increases awareness of dangers to whose production systems are faced. The author also presents a phase model from his own consulting practice in order to increase the safety of production data systems by implementation of a safety control. This phase model consists of the six following steps: (a) Stock taking of the state of the art; (b) Determination of the target (development of a safety concept); (c) Creation of an IT safety policy; (d) Application of IT safety policy; (e) Audit of the results (IT safety audit); (f) Regular safety tests.

  11. Food safety management systems performance in the lamb production chain

    NARCIS (Netherlands)

    Oses, S.M.; Luning, P.A.; Jacxsens, L.; Jaime, I.; Rovira, J.

    2012-01-01

    This study describes a performance measurement of implemented food safety management system (FSMS) along the lamb chain using an FSMS-diagnostic instrument (FSMS-DI) and a Microbiological Assessment Scheme (MAS). Three slaughterhouses, 1 processing plant and 5 butcher shops were evaluated. All the a

  12. Consumer Product Safety: What's It All About? Teacher's Guide. No. 8-T.

    Science.gov (United States)

    Consumer Product Safety Commission, Washington, DC.

    Designed as a flexible resource, this material may be used independently or in conjunction with existing safety, health, consumer education, economics, or social studies units. To facilitate the incorporation of product safety information into the curriculum, the suggested activities section lists major concepts to be developed and indicates…

  13. Towards a decision support system for control of multiple food safety hazards in raw milk production

    NARCIS (Netherlands)

    Spiegel, van der M.; Sterrenburg, P.; Haasnoot, W.; Fels-Klerx, van der H.J.

    2013-01-01

    Decision support systems (DSS) for controlling multiple food safety hazards in raw milk production have not yet been developed, but the underlying components are fragmentarily available. This article presents the state-of-the-art of essential DSS elements for judging food safety compliance of raw mi

  14. Moderating effect of perceived risk on the relationship between product safety and intention

    Directory of Open Access Journals (Sweden)

    Sarina Ismail

    2015-02-01

    Full Text Available Herbal Products industry has experienced significant growth in product demand. Therefore, this study aims to identify the factors effecting the actual buying of Herbal Product. This study also examines the moderation effect of perceived risk on the relationship between product safety and intention. Mall intercept survey was used to collect data from six various states in Malaysia. The data is analyzed using Partial Least Squares (PLS path modeling. The path coefficient results supported the direct influence of intention on actual buying. Similarly, the findings reveal that perceived risk moderate the relationship between product safety and buying intention.

  15. 16 CFR 1500.88 - Exemptions from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

    Science.gov (United States)

    2010-01-01

    ... 101 of the Consumer Product Safety Improvement Act for certain electronic devices. 1500.88 Section 1500.88 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION FEDERAL HAZARDOUS SUBSTANCES ACT... from lead limits under section 101 of the Consumer Product Safety Improvement Act for...

  16. 77 FR 10358 - Acceptance of ASTM F963-11 as a Mandatory Consumer Product Safety Standard

    Science.gov (United States)

    2012-02-22

    ... From the Federal Register Online via the Government Publishing Office CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Chapter II Acceptance of ASTM F963-11 as a Mandatory Consumer Product Safety Standard AGENCY: Consumer Product Safety Commission. ACTION: Acceptance of standard. SUMMARY: The Consumer...

  17. 9 CFR 105.3 - Notices re: worthless, contaminated, dangerous, or harmful biological products.

    Science.gov (United States)

    2010-01-01

    ..., dangerous, or harmful biological products. 105.3 Section 105.3 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS SUSPENSION, REVOCATION, OR TERMINATION OF BIOLOGICAL LICENSES OR PERMITS §...

  18. Construction of the All-region Linkage System for Emergency Management of Agricultural Product Quality and Safety in West China

    Institute of Scientific and Technical Information of China (English)

    Hua; YU; Yanbin; QI; Yubao; YAN

    2013-01-01

    Quality and safety of agricultural products are significant for national socioeconomic development,sustainable development,and vital interests of people.To safeguard quality and safety of agricultural products in west China is to safeguard economic safety and ecological safety of the country,public health and social stability,of which an important task is to properly handle emergencies concerning quality and safety of agricultural products.Considering actual conditions of west China,suggestions are given to construct the all-region linkage system for emergency management of agricultural product quality and safety in the local area,enhance the all-region linkage,and improve the linkage efficiency.

  19. Space Biology and Medicine. Volume 4; Health, Performance, and Safety of Space Crews

    Science.gov (United States)

    Dietlein, Lawrence F. (Editor); Pestov, Igor D. (Editor)

    2004-01-01

    Volume IV is devoted to examining the medical and associated organizational measures used to maintain the health of space crews and to support their performance before, during, and after space flight. These measures, collectively known as the medical flight support system, are important contributors to the safety and success of space flight. The contributions of space hardware and the spacecraft environment to flight safety and mission success are covered in previous volumes of the Space Biology and Medicine series. In Volume IV, we address means of improving the reliability of people who are required to function in the unfamiliar environment of space flight as well as the importance of those who support the crew. Please note that the extensive collaboration between Russian and American teams for this volume of work resulted in a timeframe of publication longer than originally anticipated. Therefore, new research or insights may have emerged since the authors composed their chapters and references. This volume includes a list of authors' names and addresses should readers seek specifics on new information. At least three groups of factors act to perturb human physiological homeostasis during space flight. All have significant influence on health, psychological, and emotional status, tolerance, and work capacity. The first and most important of these factors is weightlessness, the most specific and radical change in the ambient environment; it causes a variety of functional and structural changes in human physiology. The second group of factors precludes the constraints associated with living in the sealed, confined environment of spacecraft. Although these factors are not unique to space flight, the limitations they entail in terms of an uncomfortable environment can diminish the well-being and performance of crewmembers in space. The third group of factors includes the occupational and social factors associated with the difficult, critical nature of the

  20. High-pressure processing of berry and other fruit products: implications for bioactive compounds and food safety.

    Science.gov (United States)

    Tadapaneni, Ravi Kiran; Daryaei, Hossein; Krishnamurthy, Kathiravan; Edirisinghe, Indika; Burton-Freeman, Britt M

    2014-05-01

    Fruits contain a variety of nutrients and polyphenols that are associated with health benefits. Year-round availability of fresh fruits is limited due to perishability. Processing fruits extends shelf life. Individual quick-frozen fruit is the most common for fruits, but nowadays, processing fruits into beverages offers extended shelf life and new market opportunities. Conventional thermal processing is an effective method for producing safe, extended shelf life, and shelf-stable products, including beverages. However, the high temperatures negatively affect nutritive quality by destroying essential nutrients and biologically active "non-essential" components such as polyphenols. Therefore, novel technologies that can preserve nutrient quality while ensuring food safety are warranted. In this review, the application of high-pressure processing (HPP) for preserving nutrients and phytochemicals while ensuring microbiological safety in beverages and other foods containing fruits is discussed.

  1. Integrated anaerobic/aerobic biological treatment for intensive swine production.

    Science.gov (United States)

    Bortone, Giuseppe

    2009-11-01

    Manure processing could help farmers to effectively manage nitrogen (N) surplus load. Many pig farms have to treat wastewater. Piggery wastewater treatment is a complex challenge, due to the high COD and N concentrations and low C/N ratio. Anaerobic digestion (AD) could be a convenient pre-treatment, particularly from the energetic view point and farm income, but this causes further reduction of C/N ratio and makes denitrification difficult. N removal can only be obtained integrating anaerobic/aerobic treatment by taking into account the best use of electron donors. Experiences gained in Italy during development of integrated biological treatment approaches for swine manure, from bench to full scale, are reported in this paper. Solid/liquid separation as pre-treatment of raw manure is an efficient strategy to facilitate liquid fraction treatment without significantly lowering C/N ratio. In Italy, two full scale SBRs showed excellent efficiency and reliability. Current renewable energy policy and incentives makes economically attractive the application of AD to the separated solid fraction using high solid anaerobic digester (HSAD) technology. Economic evaluation showed that energy production can reduce costs up to 60%, making sustainable the overall treatment. PMID:19135363

  2. Diffuse large B-cell lymphoma associated with the use of biologic and other investigational agents: the importance of long-term post-marketing safety surveillance.

    Science.gov (United States)

    Goddard, Allison; Borovicka, Judy H; West, Dennis P; Evens, Andrew M; Laumann, Anne

    2011-01-01

    This case report describes a patient who developed diffuse large B-cell lymphoma (DLBCL) after receiving courses of two investigational biologic agents and cyclosporine followed by more than four years of subcutaneous efalizumab for the treatment of extensive chronic plaque psoriasis. Three years later, the patient remains free of lymphoma and his psoriasis is well controlled with thrice-weekly narrow-band ultraviolet phototherapy. This case emphasizes the importance of continued long-term post-marketing safety surveillance and the early reporting of all possible serious side effects, including cancers, related to the use of any newly available product. In particular, surveillance should focus on the immunomodulating biologic agents in order to identify possible dangerous sequelae.

  3. The application of transcriptomics in the comparative safety assessment of (GMO-derived) plant products

    OpenAIRE

    Kok, E.J.

    2008-01-01

    National and international organizations have discussed current approaches to the safety assessment of complex (plant) food products in general and the safety assessment of GMO-derived food products in particular. One of the recommendations of different expert meetings was that the new analytical techniques, in particular the ‘omics’ approaches, need to be explored for their potential to improve the analysis and thereby the toxicological and nutritional assessment of complex (GMO-derived) pla...

  4. Assessment of Primary Production of Horticultural Safety Management Systems of Mushroom Farms in South Africa.

    Science.gov (United States)

    Dzingirayi, Garikayi; Korsten, Lise

    2016-07-01

    Growing global consumer concern over food safety in the fresh produce industry requires producers to implement necessary quality assurance systems. Varying effectiveness has been noted in how countries and food companies interpret and implement food safety standards. A diagnostic instrument (DI) for global fresh produce industries was developed to measure the compliancy of companies with implemented food safety standards. The DI is made up of indicators and descriptive grids for context factors and control and assurance activities to measure food safety output. The instrument can be used in primary production to assess food safety performance. This study applied the DI to measure food safety standard compliancy of mushroom farming in South Africa. Ten farms representing almost half of the industry farms and more than 80% of production were independently assessed for their horticultural safety management system (HSMS) compliance via in-depth interviews with each farm's quality assurance personnel. The data were processed using Microsoft Office Excel 2010 and are represented in frequency tables. The diagnosis revealed that the mushroom farming industry had an average food safety output. The farms were implementing an average-toadvanced HSMS and operating in a medium-risk context. Insufficient performance areas in HSMSs included inadequate hazard analysis and analysis of control points, low specificity of pesticide assessment, and inadequate control of suppliers and incoming materials. Recommendations to the industry and current shortcomings are suggested for realization of an improved industry-wide food safety assurance system.

  5. Assessment of Primary Production of Horticultural Safety Management Systems of Mushroom Farms in South Africa.

    Science.gov (United States)

    Dzingirayi, Garikayi; Korsten, Lise

    2016-07-01

    Growing global consumer concern over food safety in the fresh produce industry requires producers to implement necessary quality assurance systems. Varying effectiveness has been noted in how countries and food companies interpret and implement food safety standards. A diagnostic instrument (DI) for global fresh produce industries was developed to measure the compliancy of companies with implemented food safety standards. The DI is made up of indicators and descriptive grids for context factors and control and assurance activities to measure food safety output. The instrument can be used in primary production to assess food safety performance. This study applied the DI to measure food safety standard compliancy of mushroom farming in South Africa. Ten farms representing almost half of the industry farms and more than 80% of production were independently assessed for their horticultural safety management system (HSMS) compliance via in-depth interviews with each farm's quality assurance personnel. The data were processed using Microsoft Office Excel 2010 and are represented in frequency tables. The diagnosis revealed that the mushroom farming industry had an average food safety output. The farms were implementing an average-toadvanced HSMS and operating in a medium-risk context. Insufficient performance areas in HSMSs included inadequate hazard analysis and analysis of control points, low specificity of pesticide assessment, and inadequate control of suppliers and incoming materials. Recommendations to the industry and current shortcomings are suggested for realization of an improved industry-wide food safety assurance system. PMID:27357039

  6. The causes and determination of safety stocks in upstream supply chains for mass production of customized products

    OpenAIRE

    CAMISULLIS, Carole; Giard, Vincent; Mendy-Bilek, Gisele

    2010-01-01

    In an upstream supply chain dedicated to the mass production of customized products, many sources create production instability: the level and structure of production in the final assembly line, variability of lead times, quality issues, packaging and loading constraints on transportation, demand anticipation, and the synchronization of the flows of components sent, received, and produced. For periodic replenishment systems, each member of the supply chain must have two different safety stock...

  7. A Disadvantageous Dichotomy in Product Safety Law – Some Reflections on Sense and Nonsense of the Distinction Food–Nonfood in European Product Safety Law

    NARCIS (Netherlands)

    Brack, Antoni

    2009-01-01

    This paper researches a number of similarities and differences between European legal regimens with regard to food and non–food product safety, based on the assumption that these regimens may have overly diverged. A tentative conclusion is that there are enough similarities to justify an effort to r

  8. Health, safety, and environmental risk assessment of steel production complex in central Iran using TOPSIS.

    Science.gov (United States)

    Jozi, S A; Majd, N Moradi

    2014-10-01

    This research was carried out with the aim of presenting an environmental management plan for steel production complex (SPC) in central Iran. Following precise identification of the plant activities as well as the study area, possible sources of environmental pollution and adverse impacts on the air quality, water, soil, biological environment, socioeconomic and cultural environment, and health and safety of the employees were determined considering the work processes of the steel complex. Afterwards, noise, wastewater, and air pollution sources were measured. Subsequently, factors polluting the steel complex were identified by TOPSIS and then prioritized using Excel Software. Based on the obtained results, the operation of the furnaces in hot rolling process with the score 1, effluent derived from hot rolling process with the score 0.565, nonprincipal disposal and dumping of waste at the plant enclosure with the score 0.335, walking beam process with the score 1.483 respectively allocated themselves the highest priority in terms of air, water, soil and noise pollution. In terms of habitats, land cover and socioeconomic and cultural environment, closeness to the forest area and the existence of four groups of wildlife with the score 1.106 and proximity of villages and residential areas to the plant with the score 3.771 respectively enjoyed the highest priorities while impressibility and occupational accidents with the score 2.725 and cutting and welding operations with score 2.134 had the highest priority among health and safety criteria. Finally, strategies for the control of pollution sources were identified and Training, Monitoring and environmental management plan of the SPC was prepared. PMID:25049141

  9. Biological evaluation of recombinant human erythropoietin in pharmaceutical products

    Directory of Open Access Journals (Sweden)

    Ramos A.S.

    2003-01-01

    Full Text Available The potencies of mammalian cell-derived recombinant human erythropoietin pharmaceutical preparations, from a total of five manufacturers, were assessed by in vivo bioassay using standardized protocols. Eight-week-old normocythemic mice received a single subcutaneous injection followed by blood sampling 96 h later or multiple daily injections with blood sampling 24 h after the last injection. Reticulocyte counting by microscopic examination was employed as the end-point using the brilliant cresyl blue or selective hemolysis methods, together with automated flow cytometry. Different injection schedules were investigated and dose-response curves for the European Pharmacopoeia Biological Reference Preparation of erythropoietin were compared. Manual and automated methods of reticulocyte counting were correlated with respect to assay validity and precision. Using 8 mice per treatment group, intra-assay precision determined for all of the assays in the study showed coefficients of variation of 12.1-28.4% for the brilliant cresyl blue method, 14.1-30.8% for the selective hemolysis method and 8.5-19.7% for the flow cytometry method. Applying the single injection protocol, a combination of at least two independent assays was required to achieve the precision potency and confidence limits indicated by the manufacturers, while the multiple daily injection protocol yielded the same acceptable results within a single assay. Although the latter protocol using flow cytometry for reticulocyte counting gave more precise and reproducible results (intra-assay coefficients of variation: 5.9-14.2%, the well-characterized manual methods provide equally valid alternatives for the quality control of recombinant human erythropoietin therapeutic products.

  10. Improving food safety in the supply chain: Integrating traceability in production and distribution planning

    DEFF Research Database (Denmark)

    Grunow, Martin; Rong, Aiying; Akkerman, Renzo

    2008-01-01

    on production and distribution planning. Here, we develop a methodology for production and distribution planning in food supply chains which minimizes production and logistics costs and at the same time reduces food safety concerns, limits the size of potential recalls, and satisfies product quality......After a number of food safety crises, the design and implementation of traceability systems became an important focus of the food industry. As a result, food product traceability ranks high on senior management agendas for supply chain activities. In the literature, numerous studies deal...... with traceability from the viewpoint of information system development and technology development such as radio frequency identification (RFID) and DNA-based techniques. However, traceability and its implications for food safety are thus far not incorporated in the standard operations management literature...

  11. 9 CFR 103.2 - Disposition of animals administered experimental biological products or live organisms.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Disposition of animals administered experimental biological products or live organisms. 103.2 Section 103.2 Animals and Animal Products ANIMAL AND... PRODUCTS; ORGANISMS AND VECTORS EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF...

  12. Development of biological platform for the autotrophic production of biofuels

    Science.gov (United States)

    Khan, Nymul

    The research described herein is aimed at developing an advanced biofuel platform that has the potential to surpass the natural rate of solar energy capture and CO2 fixation. The underlying concept is to use the electricity from a renewable source, such as wind or solar, to capture CO 2 via a biological agent, such as a microbe, into liquid fuels that can be used for the transportation sector. In addition to being renewable, the higher rate of energy capture by photovoltaic cells than natural photosynthesis is expected to facilitate higher rate of liquid fuel production than traditional biofuel processes. The envisioned platform is part of ARPA-E's (Advanced Research Projects Agency - Energy) Electrofuels initiative which aims at supplementing the country's petroleum based fuel production with renewable liquid fuels that can integrate easily with the existing refining and distribution infrastructure (http://arpae. energy.gov/ProgramsProjects/Electrofuels.aspx). The Electrofuels initiative aimed to develop liquid biofuels that avoid the issues encountered in the current generation of biofuels: (1) the reliance of biomass-derived technologies on the inefficient process of photosynthesis, (2) the relatively energy- and resource-intensive nature of agronomic processes, and (3) the occupation of large areas of arable land for feedstock production. The process proceeds by the capture of solar energy into electrical energy via photovoltaic cells, using the generated electricity to split water into molecular hydrogen (H2) and oxygen (O2), and feeding these gases, along with carbon dioxide (CO2) emitted from point sources such as a biomass or coal-fired power plant, to a microbial bioprocessing platform. The proposed microbial bioprocessing platform leverages a chemolithoautotrophic microorganism (Rhodobacter capsulatus or Ralstonia eutropha) naturally able to utilize these gases as growth substrates, and genetically modified to produce a triterpene hydrocarbon fuel

  13. Preclinical safety testing for cell-based products using animals.

    Science.gov (United States)

    McBlane, James W

    2015-09-01

    The objectives of preclinical testing include to show why there might be therapeutic benefit in patients and to provide information on the product's toxicity. For cell-based products, given even once, there may be long term exposure and this could imply, unlike for conventional drugs, that all preclinical studies may be needed prior to first human use. The duration of exposure to cells should be studied in animals to guide toxicity assessments. Distribution of cells after administration by a route resembling that intended in humans should be studied to understand potential risks. Risk of tumour formation with the product may also need to be characterised. To the extent that this information can be generated by in vitro testing, studies in animals may not be needed and limitations on the capability of preclinical data to predict human toxicity are recognised: species-specificity make some cell products act only in humans and a human cell-product might be expected to be rejected by immunocompetent animals. Does this suggest testing in immunosuppressed animals or of development of an animal-cell product supposedly similar to the human cell product? No single answer seems to fit every situation.

  14. Use of sanitizing products: safety practices and risk situations

    Directory of Open Access Journals (Sweden)

    Ana Aurélia Rocha da Silva

    2014-04-01

    Full Text Available OBJECTIVES: to evaluate the handling and risk factors for poisoning and/or digestive tract injuries associated with the use of sanitizing products at home. METHODS: interviews were conducted in 419 households from different regions, collecting epidemiological data from residents and risk habits related to the use and storage of cleaning products. RESULTS: sanitizing products considered to be a health risk were found in 98% of the households where the research was conducted, and in 54% of cases, they were stored in places easily accessible to children. Lye was found in 19%, followed by illicit products in 39% of homes. In 13% of households, people produced soap, and in 12% they stored products in non-original containers. The use of illicit products and the manufacture of handmade soap were associated with lower educational level of the household owners and with the regions and socioeconomic classes with lower purchasing power. CONCLUSIONS: risk practices such as inadequate storage, manufacturing, and use of sanitizing products by the population evidence the need for public health policies, including educational measures, as a means of preventing accidents.

  15. Problems of radiation safety of petroleum and gas production

    International Nuclear Information System (INIS)

    Oil and gas production is the basis of economy of the Azerbaijan Republic and its cause in ecological and radioecology problems. One form this problem is the pollution by radionuclides of environment at the time of gas and petroleum production. At the time of petroleum and gas production the three-phase radionuclides are emitted in atmosphere: Emissions consisted from solid U-238, Ra-226, Th-232, K-40 discharged to atmosphere at the time of production, exploring and exploitation of petroleum and gas. They are presented in compounds of sand, clay, and petroleum residues; During the drilling and production the gross quantities of water flows out and collects. These water areas consist of radium, uranium, Th and K-40 dissolved in water salts; There are the radionuclides being in 902 condition emitted in atmosphere at the places of petroleum and gas production. The radon and its isotopes are emitted at this time; At the places of petroleum and gas production it is observed at local pollution areas polluted by solid emissions that at this territories the doze of exposition power variable 100 - 1000 micro/hour. The radioactivity at this system according to 2-1000 year/k consists from Ra, K-40, and U. At this areas the value of total background changes 5 - 1000 micro R/hour. The total radioactivity of water polls formed at the places of petroleum and gas production consisted 50 -150 Bq/L. In the case of gas the separated radionuclides are mainly consisted from Radon and its isotopes. In the compound of produced gas the concentration of radon varied 20 - 1700 Bq/m3. Thus, at the places of petroleum and gas production radioactive pollutants emitted to atmosphere, forms the polluted environment for working and living people at the same territory. This problem's status haven't been investigated thoroughly, the sources of pollution hasn't been uncovered concretely, the cleaning technology for polluted areas is unknown

  16. The Impact of Companies’ Age on Safety Culture in the Metal Products Industry

    Directory of Open Access Journals (Sweden)

    Maryam Ooshaksaraie

    2009-01-01

    Full Text Available Problem statement: Safety culture is a complex structure in an organization that includes values and attitudes, most of which are potentially changeable and related to actual accident behavior. In this study, the components of safety culture included organizational commitment, management involvement, employee empowerment, reporting system and rewarding system. Approach: The numbers of occupational injuries in industries have steadily increased during recent years. The major objectives of this study were to evaluate the safety culture and to analyze the difference in safety culture in the metal products industry in Iran (Guilan province with regard to companies’ age. Metal products industry was chosen because of the higher occupational injuries rates amongst the industries in Iran. Results: The companies were chosen based on their age. A total of 714 respondents from 14 companies participated in the survey. The method used in this study was a questionnaires quantitative type based on a Lickert scale and the data collected were analyzed statistically. The one-way ANOVA was used to test for significant difference in safety culture in the metal products industry with regard to companies’ age. The results showed that safety culture was not strong based on the mean for average score of 2.58 which was less than 3 compared to the possible maximum of 5. One-way ANOVA analysis revealed that there was a significant difference among safety culture with respect to companies’ age. New companies had stronger safety culture compared to older one. Conclusion: Based on the findings the hypothesis of this study is accepted. This study also indicated that the safety culture in the metal products industry in target population group was not strong however, can be improved through improvement of its five components.

  17. Safety and efficacy of Labisia pumila containing products

    OpenAIRE

    Muhammad Syafiq Saleh; Shazwani Shaharuddin; Md. Moklesur Rahman Sarker; Long Chiau Ming

    2016-01-01

    Labisia pumila is a traditional medicinal plant which has wide therapeutic application including induction of labor and treatment of dysentery, dysmenorrhea and gonorrhea. We aimed for systematic review of the efficacy andsafety of L. pumila extract or its other commercial products availabe in Malaysian market. The marketed 500 mg capsule is composed of 40 mg L. pumila, 10 mg C. caudatum extract and 450 mg excipient. The commercial products did not follow the registration guidelines of Malays...

  18. Safety and efficacy of health supplement (Pegaga based product

    Directory of Open Access Journals (Sweden)

    Firdaus Abd Rahman

    2016-01-01

    Conclusions: Most traditional products claim contained herbs and have many indication although not proven by evidence based. Hence, consumers must be more selective before buying any health products. MOH continuing demonstrate enforcement action and educating the public in this matter. More research also must be conducted to confirm the efficacy and the appropriate dose for a particular situation either for prevention or treatment of disease.

  19. Natural product synthesis at the interface of chemistry and biology

    OpenAIRE

    Hong, Jiyong

    2014-01-01

    Nature has evolved to produce unique and diverse natural products that possess high target affinity and specificity. Natural products have been the richest sources for novel modulators of biomolecular function. Since the chemical synthesis of urea by Wöhler, organic chemists have been intrigued by natural products, leading to the evolution of the field of natural product synthesis over the past two centuries. Natural product synthesis has enabled natural products to play an essential role in ...

  20. Hydrological structure and biological productivity of the tropical Indian Ocean

    Digital Repository Service at National Institute of Oceanography (India)

    Muraleedharan, U.D.; Muraleedharan, P.M.

    Hydrological structure analyses of regions in the tropical Atlantic Ocean have consistently revealed the existence of a typical tropical structure characterized by a nitrate-depleted mixed layer above the thermocline. The important biological...

  1. 78 FR 20663 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-04-05

    ... DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... portion of the meeting will be closed to the public. Name of Committee: Vaccines and Related...

  2. 75 FR 17929 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-04-08

    ... will review and discuss available data regarding the unexpected finding of DNA originating from porcine... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory...

  3. 76 FR 3639 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-01-20

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... selection of strains to be included in the influenza virus vaccine for the 2011-2012 influenza season....

  4. 75 FR 2876 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2010-01-19

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... selection of strains to be included in the influenza virus vaccine for the 2010 - 2011 influenza season....

  5. 78 FR 5465 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-01-25

    ... HUMAN SERVICES Food and Drug Administration Vaccines and Related Biological Products Advisory Committee... be open to the public. Name of Committee: Vaccines and Related Biological Products Advisory Committee... strains to be included in the influenza virus vaccine for the 2013- 2014 influenza season. FDA intends...

  6. Off-label biologic regimens in psoriasis: a systematic review of efficacy and safety of dose escalation, reduction, and interrupted biologic therapy.

    Directory of Open Access Journals (Sweden)

    Elizabeth A Brezinski

    Full Text Available OBJECTIVES: While off-label dosing of biologic treatments may be necessary in selected psoriasis patients, no systematic review exists to date that synthesizes the efficacy and safety of these off-label dosing regimens. The aim of this systematic review is to evaluate efficacy and safety of off-label dosing regimens (dose escalation, dose reduction, and interrupted treatment with etanercept, adalimumab, infliximab, ustekinumab, and alefacept for psoriasis treatment. DATA SOURCES AND STUDY SELECTION: We searched OVID Medline from January 1, 1990 through August 1, 2011 for prospective clinical trials that studied biologic therapy for psoriasis treatment in adults. Individual articles were screened for studies that examined escalated, reduced, or interrupted therapy with etanercept, adalimumab, infliximab, ustekinumab, or alefacept. DATA SYNTHESIS: A total of 23 articles with 12,617 patients matched the inclusion and exclusion criteria for the systematic review. Data were examined for primary and secondary efficacy outcomes and adverse events including infections, malignancies, cardiovascular events, and anti-drug antibodies. The preponderance of data suggests that continuous treatment with anti-TNF agents and anti-IL12/23 agent was necessary for maintenance of disease control. Among non-responders, dose escalation with etanercept, adalimumab, ustekinumab, and alefacept typically resulted in greater efficacy than standard dosing. Dose reduction with etanercept and alefacept resulted in reduced efficacy. Withdrawal of the examined biologics led to an increase in disease activity; efficacy from retreatment did not result in equivalent initial response rates for most biologics. Safety data on off-label dosing regimens are limited. CONCLUSION: Dose escalation in non-responders generally resulted in increased efficacy in the examined biologics used to treat moderate-to-severe psoriasis. Continuous treatment with anti-TNF agents and anti-IL12/23 agent

  7. Effects of climate change on food safety hazards in the dairy production chain

    NARCIS (Netherlands)

    Spiegel, van der M.; Fels-Klerx, van der H.J.; Marvin, H.J.P.

    2012-01-01

    The aim of this study is to analyse the effect of climate change on emerging food safety hazards in the dairy production chain. For this purpose, a holistic approach was used to select critical factors from inside and outside the production chain that are affected by climatic factors. An expert judg

  8. Potential for widespread application of biological control of stored-product pests

    DEFF Research Database (Denmark)

    Hansen, Lise Stengaard

    2007-01-01

    Biological control of stored product pests has substantial potential in Europe". This is essentially the conclusion of the activities of a European working group funded by the COST system, an intergovernmental networking system. Working group 4 of COST action 842 (2000-2005) focussed on biological...... control of stored-product pests and has considered a number of existing and potential fields for application of biological control. Three situations were identified where biological control would be a valuable component of integrated pest management: (1) Empty room treatment against stored-product mites......, beetles and moths; (2) Preventative treatment of bulk commodities against weevils (Sitophilus spp.) and storage mites; (3) Preventative application of egg-parasitoids against moths in packaged products. Development of methods for biological control and of mass production of natural enemies...

  9. Draft safety review plan for accelerator production of tritium (APT) project

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-07-01

    The purpose of this ``living`` Safety Review Plan (SRP) is to describe the products and processes that will be followed to conduct a systematic review of the Accelerator Production of Tritium (APT) Facility Preliminary Safety Analysis Report (PSAR), and subsequently to prepare a draft Safety Evaluation Report (SER) on the PSAR. This plan is prepared for and will be implemented by the APT Independent Safety Review Committee (ISRC) over the period July 1, 1997 through September 30, 1998, in accordance with provisions established in DOE-STD-1104-96. A core team of DOE, INEEL, and AMPARO Corporation engineers and scientists will prepare the initial draft SER with assistance from other ISRC team members on an as needed basis. Guidelines for preparing the draft SER are presented in Section 7 of this SRP. The PSAR reviews will focus exclusively on safety. The ever-present two-part question will be: Does the subject matter have safety significance? If so, does the APT structural, system, component, and/or process engineering design ensure an acceptable margin of safety? The APT mission, efficiency, and cost are not considerations of this plan. A more detailed discussion of the review philosophy is presented in Section 5 of this SRP.

  10. 49 CFR 236.907 - Product Safety Plan (PSP).

    Science.gov (United States)

    2010-10-01

    ..., MAINTENANCE, AND REPAIR OF SIGNAL AND TRAIN CONTROL SYSTEMS, DEVICES, AND APPLIANCES Standards for Processor... railroad operation or categories of operations on which the product is designed to be used, including train... comprehensive description of all hazards to be addressed in the system design and development,...

  11. Safety evaluation in the development of medical devices and combination products

    CERN Document Server

    Gad, Shayne C

    2008-01-01

    Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field.The Third Edition explores these key current trends:global device marketscontinually advancing technologythe increasing harmonization of device safety regulation worldwideEach aspect of safety evaluation is considered in ter

  12. Achieving safety through the design process for the heavy water new product reactor

    International Nuclear Information System (INIS)

    The U.S. Department of Energy (DOE) is presently completing the Conceptual Design Phase (CDP) for a heavy water new production reactor (NPR). In undertaking the development of requirements for the heavy water NPR, the DOE defined as a principal requirement that the reactor would be designed such that it would meet or exceed the level of safety and safety assurance achieved by modern commercial nuclear power plants. This paper discusses the strategy and methodology of implementing the line responsibilities for achieving safety in the design of the heavy water NPR

  13. Metabolic engineering with systems biology tools to optimize production of prokaryotic secondary metabolites

    DEFF Research Database (Denmark)

    Kim, Hyun Uk; Charusanti, Pep; Lee, Sang Yup;

    2016-01-01

    Metabolic engineering using systems biology tools is increasingly applied to overproduce secondary metabolites for their potential industrial production. In this Highlight, recent relevant metabolic engineering studies are analyzed with emphasis on host selection and engineering approaches...... for the optimal production of various prokaryotic secondary metabolites: native versus heterologous hosts (e.g., Escherichia coli) and rational versus random approaches. This comparative analysis is followed by discussions on systems biology tools deployed in optimizing the production of secondary metabolites....... The potential contributions of additional systems biology tools are also discussed in the context of current challenges encountered during optimization of secondary metabolite production....

  14. Metabolic engineering with systems biology tools to optimize production of prokaryotic secondary metabolites.

    Science.gov (United States)

    Kim, Hyun Uk; Charusanti, Pep; Lee, Sang Yup; Weber, Tilmann

    2016-08-27

    Covering: 2012 to 2016Metabolic engineering using systems biology tools is increasingly applied to overproduce secondary metabolites for their potential industrial production. In this Highlight, recent relevant metabolic engineering studies are analyzed with emphasis on host selection and engineering approaches for the optimal production of various prokaryotic secondary metabolites: native versus heterologous hosts (e.g., Escherichia coli) and rational versus random approaches. This comparative analysis is followed by discussions on systems biology tools deployed in optimizing the production of secondary metabolites. The potential contributions of additional systems biology tools are also discussed in the context of current challenges encountered during optimization of secondary metabolite production. PMID:27072921

  15. The safety and regulation of natural products used as foods and food ingredients.

    Science.gov (United States)

    Abdel-Rahman, Ali; Anyangwe, Njwen; Carlacci, Louis; Casper, Steve; Danam, Rebecca P; Enongene, Evaristus; Erives, Gladys; Fabricant, Daniel; Gudi, Ramadevi; Hilmas, Corey J; Hines, Fred; Howard, Paul; Levy, Dan; Lin, Ying; Moore, Robert J; Pfeiler, Erika; Thurmond, T Scott; Turujman, Saleh; Walker, Nigel J

    2011-10-01

    The use of botanicals and dietary supplements derived from natural substances as an adjunct to an improved quality of life or for their purported medical benefits has become increasingly common in the United States. This review addresses the safety assessment and regulation of food products containing these substances by the U.S. Food and Drug Administration (FDA). The issue of safety is particularly critical given how little information is available on the toxicity of some of these products. The first section uses case studies for stevia and green tea extracts as examples of how FDA evaluates the safety of botanical and herbal products submitted for consideration as Generally Recognized as Safe under the Federal Food, Drug, and Cosmetics Act. The 1994 Dietary Supplement Health Education Act (DSHEA) created a regulatory framework for dietary supplements. The article also discusses the regulation of this class of dietary supplements under DSHEA and addresses the FDA experience in analyzing the safety of natural ingredients described in pre-market safety submissions. Lastly, we discuss an ongoing interagency collaboration to conduct safety testing of nominated dietary supplements. PMID:21821733

  16. EULAR points to consider when establishing, analysing and reporting safety data of biologics registers in rheumatology

    DEFF Research Database (Denmark)

    Dixon, William G; Carmona, Loreto; Finckh, Axel;

    2010-01-01

    upon safety data generated from observational drug registers makes it important to convert the lessons learned from such registers into recommendations for rheumatologists embarking upon the establishment of future registers, or analysing and reporting from new and existing registers....

  17. Synthetic biology for microbial production of lipid-based biofuels.

    Science.gov (United States)

    d'Espaux, Leo; Mendez-Perez, Daniel; Li, Rachel; Keasling, Jay D

    2015-12-01

    The risks of maintaining current CO2 emission trends have led to interest in producing biofuels using engineered microbes. Microbial biofuels reduce emissions because CO2 produced by fuel combustion is offset by CO2 captured by growing biomass, which is later used as feedstock for biofuel fermentation. Hydrocarbons found in petroleum fuels share striking similarity with biological lipids. Here we review synthetic metabolic pathways based on fatty acid and isoprenoid metabolism to produce alkanes and other molecules suitable as biofuels. We further discuss engineering strategies to optimize engineered biosynthetic routes, as well as the potential of synthetic biology for sustainable manufacturing.

  18. Synthetic biology for microbial production of lipid-based biofuels.

    Science.gov (United States)

    d'Espaux, Leo; Mendez-Perez, Daniel; Li, Rachel; Keasling, Jay D

    2015-12-01

    The risks of maintaining current CO2 emission trends have led to interest in producing biofuels using engineered microbes. Microbial biofuels reduce emissions because CO2 produced by fuel combustion is offset by CO2 captured by growing biomass, which is later used as feedstock for biofuel fermentation. Hydrocarbons found in petroleum fuels share striking similarity with biological lipids. Here we review synthetic metabolic pathways based on fatty acid and isoprenoid metabolism to produce alkanes and other molecules suitable as biofuels. We further discuss engineering strategies to optimize engineered biosynthetic routes, as well as the potential of synthetic biology for sustainable manufacturing. PMID:26479184

  19. REVIEW ON QUALITY SAFETY AND LEGISLATION FOR HERBAL PRODUCTS

    OpenAIRE

    Patel Vishal; Patel N.M; Patel.P.M

    2011-01-01

    In the last few decades, there has been exponential growth in the field of herbal medicine. The growing use of botanicals (drug and other products derived from plants) by the public is forcing moves to evaluate the health claims of these agents and to develop standards of quality and manufacture. It is clear that the herbal industry needs to follow strict guidelines and that regulations are needed. This article presents the element of methods of different aspects on quality control and standa...

  20. Food safety management practices in the traditional fish processing sector in Ghana and the microbiological safety of selected processed fish products from Ghana

    OpenAIRE

    Amuna, Norbert Ndaah

    2014-01-01

    Fish products contribute significantly to protein nutriture, food security, livelihoods and the economy in West Africa. Food safety of processed fish products however remains an important concern. The purpose of this study was to investigate the safety of traditionally processed fish from Ghana. Microbiological analysis of selected traditionally processed fish products was conducted. Challenge tests were employed to determine the effects of storage temperature on survival of Salmonella Typhim...

  1. Safety assessment of Maillard reaction products of chicken bone hydrolysate using Sprague-Dawley rats

    OpenAIRE

    ZHANG, CHUNHUI; Wang, Jin-Zhi; Sun, Hong-Mei; Hu, Li; Li, Xia; Wu, Xiao-Wei

    2016-01-01

    Background: The Maillard reaction products of chicken bone hydrolysate (MRPB) containing 38% protein, which is a derived product from chicken bone, is usually used as a flavor enhancer or food ingredient. In the face of a paucity of reported data regarding the safety profile of controversial Maillard reaction products, the potential health effects of MRPB were evaluated in a subchronic rodent feeding study.Methods: Sprague–Dawley rats (SD, 5/sex/group) were administered diets containing 9, 3,...

  2. Safety assessment of coagulase-negative staphylococci used in food production

    OpenAIRE

    Seitter, Marion

    2015-01-01

    Coagulase-negative staphylococci (CNS) are used in starter cultures for the production of fermented meat products due to their involvement in the development of desired red color, characteristic flavor as well as ensuring stability. But also other CNS species like S. condimenti, S. piscifermentans, S. equorum and S. succinus have a potential for future use in starter cultures. The safety of fermented food products is principally proven by long-term experience as traditional methods are consid...

  3. 9 CFR 101.3 - Biological products and related terms.

    Science.gov (United States)

    2010-01-01

    ... OF AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS DEFINITIONS..., the harvest date shall be the date blood or tissues are collected for production or the date cultures..., representing a whole culture or a concentrate thereof, with or without the unevaluated growth products,...

  4. The potential of plants as a system for the development and production of human biologics [version 1; referees: 3 approved

    Directory of Open Access Journals (Sweden)

    Qiang Chen

    2016-05-01

    Full Text Available The growing promise of plant-made biologics is highlighted by the success story of ZMapp™ as a potentially life-saving drug during the Ebola outbreak of 2014-2016. Current plant expression platforms offer features beyond the traditional advantages of low cost, high scalability, increased safety, and eukaryotic protein modification. Novel transient expression vectors have been developed that allow the production of vaccines and therapeutics at unprecedented speed to control potential pandemics or bioterrorism attacks. Plant-host engineering provides a method for producing proteins with unique and uniform mammalian post-translational modifications, providing opportunities to develop biologics with increased efficacy relative to their mammalian cell-produced counterparts. Recent demonstrations that plant-made proteins can function as biocontrol agents of foodborne pathogens further exemplify the potential utility of plant-based protein production. However, resolving the technical and regulatory challenges of commercial-scale production, garnering acceptance from large pharmaceutical companies, and obtaining U.S. Food and Drug Administration approval for several major classes of biologics are essential steps to fulfilling the untapped potential of this technology.

  5. Biological Pretreatment of Rubberwood with Ceriporiopsis subvermispora for Enzymatic Hydrolysis and Bioethanol Production

    OpenAIRE

    Forough Nazarpour; Dzulkefly Kuang Abdullah; Norhafizah Abdullah; Nazila Motedayen; Reza Zamiri

    2013-01-01

    Rubberwood (Hevea brasiliensis), a potential raw material for bioethanol production due to its high cellulose content, was used as a novel feedstock for enzymatic hydrolysis and bioethanol production using biological pretreatment. To improve ethanol production, rubberwood was pretreated with white rot fungus Ceriporiopsis subvermispora to increase fermentation efficiency. The effects of particle size of rubberwood (1 mm, 0.5 mm, and 0.25 mm) and pretreatment time on the biological pretreatmen...

  6. Sex Roles: A Product of Socialization or a Biological Heritage.

    Science.gov (United States)

    Shaha, Steven H.

    This paper reviews selected studies of aggression in males and females and concludes that physiological, emotional and behavioral differences exist between the sexes. Primate studies, conducted by Harlow, are employed as evidence that sex differences in aggression are primarily biological and not primarily cultural phenomena. It is further…

  7. Safety pharmacology in the nonclinical assessment of new medicinal products: definition, place, interest and difficulties.

    Science.gov (United States)

    Claude, Jean-Roger

    2002-04-01

    Until the year 2000 there was no internationally-accepted definition for the terms used in nonclinical pharmacology (primary, secondary pharmacodynamics, discovery, safety pharmacology, etc). Now, after ICH5 (San Diego, November 2000), a harmonisation of the nomenclature is adopted: safety pharmacology is defined as the studies that investigate the potential undesirable pharmacodynamic effects of a medicinal product on physiological functions in relationship to exposure. Consequently, safety pharmacology studies are a part of the safety assessment for a new product, in the same way than toxicological studies, and a basic battery of tests (core battery) has to be conducted prior to the first administration to humans. Safety pharmacology studies are of peculiar interest: they show a good predictive potential for humans, they do not require a large number of laboratory animals, long-term studies, large amount of products and they are more dynamic and more flexible than toxicological studies. Nevertheless, many difficulties occur for the implementation in industry, related to practical and/or scientific problems: location of the studies, routine activity for the pharmacologists, sometimes difficulties in the relationship between toxicologists and pharmacologists, adaptation to the GLP requirements, elaboration of an early relevant scientific programme, necessity to go to contract-labs or to academic research for unusual or for up to date methods, etc. To conclude, a retrospective timetable of the regulatory evolution for the last 10 years will be provided, as an illustration of the worldwide progress in the concept of 'harmonisation' for the assessment of new medicinal products.

  8. Kinetic study of biological hydrogen production by anaerobic fermentation

    Energy Technology Data Exchange (ETDEWEB)

    Sangeetha, R. [Annamalai Univ., Chidambaram (India). Dept. of Chemical Engineering; Karunanithi, T. [Annamalai Univ., Tamilnadu (India). Dept. of Chemical Engineering

    2009-07-01

    This study examined the kinetics of batch biohydrogen production from glucose. Clostridium pasteurianum was used to produce biohydrogen by dark anaerobic fermentation. The initial substrate concentration, initial pH and temperature were optimized for biohydrogen production. The maximum production of hydrogen under optimum conditions was found to be 5.376 l/l. The kinetic parameters were determined for the optimized medium and conditions in the batch reactor. The by product was expressed as total acidic equivalent. This presentation discussed the logistic equation that was used to model the growth of the organism and described how the kinetic parameters were calculated. The Leudeking piret kinetic model was used to express the hydrogen production and substrate use because it combines both growth associated and non associated contributions. It was concluded the production of biohydrogen can be predicted well using the logistic model for cell growth kinetics and the logistic incorporated Leudeking Piret model for product and substrate utilization kinetics.

  9. Importance of systems biology in engineering microbes for biofuel production

    Energy Technology Data Exchange (ETDEWEB)

    Mukhopadhyay, Aindrila; Redding, Alyssa M.; Rutherford, Becky J.; Keasling, Jay D.

    2009-12-02

    Microorganisms have been rich sources for natural products, some of which have found use as fuels, commodity chemicals, specialty chemicals, polymers, and drugs, to name a few. The recent interest in production of transportation fuels from renewable resources has catalyzed numerous research endeavors that focus on developing microbial systems for production of such natural products. Eliminating bottlenecks in microbial metabolic pathways and alleviating the stresses due to production of these chemicals are crucial in the generation of robust and efficient production hosts. The use of systems-level studies makes it possible to comprehensively understand the impact of pathway engineering within the context of the entire host metabolism, to diagnose stresses due to product synthesis, and provides the rationale to cost-effectively engineer optimal industrial microorganisms.

  10. Genotypic characterization and safety assessment of lactic acid bacteria from indigenous African fermented food products

    Directory of Open Access Journals (Sweden)

    Adimpong David B

    2012-05-01

    Full Text Available Abstract Background Indigenous fermented food products play an essential role in the diet of millions of Africans. Lactic acid bacteria (LAB are among the predominant microbial species in African indigenous fermented food products and are used for different applications in the food and biotechnology industries. Numerous studies have described antimicrobial susceptibility profiles of LAB from different parts of the world. However, there is limited information on antimicrobial resistance profiles of LAB from Africa. The aim of this study was to characterize 33 LAB previously isolated from three different African indigenous fermented food products using (GTG5-based rep-PCR, sequencing of the 16S rRNA gene and species-specific PCR techniques for differentiation of closely related species and further evaluate their antibiotic resistance profiles by the broth microdilution method and their haemolytic activity on sheep blood agar plates as indicators of safety traits among these bacteria. Results Using molecular biology based methods and selected phenotypic tests such as catalase reaction, CO2 production from glucose, colonies and cells morphology, the isolates were identified as Lactobacillus delbrueckii, Lactobacillus fermentum, Lactobacillus ghanensis, Lactobacillus plantarum, Lactobacillus salivarius, Leuconostoc pseudomesenteroides, Pediococcus acidilactici, Pediococcus pentosaceus and Weissella confusa. The bacteria were susceptible to ampicillin, chloramphenicol, clindamycin and erythromycin but resistant to vancomycin, kanamycin and streptomycin. Variable sensitivity profiles to tetracycline and gentamicin was observed among the isolates with Lb. plantarum, Lb. salivarius, W. confusa (except strain SK9-5 and Lb. fermentum strains being susceptible to tetracycline whereas Pediococcus strains and Lb. ghanensis strains were resistant. For gentamicin, Leuc. pseudomesenteroides, Lb. ghanensis and Ped. acidilactici strains were resistant to 64

  11. Solving a product safety problem using a recycled high density polyethylene container

    Science.gov (United States)

    Liu, Ping; Waskom, T. L.

    1993-01-01

    The objectives are to introduce basic problem-solving techniques for product safety including problem identification, definition, solution criteria, test process and design, and data analysis. The students are given a recycled milk jug made of high density polyethylene (HDPE) by blow molding. The objectives are to design and perform proper material test(s) so they can evaluate the product safety if the milk jug is used in a certain way which is specified in the description of the procedure for this investigation.

  12. Biophysics and Molecular Biology of Cardiac Ion Channels for the Safety Pharmacologist.

    Science.gov (United States)

    Pugsley, Michael K; Curtis, Michael J; Hayes, Eric S

    2015-01-01

    Cardiac safety pharmacology is a continuously evolving discipline that uses the basic principles of pharmacology in a regulatory-driven process to generate data to inform risk/benefit assessment of a new chemical entity (NCE). The aim of cardiac safety pharmacology is to characterise the pharmacodynamic/pharmacokinetic (PK/PD) relationship of a drug's adverse effects on the heart using continuously evolving methodology. Unlike Toxicology, safety pharmacology includes within its remit a regulatory requirement to predict the risk of rare cardiotoxic (potentially lethal) events such as torsades de pointes (TdP), which is statistically associated with drug-induced changes in the QT interval of the ECG due to blockade of I Kr or K v11.1 current encoded by hERG. This gives safety pharmacology its unique character. The key issues for the safety pharmacology assessment of a drug on the heart are detection of an adverse effect liability, projection of the data into safety margin calculation and clinical safety monitoring. This chapter will briefly review the current cardiac safety pharmacology paradigm outlined in the ICH S7A and ICH S7B guidance documents and the non-clinical models and methods used in the evaluation of new chemical entities in order to define the integrated risk assessment for submission to regulatory authorities. An overview of how the present cardiac paradigm was developed will be discussed, explaining how it was based upon marketing authorisation withdrawal of many non-cardiovascular compounds due to unanticipated proarrhythmic effects. The role of related biomarkers (of cardiac repolarisation, e.g. prolongation of the QT interval of the ECG) will be considered. We will also provide an overview of the 'non-hERG-centric' concepts utilised in the evolving comprehensive in vitro proarrhythmia assay (CIPA) that details conduct of the proposed ion channel battery test, use of human stem cells and application of in silico models to early cardiac safety

  13. Safety concerns of herbal products and traditional Chinese herbal medicines: dehydropyrrolizidine alkaloids and aristolochic acid.

    Science.gov (United States)

    Stegelmeier, Bryan L; Brown, Ammon W; Welch, Kevin D

    2015-12-01

    In many countries, including the United States, herbal supplements, tisanes and vegetable products, including traditional Chinese medicines, are largely unregulated and their content is not registered, monitored or verified. Consequently, potent plant toxins including dehydropyrrolizidine alkaloids and other potential carcinogens can contaminate these products. As herbal and food supplement producers are left to their own means to determine the safety and purity of their products prior to marketing, disturbingly often good marketing practices currently in place are ignored and content is largely undocumented. Historical examples of poisoning and health issues relating to plant material containing dehydopyrrolizidine alkaloids and aristolochic acids were used as examples to demonstrate the risk and potential toxicity of herbal products, food supplements, or traditional medicines. More work is needed to educate consumers of the potential risk and require the industry to be more responsible to verify the content and insure the safety of their products. PMID:26152912

  14. Comparing Occupational Health and Safety Management System Programming with Injury Rates in Poultry Production.

    Science.gov (United States)

    Autenrieth, Daniel A; Brazile, William J; Douphrate, David I; Román-Muñiz, Ivette N; Reynolds, Stephen J

    2016-01-01

    Effective methods to reduce work-related injuries and illnesses in animal production agriculture are sorely needed. One approach that may be helpful for agriculture producers is the adoption of occupational health and safety management systems. In this replication study, the authors compared the injury rates on 32 poultry growing operations with the level of occupational health and safety management system programming at each farm. Overall correlations between injury rates and programming level were determined, as were correlations between individual management system subcomponents to ascertain which parts might be the most useful for poultry producers. It was found that, in general, higher levels of occupational health and safety management system programming were associated with lower rates of workplace injuries and illnesses, and that Management Leadership was the system subcomponent with the strongest correlation. The strength and significance of the observed associations were greater on poultry farms with more complete management system assessments. These findings are similar to those from a previous study of the dairy production industry, suggesting that occupational health and safety management systems may hold promise as a comprehensive way for producers to improve occupational health and safety performance. Further research is needed to determine the effectiveness of such systems to reduce farm work injuries and illnesses. These results are timely given the increasing focus on occupational safety and health management systems. PMID:27409413

  15. Control of biological hazards in cold smoked salmon production

    DEFF Research Database (Denmark)

    Huss, Hans Henrik; Embarek, Peter Karim Ben; Jeppesen, V.F.

    1995-01-01

    An outline of the common processing technology for cold smoked salmon in Denmark is presented. The safety hazards related to pathogenic bacteria, parasites and biogenic amines are discussed with special emphasis on hazards related to Clostridium botulinum and Listeria monocytogenes. Critical...... control points are identified for all hazards except growth of L. monocytogenes. For this reason a limitation of shelf life to three weeks at +5 degrees C far cold smoked vacuum-packed salmon having greater than or equal to 3% water phase salt is recommended...

  16. Analysis of Supply Chain Model of Agricultural Products and Quality Safety: A Case Study of Heilongjiang Province

    OpenAIRE

    Huo, Hong; Shen, Xin; Huang, Zhipeng

    2011-01-01

    This paper analyses the supply chain models of four types of agricultural products, namely fruits and vegetables, poultry, aquatic products and dairy, and the food safety problems arising from the links of supply chain. In view of different models, corresponding suggestions are put forward to ensure the quality safety of agricultural products in Heilongjiang Province.

  17. Exploitation of biological wastes for the production of value-added products under solid-state fermentation conditions.

    Science.gov (United States)

    Rodríguez Couto, Susana

    2008-07-01

    Biological wastes contain several reusable substances of high value such as soluble sugars and fibre. Direct disposal of such wastes to soil or landfill causes serious environmental problems. Thus, the development of potential value-added processes for these wastes is highly attractive. These biological wastes can be used as support-substrates in solid-state fermentation (SSF) to produce industrially relevant metabolites with great economical advantage. In addition, it is an environmentally friendly method of waste management. This paper reviews the reutilization of biological wastes for the production of value-added products using the SSF technique. PMID:18543242

  18. Modelling of Safety Factors in the Design of GRP Composite Products

    DEFF Research Database (Denmark)

    Babu, B.J.C.; Prabhakaran, R.T. Durai; Lystrup, Aage

    2010-01-01

    An attempt has been made in this paper to arrive at the safety factor design of glass fibre reinforced polymer (GRP) composite products using graph theoretic model. In the conventional design and recommendations of the standards, these design factors affecting properties have been considered...... as independent, while in real applications these factors may interact/influence each other. Following the concept developed by the authors, a simple graph theoretic model has been used to determine overall factor of safety. This is described with the help of an example and it has been demonstrated...... that the proposed overall factor of safety is an appropriate and comprehensive measure of factor of safety. The proposed methodology is illustrated for a typical resin transfer moulded (RTM) fume hood. The concept can easily be extended for other applications....

  19. SAFETY

    CERN Multimedia

    C. Schaefer and N. Dupont

    2013-01-01

      “Safety is the highest priority”: this statement from CERN is endorsed by the CMS management. An interpretation of this statement may bring you to the conclusion that you should stop working in order to avoid risks. If the safety is the priority, work is not! This would be a misunderstanding and misinterpretation. One should understand that “working safely” or “operating safely” is the priority at CERN. CERN personnel are exposed to different hazards on many levels on a daily basis. However, risk analyses and assessments are done in order to limit the number and the gravity of accidents. For example, this process takes place each time you cross the road. The hazard is the moving vehicle, the stake is you and the risk might be the risk of collision between both. The same principle has to be applied during our daily work. In particular, keeping in mind the general principles of prevention defined in the late 1980s. These principles wer...

  20. SAFETY

    CERN Multimedia

    M. Plagge, C. Schaefer and N. Dupont

    2013-01-01

    Fire Safety – Essential for a particle detector The CMS detector is a marvel of high technology, one of the most precise particle measurement devices we have built until now. Of course it has to be protected from external and internal incidents like the ones that can occur from fires. Due to the fire load, the permanent availability of oxygen and the presence of various ignition sources mostly based on electricity this has to be addressed. Starting from the beam pipe towards the magnet coil, the detector is protected by flooding it with pure gaseous nitrogen during operation. The outer shell of CMS, namely the yoke and the muon chambers are then covered by an emergency inertion system also based on nitrogen. To ensure maximum fire safety, all materials used comply with the CERN regulations IS 23 and IS 41 with only a few exceptions. Every piece of the 30-tonne polyethylene shielding is high-density material, borated, boxed within steel and coated with intumescent (a paint that creates a thick co...

  1. Biology Needs a Modern Assessment System for Professional Productivity

    Science.gov (United States)

    McDade, Lucinda A.; Maddison, David R.; Guralnick, Robert; Piwowar, Heather A.; Jameson, Mary Liz; Helgen, Kristofer M.; Herendeen, Patrick S.; Hill, Andrew; Vis, Morgan L.

    2011-01-01

    Stimulated in large part by the advent of the Internet, research productivity in many academic disciplines has changed dramatically over the last two decades. However, the assessment system that governs professional success has not kept pace, creating a mismatch between modes of scholarly productivity and academic assessment criteria. In this…

  2. Shelf life and safety concerns of bakery products--a review.

    Science.gov (United States)

    Smith, James P; Daifas, Daphne Phillips; El-Khoury, Wassim; Koukoutsis, John; El-Khoury, Anis

    2004-01-01

    Bakery products are an important part of a balanced diet and, today, a wide variety of such products can be found on supermarket shelves. This includes unsweetened goods (bread, rolls, buns, crumpets, muffins and bagels), sweet goods (pancakes, doughnuts, waffles and cookies) and filled goods (fruit and meat pies, sausage rolls, pastries, sandwiches, cream cakes, pizza and quiche). However, bakery products, like many processed foods, are subject to physical, chemical and microbiological spoilage. While physical and chemical spoilage limits the shelf life of low and intermediate moisture bakery products, microbiological spoilage by bacteria, yeast and molds is the concern in high moisture products i.e., products with a water activity (a(w)) > 0.85. Furthermore, several bakery products also have been implicated infoodborne illnesses involving Salmonella spp., Listeria monoctyogenes and Bacillus cereus, while Clostridium botulinum is a concern in high moisture bakery products packaged under modified atmospheres. This extensive review is divided into two parts. Part I focuses on the spoilage concerns of low, intermediate and high moisture bakery products while Part II focuses on the safety concerns of high moisture bakery products only. In both parts, traditional and novel methods of food preservation that can be used by the bakery industry to extend the shelf life and enhance the safety of products are discussed in detail. PMID:15077880

  3. Progress in Biological Effects and Safety Assessment of Nanomaterials%纳米材料生物效应研究和安全性评价前沿

    Institute of Scientific and Technical Information of China (English)

    刘元方; 陈欣欣; 王海芳

    2011-01-01

    The sustainable development of nanotechnology requires the comprehensive understanding on the safety of nanomaterials. Since 2004, researches on the biological effects and safety evaluation of nanomaterials have been developing rapidly and grown to an interdisciplinary field, nanotoxicology. The safety issue of nanotechnology attracts the attentions of the academic, enterprise, government and public. The authors described the urgency and importance of safety evaluation on nanomaterials, and focused on the latest progress related to nano-product, workplace and environment. In addition, a brief discussion on the standardization in nanotechnology, the nano-ethics and the risk management of nanotechnology was presented.%纳米技术持续、健康的发展要求我们了解纳米材料的安全性.2004年以来,纳米材料生物效应和安全性研究发展迅速,形成一个跨学科的研究领域,并受到政府、学界、企业和社会公众等的广泛关注.文中叙述了纳米材料安全性评估的迫切性和重要意义,重点讨论了该领域的最新发展方向,包括纳米产品、工作场所和环境的安全等,同时简单讨论了纳米标准化、纳米技术风险管理和纳米伦理研究与纳米安全性研究的关系.

  4. 9 CFR 113.29 - Determination of moisture content in desiccated biological products.

    Science.gov (United States)

    2010-01-01

    ... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Determination of moisture content in desiccated biological products. 113.29 Section 113.29 Animals and Animal Products ANIMAL AND PLANT HEALTH... VECTORS STANDARD REQUIREMENTS Standard Procedures § 113.29 Determination of moisture content in...

  5. Coal mine safety production forewarning based on improved BP neural network

    Institute of Scientific and Technical Information of China (English)

    Wang Ying; Lu Cuijie; Zuo Cuiping

    2015-01-01

    Firstly, the early warning index system of coal mine safety production was given from four aspects as per-sonnel, environment, equipment and management. Then, improvement measures which are additional momentum method, adaptive learning rate, particle swarm optimization algorithm, variable weight method and asynchronous learning factor, are used to optimize BP neural network models. Further, the models are applied to a comparative study on coal mine safety warning instance. Results show that the identification precision of MPSO-BP network model is higher than GBP and PSO-BP model, and MPSO-BP model can not only effectively reduce the possibility of the network falling into a local minimum point, but also has fast convergence and high precision, which will provide the scientific basis for the forewarning management of coal mine safety production.

  6. Incorporation of occupational health and safety in cleaner production projects in South Africa

    DEFF Research Database (Denmark)

    Hedlund, Frank Huess

    2002-01-01

    The purpose of this research is to reveal ways in which occupational health and safety can be integrated in environmental cleaner production projects. Of particular interest are those cleaner production projects that are run by the Danish government's environmental assistance agency, Danced......, in South Africa.The study explores two main avenues of integration. First, integrating through better planning, focussing at the tools and procedures in use by Danced for project management -- integrating occupational health and safety into the project specification, so to speak.Second, integrating...... occupational health and safety into the environmental activities that take place at company level. Two ways of doing so are explored, the main distinction being company size. For large companies, integration of management systems may be attractive. For small companies, integration into a less formal network...

  7. It's No Accident: A Consumer Product Safety Education Curriculum Resource Guide for Teachers of Grades 3 through 6.

    Science.gov (United States)

    Consumer Product Safety Commission, Washington, DC.

    This guide for teachers contains product safety information appropriate for young children and suggests learning activities for third through sixth graders. Activities encourage children to examine their home environments for safety hazards and to share this information with family and friends. Unit 1 introduces five basic safety concepts upon…

  8. Applied systems biology - vanillin production in Saccharomyces cerevisiae

    DEFF Research Database (Denmark)

    Strucko, Tomas; Eriksen, Jens Christian; Nielsen, J.;

    2012-01-01

    Vanillin is the most important aroma compound based on market value, and natural vanillin is extracted from the cured seed pods of the Vanilla orchid. Most of the world’s vanillin, however, is obtained by chemical synthesis from petrochemicals or wood pulp lignins. As an alternative, de novo...... biosynthesis of vanillin in baker’s yeast Saccharomyces cerevisiae was recently demonstrated by successfully introducing the metabolic pathway for vanillin production in yeast. Nevertheless, the amount of vanillin produced in this S. cerevisiae strain is insufficient for commercial production and improvements...... need to be done. We have introduced the genes necessary for vanillin production in an identical manner in two different yeast strains S288c and CEN.PK,where comprehensive – omics datasets are available, hence, allowing vanillin production in the two strain backgrounds to be evaluated and compared...

  9. Hydrodynamics-Biology Coupling for Algae Culture and Biofuel Production

    OpenAIRE

    Bernard, Olivier; Sainte-Marie, Jacques; Sialve, Bruno; Steyer, Jean-Philippe

    2013-01-01

    Biofuel production from microalgae represents an acute optimization problem for industry. There is a wide range of parameters that must be taken into account in the development of this technology. Here, mathematical modelling has a vital role to play. The potential of microalgae as a source of biofuel and as a technological solution for CO2 fixation is the subject of intense academic and industrial research. Large-scale production of microalgae has potential for biofuel applications owing to ...

  10. Strategies for optimizing algal biology for enhanced biomass production

    Directory of Open Access Journals (Sweden)

    Amanda N. Barry

    2015-02-01

    Full Text Available One of the more environmentally sustainable ways to produce high energy density (oils feed stocks for the production of liquid transportation fuels is from biomass. Photosynthetic carbon capture combined with biomass combustion (point source and subsequent carbon capture and sequestration (BECCS has also been proposed in the Intergovernmental Panel on Climate Change Report as one of the most effective and economical strategies to remediate atmospheric greenhouse gases. To maximize photosynthetic carbon capture efficiency and energy-return-on-investment, we must develop biomass production systems that achieve the greatest yields with the lowest inputs. Numerous studies have demonstrated that microalgae have among the greatest potentials for biomass production. This is in part due to the fact that all alga cells are photoautotrophic, they have active carbon concentrating mechanisms to increase photosynthetic productivity, and all the biomass is harvestable unlike plants. All photosynthetic organisms, however, convert only a fraction of the solar energy they capture into chemical energy (reduced carbon or biomass. To increase aerial carbon capture rates and biomass productivity it will be necessary to identify the most robust algal strains and increase their biomass production efficiency often by genetic manipulation. We review recent large-scale efforts to identify the best biomass producing strains and metabolic engineering strategies to improve aerial productivity. These strategies include optimization of photosynthetic light-harvesting antenna size to increase energy capture and conversion efficiency and the potential development of advanced molecular breeding techniques. To date, these strategies have resulted in up to two-fold increases in biomass productivity.

  11. Office of the Leading Team of Product Quality and Food Safety Holds Third Meeting

    Institute of Scientific and Technical Information of China (English)

    2007-01-01

    @@ The Office of the Leading Team of Product Quality and Food Safety of the State Council held its third meeting on September 10. Li Changjiang, Minister of AQSIQ, presided over the meeting, and Pu Changcheng, Deputy Director of AQSIQ, also attended.

  12. Chapter X. Other action. Environmental and safety aspects of power production

    International Nuclear Information System (INIS)

    In this paper other action of the electric power industry in Slovakia are reviewed. The environmental effects of the energy production, the safety of the work, technical development, pay, salary, premiums, payments as well as other social aspects are discussed. The specialized schools (apprentice level, middle specialized schools and technical universities) as well as collaborate organizations are reviewed

  13. 76 FR 1137 - Publicly Available Consumer Product Safety Information Database: Notice of Public Web Conferences

    Science.gov (United States)

    2011-01-07

    ... COMMISSION Publicly Available Consumer Product Safety Information Database: Notice of Public Web Conferences... Commission. The Database must be publicly available, searchable, and accessible through the Commission's Web site. In the Federal Register of December 9, 2010 (75 FR 76832), we published a final rule to...

  14. Microbial performance of food safety management systems implemented in the lamb production chain

    NARCIS (Netherlands)

    Oses, S.M.; Luning, P.A.; Jacxsens, L.; Santillana, S.; Jaime, I.; Rovira, J.

    2012-01-01

    The actual microbial status of the lamb production chain at three slaughterhouses, one processing plant, and five butcher shops selling whole or cut lamb carcasses to consumers was assessed with a previously developed microbial assessment scheme. All studied establishments had a food safety manageme

  15. 77 FR 64588 - Highway Safety Programs; Conforming Products List of Calibrating Units for Breath Alcohol Testers

    Science.gov (United States)

    2012-10-22

    ... Products List (CPL) published in the Federal Register on June 25, 2007 (72 FR 34747) for devices that..., 2007 (72 FR 34742). This update to the CPL includes 44 new listings--3 wet bath units and 41 dry gas... INFORMATION: On August 18, 1975 (40 FR 36167), the National Highway Traffic Safety Administration...

  16. Assessing the food safety concepts within the dairy production chain: an application of conjoint analysis

    NARCIS (Netherlands)

    Valeeva, N.I.; Meuwissen, M.P.M.; Huirne, R.B.M.

    2003-01-01

    Conjoint analysis was performed in the Dutch dairy chain to obtain the relative contribution to increased food safety of more than 100 attributes. Results from the conjoint analysis show among others that 'chemical hazards procedures and instructions for compound feed production' and 'quality assura

  17. 77 FR 8818 - Public Availability of Consumer Product Safety Commission FY 2011 Service Contract Inventory

    Science.gov (United States)

    2012-02-15

    ... COMMISSION Public Availability of Consumer Product Safety Commission FY 2011 Service Contract Inventory... contract inventory for fiscal year (``FY'') 2011. This inventory provides information on service contract..., MD 20814. Telephone: 301-504-7009; email dhutton@cpsc.gov . SUPPLEMENTARY INFORMATION: On December...

  18. 78 FR 33392 - Public Availability of Consumer Product Safety Commission FY 2012 Service Contract Inventory

    Science.gov (United States)

    2013-06-04

    ... COMMISSION Public Availability of Consumer Product Safety Commission FY 2012 Service Contract Inventory... contract inventory for fiscal year (FY) 2012. This inventory provides information on service contract..., MD 20814. Telephone: 301-504-7009; email: dhutton@cpsc.gov . SUPPLEMENTARY INFORMATION: On...

  19. 76 FR 14643 - Hazardous Materials: Safety Requirements for External Product Piping on Cargo Tanks Transporting...

    Science.gov (United States)

    2011-03-17

    ... April 11, 2000 (65 FR 19477) or you may visit http://www.regulations.gov . SUPPLEMENTARY INFORMATION: I. Background On January 27, 2011, PHMSA published a notice of proposed rulemaking (NPRM) (HM-213D; 76 FR 4847...: Safety Requirements for External Product Piping on Cargo Tanks Transporting Flammable Liquids...

  20. Some aspects of biological production and fishery resources of the EEZ of India

    Digital Repository Service at National Institute of Oceanography (India)

    Bhargava, R.M.S.

    Region and season-wise biological production in the Exclusive Economic Zone (EEZ) of India has been computed from the data of more than twenty years available at the Indian National Oceanographic Data Centre of the National Institute of Oceanography...

  1. Safety assessment of cosmetic products, with emphasis on the ocular area: regulatory aspects and validation processes

    OpenAIRE

    Maythê de Lima Cancian; Mauricio Saadi Leonardi; Mariane Martins Mosca; Lucas Offenbecker Guerra; Simone Fanan Hengeltraub; Gislaine Ricci Leonardi

    2014-01-01

    Before marketing a cosmetic product, a series of biological assays, such as ocular irritation tests, must be conducted in order to prove that the product is safe. However, a few scientific articles mention the discussion and evolution of cosmetic products testing performed in the eyes area. The aim of this study was to review the available literature on the evolution of tests carried out with cosmetics, in the ocular area, as well as to describe the methodologies that have been used and that ...

  2. Survey of commercial Rhodiola products revealed species diversity and potential safety issues

    OpenAIRE

    Tianyi Xin; Xiaojin Li; Hui Yao; Yulin Lin; Xiaochong Ma; Ruiyang Cheng; Jingyuan Song; Lianghong Ni; Congzhao Fan; Shilin Chen

    2015-01-01

    The adulteration of herbal products is a threat to consumer safety. Here we surveyed the species composition of commercial Rhodiola products using DNA barcoding as a supervisory method. A Rhodiola dietary supplement DNA barcode database was successfully constructed using 82 voucher samples from 10 Rhodiola species. Based on the DNA barcoding standard operating procedure (SOP), we used this database to identify 100 Rhodiolae Crenulatae Radix et Rhizoma decoction piece samples that were purchas...

  3. The significance of food safety in trade and banning the importation of GMO products into Iran

    OpenAIRE

    Rezazadeh, Tahereh; Aghaiypour, Kh.; Heidari, Zohreh

    2013-01-01

    According to legislation in Iran, the importation of transgenic products should be banned due to the lack of strong evidence for the safety of genetically modified foods. Therefore, the detection of genetically modified on importing products should perform by food control laboratories. In this study, specific primers were designed for 35S promoter (500 bp), NOS terminator (253 bp), NPT (470 bp) and GUS (443 bp) for the detection of GMO in 134 imported samples by Polymerase chain reaction. T...

  4. Evaluation of Seafood Safety Health Hazards for Traditional Fish Products: Preventive Measures and Monitoring Issues

    OpenAIRE

    Köse, Sevim

    2010-01-01

    Traditional fish products (TFPs) are usually produced by applying old preserving methods such as salting, fermenting, drying and smoking. These products also greatly varies amongst the countries as well as within the same country by using many different applications such as differences in additives, percentage of salt or vinegar and maturing temperatures. Moreover, modifications in these techniques are also known due to food safety issues and changes in customer preference of new generation. ...

  5. 安全文化与施工企业安全生产之我见%Views on safety culture and safety production of construction enterprises

    Institute of Scientific and Technical Information of China (English)

    张新龙

    2014-01-01

    Taking the safety culture as the core-starting from the human orientation,the paper explores the safety culture construction and safety management methods of construction enterprises,describes relationship needing coordinated in safety culture construction,and shows strategies of improving enterprise safety management level,which has significant meaning for realizing safety production of the construction enterprises.%以安全文化的核心---以人为本为切入点,对施工企业安全文化建设与安全管理方法进行了探讨,阐述了安全文化建设应协调的三方面关系,给出了提升企业安全管理水平的策略,指出建设企业安全文化对实现安全生产具有重要的意义。

  6. Biological Methanol Production by a Type II Methanotroph Methylocystis bryophila.

    Science.gov (United States)

    Patel, Sanjay K S; Mardina, Primata; Kim, Sang-Yong; Lee, Jung-Kul; Kim, In-Won

    2016-04-28

    Methane (CH₄) is the most abundant component in natural gas. To reduce its harmful environmental effect as a greenhouse gas, CH₄ can be utilized as a low-cost feed for the synthesis of methanol by methanotrophs. In this study, several methanotrophs were examined for their ability to produce methanol from CH₄; including Methylocella silvestris, Methylocystis bryophila, Methyloferula stellata, and Methylomonas methanica. Among these methanotrophs, M. bryophila exhibited the highest methanol production. The optimum process parameters aided in significant enhancement of methanol production up to 4.63 mM. Maximum methanol production was observed at pH 6.8, 30°C, 175 rpm, 100 mM phosphate buffer, 50 mM MgCl₂ as a methanol dehydrogenase inhibitor, 50% CH₄ concentration, 24 h of incubation, and 9 mg of dry cell mass ml(-1) inoculum load, respectively. Optimization of the process parameters, screening of methanol dehydrogenase inhibitors, and supplementation with formate resulted in significant improvements in methanol production using M. bryophila. This report suggests, for the first time, the potential of using M. bryophila for industrial methanol production from CH₄. PMID:26838340

  7. Biological pretreatment and ethanol production from olive cake

    DEFF Research Database (Denmark)

    Jurado, Esperanza; Gavala, Hariklia N.; Baroi, George Nabin;

    2010-01-01

    Olive oil is one of the major Mediterranean products, whose nutritional and economic importance is well-known. However the extraction of olive oil yields a highly contaminating residue that causes serious environmental concerns in the olive oil producing countries. The olive cake (OC) coming out...... of the three-phase olive oil production process could be used as low price feedstock for lignocellulosic ethanol production due to its high concentration in carbohydrates. However, the binding of the carbohydrates with lignin may significantly hinder the necessary enzymatic hydrolysis of the polymeric sugars...... before ethanol fermentation. Treatment with three white rot fungi, Phaneroachaete chrysosporium, Ceriporiopsis subvermispora and Ceriolopsis polyzona has been applied on olive cake in order to investigate the potential for performing delignification and thus enhancing the efficiency of the subsequent...

  8. Systems-Level Synthetic Biology for Advanced Biofuel Production

    Energy Technology Data Exchange (ETDEWEB)

    Ruffing, Anne [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Jensen, Travis J. [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Strickland, Lucas Marshall [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Meserole, Stephen [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States); Tallant, David [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2015-03-01

    Cyanobacteria have been shown to be capable of producing a variety of advanced biofuels; however, product yields remain well below those necessary for large scale production. New genetic tools and high throughput metabolic engineering techniques are needed to optimize cyanobacterial metabolisms for enhanced biofuel production. Towards this goal, this project advances the development of a multiple promoter replacement technique for systems-level optimization of gene expression in a model cyanobacterial host: Synechococcus sp. PCC 7002. To realize this multiple-target approach, key capabilities were developed, including a high throughput detection method for advanced biofuels, enhanced transformation efficiency, and genetic tools for Synechococcus sp. PCC 7002. Moreover, several additional obstacles were identified for realization of this multiple promoter replacement technique. The techniques and tools developed in this project will help to enable future efforts in the advancement of cyanobacterial biofuels.

  9. Recent advances in biological production of sugar alcohols.

    Science.gov (United States)

    Park, Yong-Cheol; Oh, Eun Joong; Jo, Jung-Hyun; Jin, Yong-Su; Seo, Jin-Ho

    2016-02-01

    Sugar alcohols, such as xylitol, mannitol, sorbitol, and erythritol are emerging food ingredients that provide similar or better sweetness/sensory properties of sucrose, but are less calorigenic. Also, sugar alcohols can be converted into commodity chemicals through chemical catalysis. Biotechnological production offers the safe and sustainable supply of sugar alcohols from renewable biomass. In contrast to early studies that aimed to produce sugar alcohols with microorganisms capable of producing sugar alcohols naturally, recent studies have focused on rational engineering of metabolic pathways to improve yield and productivity as well as to use inexpensive and abundant substrates. Metabolic engineering strategies to utilize inexpensive substrates, alleviate catabolite repression, reduce byproduct formation, and manipulate redox balances led to enhanced production of sugar alcohols.

  10. Recent advances in biological production of sugar alcohols.

    Science.gov (United States)

    Park, Yong-Cheol; Oh, Eun Joong; Jo, Jung-Hyun; Jin, Yong-Su; Seo, Jin-Ho

    2016-02-01

    Sugar alcohols, such as xylitol, mannitol, sorbitol, and erythritol are emerging food ingredients that provide similar or better sweetness/sensory properties of sucrose, but are less calorigenic. Also, sugar alcohols can be converted into commodity chemicals through chemical catalysis. Biotechnological production offers the safe and sustainable supply of sugar alcohols from renewable biomass. In contrast to early studies that aimed to produce sugar alcohols with microorganisms capable of producing sugar alcohols naturally, recent studies have focused on rational engineering of metabolic pathways to improve yield and productivity as well as to use inexpensive and abundant substrates. Metabolic engineering strategies to utilize inexpensive substrates, alleviate catabolite repression, reduce byproduct formation, and manipulate redox balances led to enhanced production of sugar alcohols. PMID:26723007

  11. Xenicane Natural Products: Biological Activity and Total Synthesis.

    Science.gov (United States)

    Betschart, Leo; Altmann, Karl-Heinz

    2015-01-01

    The xenicanes are a large class of mostly bicyclic marine diterpenoids featuring a cyclononane ring as a common structural denominator. After a brief introduction into the characteristic structural features of xenicanes and some biogenetic considerations, the major focus of this review will be on the various biological activities that have been reported for xenicanes and on efforts towards the total synthesis of these structures. Several xenicanes have been shown to be potent antiproliferative agents in vitro, but activities have also been reported in relation to inflammatory processes. However, so far, data on the possible in vivo activity of xenicanes are lacking. The major challenge in the total synthesis of xenicanes is the construction of the nine-membered ring. Different strategies have been pursued to establish this crucial substructure, including Grob fragmentation, ring-closing olefin metathesis, or Suzuki cross coupling as the enabling transformations. PMID:26429717

  12. Safety of Animal Fats for Biodiesel Production: A Critical Review of Literature

    Energy Technology Data Exchange (ETDEWEB)

    Greene, A.; Dawson, P.; Nixon, D.; Atkins, J.; Pearl, G. [Clemson University, SC (United States)

    2007-05-15

    An in-depth review of available literature was conducted on the safety of using animal fats for biodiesel. The review indicated little or no known risk to human and animal health and to the environment relative to inherent microbial, organic or inorganic agents in animal fats destined for biodiesel production. Animal by-products are generated from the inedible tissues derived from meat, poultry and fish production. This material is thermally processed by the rendering industry to generate a number of industrial materials including use of the fat portion to produce biodiesel. As the biodiesel industry continues to develop, questions have emerged about the safety of animal versus vegetable fats for biodiesel production and utilization. The following report is the result of a detailed literature search into the potential microbial, organic, and inorganic contaminants that may be present in animal fats and the potential for human or environmental safety issues associated with each. The potential safety risks associated with prions are discussed in a separate report, 'Biodiesel from Specified Risk Material Tallow: An Appraisal of TSE Risks and their Reduction'. In certain instances, very little was reported about the potential contaminating moiety and its fate in biodiesel production and usage. Establishing an absolute zero risk assessment is impossible on any fat utilized for biodiesel production. Among the potential microbial contaminants, bacteria, viruses, fungi, yeast, parasites, and microbial toxins were considered. In each instance, the nature of the production process and usage of biodiesel via combustion reduce the possibility that microbial contaminants would be a cause for concern to humans, animals, or the environment. Potential organic moieties contaminating the fat should meet a similar fate. Current evidence suggests that metals and metalloids within animal fats will not cause significant safety issues in the production and use of rendered fat

  13. 9 CFR 113.3 - Sampling of biological products.

    Science.gov (United States)

    2010-01-01

    ... AGRICULTURE VIRUSES, SERUMS, TOXINS, AND ANALOGOUS PRODUCTS; ORGANISMS AND VECTORS STANDARD REQUIREMENTS... bacterial vaccines; (iii) Two samples of Coccidiosis Vaccine; (iv) Eighteen samples of Rabies Vaccine... as follows: (1) Ten samples of Bacterial Master Seeds. (2) Thirteen samples of viral Master Seeds...

  14. Regeneration of nutrients and biological productivity in Antarctic waters

    Digital Repository Service at National Institute of Oceanography (India)

    Verlecar, X.N.; Somasundar, K.; Qasim, S.Z.

    contribute to the biomass production, reforming of plate ice during late summer (towards the end of February) may result in a shift of zooplanktonic organisms towards the north. Other oceanic regions north of 61° S Fig. 9 shows the distribution of chlorophyll...

  15. Improvements in Fermentative Biological Hydrogen Production Through Metabolic Engineering

    International Nuclear Information System (INIS)

    Dramatically rising oil prices and increasing awareness of the dire environmental consequences of fossil fuel use, including startling effects of climate change, are refocusing attention world-wide on the search for alternative fuels. Hydrogen is poised to become an important future energy carrier. Renewable hydrogen production is pivotal in making it a truly sustainable replacement for fossil fuels. (Author)

  16. Biological production of monoethanolamine by engineered Pseudomonas putida S12

    NARCIS (Netherlands)

    Foti, M.J.; Médici, R.; Ruijssenaars, H.J.

    2013-01-01

    Pseudomonas putida S12 was engineered for the production of monoethanolamine (MEA) from glucose via the decarboxylation of the central metabolite l-serine, which is catalyzed by the enzyme l-serine decarboxylase (SDC).The host was first evaluated for its tolerance towards MEA as well as its endogeno

  17. Improvements in Fermentative Biological Hydrogen Production Through Metabolic Engineering

    Energy Technology Data Exchange (ETDEWEB)

    Hallenbeck, P. C.; Ghosh, D.; Sabourin-Provost, G.

    2009-07-01

    Dramatically rising oil prices and increasing awareness of the dire environmental consequences of fossil fuel use, including startling effects of climate change, are refocusing attention world-wide on the search for alternative fuels. Hydrogen is poised to become an important future energy carrier. Renewable hydrogen production is pivotal in making it a truly sustainable replacement for fossil fuels. (Author)

  18. BIOLOGICAL FEATURES AND PRODUCTIVITY OF BLACK-AND-WHITE CATTLE

    Directory of Open Access Journals (Sweden)

    Kochueva Y. V.

    2015-02-01

    Full Text Available The behavior, interior and milk yield of the mature Black-and-White cows with various productivity levels, as well as etology of the replacement heifers are researched. The superiority of the high milk yielding cows for the lying duration and eating feed and water is revealed. Reduced variability of vital behavioral actions of animals is found. In addition, high yielding cows has been lower variability in all feeding acts. It was noted that high yielding animals exceeded equal age cows by the level of most interior factors. The differences were significant on the content of hemoglobin, vitamin E, and especially on the content of iron. Positive correlations between some interior design indicators is found. The analysis of lifetime productivity during our research found that high milk yielding cows had highest yields on the first lactation and kept the same level in the next lactations with insignificant variations. The lower productivity animals reached maximal yields on the third lactation with the followed downward trend. Differences between groups in lifetime productivity during research amounted to 16 992 kg. The significant superiority of the heifers with high grown intensity above equal age animals for the duration of feed and water eating, physiological functions and lying. The analysis of variation coefficient is confirmed the observed regularities.

  19. Bovine mammary stem cells: Cell biology meets production agriculture

    Science.gov (United States)

    Mammary stem cells (MaSC) provide for net growth, renewal and turnover of mammary epithelial cells, and are therefore potential targets for strategies to increase production efficiency. Appropriate regulation of MaSC can potentially benefit milk yield, persistency, dry period management and tissue ...

  20. Safety and Efficacy of Biological Disease-Modifying Antirheumatic Drugs in Older Rheumatoid Arthritis Patients: Staying the Distance.

    Science.gov (United States)

    Ishchenko, Alla; Lories, Rik J

    2016-06-01

    The population of older individuals with rheumatoid arthritis (RA) is rapidly expanding, mainly due to increased life expectancy. While targeted biological therapies are well established for the treatment of this disease, their use may be lower in older patients (age > 65 years) and very old patients (age > 75 years) as a result of perceived higher risks for adverse events in this population, taking into account comorbidity, polypharmacy, and frailty. In this review, we discuss the available evidence for the use of biological therapies in this growing patient group with specific attention towards the eventual reasons for biological treatment failure or withdrawal. The majority of data is found in secondary analyses of clinical trials and in retrospective cohorts. The most information available is on tumor necrosis factor (TNF) blockers. Older patients seem to have a less robust response to anti-TNF agents than a younger population, but drug survival as a proxy for efficacy does not seem to be influenced by age. Despite an overall rate of adverse effects comparable to that in younger patients, older RA patients are at higher risk of serious infections. Other biologics appear to have an efficacy similar to anti-TNF agents, also in older RA patients. Again, the drug survival rates for tocilizumab, rituximab, and abatacept resemble those in young RA patients with good general tolerability and safety profiles. The cardiovascular risk and the risk of cancer, increased in RA patients and in the older RA patients, do not appear to be strongly influenced by biologicals. PMID:27154398

  1. Global harmonization of food safety regulation from the perspective of Korea and a novel fast automatic product recall system.

    Science.gov (United States)

    Sohn, Mun-Gi; Oh, Sangsuk

    2014-08-01

    Efforts have been made for global harmonization of food safety regulations among countries through international organizations such as WTO and WHO/FAO. Global harmonization of food safety regulations is becoming increasingly important for Korean consumers because more than half of food and agricultural products are imported and consumed. Through recent reorganization of the Korean government, a consolidated national food safety authority-the Ministry of Food and Drug Safety (MFDS)-has been established for more efficient food safety control and better communication with consumers. The Automatic Sales Blocking System (ASBS), which blocks the sales of the recalled food products at the point of sale, has been implemented at over 40,000 retail food stores around the nation using state-of-the art information and communication technology (ICT) for faster recall of adulterated food products, and the e-Food Safety Control System has been developed for more efficient monitoring of national food safety surveillance situations. The National Food Safety Information Service was also established for monitoring and collecting food safety information and incidents worldwide, and shares relevant information with all stakeholders. The new approaches adopted by the Korean Food Safety Authority are expected to enhance public trust with regard to food safety issues and expedite the recall process of adulterated products from the market. PMID:23794245

  2. Global harmonization of food safety regulation from the perspective of Korea and a novel fast automatic product recall system.

    Science.gov (United States)

    Sohn, Mun-Gi; Oh, Sangsuk

    2014-08-01

    Efforts have been made for global harmonization of food safety regulations among countries through international organizations such as WTO and WHO/FAO. Global harmonization of food safety regulations is becoming increasingly important for Korean consumers because more than half of food and agricultural products are imported and consumed. Through recent reorganization of the Korean government, a consolidated national food safety authority-the Ministry of Food and Drug Safety (MFDS)-has been established for more efficient food safety control and better communication with consumers. The Automatic Sales Blocking System (ASBS), which blocks the sales of the recalled food products at the point of sale, has been implemented at over 40,000 retail food stores around the nation using state-of-the art information and communication technology (ICT) for faster recall of adulterated food products, and the e-Food Safety Control System has been developed for more efficient monitoring of national food safety surveillance situations. The National Food Safety Information Service was also established for monitoring and collecting food safety information and incidents worldwide, and shares relevant information with all stakeholders. The new approaches adopted by the Korean Food Safety Authority are expected to enhance public trust with regard to food safety issues and expedite the recall process of adulterated products from the market.

  3. Biological material (DNA and RNA) bank of nuclear production workers and residents of nearby territories

    International Nuclear Information System (INIS)

    Seversk Biophysical Research Centre (SBRC) has been engaged in creating DNA and biological material bank of workers of nuclear production (Siberian Group of Chemical Enterprises - SGCE) and residents of nearby areas (the town of Seversk) since 2002. Following the developed methodology, for each person this bank includes three units of storage: DNA sample extracted by standard method using proteinase K (the main sample), DNA sample isolated by means of 'quick' extraction method (work sample), and 1.5 ml blood sample (spare sample). For each DNA donor there have been obtained cytogenetic agents to estimate frequency and spectrum of chromosome aberrations. There has been completed DNA bank of SGCE workers (healthy individuals, cancer patients and those who survived acute myocardial infarction) as well as Seversk children aged 9-11 examined within SBRC special screening programme to diagnose thyroid diseases. At present, this DNA and biological material bank includes 5,988 units of storage (DNA samples extracted by means of standard method, DNA work samples isolated by quick extraction method, and spare blood samples). For every donor there has been obtained an informed consent. Storage conditions comply with technical regulations and provide for long-term (for decades) safety of the material. Personal information on DNA donors (age, internal and external doses, length of service, occupational data and case history) is contained in the Regional Medicodosimetric Register. Currently work is underway to create RNA bank identical to the existing DNA bank. For each person this bank contains two units of storage: the main high quality RNA sample isolated by hot phenol extraction; a work sample - of single stranded cDNA, extracted on RNA matrix through reverse transcription reaction. RNA bank will allow complex study of radiation effects in low dose range on the transcript of nuclear production workers and people living nearby. Thus, SBNC DNA and biological material bank

  4. A method to assess safety and resilience in radiopharmaceuticals production process.

    Science.gov (United States)

    Grecco, Cláudio H S; Vidal, Mario C R; Santos, Isaac J A L; Carvalho, Paulo V R

    2012-01-01

    Radiopharmaceuticals are radiation-emitting substances used in medicine for radiotherapy and imaging diagnosis. A Research Institute, located in Rio de Janeiro, produces three radiopharmaceuticals: the sodium iodate is used in the diagnosis of thyroid dysfunctions, the meta-iodo-benzylguanidine is used in the diagnosis of cardiac diseases, and the fluordesoxyglucose is used in diagnosis in cardiology, oncology, neurology and neuropsychiatry. This paper presents a method to access safety and resilience in radiopharmaceuticals production processes. The method uses resilience indicators in order to proactively evaluate and manage the safety.

  5. Leading safety performance indicators for resilience assessment of radiopharmaceuticals production process

    International Nuclear Information System (INIS)

    Radiopharmaceuticals are radiation-emitting substances used in medicine for radiotherapy and imaging diagnosis. A Research Institute, located in Rio de Janeiro, produces three radiopharmaceuticals: the sodium iodate is used in the diagnosis of thyroid dysfunctions, the meta-iodo-benzyl guanidine is used in the diagnosis of cardiac diseases, and the fluorodeoxyglucose is used in diagnosis in cardiology, oncology, neurology and neuro psychiatry. This paper presents a leading safety performance indicators framework to assess the resilience of radiopharmaceuticals production processes. The organizations that use resilience indicators will be able to pro actively evaluate and manage safety. (author)

  6. Leading safety performance indicators for resilience assessment of radiopharmaceuticals production process

    Energy Technology Data Exchange (ETDEWEB)

    Grecco, Claudio H.S.; Santos, Isaac J.A.L.; Carvalho, Paulo V.R., E-mail: grecco@ien.gov.b, E-mail: luquetti@ien.gov.b, E-mail: paulov@ien.gov.b [Instituto de Engenharia Nuclear (IEN/CNEN-RJ), Rio de Janeiro, RJ (Brazil). Div. de Instrumentacao e Confiabilidade Humana; Vidal, Mario C.R., E-mail: mvidal@ergonomia.ufrj.b [Coordenacao dos Programas de Pos-Graduacao de Engenharia (PEP/COPPE/UFRJ), Rio de Janeiro, RJ (Brazil). Programa de Engenharia de Producao. Grupo de Ergonomia e Novas Tecnologias (GENTE)

    2011-07-01

    Radiopharmaceuticals are radiation-emitting substances used in medicine for radiotherapy and imaging diagnosis. A Research Institute, located in Rio de Janeiro, produces three radiopharmaceuticals: the sodium iodate is used in the diagnosis of thyroid dysfunctions, the meta-iodo-benzyl guanidine is used in the diagnosis of cardiac diseases, and the fluorodeoxyglucose is used in diagnosis in cardiology, oncology, neurology and neuro psychiatry. This paper presents a leading safety performance indicators framework to assess the resilience of radiopharmaceuticals production processes. The organizations that use resilience indicators will be able to pro actively evaluate and manage safety. (author)

  7. Safety research in energy-production field. Yearly report for 1982

    International Nuclear Information System (INIS)

    1982 has been the second year of the Nordic safety project implementation. 19 project groups and 28 organizations participate in efforts to make nuclear power production even more safe and reliable than it has been hitherto. Research program covers five different fields: Reactor safety, human reliability, quality assurance, radioactive wastes in emergency cases, and radioecology project for efforts of nuclear power generation. The Nordic transport research group was subsidized by NKA budget. Economy analysis and new administrative regulations as well as program control, preliminary studies and reporting of national results, are planned by the respective subcommittees. (EG)

  8. GRADUATION DETERMINANTS OF PRODUCTIVE SAFETY NET PROGRAM BENEFICIARY HOUSEHOLDS: A LOGISTIC ANALYSIS, TIGRAI-ETHIOPIA

    Directory of Open Access Journals (Sweden)

    Yibrah Hagos Gebresilassie

    2013-12-01

    Full Text Available Household food security issues have become the concern of international communities as well as national government of Ethiopia. Social safety nets (like Productive Safety Net Program in Ethiopia are programs that offer protection to poor rural people by providing income through transfer programs and employment opportunities. The main objective of this study was to identify the major graduation determinants of Productive safety Net Program beneficiary rural households using a logistic regression technique from a total of 400 sample respondents using Eastern zone of Tigrai regional national state, northern Ethiopia, as case study site. The researcher was initially identified about sixteen predicting factors of which just ten of them were found to be statistically significant, and all exhibited the expected signs. Regression results revealed thatan introduction to integrated agricultural package make use of, male-headed household, age squared of the household head, educational status of the household head, saving culture, male adults, non-government organizations follow-up, access to credit, access to petty trading and irrigation have led productive safety net program beneficiary households to have more probability of graduation. Finally, it is recommended that assisting farming rural households to diversify and expand their sources of income in order to be able to meet their minimum food requirement and graduate soon through the provision of integrated agricultural packages. Besides, program participants should be followed up by non-government organizations and highly engaged in petty trading to graduate sooner, boost their income and food secure.

  9. Safety aspects of "sous vide" products and prevention of microbial risks.

    Science.gov (United States)

    Martens, T

    1995-03-01

    The diversity and quantities of vacuum packed and vacuum cooked prepared meals and menu components are rapidly growing on the European market. Because of the minimal heat processing, high water activity, absence of preservatives, and the use of many different often exotic ingredients, these products have a high risk potential. For this reason, Anglo-Saxon governments and industries are very sceptical about the safety of "sous vide" products. Industrial practice, as well as parallel tests and recent studies on inoculated packs have shown that, in many cases, it is more a potential than a real risk. Quality is the primary concern for "sous vide" products, and safety must be guaranteed by the application of the Hazard Analysis Critical Control Point (HACCP) concept, along with an adequate combination of different inhibitory factors (temperature of heating and cooling, pH, incorporation of starter cultures, bacteriocins and some particular enzymes). PMID:7546442

  10. Production of biological reagents for radioimmunoassay second antibody

    International Nuclear Information System (INIS)

    The experimental production of second antibody to be used in hormonal assays, in which the first antibody is raised in rabbits, is described. Four sheep were immunized with the rabbit immunoglobulin prepared at IPEN-CNEN laboratory. Their antisera were evaluated by the human thyrotropin radioimmunoassay employing materials provided by the National Hormone and Pituitary Program (USA), in comparison with a reference antiserum of known quality, produced in goat by the Radioassay Systems Laboratories - RSL (USA). From the fourth booster injection the animals developed antiserum with titer similar to that exhibited by the commercial product, even presenting higher values. These antisera are now being examinated for the optimal conditions of precipitation before be packed for future use and distribution. (author)

  11. Biological Impact of Bioactive Glasses and Their Dissolution Products.

    Science.gov (United States)

    Hoppe, Alexander; Boccaccini, Aldo R

    2015-01-01

    For many years, bioactive glasses (BGs) have been widely considered for bone tissue engineering applications due to their ability to bond to hard as well as soft tissue (a property termed bioactivity) and for their stimulating effects on bone formation. Ionic dissolution products released during the degradation of the BG matrix induce osteogenic gene expression leading to enhanced bone regeneration. Recently, adding bioactive metallic ions (e.g. boron, copper, cobalt, silver, zinc and strontium) to silicate (or phosphate and borate) glasses has emerged as a promising route for developing novel BG formulations with specific therapeutic functionalities, including antibacterial, angiogenic and osteogenic properties. The degradation behaviour of BGs can be tailored by adjusting the glass chemistry making these glass matrices potential carrier systems for controlled therapeutic ion release. This book chapter summarises the fundamental aspects of the effect of ionic dissolution products from BGs on osteogenesis and angiogenesis, whilst discussing novel BG compositions with controlled therapeutic ion release. PMID:26201273

  12. Applied systems biology - vanillin production in Saccharomyces cerevisiae

    OpenAIRE

    Strucko, Tomas; Eriksen, Carsten; Nielsen, J.; Mortensen, Uffe Hasbro

    2012-01-01

    Vanillin is the most important aroma compound based on market value, and natural vanillin is extracted from the cured seed pods of the Vanilla orchid. Most of the world’s vanillin, however, is obtained by chemical synthesis from petrochemicals or wood pulp lignins. As an alternative, de novo biosynthesis of vanillin in baker’s yeast Saccharomyces cerevisiae was recently demonstrated by successfully introducing the metabolic pathway for vanillin production in yeast. Nevertheless, the amount of...

  13. Strategies for optimizing algal biology for enhanced biomass production

    OpenAIRE

    Barry, Amanda N.; Starkenburg, Shawn R.; Richard eSayre

    2015-01-01

    One of the more environmentally sustainable ways to produce high energy density (oils) feed stocks for the production of liquid transportation fuels is from biomass. Photosynthetic carbon capture combined with biomass combustion (point source) and subsequent carbon capture and sequestration (BECCS) has also been proposed in the Intergovernmental Panel on Climate Change Report as one of the most effective and economical strategies to remediate atmospheric greenhouse gases. To maximize photosyn...

  14. Strategies for Optimizing Algal Biology for Enhanced Biomass Production

    OpenAIRE

    Barry, Amanda N.; Starkenburg, Shawn R.; Sayre, Richard T.

    2015-01-01

    One of the most environmentally sustainable ways to produce high-energy density (oils) feed stocks for the production of liquid transportation fuels is from biomass. Photosynthetic carbon capture combined with biomass combustion (point source) and subsequent carbon capture and sequestration has also been proposed in the intergovernmental panel on climate change report as one of the most effective and economical strategies to remediate atmospheric greenhouse gases. To maximize photosynthetic c...

  15. Selection for milk production from a lactation biology viewpoint.

    Science.gov (United States)

    Akers, R M

    2000-05-01

    The success of selection for increased milk production in dairy cows is apparent. Certainly, many herds now have average production levels that would have only been associated with the best producers in the herd 30 yr ago. There are, of course, many reasons for this success. Among these are improvements in genetic selection methods and associated use of artificial insemination, better fulfillment of nutritional needs and diet formulation, and careful attention to mastitis control and milking management. Development of new management tools (i.e., bovine somatotropin, improved crops, estrus detection devices, estrus synchronization, monitoring of individual animal performance, and disease prevention) should not be forgotten. Although many aspects of a dairy operation determine overall performance and profitability, the focus of this paper is the udder. Information indicates that both the structure and function of the bovine mammary gland have been directly impacted by long-term selection for increased milk production but improved functionality may have been more important. This review also considered studies that attempt to develop techniques and measurements for possible selection of genetically superior animals including measurement of circulating hormones and direct assay of mammary tissue function. PMID:10821592

  16. BIOLOGICAL AND PRODUCTIVE RESOURCES OF LACTATING COWS AT DENITRIFICATION

    Directory of Open Access Journals (Sweden)

    Kokaeva M. G.

    2015-09-01

    Full Text Available The article presents the results obtained in the process of two scientific-practical experiments carried jut on two milk cows (Shvitskay breed aimed at the antioxidants detoxication properties and mould inhibitor revealing. This factor is actual in the Republic of North Ossetia-Alania as the intensive technologies of the fodder crops cultivation using the nitrate fertilizers are widely applied in the region leading to the excess nitrates and nitrite penetration into the animals’ organism. During the first experiment, the antioxidants of epophen and vitamin C were added into the ration of the lactating cows with the subtoxic dosage of nitrates both separately and in complex. The complex feeding proved to increase the milk productivity, the fat mass and protein mass in milk while reducing the fodder expenditure per product unit. Beside, the lactating cows revealed the digestive and intermediate exchange betterment and the reduction of nitrates and nitrites level in blood. The second experiment helped to study Khadoks antioxidant and mould inhibitor called Mold-Zap efficiency use for the nitrates and aflotoxicin B1 detoxication. The researches showed that the complex admixtures of the said preparations introduction into the rations of the animals increased the milk productivity, fat and protein content and reduced aflatoxineM1 content. The cows activated the digestive and intermediate exchange, accompanied with the nitrates and nitrites level reduction in the organism

  17. Biological fouling of ethylene production water recycling system

    Energy Technology Data Exchange (ETDEWEB)

    Kurdish, I.K.; Khenkina, L.M.; Pavlenko, N.I.

    A study was made of biotic factors determining the intensity of biological overgrowth of ethylene as well as the distribution of sulfate-reducing bacteria in the system. The total quantity of microorganisms was determined by counting on membrane filters. The content of heterotrophic aerobic and anaerobic microorganisms was determined by inoculating specimens on meat-peptone agar and wort agar. The resistance of the microflora in the water supply system to high temperatures was studied by exposure of the specimens to various temperatures for one hour. The results indicated presence of large quantities of a number of biogenous substances in the water, including compounds of phosphorus and carbon. Large numbers of both aerobic and anaerobic microorganisms were present, consuming the oxygen absorbed by the water in the cooling tower, creating favorable conditions for development of both aerobic and anaerobic microorganisms. The sulfate-reducing bacteria present caused accumulation of hydrogen sulfide in the system, increasing corrosion. One possible means of controlling the fouling organisms might be to heat the water. Heating to 60C for sixty minutes significantly reduces the microorganism population, while 70C results in almost total elimination. 8 references, 4 figures.

  18. Biological Hydrogen Production Using Chloroform-treated Methanogenic Granules

    Science.gov (United States)

    Hu, Bo; Chen, Shulin

    In fermentative hydrogen production, the low-hydrogen-producing bacteria retention rate limits the suspended growth reactor productivity because of the long hydraulic retention time (HRT) required to maintain adequate bacteria population. Traditional bacteria immobilization methods such as calcium alginate entrapment have many application limitations in hydrogen fermentation, including limited duration time, bacteria leakage, cost, and so on. The use of chloroform-treated anaerobic granular sludge as immobilized hydrogen-producing bacteria in an immobilized hydrogen culture may be able to overcome the limitations of traditional immobilization methods. This paper reports the findings on the performance of fed-batch cultures and continuous cultures inoculated with chloroform-treated granules. The chloroform-treated granules were able to be reused over four fed-batch cultures, with pH adjustment. The upflow reactor packed with chloroform-treated granules was studied, and the HRT of the upflow reactor was found to be as low as 4 h without any decrease in hydrogen production yield. Initial pH and glucose concentration of the culture medium significantly influenced the performance of the reactor. The optimum initial pH of the culture medium was neutral, and the optimum glucose concentration of the culture medium was below 20 g chemical oxygen demand/L at HRT 4 h. This study also investigated the possibility of integrating immobilized hydrogen fermentation using chloroform-treated granules with immobilized methane production using untreated granular sludge. The results showed that the integrated batch cultures produced 1.01 mol hydrogen and 2 mol methane per mol glucose. Treating the methanogenic granules with chloroform and then using the treated granules as immobilized hydrogen-producing sludge demonstrated advantages over other immobilization methods because the treated granules provide hydrogen-producing bacteria with a protective niche, a long duration of an active

  19. Evaluation of a class III biological safety cabinet for enclosure of an ultracentrifuge.

    Science.gov (United States)

    Chatigny, M A; Dunn, S; Ishimaru, K; Eagleson, J A; Prusiner, S B

    1979-11-01

    An evaluation of a special safety cabinet housing a high-speed centrifuge was made. The cabinet enclosed both the top access port and the drive and pumping machinery of the centrifuge. A titanium rotor was loaded with tubes containing a bacterial culture, weakened, and driven until rotor rupture occurred. There were several bent and broken components in the centrifuge, and bacteria leaked from the vacuum chamber. Although the forces were sufficient to displace the cabinet, none of the test bacteria were found outside the cabinet. PMID:543704

  20. Increasing the quality and safety of meat products through high technology methods during their storage

    International Nuclear Information System (INIS)

    The aim of this study was to increase the quality and safety of different meat products by applying two high technology methods – lyophilization and gamma-irradiation. Object of study were chicken, pork and beef meat products. The organoleptic, physicochemical and microbiological properties after lyophilization, irradiation with gamma-rays and during the preservation of the samples were studied. The results indicated that the application of the two original technologies for preservation could ensure qualitative and long-lasting preservation of meat products with excellently preserved taste and organoleptic properties

  1. Importance of Decision Support Systems About Food Safety in Raw Milk Production

    Directory of Open Access Journals (Sweden)

    Ecem Akan

    2015-12-01

    Full Text Available In raw milk production decision support systems for control of food safety hazards has not been developed but main points of this system are available. The decision support systems’ elements include data identification at critical points in the milk supply chain, an information management system and data exchange. Decision supports systems has been developed on the basis of these elements. In dairy sector decision support systems are significant for controlling of food safety hazards and preferred by producers. When these systems are implemented in the milk supply chain, it can be prevented unnecessary sampling and analysis. In this article it will be underlined effects of decision support system elements on food safety of raw milk.

  2. Production, Secretion and Biological Activity of Bacillus cereus Enterotoxins

    Directory of Open Access Journals (Sweden)

    Sonia Senesi

    2010-06-01

    Full Text Available Bacillus cereus behaves as an opportunistic pathogen frequently causing gastrointestinal diseases, and it is increasingly recognized to be responsible for severe local or systemic infections. Pathogenicity of B. cereus mainly relies on the secretion of a wide array of toxins and enzymes and also on the ability to undergo swarming differentiation in response to surface-sensing. In this report, the pathogenicity exerted by B. cereus toxins is described with particular attention to the regulatory mechanisms of production and secretion of HBL, Nhe and CytK enterotoxins.

  3. Application of Olefin Cross-Metathesis to the Synthesis of Biologically Active Natural Products

    OpenAIRE

    Prunet, Joëlle

    2005-01-01

    An overview of the use of olefin cross-metathesis in the synthesis of biologically active natural products is presented. The diverse examples are organized according to the outcome of the olefin constructed by the cross-metathesis reaction: this olefin can be either present in the final product, reduced, engaged in other transformations, or involved in tandem processes.

  4. 78 FR 65904 - Permanent Discontinuance or Interruption in Manufacturing of Certain Drug or Biological Products

    Science.gov (United States)

    2013-11-04

    ...(D) Immune Globulin and Hepatitis B Immune Globulin; Coagulation Factor VIIa (Recombinant); and..., or mitigate shortages of these products. b. Vaccines. We are proposing to apply section 506C of the FD&C Act to all biological products, including vaccines. Under section 506C(i)(3)(B) of the FD&C...

  5. Natural product diversity and its role in chemical biology and drug discovery

    OpenAIRE

    Hong, Jiyong

    2011-01-01

    Through the natural selection process, natural products possess a unique and vast chemical diversity and have been evolved for optimal interactions with biological macromolecules. Owing to their diversity, target affinity, and specificity, natural products have demonstrated enormous potential as modulators of biomolecular function, been an essential source for drug discovery, and provided design principles for combinatorial library development.

  6. 9 CFR 113.51 - Requirements for primary cells used for production of biologics.

    Science.gov (United States)

    2010-01-01

    ... of the final pool of harvested material or samples of each subculture of cells used to prepare the... completed product or samples of the final pool of harvested material or samples of each subculture of cells... cells or each subculture of primary cells used to prepare a biological product shall be shown free...

  7. Development of biological functional material and product from Nelumbo nucifera

    International Nuclear Information System (INIS)

    The solvent extracts of Nelumbo nucifera G. were investigated for the activities of antioxidant, whitening, anti-wrinkle and antimicrobial effects to apply as a functional ingredient for cosmetic products. The electron donating ability of irradiated NN-L extract was above 85% at the concentration of 50ppm. The superoxide dismutase(SOD)-like activity of irradiated NN-L extract was about 76% at 1,000ppm concentration. The xanthine oxidase inhibitory effect of irradiated NN-L extract was about 15% at 1,000ppm. The tyrosinase inhibitory effect of irradiated NN-L extract was about 18% at 1,000ppm. Anti-wrinkle effect, the elastase inhibition activity of irradiated NN-L extract was about 45% at 1,000ppm concentration. All these findings suggested that Nelumbo nucifera G. has a great potential as a cosmeceutical ingredient

  8. Development of biological functional material and product from Nelumbo nucifera

    Energy Technology Data Exchange (ETDEWEB)

    Jeong, Il Yun; Park, Yong Dae; Jin, Chang Hyun; Choi, Dae Seong

    2008-01-15

    The solvent extracts of Nelumbo nucifera G. were investigated for the activities of antioxidant, whitening, anti-wrinkle and antimicrobial effects to apply as a functional ingredient for cosmetic products. The electron donating ability of irradiated NN-L extract was above 85% at the concentration of 50ppm. The superoxide dismutase(SOD)-like activity of irradiated NN-L extract was about 76% at 1,000ppm concentration. The xanthine oxidase inhibitory effect of irradiated NN-L extract was about 15% at 1,000ppm. The tyrosinase inhibitory effect of irradiated NN-L extract was about 18% at 1,000ppm. Anti-wrinkle effect, the elastase inhibition activity of irradiated NN-L extract was about 45% at 1,000ppm concentration. All these findings suggested that Nelumbo nucifera G. has a great potential as a cosmeceutical ingredient.

  9. A novel biological hydrogen production system. Impact of organic loading

    Energy Technology Data Exchange (ETDEWEB)

    Hafez, Hisham; Nakhla, George; El Naggar, Hesham [Western Ontario Univ. (Canada)

    2010-07-01

    The patent-pending system comprises a novel biohydrogen reactor with a gravity settler for decoupling of SRT from HRT. Two biohydrogenators were operated for 220 days at 37 C, hydraulic retention time 8 h and solids retention time ranged from 1.4 to 2 days under four different glucose concentrations of 2, 8, 16, 32, 48 and 64 g/L, corresponding to organic loading rates of 6.5-206 kg COD/m{sup 3}-d, and started up using anaerobically-digested sludge from the St. Marys wastewater treatment plant (St.Mary, Ontario, Canada) as the seed. The system steadily produced hydrogen with no methane. A maximum hydrogen yield of 3.1 mol H{sub 2} /mol glucose was achieved in the system for all the organic loading rates with an average of 2.8mol H{sub 2} /mol glucose. Acetate and butyrate were the main effluent liquid products at concentrations ranging from 640-7400 mg/L and 400-4600 mg/l, respectively, with no lactate detection. Microbial community analysis using denaturing gradient gel electrophoresis (DGGE) confirmed the absence of lactate producing bacteria Lactobacillus fermentum and other non-hydrogen producing species, and the predominance of various Clostridium species. Biomass concentrations in the biohydrogenators were steady, during the runs, varying form 1500 mg/L at the OLR of 6.5 kg COD/m{sup 3}-d to 14000 mg/L at the 104 kg COD/m{sup 3}-d, thus emphasizing the potential of this novel system for sustained stable hydrogen production and prevention of biomass washout. (orig.)

  10. Building Design Guidelines of Interior Architecture for Bio safety Levels of Biology Laboratories

    International Nuclear Information System (INIS)

    This paper discusses the pivotal role of the Interior Architecture As one of the scientific disciplines minute to complete the Architectural Sciences, which relied upon the achievement and development of facilities containing scientific research laboratories, in terms of planning and design, particularly those containing biological laboratories using radioactive materials, adding to that, the application of the materials or raw materials commensurate with each discipline of laboratory and its work nature, and by the discussion the processing of design techniques and requirements of interior architecture dealing with Research Laboratory for electronic circuits an their applications with the making of its prototypes

  11. Understanding of definition and safety of oral health products among patients, physicians and pharmacists.

    Science.gov (United States)

    Asahina, Yasuko; Hori, Satoko; Sawada, Yasufumi

    2010-07-01

    Our objective was to clarify the current understanding of the definition and safety of oral health products among patients and health professionals, and patients' perception about their communication with physicians and pharmacists regarding those products. Self-administered questionnaires were completed by patients at 17 community pharmacies in 14 prefectures of Japan. For health professionals, we sent a questionnaire to pharmacists and physicians who were registered as members of the Internet-based Medical Doctor's and Pharmacist's Information-Sharing System. The respondents were 242 patients, 158 physicians and 407 pharmacists. Some patients did not categorize dietary supplements as health products, while they did so categorize conventional foods (e.g., fermented soybeans, yogurt). Their understanding of the definition of health products was different from that of health professionals. Less than half of the patients considered that health products might potentiate or attenuate the effects of concomitant drugs, and this view was especially common among the elderly. The percentage of patients who reported that they rarely or never asked for advice from a pharmacist about their use of health products was significantly higher among those who had an incorrect understanding about health products. In conclusion, some patients' recognition of oral health products was different from that of health professionals, and most patients do not discuss their use of such products unless they are asked. Therefore, it is important for health professionals to check a patient's use of health products and be sure what he or she means when using the term 'health product'.

  12. Metabolic Engineering for Production of Biorenewable Fuels and Chemicals: Contributions of Synthetic Biology

    Directory of Open Access Journals (Sweden)

    Laura R. Jarboe

    2010-01-01

    Full Text Available Production of fuels and chemicals through microbial fermentation of plant material is a desirable alternative to petrochemical-based production. Fermentative production of biorenewable fuels and chemicals requires the engineering of biocatalysts that can quickly and efficiently convert sugars to target products at a cost that is competitive with existing petrochemical-based processes. It is also important that biocatalysts be robust to extreme fermentation conditions, biomass-derived inhibitors, and their target products. Traditional metabolic engineering has made great advances in this area, but synthetic biology has contributed and will continue to contribute to this field, particularly with next-generation biofuels. This work reviews the use of metabolic engineering and synthetic biology in biocatalyst engineering for biorenewable fuels and chemicals production, such as ethanol, butanol, acetate, lactate, succinate, alanine, and xylitol. We also examine the existing challenges in this area and discuss strategies for improving biocatalyst tolerance to chemical inhibitors.

  13. Strengthening Safety Management to Ensure Safety in Production%加强安全管理确保安全生产

    Institute of Scientific and Technical Information of China (English)

    卢常盛

    2012-01-01

    生产与安全是一个有机整体,二者不能分割,更不能对立起来.只有将安全时刻镶嵌在生产之中,将安全与生产的统一,才能有效的加强生产安全管理水平.而生产安全管理是国家明确指出企业应贯彻、遵守、执行的规章制度,通过安全管理体系及人员措施,可确保群众的切身利益、企业的最优生产目标、以及国家和谐稳健发展.%Production and safely is an organic whole, both of them cannot be separated and can't be opposite. Only running through safety idea into production and integrating safety and production together, can we effectively strengthen safety management level. Safety management in production is the rules and regulations that enterprise should implement, abide by, and execute. The implementation of safety management system and measure about employee can ensure employee's benefits, achieve optimal production target, and state harmonious and stable development.

  14. Phototrophic pigment production with microalgae: biological constraints and opportunities.

    Science.gov (United States)

    Mulders, Kim J M; Lamers, Packo P; Martens, Dirk E; Wijffels, René H

    2014-04-01

    There is increasing interest in naturally produced colorants, and microalgae represent a bio-technologically interesting source due to their wide range of colored pigments, including chlorophylls (green), carotenoids (red, orange and yellow), and phycobiliproteins (red and blue). However, the concentration of these pigments, under optimal growth conditions, is often too low to make microalgal-based pigment production economically feasible. In some Chlorophyta (green algae), specific process conditions such as oversaturating light intensities or a high salt concentration induce the overproduction of secondary carotenoids (β-carotene in Dunaliella salina (Dunal) Teodoresco and astaxanthin in Haematococcus pluvialis (Flotow)). Overproduction of all other pigments (including lutein, fucoxanthin, and phycocyanin) requires modification in gene expression or enzyme activity, most likely combined with the creation of storage space outside of the photosystems. The success of such modification strategies depends on an adequate understanding of the metabolic pathways and the functional roles of all the pigments involved. In this review, the distribution of commercially interesting pigments across the most common microalgal groups, the roles of these pigments in vivo and their biosynthesis routes are reviewed, and constraints and opportunities for overproduction of both primary and secondary pigments are presented.

  15. Quality and safety assessment of meat products obtained by traditional romanian recipes

    Directory of Open Access Journals (Sweden)

    Adriana Morar

    2016-05-01

    Full Text Available Meat products obtained following traditional recipes are considered healthy foods, with superior sensory characteristics, being highly appreciated by consumers. This study aimed to evaluate the quality and safety of 18 meat products obtained by traditional receipts, including raw/smoked pork sausages (n=3, loin (n=1, bacon (n=2, kaizer (n=1, ham (n=1, spareribs (n=1, pork pastrami (n=1, and sausages prepared from edible meat offal of pork (n=8. All samples were bacteriologically examined (Salmonella, L. monocytogenes and E. coli. Also, moisture, fat, total protein, salt and nitrite contents were quantified. All products were Salmonella and L. monocytogenes free. E. coli was recovered in two samples (11.1%, a smoked pork sausage and a sausage prepared from edible meat offal of pork, at levels between 1.5 log and 3.25 log cfu/g. Moisture ranged from 17.21 to 67.46%, fat 17.37–62.18%, protein 8.13–23.18%, sodium chloride 1.50–6.39%, and nitrites <10–35 ppm, respectively. In two samples (11.1% of smoked meat products the salt content exceeded the maximum limits allowed by law. These results have shown that meat products obtained by traditional recipes are nutritive and safety. However, some varieties of meat products with high salt concentrations should be avoided by persons with dietary salt restriction.

  16. Organic Production Systems: What the Biological Cell Can Teach Us About Manufacturing

    OpenAIRE

    Lieven Demeester; Knut Eichler; Christoph H. Loch

    2004-01-01

    Biological cells run complicated and sophisticated production systems. The study of the cell's production technology provides us with insights that are potentially useful in industrial manufacturing. When comparing cell metabolism with manufacturing techniques in industry, we find some striking commonalities, but also some important differences. Like today's well-run factories, the cell operates a very lean production system, assures quality at the source, and uses component commonality to si...

  17. Enhancing Food Safety and Productivity: Technology Use in the Canadian Food Processing Industry

    OpenAIRE

    Sabourin, David; Baldwin, John R.

    2002-01-01

    This paper examines the factors contributing to the adoption of advanced technologies in the Canadian food-processing sector. The numbers of technologies used by a plant is found to be highly correlated with expected gains in firm performance. The benefits of enhanced food safety and quality, as well as productivity improvements, are closely associated with technology use. Impediments that negatively affect technology use include software costs, problems with external financing, lack of cash ...

  18. Evaluation of hygiene and safety criteria in the production of a traditional Piedmont cheese

    Directory of Open Access Journals (Sweden)

    Sara Astegiano

    2014-08-01

    Full Text Available Traditional products and related processes must be safe to protect consumers’ health. The aim of this study was to evaluate microbiological criteria of a traditional Piedmont cheese, made by two different cheese producers (A and B. Three batches of each cheese were considered. The following seven samples of each batch were collected: raw milk, milk at 38°C, curd, cheese at 7, 30, 60, 90 days of ripening. During cheese making process, training activities dealing with food safety were conducted. Analyses regarding food safety and process hygiene criteria were set up according to the EC Regulation 2073/2005. Other microbiological and chemical-physical analyses [lactic streptococci, lactobacilli, pH and water activity (Aw] were performed as well. Shiga-toxin Escherichia coli, aflatoxin M1 and antimicrobial substances were considered only for raw milk. All samples resulted negative for food safety criteria; Enterobacteriaceae, E.coli and coagulase-positive staphylococci (CPS were high in the first phase of cheese production, however they decreased at the end of ripening. A high level of CPS in milk was found in producer A, likewise in some cheese samples a count of >5 Log CFU/g was reached; staphylococcal enterotoxins resulted negative. The pH and Aw values decreased during the cheese ripening period. The competition between lactic flora and potential pathogen microorganisms and decreasing of pH and Aw are considered positive factors in order to ensure safety of dairy products. Moreover, training activities play a crucial role to manage critical points and perform corrective action. Responsible application of good manufacturing practices are considered key factors to obtain a high hygienic level in dairy products.

  19. Evaluation of Hygiene and Safety Criteria in the Production of a Traditional Piedmont Cheese

    Science.gov (United States)

    Bellio, Alberto; Adriano, Daniela; Bianchi, Daniela Manila; Gallina, Silvia; Gorlier, Alessandra; Gramaglia, Monica; Lombardi, Giampiero; Macori, Guerrino; Zuccon, Fabio; Decastelli, Lucia

    2014-01-01

    Traditional products and related processes must be safe to protect consumers’ health. The aim of this study was to evaluate microbiological criteria of a traditional Piedmont cheese, made by two different cheese producers (A and B). Three batches of each cheese were considered. The following seven samples of each batch were collected: raw milk, milk at 38°C, curd, cheese at 7, 30, 60, 90 days of ripening. During cheese making process, training activities dealing with food safety were conducted. Analyses regarding food safety and process hygiene criteria were set up according to the EC Regulation 2073/2005. Other microbiological and chemical-physical analyses [lactic streptococci, lactobacilli, pH and water activity (Aw)] were performed as well. Shiga-toxin Escherichia coli, aflatoxin M1 and antimicrobial substances were considered only for raw milk. All samples resulted negative for food safety criteria; Enterobacteriaceae, E.coli and coagulase-positive staphylococci (CPS) were high in the first phase of cheese production, however they decreased at the end of ripening. A high level of CPS in milk was found in producer A, likewise in some cheese samples a count of >5 Log CFU/g was reached; staphylococcal enterotoxins resulted negative. The pH and Aw values decreased during the cheese ripening period. The competition between lactic flora and potential pathogen microorganisms and decreasing of pH and Aw are considered positive factors in order to ensure safety of dairy products. Moreover, training activities play a crucial role to manage critical points and perform corrective action. Responsible application of good manufacturing practices are considered key factors to obtain a high hygienic level in dairy products.

  20. Occurrence, pathways and implications of biological production of reactive oxygen species in natural waters

    Science.gov (United States)

    Zhang, T.; Hansel, C. M.; Voelker, B. M.; Lamborg, C. H.

    2014-12-01

    Reactive oxygen species (ROS), such as superoxide (O2-) and hydrogen peroxide (H2O2) play a critical role in the redox cycling of both toxic (e.g., Hg) and nutrient (e.g., Fe) metals. Despite the discovery of extracellular ROS production in various microbial cultures, including fungi, algae and bacteria, photo-dependent processes are generally considered as the predominant source of ROS in natural waters. Here we show that biological production of ROS is ubiquitous and occurs at a significant rate in freshwater and brackish water environments. Water samples were collected from three freshwater and one brackish water ponds in Cape Cod, Massachusetts, USA, periodically from 2012 to 2014. Production of O2- and H2O2 were measured in dark incubations of natural water using a chemiluminescent and a colorimetric probe, respectively. Rates of biological ROS production were obtained by comparing unfiltered with 0.2-μm filtered samples. The role of biological activity in ROS production was confirmed by the cessation of ROS production upon addition of formaldehyde. In surface water, production rates of O2- ranged from undetectable to 96.0 ± 30.0 nmol L-1 h-1, and production rates of H2O2 varied between 9.9 ± 1.3 nmol L-1 h-1 and 145.6 ± 11.2 nmol L-1 h-1. The maximum production rates of both ROS were observed in mid-summer 2013, which coincides with peak biological activity. ROS production in the water from aphotic zone was greater than in the water from photic zone. Thus, non-light dependent biological processes are likely the major contributors to ROS production in this system. Moreover, O2- production appeared to be enhanced by NADH and inhibited by proteinase-K, suggesting the possible involvement of NADH oxidoreductases in this process. The potential role of different microbial communities in ROS production, and the implications of biological ROS production for mercury speciation will also be discussed.

  1. Biologic

    CERN Document Server

    Kauffman, L H

    2002-01-01

    In this paper we explore the boundary between biology and the study of formal systems (logic). In the end, we arrive at a summary formalism, a chapter in "boundary mathematics" where there are not only containers but also extainers ><, entities open to interaction and distinguishing the space that they are not. The boundary algebra of containers and extainers is to biologic what boolean algebra is to classical logic. We show how this formalism encompasses significant parts of the logic of DNA replication, the Dirac formalism for quantum mechanics, formalisms for protein folding and the basic structure of the Temperley Lieb algebra at the foundations of topological invariants of knots and links.

  2. Application of synthetic biology for production of chemicals in yeast Saccharomyces cerevisiae

    DEFF Research Database (Denmark)

    Borodina, Irina; Li, Mingji

    2015-01-01

    biology has the potential to bring down this cost by improving our ability to predictably engineer biological systems. This review highlights synthetic biology applications for design, assembly, and optimization of non-native biochemical pathways in baker's yeast Saccharomyces cerevisiae. We describe......-of-concept chemicals have been made in yeast, only a very small fraction of those has reached commercial-scale production so far. The limiting factor is the high research cost associated with the development of a robust cell factory that can produce the desired chemical at high titer, rate, and yield. Synthetic...

  3. Human Pluripotent Stem Cell Based Developmental Toxicity Assays for Chemical Safety Screening and Systems Biology Data Generation.

    Science.gov (United States)

    Shinde, Vaibhav; Klima, Stefanie; Sureshkumar, Perumal Srinivasan; Meganathan, Kesavan; Jagtap, Smita; Rempel, Eugen; Rahnenführer, Jörg; Hengstler, Jan Georg; Waldmann, Tanja; Hescheler, Jürgen; Leist, Marcel; Sachinidis, Agapios

    2015-01-01

    Efficient protocols to differentiate human pluripotent stem cells to various tissues in combination with -omics technologies opened up new horizons for in vitro toxicity testing of potential drugs. To provide a solid scientific basis for such assays, it will be important to gain quantitative information on the time course of development and on the underlying regulatory mechanisms by systems biology approaches. Two assays have therefore been tuned here for these requirements. In the UKK test system, human embryonic stem cells (hESC) (or other pluripotent cells) are left to spontaneously differentiate for 14 days in embryoid bodies, to allow generation of cells of all three germ layers. This system recapitulates key steps of early human embryonic development, and it can predict human-specific early embryonic toxicity/teratogenicity, if cells are exposed to chemicals during differentiation. The UKN1 test system is based on hESC differentiating to a population of neuroectodermal progenitor (NEP) cells for 6 days. This system recapitulates early neural development and predicts early developmental neurotoxicity and epigenetic changes triggered by chemicals. Both systems, in combination with transcriptome microarray studies, are suitable for identifying toxicity biomarkers. Moreover, they may be used in combination to generate input data for systems biology analysis. These test systems have advantages over the traditional toxicological studies requiring large amounts of animals. The test systems may contribute to a reduction of the costs for drug development and chemical safety evaluation. Their combination sheds light especially on compounds that may influence neurodevelopment specifically. PMID:26132533

  4. Further research on the biological activities and the safety of raspberry ketone are needed

    Science.gov (United States)

    Raspberry ketone supplements have grabbed consumer attention with the possibility they might help burn fat and aid weight loss. While raspberry ketone occurs naturally, and is found in raspberry fruit, most is synthetically produced for use in commercial products as flavorings, fragrances, or dietar...

  5. Traditional and regional food products in Poland and European Union – legislation and food safety

    Directory of Open Access Journals (Sweden)

    Mirosław M. Michalski

    2011-09-01

    Full Text Available The paper aims at presenting the present state of law and food safety regarding traditional/regional foods. The production has to be carried out hygienically assuring food safety to the products. Legal regulations connected with production and protection of the traditional foods arecontained in Council Regulations (EC No 509/2006 and No 510/2006. The mentioned above decrees create marking and requirement for three groups of food products: Traditional Specialities Guaranteed (TSG, Protected Designation of Origin (PDO and Protected of Geographical Indication (PGI. Manufacturers must produce this type of foodstuff according to general hygienic rules. In order to protect the consumer, they should be subject to inspection based on Commission Regulation (EC No 882/2004. Foodstuff should be subject to ensure that operators comply with the product specification before marketing. Verification of compliance with the specifications of any agricultural product and foodstuff produced within the EC shall be ensured by one or more competent verification organisation/body or/and authorities certification bodies operating as a product certification body after accreditation in accordance with European standard EN 45011 (2000. Foodstuffs should not contain microorganisms or their toxins or metabolites in quantities that present an unacceptable risk for human health. Foodstuff producers are obligated to fulfil microbiological requirements. Products should be monitored according to the national plan of monitoring, in range of residues of pesticides, heavy metals, dioxin or inhibitory substances and also controlled on permitted additives. The promotion of our traditional and regional foods is carried out by several organisations which are active in Poland, i.e. Polish Chamber of Regional and Local Products and Centre for Studies of Natural and Traditional Food (at University of Warmia and Mazury in Olsztyn.  

  6. Recent progress in synthetic biology for microbial production of C3-C10 alcohols

    Directory of Open Access Journals (Sweden)

    Edna N. Lamsen

    2012-06-01

    Full Text Available The growing need to address current energy and environmental problems has sparked an interest in developing improved biological methods to produce liquid fuels from renewable sources. While microbial ethanol production is well established, higher chain alcohols possess chemical properties that are more similar to gasoline. Unfortunately, these alcohols (except 1-butanol are not produced efficiently in natural microorganisms, and thus economical production in industrial volumes remains a challenge. Synthetic biology, however, offers additional tools to engineer synthetic pathways in user-friendly hosts to help increase titers and productivity of these advanced biofuels. This review concentrates on recent developments in synthetic biology to produce higher-chain alcohols as viable renewable replacements for traditional fuel.

  7. Assessment of herbal medicinal products: Challenges, and opportunities to increase the knowledge base for safety assessment

    International Nuclear Information System (INIS)

    Although herbal medicinal products (HMP) have been perceived by the public as relatively low risk, there has been more recognition of the potential risks associated with this type of product as the use of HMPs increases. Potential harm can occur via inherent toxicity of herbs, as well as from contamination, adulteration, plant misidentification, and interactions with other herbal products or pharmaceutical drugs. Regulatory safety assessment for HMPs relies on both the assessment of cases of adverse reactions and the review of published toxicity information. However, the conduct of such an integrated investigation has many challenges in terms of the quantity and quality of information. Adverse reactions are under-reported, product quality may be less than ideal, herbs have a complex composition and there is lack of information on the toxicity of medicinal herbs or their constituents. Nevertheless, opportunities exist to capitalise on newer information to increase the current body of scientific evidence. Novel sources of information are reviewed, such as the use of poison control data to augment adverse reaction information from national pharmacovigilance databases, and the use of more recent toxicological assessment techniques such as predictive toxicology and omics. The integration of all available information can reduce the uncertainty in decision making with respect to herbal medicinal products. The example of Aristolochia and aristolochic acids is used to highlight the challenges related to safety assessment, and the opportunities that exist to more accurately elucidate the toxicity of herbal medicines.

  8. Effects of genetic, processing, or product formulation changes on efficacy and safety of probiotics.

    Science.gov (United States)

    Sanders, Mary Ellen; Klaenhammer, Todd R; Ouwehand, Arthur C; Pot, Bruno; Johansen, Eric; Heimbach, James T; Marco, Maria L; Tennilä, Julia; Ross, R Paul; Franz, Charles; Pagé, Nicolas; Pridmore, R David; Leyer, Greg; Salminen, Seppo; Charbonneau, Duane; Call, Emma; Lenoir-Wijnkoop, Irene

    2014-02-01

    Commercial probiotic strains for food or supplement use can be altered in different ways for a variety of purposes. Production conditions for the strain or final product may be changed to address probiotic yield, functionality, or stability. Final food products may be modified to improve flavor and other sensory properties, provide new product formats, or respond to market opportunities. Such changes can alter the expression of physiological traits owing to the live nature of probiotics. In addition, genetic approaches may be used to improve strain attributes. This review explores whether genetic or phenotypic changes, by accident or design, might affect the efficacy or safety of commercial probiotics. We highlight key issues important to determining the need to re-confirm efficacy or safety after strain improvement, process optimization, or product formulation changes. Research pinpointing the mechanisms of action for probiotic function and the development of assays to measure them are greatly needed to better understand if such changes have a substantive impact on probiotic efficacy.

  9. Quality and safety aspects of food products addressing the needs of pregnant women and infants.

    Science.gov (United States)

    Hoeft, Birgit; Eggersdorfer, Manfred; Heck, Stephan

    2014-01-01

    Food safety is a primary concern for pregnant women and infants as the immune system is weakened during pregnancy and not developed enough in infants, which makes them especially vulnerable to suffering from the negative effects of nonquality food products. However, food contaminations not only affect an individual's health but also a country's economic development, social harmony, food trade and even politics, as seen during the Chinese infant formula crisis in 2008. Thus, quality control is crucial in the production processes in order to have safe food products on the market. But quality control alone is not enough: manufacturers must embrace quality beyond classic in-process parameters and perform a final microbiological analysis at the end of the production process. This requires a clear and trustworthy approach to quality and safety and the involvement of all stakeholders from industry, government and academia over policy makers to consumers. This paper provides an introductory context for current quality management systems and gives real-life examples of challenges that manufacturers face during quality management and control throughout the production process.

  10. Studies on production and biological potential of prodigiosin by Serratia marcescens.

    Science.gov (United States)

    Suryawanshi, Rahul K; Patil, Chandrashekhar D; Borase, Hemant P; Salunke, Bipinchandra K; Patil, Satish V

    2014-07-01

    Efficacy of Serratia marcescens for pigment production and biological activity was investigated. Natural substrates like sweet potato, mahua flower extract (Madhuca latifolia L.), and sesam at different concentrations were taken. As a carbon source microorganism favored potato powder was followed by sesam and mannitol, and as nitrogen source casein hydrolysate was followed by yeast and malt extract. The effect of inorganic salts on pigment production was also studied. At final optimized composition of suitable carbon, nitrogen source, and trace materials and at suitable physiological conditions, prodigiosin production was 4.8 g L(-1). The isolated pigment showed antimicrobial activity against different pathogenic bacteria and fungi. Extracted pigment was characterized by spectroscopy, Fourier transform infrared (FTIR), and thin layer chromatography (TLC) which confirm production of biological compound prodigiosin. This study suggests that use of sweet potato powder and casein can be a potential alternative bioresource for commercial production of pigment prodigiosin. PMID:24781979

  11. Safety assessment of personal care products/cosmetics and their ingredients.

    Science.gov (United States)

    Nohynek, Gerhard J; Antignac, Eric; Re, Thomas; Toutain, Herve

    2010-03-01

    We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed, the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO(2) and ZnO in sunscreens. However

  12. Safety assessment of personal care products/cosmetics and their ingredients.

    Science.gov (United States)

    Nohynek, Gerhard J; Antignac, Eric; Re, Thomas; Toutain, Herve

    2010-03-01

    We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed, the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO(2) and ZnO in sunscreens. However

  13. Safety assessment of personal care products/cosmetics and their ingredients

    International Nuclear Information System (INIS)

    We attempt to review the safety assessment of personal care products (PCP) and ingredients that are representative and pose complex safety issues. PCP are generally applied to human skin and mainly produce local exposure, although skin penetration or use in the oral cavity, on the face, lips, eyes and mucosa may also produce human systemic exposure. In the EU, US and Japan, the safety of PCP is regulated under cosmetic and/or drug regulations. Oxidative hair dyes contain arylamines, the most chemically reactive ingredients of PCP. Although arylamines have an allergic potential, taking into account the high number of consumers exposed, the incidence and prevalence of hair dye allergy appears to be low and stable. A recent (2001) epidemiology study suggested an association of oxidative hair dye use and increased bladder cancer risk in consumers, although this was not confirmed by subsequent or previous epidemiologic investigations. The results of genetic toxicity, carcinogenicity and reproductive toxicity studies suggest that modern hair dyes and their ingredients pose no genotoxic, carcinogenic or reproductive risk. Recent reports suggest that arylamines contained in oxidative hair dyes are N-acetylated in human or mammalian skin resulting in systemic exposure to traces of detoxified, i.e. non-genotoxic, metabolites, whereas human hepatocytes were unable to transform hair dye arylamines to potentially carcinogenic metabolites. An expert panel of the International Agency on Research of Cancer (IARC) concluded that there is no evidence for a causal association of hair dye exposure with an elevated cancer risk in consumers. Ultraviolet filters have important benefits by protecting the consumer against adverse effects of UV radiation; these substances undergo a stringent safety evaluation under current international regulations prior to their marketing. Concerns were also raised about the safety of solid nanoparticles in PCP, mainly TiO2 and ZnO in sunscreens. However

  14. Impact of irradiation on the safety and quality of poultry and meat products: a review.

    Science.gov (United States)

    O'Bryan, Corliss A; Crandall, Philip G; Ricke, Steven C; Olson, Dennis G

    2008-05-01

    For more than 100 years research on food irradiation has demonstrated that radiation will make food safer and improve the shelf life of irradiated foods. Using the current food safety technology, we may have reached the point of diminishing returns even though recent figures from the CDC show a significant drop in the number of foodborne illnesses. However, too many people continue to get sick and die from eating contaminated food. New and under utilized technologies such as food irradiation need to be re-examined to achieve new levels of safety for the food supply. Effects of irradiation on the safety and quality of meat and poultry are discussed. Irradiation control of the principle microbial pathogens including viruses, the differences among at-risk sub-populations, factors affecting the diminished rate of improvement in food safety and published D values for irradiating raw meat and poultry are presented. Currently permitted levels of irradiation are probably not sufficient to control pathogenic viruses. Typical gram-negative spoilage organisms are very sensitive to irradiation. Their destruction leads to a significant increase in the acceptable shelf life. In addition, the destruction of these normal spoilage organisms did not provide a competitive growth advantage for irradiation injured food pathogens. Another of the main focuses of this review is a detailed compilation of the effects of most of the food additives that have been proposed to minimize the negative quality effect of irradiation. Most of the antimicrobials and antioxidants used singly or in combination produced an increased lethality of irradiation and a decrease in oxidation by-products. Combinations of dosage, temperature, dietary and direct additives, storage temperature and packaging atmosphere can produce meats that the average consumer will find indistinguishable from non-irradiated meats. A discussion of the production of unique radiological by-products is also included. PMID:18464033

  15. Effects of an onion by-product on bioactivity and safety markers in healthy rats

    DEFF Research Database (Denmark)

    Roldan-Marin, Eduvigis; Krath, Britta; Poulsen, Morten;

    2009-01-01

    Onions are excellent sources of bioactive compounds including fructo-oligosaccharides (FOS) and polyphenols. An onion by-product was characterised in order to be developed as a potentially bioactive food ingredient. Our main aim was to investigate whether the potential health and safety effects......-glutamate cysteine ligase catalytic subunit gene expression was upregulated but only in rats given the onion residue. The onion by-products as well as the soluble and insoluble fractions had prebiotic effects as evidenced by decreased pH, increased butyrate production and altered gut microbiota enzyme activities....... In conclusion, the onion by-products have no in vivo genotoxicity, may support in vivo antioxidative defence and alter the functionality of the rat gut microbiota....

  16. Reliability and safety of the electrical power supply complex of the Hanford production reactors

    Energy Technology Data Exchange (ETDEWEB)

    Robbins, F.D.

    1960-09-15

    Safety has been and must continue to be the inviolable modulus by which the operation of a nuclear reactor must be judged. A malfunction in any reactor may well result in a release of fission products which may dissipate over a wide geographical area. Such dissipation may place the health, happiness and even the lives of the people in the region in serious jeopardy. As a result, the property damage and liability cost may reach astronomical values in the order of magnitude of billions of dollars. Reliability of the electrical network is an indispensable factor in attaining a high order of safety assurance. Progress in the peaceful use of atomic energy may take the form of electrical power generation using the nuclear reactor as a source of thermal energy. In view of these factors it seems appropriate and profitable that a critical engineering study be made of the safety and reliability of the Hanford reactors without regard to cost economics. This individual and independent technical engineering analysis was made without regard to Hanford traditional engineering and administration assignments. The main objective has been to focus attention on areas which seem to merit further detailed study on conditions which seem to need adjustment but most of all on those changes which will improve reactor safety. This report is the result of such a study.

  17. Patient Preferences for Biologicals in Psoriasis: Top Priority of Safety for Cardiovascular Patients.

    Directory of Open Access Journals (Sweden)

    Marthe-Lisa Schaarschmidt

    Full Text Available Patients with psoriasis are often affected by comorbidities, which largely influence treatment decisions. Here we performed conjoint analysis to assess the impact of comorbidities on preferences of patients with moderate-to-severe psoriasis for outcome (probability of 50% and 90% improvement, time until response, sustainability of success, probability of mild and severe adverse events (AE, probability of ACR 20 response and process attributes (treatment location, frequency, duration and delivery method of biologicals. The influence of comorbidities on Relative Importance Scores (RIS was determined with analysis of variance and multivariate regression. Among the 200 participants completing the study, 22.5% suffered from psoriatic arthritis, 31.5% from arterial hypertension, 15% from cardiovascular disease (myocardial infarction, stroke, coronary artery disease, and/or arterial occlusive disease, 14.5% from diabetes, 11% from hyperlipidemia, 26% from chronic bronchitis or asthma and 12.5% from depression. Participants with psoriatic arthritis attached greater importance to ACR 20 response (RIS = 10.3 vs. 5.0, p<0.001; β = 0.278, p<0.001 and sustainability (RIS = 5.8 vs. 5.0, p = 0.032 but less value to time until response (RIS = 3.4 vs. 4.8, p = 0.045 than those without arthritis. Participants with arterial hypertension were particularly interested in a low risk of mild AE (RIS 9.7 vs. 12.1; p = 0.033 and a short treatment duration (RIS = 8.0 vs. 9.6, p = 0.002. Those with cardiovascular disease worried more about mild AE (RIS = 12.8 vs. 10, p = 0.027; β = 0.170, p = 0.027 and severe AE (RIS = 23.2 vs. 16.2, p = 0.001; β = 0.203, p = 0.007 but cared less about time until response (β = -0.189, p = 0.013, treatment location (β = -0.153, p = 0.049, frequency (β = -0.20, p = 0.008 and delivery method (β = -0.175, p = 0.023 than others. Patients' concerns should be addressed in-depth when prescribing biologicals to comorbid patients, keeping in

  18. Are eddies nature’s trigger to enhance biological productivity in the Bay of Bengal?

    Digital Repository Service at National Institute of Oceanography (India)

    PrasannaKumar, S.; Nuncio, M.; Kumar, A.; Sardessai, S.; DeSouza, S.N.; Gauns, M.; Ramaiah, N.; Madhupratap, M.

    -1 Are eddies nature?s trigger to enhance biological productivity in the Bay of Bengal? S. Prasanna Kumar, M. Nuncio, Jayu Narvekar, Ajoy Kumar1, S. Sardesai, S.N. de Souza, Mangesh Gauns, N. Ramaiah and M. Madhupratap National Institute of Oceanography... of nutrient supply to the oligotrophic upper ocean waters such as wind- driven mixing, upwelling etc. cannot account for this. In this paper we explore the role of eddies in enhancing the biological productivity in the Bay of Bengal. 2. Data and Analysis...

  19. Bioinformatics for the synthetic biology of natural products: integrating across the Design-Build-Test cycle.

    Science.gov (United States)

    Carbonell, Pablo; Currin, Andrew; Jervis, Adrian J; Rattray, Nicholas J W; Swainston, Neil; Yan, Cunyu; Takano, Eriko; Breitling, Rainer

    2016-08-27

    Covering: 2000 to 2016Progress in synthetic biology is enabled by powerful bioinformatics tools allowing the integration of the design, build and test stages of the biological engineering cycle. In this review we illustrate how this integration can be achieved, with a particular focus on natural products discovery and production. Bioinformatics tools for the DESIGN and BUILD stages include tools for the selection, synthesis, assembly and optimization of parts (enzymes and regulatory elements), devices (pathways) and systems (chassis). TEST tools include those for screening, identification and quantification of metabolites for rapid prototyping. The main advantages and limitations of these tools as well as their interoperability capabilities are highlighted. PMID:27185383

  20. Bioinformatics for the synthetic biology of natural products: integrating across the Design–Build–Test cycle

    Science.gov (United States)

    Currin, Andrew; Jervis, Adrian J.; Rattray, Nicholas J. W.; Swainston, Neil; Yan, Cunyu; Breitling, Rainer

    2016-01-01

    Covering: 2000 to 2016 Progress in synthetic biology is enabled by powerful bioinformatics tools allowing the integration of the design, build and test stages of the biological engineering cycle. In this review we illustrate how this integration can be achieved, with a particular focus on natural products discovery and production. Bioinformatics tools for the DESIGN and BUILD stages include tools for the selection, synthesis, assembly and optimization of parts (enzymes and regulatory elements), devices (pathways) and systems (chassis). TEST tools include those for screening, identification and quantification of metabolites for rapid prototyping. The main advantages and limitations of these tools as well as their interoperability capabilities are highlighted. PMID:27185383

  1. Quality and safety evaluation of a Ghanaian polyherbal product EAF-2011 for the management of superficial mycoses

    OpenAIRE

    Dickson R.A; Mensah M.L.K; Thomford K.P; Annan K; Mills-Robertson F.C; Appiah AA; Quarshie O; Antwi S; Kaminta S; Edoh D

    2013-01-01

    Background: The widespread use of herbal medicines in recent years means that issues concerning their quality, safety and efficacy need to be answered. In the current study, the polyherbal formulation EAF-2011 used in the Centre for Scientific Research into Plant Medicine, Mampong-Akwapemfor the management of superficial mycoses was evaluated for its quality and safety. Aim: The study sought to evaluate the quality and safety of the product in the management of superficial mycoses. Method: Th...

  2. Biological effects and physical safety aspects of NMR imaging and in vivo spectroscopy

    Energy Technology Data Exchange (ETDEWEB)

    Tenforde, T.S.; Budinger, T.F.

    1985-08-01

    An assessment is made of the biological effects and physical hazards of static and time-varying fields associated with the NMR devices that are being used for clinical imaging and in vivo spectroscopy. A summary is given of the current state of knowledge concerning the mechanisms of interaction and the bioeffects of these fields. Additional topics that are discussed include: (1) physical effects on pacemakers and metallic implants such as aneurysm clips, (2) human health studies related to the effects of exposure to nonionizing electromagnetic radiation, and (3) extant guidelines for limiting exposure of patients and medical personnel to the fields produced by NMR devices. On the basis of information available at the present time, it is concluded that the fields associated with the current generation of NMR devices do not pose a significant health risk in themselves. However, rigorous guidelines must be followed to avoid the physical interaction of these fields with metallic implants and medical electronic devices. 476 refs., 5 figs., 2 tabs.

  3. An overview of the safety and biological effects of Bacillus thuringiensis Cry toxins in mammals.

    Science.gov (United States)

    Rubio-Infante, Néstor; Moreno-Fierros, Leticia

    2016-05-01

    Crystal proteins (Cry) produced during the growth and sporulation phases of Bacillus thuringiensis (Bt) bacterium are known as delta endotoxins. These toxins are being used worldwide as bioinsecticides to control pests in agriculture, and some Cry toxins are used against mosquitoes to control vector transmission. This review summarizes the relevant information currently available regarding the biosafety and biological effects that Bt and its insecticidal Cry proteins elicit in mammals. This work was performed because of concerns regarding the possible health impact of Cry toxins on vertebrates, particularly because Bt toxins might be associated with immune-activating or allergic responses. The controversial data published to date are discussed in this review considering earlier toxicological studies of B. thuringiensis, spores, toxins and Bt crops. We discussed the experimental studies performed in humans, mice, rats and sheep as well as in diverse mammalian cell lines. Although the term 'toxic' is not appropriate for defining the effects these toxins have on mammals, they cannot be considered innocuous, as they have some physiological effects that may become pathological; thus, trials that are more comprehensive are necessary to determine their effects on mammals because knowledge in this field remains limited.

  4. Biological effects and physical safety aspects of NMR imaging and in vivo spectroscopy

    International Nuclear Information System (INIS)

    An assessment is made of the biological effects and physical hazards of static and time-varying fields associated with the NMR devices that are being used for clinical imaging and in vivo spectroscopy. A summary is given of the current state of knowledge concerning the mechanisms of interaction and the bioeffects of these fields. Additional topics that are discussed include: (1) physical effects on pacemakers and metallic implants such as aneurysm clips, (2) human health studies related to the effects of exposure to nonionizing electromagnetic radiation, and (3) extant guidelines for limiting exposure of patients and medical personnel to the fields produced by NMR devices. On the basis of information available at the present time, it is concluded that the fields associated with the current generation of NMR devices do not pose a significant health risk in themselves. However, rigorous guidelines must be followed to avoid the physical interaction of these fields with metallic implants and medical electronic devices. 476 refs., 5 figs., 2 tabs

  5. An overview of the safety and biological effects of Bacillus thuringiensis Cry toxins in mammals.

    Science.gov (United States)

    Rubio-Infante, Néstor; Moreno-Fierros, Leticia

    2016-05-01

    Crystal proteins (Cry) produced during the growth and sporulation phases of Bacillus thuringiensis (Bt) bacterium are known as delta endotoxins. These toxins are being used worldwide as bioinsecticides to control pests in agriculture, and some Cry toxins are used against mosquitoes to control vector transmission. This review summarizes the relevant information currently available regarding the biosafety and biological effects that Bt and its insecticidal Cry proteins elicit in mammals. This work was performed because of concerns regarding the possible health impact of Cry toxins on vertebrates, particularly because Bt toxins might be associated with immune-activating or allergic responses. The controversial data published to date are discussed in this review considering earlier toxicological studies of B. thuringiensis, spores, toxins and Bt crops. We discussed the experimental studies performed in humans, mice, rats and sheep as well as in diverse mammalian cell lines. Although the term 'toxic' is not appropriate for defining the effects these toxins have on mammals, they cannot be considered innocuous, as they have some physiological effects that may become pathological; thus, trials that are more comprehensive are necessary to determine their effects on mammals because knowledge in this field remains limited. PMID:26537666

  6. Ensuring Microbial Safety in Food Product/Process Development: Alternative Processing of Meat Products and Pathogen Survival in Low-Salt Cheddar Cheese

    OpenAIRE

    Shrestha, Subash

    2012-01-01

    Most outbreaks of foodborne illness in the United States occur as a result of improper food-handling and preparation practices in homes or food establishments. Some food-safety recommendations that are difficult to incorporate into handling and cooking procedures have contributed to a gap between food-safety knowledge and the actual behavior. The first part (Chapter 3, 4) of this study sought to ensure microbial safety by establishing alternative processing of meat products that can be easily...

  7. Assessment of biochar safety via its leachate characterization using physicochemical and biological assays

    Science.gov (United States)

    Dailianis, Stefanos; Tsouloufa, Argyro; Antonopoulou, Maria; Konstantinou, Ioannis; Karapanagioti, Hrissi K.; Manariotis, Ioannis D.

    2016-04-01

    The present study investigates the physicochemical composition of water aliquots derived from biochars produced from the pyrolysis of malt spent rootlets, in combination with the concomitant toxicological profile in each case. Specifically, physicochemical parameters and heavy metal ions were determined in aliquots of six (6) serial washes of biochar (1.5 g of solid was added in column and washed 6 times with 40 mL of distilled water per wash). The chemical analysis of each aliquot showed increased levels of PO4-3, Cl-, NO3-, SO4-2, F- and Br- in the first wash aliquot, followed by a significant decrease over washes. Non-detectable concentrations were observed after 3 washes in almost all cases. Similarly, the increased levels of Zn, Be, Cs, Mn, V and Se determined in the first wash aliquot were eliminated followed successive washes. In parallel, the toxic potency of each wash aliquot was recorded by (a) a multi-well test plate bioassay, using instars II-III larvae of the fairy shrimp Thamnocephalus platyurus, hatched from cysts derived from Screening Toxicity test supplied by MicroBio Tests Inc. (Thamnotoxkit FTM) and (b) the Microtox bioassay, using bioluminescent bacteria Vibrio fischeri. According to the results, first and second wash aliquots were toxic for T. platyurus (LC50 values of 22.12 and 68.28% v/v, respectively), followed by a significant elimination of toxicity after further washes in all cases. Similarly, the Microtox bioassay showed a significant inhibition of Vibrio luminescence after treatment for a period of 5-90 min (98-100% inhibition of luminescence) with the first wash aliquot (EC50 ≤ 0.01 % v/v), with no toxicity to be observed after successive washes. According to the results, at least one wash of biochar is prerequisite for improving its safety for further use. Moreover, the removal of both inorganic and organic, such as metal ions, substances commonly washed by the biochar, could be a crucial step for its sustainable use and final

  8. Hazardous organic compounds in biogas plant end products-Soil burden and risk to food safety

    International Nuclear Information System (INIS)

    The end products (digestate, solid fraction of the digestate, liquid fraction of the digestate) of ten biogas production lines in Finland were analyzed for ten hazardous organic compounds or compound groups: polychlorinated dibenzo-p-dioxins and furans (PCDD/Fs), polychlorinated biphenyls (PCB(7)), polyaromatic hydrocarbons (PAH(16)), bis-(2-ethylhexyl) phthalate (DEHP), perfluorinated alkyl compounds (PFCs), linear alkylbenzene sulfonates (LASs), nonylphenols and nonylphenol ethoxylates (NP + NPEOs), polybrominated diphenyl ethers (PBDEs), hexabromocyclododecane (HBCD) and tetrabromobisphenol A (TBBPA). Biogas plant feedstocks were divided into six groups: municipal sewage sludge, municipal biowaste, fat, food industry by-products, animal manure and others (consisting of milling by-products (husk) and raw former foodstuffs of animal origin from the retail trade). There was no clear connection between the origin of the feedstocks of a plant and the concentrations of hazardous organic compounds in the digestate. For PCDD/Fs and for DEHP, the median soil burden of the compound after a single addition of digestate was similar to the annual atmospheric deposition of the compound or compound group in Finland or other Nordic countries. For PFCs, the median soil burden was somewhat lower than the atmospheric deposition in Finland or Sweden. For NP + NPEOs, the soil burden was somewhat higher than the atmospheric deposition in Denmark. The median soil burden of PBDEs was 400 to 1000 times higher than the PBDE air deposition in Finland or in Sweden. With PBDEs, PFCs and HBCD, the impact of the use of end products should be a focus of further research. Highly persistent compounds, such as PBDE- and PFC-compounds may accumulate in agricultural soil after repeated use of organic fertilizers containing these compounds. For other compounds included in this study, agricultural use of biogas plant end products is unlikely to cause risk to food safety in Finland. - Highlights:

  9. Hazardous organic compounds in biogas plant end products-Soil burden and risk to food safety

    Energy Technology Data Exchange (ETDEWEB)

    Suominen, K., E-mail: kimmo.suominen@evira.fi [Finnish Food Safety Authority Evira, Risk Assessment Research Unit, Mustialankatu 3, 00790 Helsinki (Finland); Verta, M. [Finnish Environmental Institute (SYKE), Mechelininkatu 34a, P.O. Box 140, 00251 Helsinki (Finland); Marttinen, S. [MTT Agrifood Research Finland, 31600 Jokioinen (Finland)

    2014-09-01

    The end products (digestate, solid fraction of the digestate, liquid fraction of the digestate) of ten biogas production lines in Finland were analyzed for ten hazardous organic compounds or compound groups: polychlorinated dibenzo-p-dioxins and furans (PCDD/Fs), polychlorinated biphenyls (PCB(7)), polyaromatic hydrocarbons (PAH(16)), bis-(2-ethylhexyl) phthalate (DEHP), perfluorinated alkyl compounds (PFCs), linear alkylbenzene sulfonates (LASs), nonylphenols and nonylphenol ethoxylates (NP + NPEOs), polybrominated diphenyl ethers (PBDEs), hexabromocyclododecane (HBCD) and tetrabromobisphenol A (TBBPA). Biogas plant feedstocks were divided into six groups: municipal sewage sludge, municipal biowaste, fat, food industry by-products, animal manure and others (consisting of milling by-products (husk) and raw former foodstuffs of animal origin from the retail trade). There was no clear connection between the origin of the feedstocks of a plant and the concentrations of hazardous organic compounds in the digestate. For PCDD/Fs and for DEHP, the median soil burden of the compound after a single addition of digestate was similar to the annual atmospheric deposition of the compound or compound group in Finland or other Nordic countries. For PFCs, the median soil burden was somewhat lower than the atmospheric deposition in Finland or Sweden. For NP + NPEOs, the soil burden was somewhat higher than the atmospheric deposition in Denmark. The median soil burden of PBDEs was 400 to 1000 times higher than the PBDE air deposition in Finland or in Sweden. With PBDEs, PFCs and HBCD, the impact of the use of end products should be a focus of further research. Highly persistent compounds, such as PBDE- and PFC-compounds may accumulate in agricultural soil after repeated use of organic fertilizers containing these compounds. For other compounds included in this study, agricultural use of biogas plant end products is unlikely to cause risk to food safety in Finland. - Highlights:

  10. [Problems in microbial safety of advanced therapy medicinal products. Squaring the circle].

    Science.gov (United States)

    Montag-Lessing, T; Störmer, M; Schurig, U; Brachert, J; Bubenzer, M; Sicker, U; Beshir, R; Spreitzer, I; Löschner, B; Bache, C; Becker, B; Schneider, C K

    2010-01-01

    Today, sterility of parenteral drugs is practically guaranteed. Well-defined procedures in the pharmaceutical industry enable effective protection against contamination by bacteria and fungi. In contrast, problems regarding microbial safety of advanced therapy medicinal products (ATMPs), especially of cell therapeutics, are at best only partially solved. The latter should be understood as a challenge for manufacturers, regulators, and physicians. Many of the manufacturing principles mentioned above are not applicable in production of cell therapeutics. Sterility of source materials cannot be guaranteed and the hitherto known procedures for sterilization are, as a rule, not feasible. Thus, the sterility of the final product cannot be guaranteed. Considering the extremely short shelf life of many cell therapeutics, sometimes only a few hours, the results from established methods for sterility testing are often available too late. Furthermore, the sterility of a test sample does not indicate sterility of the whole product. In most cases, conventional methods for pyrogen testing are not applicable for ATMPs. This paper demonstrates relevant limitations regarding microbial safety and pyrogenicity. Possibilities to overcome these problems are discussed and some novel solutions are proposed.

  11. 78 FR 54417 - Oil and Gas and Sulphur Operations on the Outer Continental Shelf-Oil and Gas Production Safety...

    Science.gov (United States)

    2013-09-04

    ... Bureau of Safety and Environmental Enforcement 30 CFR Part 250 RIN 1014-AA10 Oil and Gas and Sulphur Operations on the Outer Continental Shelf--Oil and Gas Production Safety Systems Correction In proposed rule... hydrocarbons (i.e., natural gas, oil) that are produced, handled, stored, or processed at the facility. (B)...

  12. Proceedings of the first international conference on health, safety and environment in oil and gas exploration and production

    International Nuclear Information System (INIS)

    The papers in this volume were prepared for the First International Conference on Health, Safety and Environment in Oil and Gas Exploration and Production. Included are the following papers: Environmental risk in the offshore industry; System for modeling and monitoring of offshore discharge water; Measuring safety culture and attitudes

  13. Safety of Switching Factor VIII Products in the Era of Evolving Concentrates: Myths and Facts.

    Science.gov (United States)

    Coppola, Antonio; Marrone, Emiliana; Conca, Paolo; Cimino, Ernesto; Mormile, Rosaria; Baldacci, Erminia; Santoro, Cristina

    2016-07-01

    Recent advances in the development of factor VIII (FVIII) concentrates offer patients with hemophilia the opportunity to switch to products considered safer or with improved properties. In some cases, product switch occurs due to side effects, convenience issues, or economic reasons affecting clinical choices. Reluctance to change FVIII concentrates is shown by patients and also by their physicians, because of concerns in particular about the risk of inhibitor development. A literature review was performed to retrieve the best evidence regarding safety issues of switching FVIII concentrate in patients with severe hemophilia A. Product switch was not associated with an increased inhibitor risk in four studies in patients during the first 50 to 75 exposure days, or in three studies reporting national switches in Canada and United Kingdom. The latter, the only available study comparing switcher and nonswitcher patients, showed an inhibitor incidence similar to that historically reported in the United Kingdom. In 16 phase III clinical trials and 6 postmarketing studies of FVIII concentrates, few de novo inhibitors were detected in previously treated patients, mostly transient and low-titer, with some additional recurrent inhibitors in patients with previous positive testing. On the whole, although rigorous controlled studies are lacking, literature data do not support increased risk of inhibitor development or other safety issues related to product switch. Therefore, in the presence of clinical needs, the advantages of switching FVIII products should not be missed because of perceived more than evidence-based challenges, in particular in this era of products with improved properties recently introduced or available in few years. Caution, however, is suggested in patients with high inhibitor risk, including in those in concomitance with surgery or intensive treatment. A careful inhibitor testing prior to and after product switch is always needed, to identify real de

  14. Safety Prediction Analysis of the Agricultural Products Processing Based on the BP Neural Network

    Directory of Open Access Journals (Sweden)

    Jing Li

    2015-09-01

    Full Text Available By using BP neural network algorithm, this study aims at prompting the accuracy of safety prediction of the agriculture products processing. The science prediction of the deep-frozen dumplings' shelf-life has an important guiding significance for human health and the safety of quick-frozen food. Artificial Neural Network (ANN is a kind of information processing system which is established by simulating the human nervous system. Based on these, by using the effective theory of integrated temperature combined with BP neural network method to predict the shelf-life of the frozen dumplings in this study, we aim at providing a theory basis for monitoring and controlling the quality change in the storage process of deep-frozen dumplings’ temperature fluctuations. Finally, an example is given to show that it is very effective by using the method adopted in this study.

  15. Subsea nuclear power generating stations for offshore oil production operations. Preliminary safety and licensing information document

    Energy Technology Data Exchange (ETDEWEB)

    1977-02-15

    This document presents preliminary safety and licensing information relating to the manufacture, installation, and operation of small subsea nuclear generating stations in remote offshore locations, and the associated onshore base-site activities of reactor refueling and system refurbishment at 4-year intervals. The purpose of the proposed facilities is to provide a subsea power capability for offshore oil production operations in areas where surface conditions, water depths, or other environmental constraints may preclude the use of surface-mounted power sources. This will provide the capability to achieve the maximum recovery of petroleum resources from the U.S. frontier areas. Summary descriptions of a typical subsea nuclear generating station and a typical base site-facility are presented. General safety and licensing considerations are discussed, and a representative schedule of licensing activities is outlined.

  16. New approaches to estimation of peat deposits for production of biologically active compounds

    Science.gov (United States)

    Stepchenko, L. M.; Yurchenko, V. I.; Krasnik, V. G.; Syedykh, N. J.

    2009-04-01

    It is known, that biologically active preparations from peat increase animals productivity as well as resistance against stress-factors and have adaptogeneous, antioxidant, immunomodulative properties. Optymal choice of peat deposits for the production of biologically active preparations supposes the detailed comparative analysis of peat properties from different deposits. For this the cadastre of peat of Ukraine is developed in the humic substances laboratory named after prof. Khristeva L.A. (Dnipropetrovsk Agrarian University, Ukraine). It based on the research of its physical and chemical properties, toxicity and biological activity, and called Biocadastre. The Biocadastre is based on the set of parameters, including the descriptions of physical and chemical properties (active acidity, degree of decomposition, botanical composition etc.), toxicity estimation (by parabyotyc, infusorial, inhibitor and other tests), biological activity indexes (growth-promoting, antioxidative, adaptogeneous, immunomodulative antistress and other actions). The blocks of Biocadastre indexes are differentiated, taking into account their use for creation the preparations for vegetable, animals and microorganisms. The Biocadastre will allow to choose the peat deposits, most suitable for the production of different biologically active preparations, both wide directed and narrow spectrum of action, depending on application fields (medicine, agriculture, veterinary medicine, microbiological industry, balneology, cosmetology).

  17. Compound Activity Mapping: Integrating Chemical and Biological Profiling for the Functional Annotation of Natural Product Libraries

    OpenAIRE

    Kurita, Kenji Long

    2015-01-01

    Natural products research has had a significant impact on human-health and our understanding of the natural world as a pillar of pharmacognosy, organic chemistry, ecology, and chemical biology. But while this science has yielded countless discoveries such as penicillin, taxol, and artimesinin and will continue to improve quality of life around the world, the idea that natural products is a panacea of chemical diversity has been challenged by problems including the endless rediscovery of known...

  18. What controls biological productivity in coastal upwelling systems? Insights from a comparative modeling study

    OpenAIRE

    Z. Lachkar; Gruber, N.

    2011-01-01

    The magnitude of the biological productivity in Eastern Boundary Upwelling Systems (EBUS) is traditionally viewed as directly reflecting the upwelling intensity. Yet, different EBUS show different sensitivities of productivity to upwelling-favorable winds (Carr and Kearns, 2003). Here, using a comparative modeling study of the California Current System (California CS) and Canary Current System (Canary CS), we show how physical and environmental factors, such as light, temperature and c...

  19. REGULATION OF PRODUCTION PERFORMANCE OF CHICORY PLANTS BY FOLIAR APPLICATION OF BIOLOGICALLY ACTIVE SUBSTANCES

    OpenAIRE

    MAREK KOVÁR; IVAN ČERNÝ

    2012-01-01

    In this study were evaluated both the growth and yield potentials of three chicory (Cichorium intybus var. sativum) varieties ('Fredonia Nova', 'Oesia' a 'Maurane') growing in natural agro-ecological conditions from 2006 to 2008. Regulation of the crop productivity by foliar application of biologically active substances (Atonik, Polybor 150, and Biafit Gold) was also studied. Evaluation of growth-production performance of chicory was realized as: leaf area index (LAI), photosynthetic potentia...

  20. Evaluation of the chemical compatibility of plastic contact materials and pharmaceutical products; safety considerations related to extractables and leachables.

    Science.gov (United States)

    Jenke, Dennis

    2007-10-01

    A review is provided on the general topic of the compatibility of plastic materials with pharmaceutical products, with specific emphasis on the safety aspects associated with extractables and leachables related to such plastic materials. PMID:17701994

  1. 78 FR 58311 - Complex Issues in Developing Drug and Biological Products for Rare Diseases; Public Workshop...

    Science.gov (United States)

    2013-09-23

    ... for Rare Diseases; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS... for Rare Diseases.'' The purpose of the public workshop is twofold: To discuss complex issues in clinical trials for developing drug and biological products (``drugs'') for rare diseases,...

  2. Eddy-mediated biological productivity in the Bay of Bengal during fall and spring intermonsoons

    Digital Repository Service at National Institute of Oceanography (India)

    PrasannaKumar, S.; Nuncio, M.; Ramaiah, N.; Sardesai, S.; Narvekar, J.; Fernandes, V.; Paul, J.T.

    but also enhanced the nutrient concentrations. This in turn increased the biological productivity of the Bay to 1½-2 times. In addition, the subsurface chlorophyll maximum (SCM), which is generally located between 40 and 70 m in fall and 60 and 90 m...

  3. Process for the continuous biological production of lipids, hydrocarbons or mixtures thereof

    NARCIS (Netherlands)

    Van der Wielen, L.A.M.; Heijnen, J.J.

    2010-01-01

    The present invention is directed to a process for the continuous biological production of lipids, hydrocarbons, hydrocarbon like material or mixtures thereof by conversion of a suitable substrate using micro-organisms, in which process the said substrate is continuously, anaerobically fermented to

  4. 9 CFR 113.52 - Requirements for cell lines used for production of biologics.

    Science.gov (United States)

    2010-01-01

    ... of origin of the MCS may be used if approved by APHIS. (c) The MCS and either each subculture of... sources of cells in the batch. (d) The MCS and either each subculture used to prepare a biological product... not be used. If bacteria or fungi are found in a subculture, the subculture shall not be used. (e)...

  5. Dilute-acid pretreatment of barley straw for biological hydrogen production using Caldicellulosiruptor saccharolyticus

    NARCIS (Netherlands)

    Panagiotopoulos, I.A.; Bakker, R.R.C.; Vrije, de G.J.; Claassen, P.A.M.; Koukios, E.G.

    2012-01-01

    The main objective of this study was to use the fermentability test to investigate the feasibility of applying various dilute acids in the pretreatment of barley straw for biological hydrogen production. At a fixed acid loading of 1% (w/w dry matter) 28-32% of barley straw was converted to soluble m

  6. 21 CFR 310.4 - Biologics; products subject to license control.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 5 2010-04-01 2010-04-01 false Biologics; products subject to license control. 310.4 Section 310.4 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN... to license control. (a) If a drug has an approved license under section 351 of the Public...

  7. 21 CFR 740.10 - Labeling of cosmetic products for which adequate substantiation of safety has not been obtained.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Labeling of cosmetic products for which adequate..., DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) COSMETICS COSMETIC PRODUCT WARNING STATEMENTS Warning Statements § 740.10 Labeling of cosmetic products for which adequate substantiation of safety has not...

  8. Safety and immunogenicity of Onderstepoort Biological Products’ Rift Valley fever Clone 13 vaccine in sheep and goats under field conditions in Senegal

    Directory of Open Access Journals (Sweden)

    Modou M. Lo

    2015-02-01

    Full Text Available This blinded field safety study was conducted in Senegal to assess safety and immunogenicity of administration of the registered dose of Rift Valley fever virus (RVFV Clone 13 vaccine (Onderstepoort Biological Products to sheep and goats of West African breeds under natural conditions. A total of 267 small ruminants (220 sheep, 47 goats were included; half received RVFV Clone 13 vaccine at the recommended dose and half received the diluent (as placebo only. The study was performed on three commercial farms in the northern and eastern region of Senegal in accordance with veterinary good clinical practices. The animals were observed daily for 3 days after vaccination, and then weekly for 1 year. In both sheep and goats vaccinated against RVFV seroconversion rates above 70% were recorded. No seroconversion related to RVFV was observed in placebo-treated animals. No statistically significant differences were determined between placebo and vaccinated groups for mean rectal temperatures for the first 3 days after administration (p > 0.05. No abnormal clinical signs related to treatment were noted, and only one slight injection site reaction was observed in one vaccinated animal for 2 days after vaccination. Out of 176 births assessed over 1 year (93 from the vaccinated group, 83 from the placebo group, 9 were abnormal in the placebo group and 3 in the vaccinated group (p > 0.05. The frequency of adverse events was similar in the placebo and vaccinated groups. RVFV Clone 13 vaccine administered according to the manufacturer’s instructions was safe and well tolerated in West African breeds of sheep and goats, including animals of approximately 6 months of age and pregnant females, under field conditions in Senegal. Antibody levels persisted up to 1 year after vaccination.

  9. Gold nanoparticles prepared by laser ablation in aqueous biocompatible solutions: assessment of safety and biological identity for nanomedicine applications

    Directory of Open Access Journals (Sweden)

    Correard F

    2014-11-01

    Full Text Available Florian Correard,1,2 Ksenia Maximova,3 Marie-Anne Estève,1,2 Claude Villard,1 Myriam Roy,4 Ahmed Al-Kattan,3 Marc Sentis,3 Marc Gingras,4 Andrei V Kabashin,3 Diane Braguer1,2 1Aix Marseille Université, INSERM, CR02 UMR_S911, Marseille, France; 2APHM, Hôpital Timone, Marseille, France; 3Aix Marseille Université, CNRS, LP3 UMR 7341, Marseille, France; 4Aix Marseille Université, CNRS, CINAM, UMR 7325 Marseille, France Abstract: Due to excellent biocompatibility, chemical stability, and promising optical properties, gold nanoparticles (Au-NPs are the focus of research and applications in nanomedicine. Au-NPs prepared by laser ablation in aqueous biocompatible solutions present an essentially novel object that is unique in avoiding any residual toxic contaminant. This paper is conceived as the next step in development of laser-ablated Au-NPs for future in vivo applications. The aim of the study was to assess the safety, uptake, and biological behavior of laser-synthesized Au-NPs prepared in water or polymer solutions in human cell lines. Our results showed that laser ablation allows the obtaining of stable and monodisperse Au-NPs in water, polyethylene glycol, and dextran solutions. The three types of Au-NPs were internalized in human cell lines, as shown by transmission electron microscopy. Biocompatibility and safety of Au-NPs were demonstrated by analyzing cell survival and cell morphology. Furthermore, incubation of the three Au-NPs in serum-containing culture medium modified their physicochemical characteristics, such as the size and the charge. The composition of the protein corona adsorbed on Au-NPs was investigated by mass spectrometry. Regarding composition of complement C3 proteins and apolipoproteins, Au-NPs prepared in dextran solution appeared as a promising drug carrier. Altogether, our results revealed the safety of laser-ablated Au-NPs in human cell lines and support their use for theranostic applications. Keywords: protein

  10. Safety assessment of Maillard reaction products of chicken bone hydrolysate using Sprague-Dawley rats

    Directory of Open Access Journals (Sweden)

    Jin-Zhi Wang

    2016-03-01

    Full Text Available Background: The Maillard reaction products of chicken bone hydrolysate (MRPB containing 38% protein, which is a derived product from chicken bone, is usually used as a flavor enhancer or food ingredient. In the face of a paucity of reported data regarding the safety profile of controversial Maillard reaction products, the potential health effects of MRPB were evaluated in a subchronic rodent feeding study. Methods: Sprague–Dawley rats (SD, 5/sex/group were administered diets containing 9, 3, 1, or 0% of MRPB derived from chicken bone for 13 weeks. Results: During the 13-week treatment period, no mortality occurred, and no remarkable changes in general condition and behavior were observed. The consumption of MRPB did not have any effect on body weight or feed and water consumption. At the same time, there was no significant increase in the weights of the heart, liver, lung, kidney, spleen, small intestine, and thymus in groups for both sexes. Serological examination showed serum alanine aminotransferase in both sexes was decreased significantly, indicating liver cell protection. No treatment-related histopathological differences were observed between the control and test groups. Conclusion: Based on the results of this study, the addition of 9% MRPB in the diet had no adverse effect on both male and female SD rats during the 90-day observation. Those results would provide useful information on the safety of a meaty flavor enhancer from bone residue as a byproduct of meat industry.

  11. Statistical and regulatory considerations in assessments of interchangeability of biological drug products.

    Science.gov (United States)

    Tóthfalusi, Lászlo; Endrényi, László; Chow, Shein-Chung

    2014-05-01

    When the patent of a brand-name, marketed drug expires, new, generic products are usually offered. Small-molecule generic and originator drug products are expected to be chemically identical. Their pharmaceutical similarity can be typically assessed by simple regulatory criteria such as the expectation that the 90% confidence interval for the ratio of geometric means of some pharmacokinetic parameters be between 0.80 and 1.25. When such criteria are satisfied, the drug products are generally considered to exhibit therapeutic equivalence. They are then usually interchanged freely within individual patients. Biological drugs are complex proteins, for instance, because of their large size, intricate structure, sensitivity to environmental conditions, difficult manufacturing procedures, and the possibility of immunogenicity. Generic and brand-name biologic products can be expected to show only similarity but not identity in their various features and clinical effects. Consequently, the determination of biosimilarity is also a complicated process which involves assessment of the totality of the evidence for the close similarity of the two products. Moreover, even when biosimilarity has been established, it may not be assumed that the two biosimilar products can be automatically substituted by pharmacists. This generally requires additional, careful considerations. Without declaring interchangeability, a new product could be prescribed, i.e. it is prescribable. However, two products can be automatically substituted only if they are interchangeable. Interchangeability is a statistical term and it means that products can be used in any order in the same patient without considering the treatment history. The concepts of interchangeability and prescribability have been widely discussed in the past but only in relation to small molecule generics. In this paper we apply these concepts to biosimilars and we discuss: definitions of prescribability and interchangeability and

  12. Safety considerations for continuous hydrogen production test apparatus with capacity of 50 N-litter hydrogen per hour

    International Nuclear Information System (INIS)

    Since the thermochemical hydrogen production Iodine-Sulfur process decomposes water into hydrogen and oxygen using toxic chemicals such as sulfuric acid, iodine and hydriodic acid, safety considerations are very important in its research and development. Therefore, before construction of continuous hydrogen production test apparatus with capacity of 50 N-litter hydrogen per hour, comprehensive safety considerations were carried out to examine the design and construction works of the test apparatus, and the experimental plans using the apparatus. Emphasis was given on the safety considerations on prevention of breakage of glasswares and presumable abnormalities, accidents and their countermeasures. This report summarizes the results of the considerations. (author)

  13. Safety considerations for continuous hydrogen production test apparatus with capacity of 50 N-litter hydrogen per hour

    Energy Technology Data Exchange (ETDEWEB)

    Onuki, Kaoru; Akino, Norio; Shimizu, Saburo; Nakajima, Hayato; Higashi, Shunichi; Kubo, Shinji [Japan Atomic Energy Research Inst., Oarai, Ibaraki (Japan). Oarai Research Establishment

    2001-03-01

    Since the thermochemical hydrogen production Iodine-Sulfur process decomposes water into hydrogen and oxygen using toxic chemicals such as sulfuric acid, iodine and hydriodic acid, safety considerations are very important in its research and development. Therefore, before construction of continuous hydrogen production test apparatus with capacity of 50 N-litter hydrogen per hour, comprehensive safety considerations were carried out to examine the design and construction works of the test apparatus, and the experimental plans using the apparatus. Emphasis was given on the safety considerations on prevention of breakage of glasswares and presumable abnormalities, accidents and their countermeasures. This report summarizes the results of the considerations. (author)

  14. Control of Listeria species food safety at a poultry food production facility.

    Science.gov (United States)

    Fox, Edward M; Wall, Patrick G; Fanning, Séamus

    2015-10-01

    Surveillance and control of food-borne human pathogens, such as Listeria monocytogenes, is a critical aspect of modern food safety programs at food production facilities. This study evaluated contamination patterns of Listeria species at a poultry food production facility, and evaluated the efficacy of procedures to control the contamination and transfer of the bacteria throughout the plant. The presence of Listeria species was studied along the production chain, including raw ingredients, food-contact, non-food-contact surfaces, and finished product. All isolates were sub-typed by pulsed-field gel electrophoresis (PFGE) to identify possible entry points for Listeria species into the production chain, as well as identifying possible transfer routes through the facility. The efficacy of selected in-house sanitizers against a sub-set of the isolates was evaluated. Of the 77 different PFGE-types identified, 10 were found among two or more of the five categories/areas (ingredients, food preparation, cooking and packing, bulk packing, and product), indicating potential transfer routes at the facility. One of the six sanitizers used was identified as unsuitable for control of Listeria species. Combining PFGE data, together with information on isolate location and timeframe, facilitated identification of a persistent Listeria species contamination that had colonized the facility, along with others that were transient.

  15. [Discussion on agricultural product quality and safety problem from ecological view].

    Science.gov (United States)

    Xiao, Ming; Dong, Nan; Lyu, Xin

    2015-08-01

    There are many different perspectives about the sustainable agriculture, which had been proposed since the last three decades in the world. While China's ecologists and agronomists proposed a similar concept named 'ecological agriculture'. Although ecological agriculture in China has achieved substantial progress, including theory, models and supporting technologies nearly several decades of practice and development, its application guidance still is not yet clear. The organic agriculture model proposed by European Union is popular, but it is limited in the beneficiary groups and the social and ecological responsibility. In this context, the article based on an ecological point of view, analyzed the shortcomings of ecological imbalance caused by a single mode of agricultural production and the negative impact on the quality of agricultural products, and discussed the core values of ecological agriculture. On this basis, we put forward the concept of sustainable security of agricultural products. Based on this concept, an agricultural platform was established under the healthy ecosysphere environment, and from this agricultural platform, agricultural products could be safely and sustainably obtained. Around the central value of the concept, we designed the agricultural sustainable and security production model. Finally, we compared the responsibility, benefiting groups, agronomic practices selection and other aspects of sustainable agriculture with organic agriculture, and proved the advancement of sustainable agricultural model in agricultural production quality and safety. PMID:26685623

  16. [Discussion on agricultural product quality and safety problem from ecological view].

    Science.gov (United States)

    Xiao, Ming; Dong, Nan; Lyu, Xin

    2015-08-01

    There are many different perspectives about the sustainable agriculture, which had been proposed since the last three decades in the world. While China's ecologists and agronomists proposed a similar concept named 'ecological agriculture'. Although ecological agriculture in China has achieved substantial progress, including theory, models and supporting technologies nearly several decades of practice and development, its application guidance still is not yet clear. The organic agriculture model proposed by European Union is popular, but it is limited in the beneficiary groups and the social and ecological responsibility. In this context, the article based on an ecological point of view, analyzed the shortcomings of ecological imbalance caused by a single mode of agricultural production and the negative impact on the quality of agricultural products, and discussed the core values of ecological agriculture. On this basis, we put forward the concept of sustainable security of agricultural products. Based on this concept, an agricultural platform was established under the healthy ecosysphere environment, and from this agricultural platform, agricultural products could be safely and sustainably obtained. Around the central value of the concept, we designed the agricultural sustainable and security production model. Finally, we compared the responsibility, benefiting groups, agronomic practices selection and other aspects of sustainable agriculture with organic agriculture, and proved the advancement of sustainable agricultural model in agricultural production quality and safety.

  17. Immobilized Biofilm in Thermophilic Biohydrogen Production using Synthetic versus Biological Materials

    Directory of Open Access Journals (Sweden)

    Jaruwan Wongthanate

    2015-02-01

    Full Text Available Biohydrogen production was studied from the vermicelli processing wastewater using synthetic and biological materials as immobilizing substrate employing a mixed culture in a batch reactor operated at the initial pH 6.0 and thermophilic condition (55 ± 1ºC. Maximum cumulative hydrogen production (1,210 mL H2/L wastewater was observed at 5% (v/v addition of ring-shaped synthetic material, which was the ring-shaped hydrophobic acrylic. Regarding 5% (v/v addition of synthetic and biological materials, the maximum cumulative hydrogen production using immobilizing synthetic material of ball-shaped hydrophobic polyethylene (HBPE (1,256.5 mL H2/L wastewater was a two-fold increase of cumulative hydrogen production when compared to its production using immobilizing biological material of rope-shaped hydrophilic ramie (609.8 mL H2/L wastewater. SEM observation of immobilized biofilm on a ball-shaped HBPE or a rope-shaped hydrophilic ramie was the rod shape and gathered into group.

  18. Apple biological and physiological disorders in the orchard and in postharvest according to production system

    Directory of Open Access Journals (Sweden)

    Carlos Roberto Martins

    2013-03-01

    Full Text Available The study aimed to evaluate the incidence of biological and physiological disorders in the field and postharvested apples cvs. Gala, Fuji and Catarina grown in four production systems: conventional, organic transition, integrated and organic. Apples were evaluated for damages related to biological and physiological disorders in the orchard and after harvest. The greatest damages were attributed to pests, especially Anastrepha fraterculus in the organic system and Grapholita molesta in the organic transition. Apples produced in organic orchards had higher damage levels caused by postharvest physiological disorders than those grown in other production systems. For apples becoming from organic orchards most of the damage was due to lenticels breakdown and degeneration ('Gala', and bitter pit ('Fuji' and 'Catarina'. The incidence of postharvest rot was not influenced by apple production system.

  19. Effects of an onion by-product on bioactivity and safety markers in healthy rats.

    Science.gov (United States)

    Roldán-Marín, Eduvigis; Krath, Britta N; Poulsen, Morten; Binderup, Mona-Lise; Nielsen, Tom H; Hansen, Max; Barri, Thaer; Langkilde, Søren; Cano, M Pilar; Sánchez-Moreno, Concepción; Dragsted, Lars O

    2009-12-01

    Onions are excellent sources of bioactive compounds including fructo-oligosaccharides (FOS) and polyphenols. An onion by-product was characterised in order to be developed as a potentially bioactive food ingredient. Our main aim was to investigate whether the potential health and safety effects of this onion by-product were shared by either of two derived fractions, an extract containing the onion FOS and polyphenols and a residue fraction containing mainly cell wall materials. We report here on the effects of feeding these products on markers of potential toxicity, protective enzymes and gut environment in healthy rats. Rats were fed during 4 weeks with a diet containing the products or a control feed balanced in carbohydrate. The onion by-product and the extract caused anaemia as expected in rodents for Allium products. No other toxicity was observed, including genotoxicity. Glutathione reductase (GR) and glutathione peroxidase (GPx1) activities in erythrocytes increased when rats were fed with the onion extract. Hepatic gene expression of Gr, Gpx1, catalase, 5-aminolevulinate synthase and NAD(P)H:quinone oxidoreductase was not altered in any group of the onion fed rats. By contrast, gamma-glutamate cysteine ligase catalytic subunit gene expression was upregulated but only in rats given the onion residue. The onion by-products as well as the soluble and insoluble fractions had prebiotic effects as evidenced by decreased pH, increased butyrate production and altered gut microbiota enzyme activities. In conclusion, the onion by-products have no in vivo genotoxicity, may support in vivo antioxidative defence and alter the functionality of the rat gut microbiota.

  20. What controls biological productivity in coastal upwelling systems? Insights from a comparative modeling study

    Directory of Open Access Journals (Sweden)

    Z. Lachkar

    2011-06-01

    Full Text Available The magnitude of the biological productivity in Eastern Boundary Upwelling Systems (EBUS is traditionally viewed as directly reflecting the upwelling intensity. Yet, different EBUS show different sensitivities of productivity to upwelling-favorable winds (Carr and Kearns, 2003. Here, using a comparative modeling study of the California Current System (California CS and Canary Current System (Canary CS, we show how physical and environmental factors, such as light, temperature and cross-shore circulation modulate the response of biological productivity to upwelling strength. To this end, we made a series of eddy-resolving simulations of the California CS and Canary CS using the Regional Ocean Modeling System (ROMS, coupled to a nitrogen based Nutrient-Phytoplankton-Zooplankton-Detritus (NPZD ecosystem model. We find the nutrient content of the euphotic zone to be 20 % smaller in the Canary CS relative to the California CS. Yet, the biological productivity is 50 % smaller in the latter. This is due to: (1 a faster nutrient-replete growth in the Canary CS relative to the California CS, related to a more favorable light and temperature conditions in the Canary CS, and (2 the longer nearshore water residence times in the Canary CS which lead to larger buildup of biomass in the upwelling zone, thereby enhancing the productivity. The longer residence times in the Canary CS appear to be associated with the wider continental shelves and the lower eddy activity characterizing this upwelling system. This results in a weaker offshore export of nutrients and organic matter, thereby increasing local nutrient recycling and enhancing the coupling between new and export production in the Northwest African system. Our results suggest that climate change induced perturbations such as upwelling favorable wind intensification might lead to contrasting biological responses in the California CS and the Canary CS, with major implications for the biogeochemical cycles

  1. Health, safety, and ecological implications of using biobased floor-stripping products.

    Science.gov (United States)

    Massawe, Ephraim; Geiser, Kenneth; Ellenbecker, Michael; Marshall, Jason

    2007-05-01

    The main objective of the study reported here was to investigate the ecological, health, and safety (EHS) implications of using biobased floor strippers as alternatives to solvent-based products such as Johnson Wax Professional (Pro Strip). The authors applied a quick EHS-scoring technique developed by the Surface Solution Laboratory (SSL) of the Toxics Use Reduction Institute (TURI) to some alternative, biobased products that had previously performed as well as or close to as well as the currently used product. The quick technique is considered an important step in EHS assessment, particularly for toxics use reduction planners and advocates who may not have the resources to subject many alternative products or processes at once to detailed EHS analysis. Taking this step narrows available options to a manageable number. (Technical-performance experiments were also conducted, but the results are not discussed or reported in this paper). The cost of switching to biobased floor strippers was assessed and compared with the cost of using the traditional product, both at full strength and at the dilution ratios recommended by the respective manufacturers. The EHS analysis was based on a framework consisting of five parameters: volatile organic compounds (VOCs); pH; global-warming potential (GWP); ozone depletion potential (ODP); and safety scores in areas such as flammability, stability, and special hazards, based on ratings from the Hazardous Material Classification System (HMIS) and the National Fire Protection Association (NFPA). Total EHS scores were calculated with data derived from the material safety data sheets. For most cleaning products previously investigated by the TURI SSL, the investigators have demonstrated that the five key parameters used in the study reported here can successfully be used for quick screening of the EHS impacts of cleaning alternatives. All eight biobased, or green, products evaluated in the study had better EHS-screening scores than did

  2. Health, safety, and ecological implications of using biobased floor-stripping products.

    Science.gov (United States)

    Massawe, Ephraim; Geiser, Kenneth; Ellenbecker, Michael; Marshall, Jason

    2007-05-01

    The main objective of the study reported here was to investigate the ecological, health, and safety (EHS) implications of using biobased floor strippers as alternatives to solvent-based products such as Johnson Wax Professional (Pro Strip). The authors applied a quick EHS-scoring technique developed by the Surface Solution Laboratory (SSL) of the Toxics Use Reduction Institute (TURI) to some alternative, biobased products that had previously performed as well as or close to as well as the currently used product. The quick technique is considered an important step in EHS assessment, particularly for toxics use reduction planners and advocates who may not have the resources to subject many alternative products or processes at once to detailed EHS analysis. Taking this step narrows available options to a manageable number. (Technical-performance experiments were also conducted, but the results are not discussed or reported in this paper). The cost of switching to biobased floor strippers was assessed and compared with the cost of using the traditional product, both at full strength and at the dilution ratios recommended by the respective manufacturers. The EHS analysis was based on a framework consisting of five parameters: volatile organic compounds (VOCs); pH; global-warming potential (GWP); ozone depletion potential (ODP); and safety scores in areas such as flammability, stability, and special hazards, based on ratings from the Hazardous Material Classification System (HMIS) and the National Fire Protection Association (NFPA). Total EHS scores were calculated with data derived from the material safety data sheets. For most cleaning products previously investigated by the TURI SSL, the investigators have demonstrated that the five key parameters used in the study reported here can successfully be used for quick screening of the EHS impacts of cleaning alternatives. All eight biobased, or green, products evaluated in the study had better EHS-screening scores than did

  3. Performance Testing and Quality Control of Biological Safety Cabinets%生物安全柜的性能检测与质量控制

    Institute of Scientific and Technical Information of China (English)

    赵伟

    2013-01-01

    Objective Through performance testing of biological safety cabinet,to understand its performance,so as to improve its safety.Methods Six required items are tested according to the standard of Biological Safety Cabinets.Results The six required items can meet the technical requirements,the biological safety cabinet is qualified.Conclusion Quality control of medical equipment is of great significance.%目的 通过对生物安全柜的性能检测,以掌握其性能现状,提高使用的安全性.方法 依据《生物安全柜》标准,对生物安全性等6个必检项目进行性能检测.结果 6个检测项目符合技术要求,生物安全柜性能合格.结论 加强医疗设备质量控制关系重大,不容忽视.

  4. Empowering consumers as contributors for health product safety: lessons from the Philippines.

    Science.gov (United States)

    Hartigan-Go, Kenneth

    2015-04-01

    Empowering consumers to contribute to adverse drug reaction reporting seems a sensible innovation, particularly when traditional reports emanating from healthcare professionals are neither increasing nor improving. This work, inspired by an EU-FP7-funded project, describes an attempt by the Philippines to introduce a consumer reporting system through education and an online platform for reporting, and the lessons that were captured in the process. While participating consumers did not contribute to the adverse drug reporting process in the traditional sense as originally expected, the reports received by the drug regulatory agency revealed consumers' concerns regarding health product legitimacy, quality and market claims, as well as the lack of available and accessible information. These reports led regulators to take action. Initial insights on consumer behavior are proposed for regulators and industry to consider in greater depth and how this may impact on consumers providing valued information that will promote other aspects of product safety.

  5. Field Safety Notes in Product Problems of Medical Devices for Use in Pulmonology.

    Science.gov (United States)

    Hannig, Jürgen; Siekmeier, Rüdiger

    2015-01-01

    The current European system for medical devices is governed by three EC directives: the Medical Device Directive 93/42/EEC, the In-Vitro Diagnostic Directive 98/79/EC and the Active Implantable Medical Device Directive 90/385/EEC and regulates marketing and post-market surveillance of medical devices in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform the responsible Competent Authority, which is the Federal Institute for Drugs and Medical Devices (BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of medical devices exclusively serving for diagnostics or treatment in pulmonology (e.g. nebulizers, oxygen concentrators, pulse oximeters, lung function analyzers, and non-active devices for treatment). FSCA and FSN publicized by BfArM in 2005-2013 were analyzed in respect to the MEDDEV 2.12-1 rev 8. In total 41 FSCA were publicized for the included products. German and English FSN were found in 36/35 cases, respectively. FSN were clearly characterized as FSN in 22/20 cases and declaration of the type of action was found in 27/26 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/8 and 26/24 cases, respectively. Detailed information regarding FSCA and product malfunction were found in 27/33 and 36/35 cases, respectively. Information on product related risks with previous use of the affected product was provided in 24/23 cases. In 34/34 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness were found in 10/14 cases. Contact data were provided in 30/30 cases. Confirmation that the Competent Authority was informed was found in 12/14 cases and in 19/18 cases a customer confirmation was included. The obtained data suggest that there is an increasing annual number of FSCA and most FSN fulfill the criteria of

  6. Radiation safety aspects of production of commercial levels of medical radioisotopes

    Science.gov (United States)

    Boothe, T. E.; McLeod, T. F.; Fernandez-Rubio, F.

    1993-06-01

    The first step toward efficient radiation safety in a facility that intends to produce commercial levels of radionuclides is to nticipate the scope of the facility during the design stages of the physical plant and during formulation of operating procedures. The design and operation must include flexibility to accommodate changing needs of production and research and development while providing radiation safety. A recently proposed licensing guide from the Bureau of Radiation Control, Texas Department of Health, while providing for safe operation, would severely limit flexibility and development. For example, engineering controls and procedures should be specified for generic systems as opposed to each specific radionuclide and by-products. Operator training is critical for reduced exposure and should be addressed, but requiring prior training for all operators is not reasonably achievable and would result in loss of proprietary information. Procedures to reduce exposure should include experimentally determined "cooldown" times, "problem indexes" for specific jobs related to particular cyclotrons, and proper management and administrative structures.

  7. Processing, food applications and safety of aloe vera products: a review.

    Science.gov (United States)

    Ahlawat, Kulveer Singh; Khatkar, Bhupender Singh

    2011-10-01

    Aloe vera is used for vigor, wellness and medicinal purposes since rigvedic times. Health benefits of aloe vera include its application in wound healing, treating burns, minimizing frost bite damage, protection against skin damage from x-rays, lung cancer, intestinal problems, increasing high density lipoprotein (HDL), reducing low density lipoprotein (LDL), reducing blood sugar in diabetics, fighting acquired immune deficiency syndrome (AIDS), allergies and improving immune system. Phytochemistry of aloe vera gel has revealed the presence of more than 200 bioactive chemicals. Aloe vera gel is extracted from its leaves and appropriate processing techniques are needed for stabilization as well as preparation of the end products. The industries involved in processing of aloe vera need Government surveillance to ensure that the aloe vera products have beneficial bio-active chemicals as per claims of the manufacturers. Regulatory bodies also need to look into the safety and toxicological aspects of aloe vera products for food applications. The claims made for medicinal value of aloe products should be supported by authentic and approved clinical trial data. It is presumptive to mention that nutraceutical claims of aloe products made by the manufacturers are numerous. However, approved clinical evidences are available only for lowering LDL, increasing HDL, decreasing blood glucose level, treating genital herpes and psoriases.

  8. Processing, food applications and safety of aloe vera products: a review.

    Science.gov (United States)

    Ahlawat, Kulveer Singh; Khatkar, Bhupender Singh

    2011-10-01

    Aloe vera is used for vigor, wellness and medicinal purposes since rigvedic times. Health benefits of aloe vera include its application in wound healing, treating burns, minimizing frost bite damage, protection against skin damage from x-rays, lung cancer, intestinal problems, increasing high density lipoprotein (HDL), reducing low density lipoprotein (LDL), reducing blood sugar in diabetics, fighting acquired immune deficiency syndrome (AIDS), allergies and improving immune system. Phytochemistry of aloe vera gel has revealed the presence of more than 200 bioactive chemicals. Aloe vera gel is extracted from its leaves and appropriate processing techniques are needed for stabilization as well as preparation of the end products. The industries involved in processing of aloe vera need Government surveillance to ensure that the aloe vera products have beneficial bio-active chemicals as per claims of the manufacturers. Regulatory bodies also need to look into the safety and toxicological aspects of aloe vera products for food applications. The claims made for medicinal value of aloe products should be supported by authentic and approved clinical trial data. It is presumptive to mention that nutraceutical claims of aloe products made by the manufacturers are numerous. However, approved clinical evidences are available only for lowering LDL, increasing HDL, decreasing blood glucose level, treating genital herpes and psoriases. PMID:23572784

  9. 有关生物实验室安全问题的思考%Thinking about the Safety of Biological Laboratories

    Institute of Scientific and Technical Information of China (English)

    赵伟辰

    2015-01-01

    The 21st century, scientific research projects in universities and the creation of course more and more diverse, the study and application of biological technology becomes more common, the corresponding biological laboratory use and safety is particularly important. Laboratory safety problems and corresponding safety measures were profound thinking, illustrates the biological laboratory hardware and software security risks from ideology, full participation, security system from three aspects: describes the biological laboratory of the central task and countermeasures.%21世纪后,高校科研项目和开设课程越来越多样化,生物技术的学习和应用也随之更为普遍,相应的生物实验室的使用和安全就尤为重要。就实验室安全方面出现的问题及相应的安全对策进行了深刻的思考,说明了生物实验室硬件和软件两方面存在的安全隐患,从思想意识、全员参与、安全制度三个方面阐述了生物实验室的中心任务和对策。

  10. Metabolic engineering of microorganisms for biofuels production: from bugs to synthetic biology to fuels

    Energy Technology Data Exchange (ETDEWEB)

    Kuk Lee, Sung; Chou, Howard; Ham, Timothy S.; Soon Lee, Taek; Keasling, Jay D.

    2009-12-02

    The ability to generate microorganisms that can produce biofuels similar to petroleum-based transportation fuels would allow the use of existing engines and infrastructure and would save an enormous amount of capital required for replacing the current infrastructure to accommodate biofuels that have properties significantly different from petroleum-based fuels. Several groups have demonstrated the feasibility of manipulating microbes to produce molecules similar to petroleum-derived products, albeit at relatively low productivity (e.g. maximum butanol production is around 20 g/L). For cost-effective production of biofuels, the fuel-producing hosts and pathways must be engineered and optimized. Advances in metabolic engineering and synthetic biology will provide new tools for metabolic engineers to better understand how to rewire the cell in order to create the desired phenotypes for the production of economically viable biofuels.

  11. Use of OECD/NEA Data Project Products in Probabilistic Safety Assessment

    International Nuclear Information System (INIS)

    The Nuclear Energy Agency (NEA)/Committee for the Safety of Nuclear Installations' (CSNI) Working Group on Risk Assessment (WGRISK) is tasked with supporting the improved use of Probabilistic Safety Assessment (PSA) in risk informed regulation and safety management through the analysis of results and the development of perspectives regarding potentially important risk contributors and associated risk reduction strategies. The task consists of the following major activities: Development, distribution, and completion of survey questionnaires; Analysis of survey questionnaire results at a task workshop; Preparation of the final task report. The main objectives of this task, as proposed by WGRISK and approved by CSNI, are the following: - Identification and characterization of the current uses of OECD data project products and data in support of PSA. In this context, the term 'products' refers to data analysis results, technical reports, and other project outputs. - Identification and characterization of technical and programmatic characteristics that either support or impede use of data project products in PSA. This includes an assessment of which PSA parameters could be potentially estimated from the various data project products and gaps between available product information and PSA data needs. - Identification of recommendations for enhancing the usefulness of data project products and the coordination between WGRISK and the data projects. This task report consists of the following sections: - Chapter 1 Provides a general overview of motivation and approach used for this task. - Chapter 2 Describes scope and objectives of the task. - Chapter 3 Provides an overview of the ICDE, FIRE, OPDE/CODAP, and COMPSIS data projects. For each project, the project objectives, project history, data collection methodology and quality assurance, project status, example PSA Applications, and information related to project participation is provided. - Chapter 4 Describes the

  12. Study on Separation of Factors of Production from Grain and Food Safety during the Evolution of Chinese Agricultural Structure

    OpenAIRE

    SHAN, Kangkang; WANG, Anran

    2015-01-01

    China is the world's largest food producer, and it also has the largest food demand. The stability of China's food production directly affects the supply and demand situation of the world food market. In the context of evolving Chinese agricultural structure, this paper studies the separation of factors of production from grain and issues concerning food safety. It is found that the arable land for food production within agricultural sector continues to flow to non-food production sector whil...

  13. Milk proteins-derived bioactive peptides in dairy products: molecular, biological and methodological aspects

    Directory of Open Access Journals (Sweden)

    Bartłomiej Dziuba

    2014-03-01

    Full Text Available Proteins are one of the primary components of the food, both in terms of nutrition and function. They are main source of amino acids, essential for synthesis of proteins, and also source of energy. Additionally, many proteins exhibit specifi c biological activities, which may have effect on functional or pro-health properties of food products. These proteins and their hydrolysis products, peptides, may infl uence the properties of food and human organism. The number of commercially available food products containing bioactive peptides is very low, apart from that milk proteins are their rich source. It could be supposed that number of available products with declared activity will rise in near future because of observed strong uptrend on interest in such products. Molecular and biological properties of milk proteins, as precursors of bioactive peptides was characterised in the work. Therefore, the strategy of research and obtaining of such peptides both in laboratory and industrial scale, as well as the range of their commercial application, was presented. Several examples of research efforts presenting high potential to develop new products containing bioactive peptides from milk proteins and predetermined as nutraceuticals was described.

  14. Milk proteins-derived bioactive peptides in dairy products: molecular, biological and methodological aspects.

    Science.gov (United States)

    Dziuba, Bartłomiej; Dziuba, Marta

    2014-01-01

    Proteins are one of the primary components of the food, both in terms of nutrition and function. They are main source of amino acids, essential for synthesis of proteins, and also source of energy. Additionally, many proteins exhibit specific biological activities, which may have effect on functional or pro-health properties of food products. These proteins and their hydrolysis products, peptides, may influence the properties of food and human organism. The number of commercially available food products containing bioactive peptides is very low, apart from that milk proteins are their rich source. It could be supposed that number of available products with declared activity will rise in near future because of observed strong uptrend on interest in such products. Molecular and biological properties of milk proteins, as precursors of bioactive peptides was characterised in the work. Therefore, the strategy of research and obtaining of such peptides both in laboratory and industrial scale, as well as the range of their commercial application, was presented. Several examples of research efforts presenting high potential to develop new products containing bioactive peptides from milk proteins and predetermined as nutraceuticals was described.

  15. Risk assessment of low-level chemical exposures from consumer products under the U.S. Consumer Product Safety Commission chronic hazard guidelines.

    OpenAIRE

    Babich, M A

    1998-01-01

    The U.S. Consumer Product Safety Commission (CPSC) is an independent regulatory agency that was created in 1973. The CPSC has jurisdiction over more the 15,000 types of consumer products used in and around the home or by children, except items such as food, drugs, cosmetics, medical devices, pesticides, certain radioactive materials, products that emit radiation (e.g., microwave ovens), and automobiles. The CPSC has investigated many low-level exposures from consumer products, including forma...

  16. High-latitude controls of thermocline nutrients and low latitude biological productivity.

    Science.gov (United States)

    Sarmiento, J L; Gruber, N; Brzezinski, M A; Dunne, J P

    2004-01-01

    The ocean's biological pump strips nutrients out of the surface waters and exports them into the thermocline and deep waters. If there were no return path of nutrients from deep waters, the biological pump would eventually deplete the surface waters and thermocline of nutrients; surface biological productivity would plummet. Here we make use of the combined distributions of silicic acid and nitrate to trace the main nutrient return path from deep waters by upwelling in the Southern Ocean and subsequent entrainment into subantarctic mode water. We show that the subantarctic mode water, which spreads throughout the entire Southern Hemisphere and North Atlantic Ocean, is the main source of nutrients for the thermocline. We also find that an additional return path exists in the northwest corner of the Pacific Ocean, where enhanced vertical mixing, perhaps driven by tides, brings abyssal nutrients to the surface and supplies them to the thermocline of the North Pacific. Our analysis has important implications for our understanding of large-scale controls on the nature and magnitude of low-latitude biological productivity and its sensitivity to climate change.

  17. Safety Evaluation Method of power production%电力生产安全性评价方法研究

    Institute of Scientific and Technical Information of China (English)

    陈萍

    2015-01-01

    近年来,随着我国工农业用电量的持续增加,电力企业面临着非常严峻的问题,即如何确保电力生产的安全性.针对电力生产安全问题,本文主要在介绍安全性评价概念的基础上,对电力生产与运行中的安全性评价作了详细研究,并提出了电力生产安全评价的具体方法,从而确保电力系统的安全运行.%In recent years, with the continued increase in industrial and agricultural use of electricity, power companies facing a very serious problem, namely, how to ensure the safety of power production. For power production safety issue, this paper describes the safety evaluation on the basis of the concept, the production of electricity and the operation of the safety evaluation of detailed study and propose concrete methods of power production safety evaluation to ensure the safety of the power system run.

  18. Microbiological Food Safety Status of Commercially Produced Tomatoes from Production to Marketing.

    Science.gov (United States)

    van Dyk, Brigitte N; de Bruin, Willeke; du Plessis, Erika M; Korsten, Lise

    2016-03-01

    Tomatoes have been implicated in various microbial disease outbreaks and are considered a potential vehicle for foodborne pathogens. Traceback studies mostly implicate contamination during production and/or processing. The microbiological quality of commercially produced tomatoes was thus investigated from the farm to market, focusing on the impact of contaminated irrigation and washing water, facility sanitation, and personal hygiene. A total of 905 samples were collected from three largescale commercial farms from 2012 through 2014. The farms differed in water sources used (surface versus well) and production methods (open field versus tunnel). Levels of total coliforms and Escherichia coli and prevalence of E. coli O157:H7 and Salmonella Typhimurium were determined. Dominant coliforms were identified using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. No pathogens or E. coli were detected on any of the tomatoes tested throughout the study despite the high levels of coliforms (4.2 to 6.2 log CFU/g) present on the tomatoes at the market. The dominant species associated with tomatoes belonged to the genera Enterobacter, Klebsiella, and Citrobacter. Water used on the farm for irrigation considered not fit for purpose according to national agricultural irrigation standards, with high E. coli levels resulting from either a highly contaminated source water (river water at 3.19 log most probable number [MPN]/100 ml) or improper storage of source water (stored well water at 1.72 log MPN/100 ml). Salmonella Typhimurium was detected on two occasions on a contact surface in the processing facility of the first farm in 2012. Contact surface coliform counts were 2.9 to 4.8 log CFU/cm(2). Risk areas identified in this study were water used for irrigation and poor sanitation practices in the processing facility. Implementation of effective food safety management systems in the fresh produce industry is of the utmost importance to ensure product

  19. Microbiological Food Safety Status of Commercially Produced Tomatoes from Production to Marketing.

    Science.gov (United States)

    van Dyk, Brigitte N; de Bruin, Willeke; du Plessis, Erika M; Korsten, Lise

    2016-03-01

    Tomatoes have been implicated in various microbial disease outbreaks and are considered a potential vehicle for foodborne pathogens. Traceback studies mostly implicate contamination during production and/or processing. The microbiological quality of commercially produced tomatoes was thus investigated from the farm to market, focusing on the impact of contaminated irrigation and washing water, facility sanitation, and personal hygiene. A total of 905 samples were collected from three largescale commercial farms from 2012 through 2014. The farms differed in water sources used (surface versus well) and production methods (open field versus tunnel). Levels of total coliforms and Escherichia coli and prevalence of E. coli O157:H7 and Salmonella Typhimurium were determined. Dominant coliforms were identified using matrix-assisted laser desorption/ionization time-of-flight mass spectrometry. No pathogens or E. coli were detected on any of the tomatoes tested throughout the study despite the high levels of coliforms (4.2 to 6.2 log CFU/g) present on the tomatoes at the market. The dominant species associated with tomatoes belonged to the genera Enterobacter, Klebsiella, and Citrobacter. Water used on the farm for irrigation considered not fit for purpose according to national agricultural irrigation standards, with high E. coli levels resulting from either a highly contaminated source water (river water at 3.19 log most probable number [MPN]/100 ml) or improper storage of source water (stored well water at 1.72 log MPN/100 ml). Salmonella Typhimurium was detected on two occasions on a contact surface in the processing facility of the first farm in 2012. Contact surface coliform counts were 2.9 to 4.8 log CFU/cm(2). Risk areas identified in this study were water used for irrigation and poor sanitation practices in the processing facility. Implementation of effective food safety management systems in the fresh produce industry is of the utmost importance to ensure product

  20. European legal developments in product safety and liability: the role of customer complaint management as a defensive marketing tool

    NARCIS (Netherlands)

    Ruyter, de Ko; Brack, Antoni

    1993-01-01

    In view of recent European legal developments, our purpose in this article is to position customer complaint management as an essential instrument for a defensive marketing strategy, specifically to prevent legal problems in the fields of product liability and product safety.

  1. 77 FR 46764 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

    Science.gov (United States)

    2012-08-06

    ... HUMAN SERVICES Food and Drug Administration Clinical Studies of Safety and Effectiveness of Orphan... of FDA's Office of Orphan Products Development (OPD) grant program. The goal of FDA's OPD grant... Needleman, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire...

  2. Solid recovered fuel production through the mechanical-biological treatment of wastes

    OpenAIRE

    Velis, C.A.

    2010-01-01

    This thesis is concerned with the production of solid recovered fuel (SRF) from municipal solid waste using mechanical biological treatment (MBT) plants. It describes the first in-depth analysis of a UK MBT plant and addresses the fundamental research question: are MBT plants and their unit operations optimised to produce high quality SRF in the UK? A critical review of the process science and engineering of MBT provides timely insights into the quality management and standa...

  3. [Biologic age as a criterion for work evaluation (exemplified by titanium alloys production)].

    Science.gov (United States)

    Afanas'eva, R F; Prokopenko, L V

    2009-01-01

    The article deals with results of studies concerning biologic age of workers (males) under occupational hazards of titanium alloys (jeopardy classes 3.3, 3.4.4) in Verkhne-Saldinsky metallurgic production association. Based on mathematic statistic analysis, the authors worked out an equation of multiple regression for ageing pace to forecast the ageing with consideration of age, length of service, occupation. The authors determined occupational groups characterized by premature ageing and increased risk of health disorders.

  4. Biologics in the management of ulcerative colitis – comparative safety and efficacy of TNF-α antagonists

    Directory of Open Access Journals (Sweden)

    Fausel R

    2015-01-01

    Full Text Available Rebecca Fausel,1 Anita Afzali1,2 1Division of Gastroenterology, Department of Medicine, University of Washington, Seattle, WA, USA; 2Inflammatory Bowel Disease Program, UW Medicine – Harborview Medical Center, Seattle, WA, USA Abstract: Ulcerative colitis can cause debilitating symptoms and complications such as colonic strictures, colonic dysplasia, colorectal cancer, and toxic megacolon or perforation. Goals of treatment in ulcerative colitis include resolution of gastrointestinal symptoms, healing of colonic mucosa, and prevention of disease complications. Our treatment armamentarium has expanded dramatically over the past 10 years, and we now have multiple biologic agents approved for the treatment of moderate-severe disease, in addition to conventional therapies such as 5-aminosalicylates, thiopurines, and corticosteroids. In this review, we will provide a detailed discussion of the three tumor necrosis factor-alpha (TNF-α inhibitors currently approved for treatment of ulcerative colitis: infliximab, adalimumab, and golimumab. All three agents are effective for inducing and maintaining clinical response and remission in patients with ulcerative colitis, and they have comparable safety profiles. There are no head-to-head trials comparing their efficacy, and the choice of agent is most often based on insurance coverage, route of administration, and patient preference. Combination therapy with an immunomodulator is proven to be more effective than anti-TNF monotherapy, and patients who lose response to an anti-TNF agent should undergo dose intensification in order to regain clinical response. Despite therapeutic optimization, a significant percentage of patients will not achieve clinical remission with anti-TNF agents, and so newer therapies are on the horizon. Keywords: ulcerative colitis, inflammatory bowel disease, infliximab, adalimumab, golimumab

  5. Mapping the patent landscape of synthetic biology for fine chemical production pathways.

    Science.gov (United States)

    Carbonell, Pablo; Gök, Abdullah; Shapira, Philip; Faulon, Jean-Loup

    2016-09-01

    A goal of synthetic biology bio-foundries is to innovate through an iterative design/build/test/learn pipeline. In assessing the value of new chemical production routes, the intellectual property (IP) novelty of the pathway is important. Exploratory studies can be carried using knowledge of the patent/IP landscape for synthetic biology and metabolic engineering. In this paper, we perform an assessment of pathways as potential targets for chemical production across the full catalogue of reachable chemicals in the extended metabolic space of chassis organisms, as computed by the retrosynthesis-based algorithm RetroPath. Our database for reactions processed by sequences in heterologous pathways was screened against the PatSeq database, a comprehensive collection of more than 150M sequences present in patent grants and applications. We also examine related patent families using Derwent Innovations. This large-scale computational study provides useful insights into the IP landscape of synthetic biology for fine and specialty chemicals production. PMID:27489206

  6. Fungi as chemical industries and genetic engineering for the production of biologically active secondary metabolites

    Institute of Scientific and Technical Information of China (English)

    Abid; Ali; Khan; Nafees; Bacha; Bashir; Ahmad; Ghosia; Lutfullah; Umar; Farooq; Russell; John; Cox

    2014-01-01

    Fungi is somewhere in between the micro and macro organisms which is a good source of producing biologically active secondary metabolites.Fungi have been used as tool for producing different types of secondary metabolites by providing different nutrients at different laboratory conditions.The fungi have been engineered for the desired secondary metabolites by using different laboratory techniques,for example,homologous and heterologous expressions.This review reported how the fungi are used as chemical industry for the production of secondary metabolites and how they are engineered in laboratory for the production of desirable metabolites:also the biosynthetic pathways of the bio-organic-molecules were reported.

  7. Fungi as chemical industries and genetic engineering for the production of biologically active secondary metabolites

    Institute of Scientific and Technical Information of China (English)

    Abid Ali Khan; Nafees Bacha; Bashir Ahmad; Ghosia Lutfullah; Umar Farooq; Russell John Cox

    2014-01-01

    Fungi is somewhere in between the micro and macro organisms which is a good source of producing biologically active secondary metabolites. Fungi have been used as tool for producing different types of secondary metabolites by providing different nutrients at different laboratory conditions. The fungi have been engineered for the desired secondary metabolites by using different laboratory techniques, for example, homologous and heterologous expressions. This review reported how the fungi are used as chemical industry for the production of secondary metabolites and how they are engineered in laboratory for the production of desirable metabolites;also the biosynthetic pathways of the bio-organic-molecules were reported.

  8. Scientific opinion on the safety of smoke flavouring Primary Product SmokEz Enviro 23 - 2012 Update

    Directory of Open Access Journals (Sweden)

    EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF

    2012-07-01

    Full Text Available

    The EFSA CEF Panel updated the safety assessment of the smoke flavouring Primary Product SmokEz Enviro 23. In 2009, the Panel concluded that the margins of safety for this Primary Product were insufficient and the proposed use levels were considered of safety concern. After the opinion of 2009 the Panel received new data i.e. new use levels, chemical data and a new 90-day toxicity study, which resulted in this update of the previous opinion. The new chemical data provided demonstrate that the test material used in the new 90-day toxicity study is representative of the Primary Product evaluated by EFSA. Based on the findings from the 90-day study submitted in 2009 and from the newly submitted one, the Panel derived a NOAEL for Primary Product SmokEz Enviro 23 of 598 mg/kg bw/day based on absolute and relative kidney weight changes in female rats. Based on newly submitted normal use levels, the margins of safety are 62 and 77 (total dietary exposure and 65 and 89 (use in traditionally smoked foods only depending on the exposure scenario used. Given that these margins of safety are based on 90-day toxicity studies, and given the absence of data on reproduction, developmental toxicity and of long term studies, it is concluded that the uses and use levels of Primary Product would require a larger margin of safety. The Panel concluded that the proposed use of the Primary Product at the uses and use levels specified is of safety concern.

  9. Technical Key Figures for Photo-biological Hydrogen Production by Micro-algae

    International Nuclear Information System (INIS)

    One regenerative path to produce hydrogen is the photo-biological hydrogen production by the green micro-alga Chlamydomonas reinhardtii. This process can be divided into three phases: a growth phase, a phase in which the algae adapt from oxygen production and CO2-fixation to fermentative H2 production, and a phase in which H2 is produced. In a research project carried out at Ruhr-Universitat Bochum, a new developed flat panel bioreactor was investigated. A system analysis was conducted and energetic and environmental key figures were determined. The intention of this assessment on a very early technological stage was to collect first technical data in order to classify the current technological status of the photo-biological H2 production to identify future potentials and to uncover weaknesses. For this reason the key figures were evaluated for the status quo and for two scenarios which allow an outlook on the mid and the long term. The results were compared with other ways of regenerative H2 production. (authors)

  10. Current good manufacturing practice in plant automation of biological production processes.

    Science.gov (United States)

    Dorresteijn, R C; Wieten, G; van Santen, P T; Philippi, M C; de Gooijer, C D; Tramper, J; Beuvery, E C

    1997-01-01

    The production of biologicals is subject to strict governmental regulations. These are drawn up in current good manufacturing practices (cGMP), a.o. by the U.S. Food and Drug Administration. To implement cGMP in a production facility, plant automation becomes an essential tool. For this purpose Manufacturing Execution Systems (MES) have been developed that control all operations inside a production facility. The introduction of these recipe-driven control systems that follow ISA S88 standards for batch processes has made it possible to implement cGMP regulations in the control strategy of biological production processes. Next to this, an MES offers additional features such as stock management, planning and routing tools, process-dependent control, implementation of software sensors and predictive models, application of historical data and on-line statistical techniques for trend analysis and detection of instrumentation failures. This paper focuses on the development of new production strategies in which cGMP guidelines are an essential part.

  11. Impact of synthetic biology and metabolic engineering on industrial production of fine chemicals.

    Science.gov (United States)

    Jullesson, David; David, Florian; Pfleger, Brian; Nielsen, Jens

    2015-11-15

    Industrial bio-processes for fine chemical production are increasingly relying on cell factories developed through metabolic engineering and synthetic biology. The use of high throughput techniques and automation for the design of cell factories, and especially platform strains, has played an important role in the transition from laboratory research to industrial production. Model organisms such as Saccharomyces cerevisiae and Escherichia coli remain widely used host strains for industrial production due to their robust and desirable traits. This review describes some of the bio-based fine chemicals that have reached the market, key metabolic engineering tools that have allowed this to happen and some of the companies that are currently utilizing these technologies for developing industrial production processes.

  12. Impact of synthetic biology and metabolic engineering on industrial production of fine chemicals

    DEFF Research Database (Denmark)

    Jullesson, David; David, Florian; Pfleger, Brian;

    2015-01-01

    Industrial bio-processes for fine chemical production are increasingly relying on cell factories developed through metabolic engineering and synthetic biology. The use of high throughput techniques and automation for the design of cell factories, and especially platform strains, has played...... chemicals that have reached the market, key metabolic engineering tools that have allowed this to happen and some of the companies that are currently utilizing these technologies for developing industrial production processes....... an important role in the transition from laboratory research to industrial production. Model organisms such as Saccharomyces cerevisiae and Escherichia coli remain widely used host strains for industrial production due to their robust and desirable traits. This review describes some of the bio-based fine...

  13. Microbial production of amino acids and derived chemicals: synthetic biology approaches to strain development.

    Science.gov (United States)

    Wendisch, Volker F

    2014-12-01

    Amino acids are produced at the multi-million-ton-scale with fermentative production of l-glutamate and l-lysine alone being estimated to amount to more than five million tons in the year 2013. Metabolic engineering constantly improves productivities of amino acid producing strains, mainly Corynebacterium glutamicum and Escherichia coli strains. Classical mutagenesis and screening have been accelerated by combination with intracellular metabolite sensing. Synthetic biology approaches have allowed access to new carbon sources to realize a flexible feedstock concept. Moreover, new pathways for amino acid production as well as fermentative production of non-native compounds derived from amino acids or their metabolic precursors were developed. These include dipeptides, α,ω-diamines, α,ω-diacids, keto acids, acetylated amino acids and ω-amino acids. PMID:24922334

  14. The availability and validity of safety information of Over the Counter herbal products for use in diabetes in Sri Lanka: a cross sectional study.

    Directory of Open Access Journals (Sweden)

    Arjuna Bandara Medagama

    2015-12-01

    Conclusions: Key safety information was absent in most products. Regulation of sale, provision of key safety information and adverse event reporting should be a priority. [J Intercult Ethnopharmacol 2015; 4(4.000: 264-269

  15. Safety of human blood products: inactivation of retroviruses by heat treatment at 60 degrees C.

    Science.gov (United States)

    Hilfenhaus, J; Mauler, R; Friis, R; Bauer, H

    1985-04-01

    Acquired immune deficiency syndrome (AIDS) can be transferred to patients by blood transfusions or human blood preparations, such as cryoprecipitates or factor VIII concentrates. Retroviruses have been discussed as infectious AIDS agents and more recently human T-lymphotropic retroviruses designated as HTLV type III and LAV (lymphadenopathy-associated virus) have been isolated from AIDS patients. Whether heat treatment at 60 degrees C (pasteurization) of liquid human plasma protein preparations inactivates retroviruses was therefore investigated. Pasteurization had already been included in the routine manufacturing process of human plasma protein preparations in order to guarantee safety with regard to hepatitis B. Since high titer preparations of human retroviruses were not available, heat inactivation was studied using Rous sarcoma virus added to the various plasma protein preparations tested. This retrovirus which was obtained in preparations of 6.0 log10 FFU/ml was shown to be at least as heat stable as two mammalian retroviruses studied, i.e., feline and simian sarcoma virus. In all of eight different plasma protein preparations tested, Rous sarcoma virus was completely inactivated after a heat treatment lasting no longer than 4 hr. It is thus concluded that pasteurization of liquid plasma protein preparations at 60 degrees C over a period of 10 hr must confer safety to these products with respect to AIDS, provided that the AIDS agents are retroviruses of comparable heat stability as Rous sarcoma virus and the mammalian retroviruses tested.

  16. Assessing Natural Product-Drug Interactions: An End-to-End Safety Framework.

    Science.gov (United States)

    Roe, Amy L; Paine, Mary F; Gurley, Bill J; Brouwer, Kenneth R; Jordan, Scott; Griffiths, James C

    2016-04-01

    The use of natural products (NPs), including herbal medicines and other dietary supplements, by North Americans continues to increase across all age groups. This population has access to conventional medications, with significant polypharmacy observed in older adults. Thus, the safety of the interactions between multi-ingredient NPs and drugs is a topic of paramount importance. Considerations such as history of safe use, literature data from animal toxicity and human clinical studies, and NP constituent characterization would provide guidance on whether to assess NP-drug interactions experimentally. The literature is replete with reports of various NP extracts and constituents as potent inhibitors of drug metabolizing enzymes, and transporters. However, without standard methods for NP characterization or in vitro testing, extrapolating these reports to clinically-relevant NP-drug interactions is difficult. This lack of a clear definition of risk precludes clinicians and consumers from making informed decisions about the safety of taking NPs with conventional medications. A framework is needed that describes an integrated robust approach for assessing NP-drug interactions; and, translation of the data into formulation alterations, dose adjustment, labelling, and/or post-marketing surveillance strategies. A session was held at the 41st Annual Summer Meeting of the Toxicology Forum in Colorado Springs, CO, to highlight the challenges and critical components that should be included in a framework approach.

  17. Antibiotic susceptibility and antimicrobial activity of autochthonous starter cultures as safety parameters for fresh cheese production

    Directory of Open Access Journals (Sweden)

    Dora Bučan

    2013-11-01

    Full Text Available The antibiotic susceptibility and antimicrobial activity, as food safety parameters important for application of autochthonous lactic acid bacteria (LAB, that previously satisfied technological criteria for functional starter cultures in fresh cheese production were examined. Soluble whole cell protein patterns of autochthonous LAB strains from fresh cheese, obtained by SDS-PAGE, revealed the presence of two predominant strains, which were identified as Lactobacillus fermentum A8 and Enterococcus faecium A7. These strains were not resistant and shown susceptibility to antibiotics: ampicillin, bacitracin, penicillin G, azithromycin, chloramphenicol, clarithromycin, clindamycin, spiramycin, tetracycline, streptomycin, neomycin, gentamicin, erythromycin, rifampicin and novobiocin. Lb. fermentum A8 strain displayed phenotypic resistance to vancomycin, but this resistance is intrinsic, not transferable and it is acceptable from the safety aspect. The capacity of Lb. fermentum A8 and Ec. faecium A7 to inhibit growth of test-microorganisms Listeria monocytogenes ATCC 11911, Escherichia coli 3014, Salmonella enterica serovar Typhimurium FP1 and Staphylococcus aureus 3048, was also analysed. According to obtained results, Lb. fermentum A8 and Ec. faecium A7 are safe from the aspect of spreading antibiotic resistance and could be useful as bioprotective cultures that inhibit common bacterial food contaminants, including L. monocytogenes.

  18. Assessing Natural Product-Drug Interactions: An End-to-End Safety Framework.

    Science.gov (United States)

    Roe, Amy L; Paine, Mary F; Gurley, Bill J; Brouwer, Kenneth R; Jordan, Scott; Griffiths, James C

    2016-04-01

    The use of natural products (NPs), including herbal medicines and other dietary supplements, by North Americans continues to increase across all age groups. This population has access to conventional medications, with significant polypharmacy observed in older adults. Thus, the safety of the interactions between multi-ingredient NPs and drugs is a topic of paramount importance. Considerations such as history of safe use, literature data from animal toxicity and human clinical studies, and NP constituent characterization would provide guidance on whether to assess NP-drug interactions experimentally. The literature is replete with reports of various NP extracts and constituents as potent inhibitors of drug metabolizing enzymes, and transporters. However, without standard methods for NP characterization or in vitro testing, extrapolating these reports to clinically-relevant NP-drug interactions is difficult. This lack of a clear definition of risk precludes clinicians and consumers from making informed decisions about the safety of taking NPs with conventional medications. A framework is needed that describes an integrated robust approach for assessing NP-drug interactions; and, translation of the data into formulation alterations, dose adjustment, labelling, and/or post-marketing surveillance strategies. A session was held at the 41st Annual Summer Meeting of the Toxicology Forum in Colorado Springs, CO, to highlight the challenges and critical components that should be included in a framework approach. PMID:26776752

  19. Adult Stem Cells Properties in Terms of Commitment, Aging and Biological Safety of Grit-Blasted and Acid-Etched Ti Dental Implants Surfaces

    OpenAIRE

    Gardin, Chiara; Ferroni, Letizia; Bressan, Eriberto; Calvo - Guirado, José L.; Degidi, Marco; Piattelli, Adriano; Zavan, Barbara

    2014-01-01

    Titanium (Ti) is one of the most widely used biomaterials for manufacturing dental implants. The implant surface properties strongly influence osseointegration. The aim of the present study was to in vitro investigate the characteristics of Ti dental implants in terms of mutagenicity, hemocompatibility, biocompatibility, osteoinductivity and biological safety. The Ames test was used to test the mutagenicity of the Ti dental implants, and the hemolysis assay for evaluating their hemocompatibil...

  20. Techno-economic evaluation of a two-step biological process for hydrogen production.

    Science.gov (United States)

    Ljunggren, Mattias; Zacchi, Guido

    2010-01-01

    An integrated biological process for the production of hydrogen based on thermophilic and photo-heterotrophic fermentation was evaluated from a technical and economic standpoint. Besides the two fermentation steps the process also includes pretreatment of the raw material (potato steam peels) and purification of hydrogen using amine absorption. The study aimed neither at determining the absolute cost of biohydrogen nor at an economic optimization of the production process, but rather at studying the effects of different parameters on the production costs of biohydrogen as a guideline for future improvements. The effect of the key parameters, hydrogen productivity and yield and substrate concentration in the two fermentations on the cost of the hydrogen produced was studied. The selection of the process conditions was based mainly on laboratory data. The process was simulated by use of the software Aspen Plus and the capital costs were estimated using the program Aspen Icarus Process Evaluator. The study shows that the photo-fermentation is the main contributor to the hydrogen production cost mainly because of the cost of plastic tubing, for the photo-fermentors, which represents 40.5% of the hydrogen production cost. The costs of the capital investment and chemicals were also notable contributors to the hydrogen production cost. Major economic improvements could be achieved by increasing the productivity of the two fermentation steps on a medium-term to long-term scale. PMID:20039381

  1. Environment, safety and health compliance assessment, Feed Materials Production Center, Fernald, Ohio

    Energy Technology Data Exchange (ETDEWEB)

    1989-09-01

    The Secretary of Energy established independent Tiger Teams to conduct environment, safety, and health (ES H) compliance assessments at US Department of Energy (DOE) facilities. This report presents the assessment of the Feed Materials Production Center (FMPC) at Fernald, Ohio. The purpose of the assessment at FMPC is to provide the Secretary with information regarding current ES H compliance status, specific ES H noncompliance items, evaluation of the adequacy of the ES H organizations and resources (DOE and contractor), and root causes for noncompliance items. Areas reviewed included performance under Federal, state, and local agreements and permits; compliance with Federal, state and DOE orders and requirements; adequacy of operations and other site activities, such as training, procedures, document control, quality assurance, and emergency preparedness; and management and staff, including resources, planning, and interactions with outside agencies.

  2. Consumer perception: Quality, safety and security of food products based on the Consumer Protection Law

    Directory of Open Access Journals (Sweden)

    Rodolfo Misael Mejía Dietrich

    2016-06-01

    Full Text Available In the last few years the culture of respect toward Salvadoran consumer´s rights has been promoted by government and non-government institutions. The objective of this research was to investigate about the experiences, concerns, and expectations of consumers of the city of San Miguel in relation to the perception about the fulfillment and non-fulfillment of their rights, associated with food quality, safety, and security. This was also contrasted with the opinion emitted by businesspeople with the purpose of establishing similarities and differences related to this topic. Besides, the research was descriptive and explanatory which detailed and analyzed the causes and effects of the relation between the variables to comply with the requirements of: quality and security of food products with rights fulfillment. Data analysis was made by using basic statistic techniques: frequency tables and graphs. Finally, it was found that consumers are sensible to high prices of the basic food basket and this influences their purchase decision; that they receive food products of average quality and that these products are not always accessible to their budgets; likewise, there is a high percentage of consumers that know their rights and duties given by the Consumer Protection Law.

  3. Establishing Effective Environmental and Safety Performance Indicators: A Best Practice Approach in Uranium Production

    International Nuclear Information System (INIS)

    Cameco Corporation (Cameco), with headquarters in Saskatoon, Saskatchewan, Canada, is the world's largest, low-cost uranium producer, currently supplying sufficient uranium to meet 20% of the world's demand. It is characterized by a diverse range of operations in Canada, the United States and Central Asia, for which Cameco is the majority owner and/or operator, including exploration, mining, milling, refining and conversion. Cameco had four business segments: Uranium; Conversion services; Nuclear energy generation; and Gold Also, in 2002, Cameco revised its vision statement to indicate, 'Cameco will be a dominant nuclear energy company producing uranium fuel and generating clean electricity'. Commensurate with this, Cameco has re-confirmed its overall measures of success as follows: A safe, healthy and rewarding workplace; A clean environment; Supportive communities; and Solid financial performance - all reflected in a growing return to shareholders. Like most organizations, Cameco recognizes the importance of conducting its operations in ways that promote continual improvement in environmental and safety performance. Demonstrating the environmental advantages of nuclear is a vital part of the overall best management practices approach. Detractors often try to point to the uranium production side of the nuclear fuel cycle in pursuit of trying to make the case that the nuclear option does not carry any special environmental advantage. These attempts are mostly based on performance from eras past, not modern performance. The uranium sector must be able to present its case in a modern context, which is largely based on sustainable development principles. This paper focuses on establishing environment and safety performance indicators for the uranium production and conversion aspects of Cameco's business, as well as in support of the environmental advantages of nuclear energy generation

  4. Consumer product safety: Risk assessment of exposure to asbestos emissions from hand-held hair dryers

    Science.gov (United States)

    Hallenbeck, William H.

    1981-01-01

    The United States Consumer Product Safety Commission (CPSC) is concerned that consumer exposure to asbestos from consumer products may present an unreasonable risk of injury. Recently, CPSC has obtained agreement by industry to cease production and distribution of hair dryers containing asbestos heat insulation. CPSC intends to broaden its investigation by selecting consumer products containing asbestos for “priority attention.” The Commission does not intend to make quantitative estimates of cancer risks posed by exposure to asbestos fibers in making regulatory decisions. This position may lead to a serious waste of resources for the Commission, industry, and society. The Commission should focus its initial attention on those products for which the release of asbestos is significant enough to cause an unreasonable health risk. To make a risk assessment for a particular use of asbestos, CPSC must acquire or request data on asbestos emissions and define “unreasonable risk to health.” In an attempt to give some meaning to the phrase “risk assessment,” the primary goal of this paper is to present a detailed risk assessment of exposure to asbestos from hand-held hair dryers. Several scenarios of use are presented using various assumptions regarding time of operation, mixing of fibers in a small room, rate of fiber emission, and time of exposure. The worst case analysis of the health risk of exposure to hair dryer emissions is based on several conservative assumptions and shows that the increased number of deaths per year due to respiratory cancer is 4 for the entire United States population. A more representative case analysis shows the increased number of deaths to be on the order of 0.15 per year.

  5. A synthetic biology approach to self-regulatory recombinant protein production in Escherichia coli

    Directory of Open Access Journals (Sweden)

    Dragosits Martin

    2012-03-01

    Full Text Available Abstract Background Recombinant protein production is a process of great industrial interest, with products that range from pharmaceuticals to biofuels. Since high level production of recombinant protein imposes significant stress in the host organism, several methods have been developed over the years to optimize protein production. So far, these trial-and-error techniques have proved laborious and sensitive to process parameters, while there has been no attempt to address the problem by applying Synthetic Biology principles and methods, such as integration of standardized parts in novel synthetic circuits. Results We present a novel self-regulatory protein production system that couples the control of recombinant protein production with a stress-induced, negative feedback mechanism. The synthetic circuit allows the down-regulation of recombinant protein expression through a stress-induced promoter. We used E. coli as the host organism, since it is widely used in recombinant processes. Our results show that the introduction of the self-regulatory circuit increases the soluble/insoluble ratio of recombinant protein at the expense of total protein yield. To further elucidate the dynamics of the system, we developed a computational model that is in agreement with the observed experimental data, and provides insight on the interplay between protein solubility and yield. Conclusion Our work introduces the idea of a self-regulatory circuit for recombinant protein products, and paves the way for processes with reduced external control or monitoring needs. It demonstrates that the library of standard biological parts serves as a valuable resource for initial synthetic blocks that needs to be further refined to be successfully applied in practical problems of biotechnological significance. Finally, the development of a predictive model in conjunction with experimental validation facilitates a better understanding of the underlying dynamics and can be

  6. Biological Pretreatment of Rubberwood with Ceriporiopsis subvermispora for Enzymatic Hydrolysis and Bioethanol Production

    Directory of Open Access Journals (Sweden)

    Forough Nazarpour

    2013-01-01

    Full Text Available Rubberwood (Hevea brasiliensis, a potential raw material for bioethanol production due to its high cellulose content, was used as a novel feedstock for enzymatic hydrolysis and bioethanol production using biological pretreatment. To improve ethanol production, rubberwood was pretreated with white rot fungus Ceriporiopsis subvermispora to increase fermentation efficiency. The effects of particle size of rubberwood (1 mm, 0.5 mm, and 0.25 mm and pretreatment time on the biological pretreatment were first determined by chemical analysis and X-ray diffraction and their best condition obtained with 1 mm particle size and 90 days pretreatment. Further morphological study on rubberwood with 1 mm particle size pretreated by fungus was performed by FT-IR spectra analysis and SEM observation and the result indicated the ability of this fungus for pretreatment. A study on enzymatic hydrolysis resulted in an increased sugar yield of 27.67% as compared with untreated rubberwood (2.88%. The maximum ethanol concentration and yield were 17.9 g/L and 53% yield, respectively, after 120 hours. The results obtained demonstrate that rubberwood pretreated by C. subvermispora can be used as an alternative material for the enzymatic hydrolysis and bioethanol production.

  7. Biological production of hydrogen by dark fermentation of OFMSW and co-fermentation with slaughterhouse wastes

    Energy Technology Data Exchange (ETDEWEB)

    Moran, A.; Gomez, X.; Cuestos, M. J.

    2005-07-01

    Hydrogen is an ideal, clean and sustainable energy source for the future because of its high conversion and nonpolluting nature (Lin and Lay, 2003). There are different methods for the production of hydrogen, the traditional ones, are the production from fossil fuels. Aiming to reach a development based on sustainable principles the production of hydrogen from renewable sources is a desirable goal. Among the environmental friendly alternatives for the production of hydrogen are the biological means. Dark fermentation as it is known the process when light is not used; it is a preferable option thanks to the knowledge already collected from its homologous process, the anaerobic digestion for the production of methane. There are several studies intended to the evaluation of the production of hydrogen, many are dedicated to the use of pure cultures or the utilization of basic substrates as glucose or sucrose (Lin and Lay, 2003; Chang et al., 2002, Kim et al., 2005). This study is performed to evaluate the fermentation of a mixture of wastes for the production of hydrogen. It is used as substrate the organic fraction of municipal solid wastes (OFMSW) and a mixture of this residue with slaughterhouse waste. (Author)

  8. The Effect of Peat and Vermicompost Cavitation Products on the Soil Biological Activity

    Directory of Open Access Journals (Sweden)

    Steinberga Vilhelmine

    2014-12-01

    Full Text Available Commercial products with humic substances have often been recommended for plant growth stimulation and yield improvement. The aim of this study was to clarify the effects of two products, containing cavited peat and vermicompost respectively on the soil biological activity. Vegetation experiments with garden cress and cucumbers were arranged in pots with a peat substratum in the greenhouses of the Latvia University of Agriculture. The plants were treated with the preparations once a month. The first treatment was done at sowing. Dose of 20, 2, 0.2 mL per m2 during each treatment time were used. A control variant was without peat or vermicompost preparation. Field experiments with onions were carried out in the organic farming experimental field of the Latvia State Institute of Cereal Breeding. Plant growth and soil (substratum biological activity (respiration and enzymatic activity were tested. Plant growth and response to the different preparations depended on the plant species and its development stage. The effect of preparations decreases during plant development. The impact of peat or vermicompost preparation on soil biological activity depended not only on the concentration of preparation, but was influenced by the soil or growth media type. The decrease of onion yield in field conditions as a result of preparations was observed.

  9. Comparison of fission product release predictions using PARFUME with results from the AGR-1 safety tests

    Energy Technology Data Exchange (ETDEWEB)

    Blaise Collin

    2014-09-01

    Safety tests were conducted on fourteen fuel compacts from AGR-1, the first irradiation experiment of the Advanced Gas Reactor (AGR) Fuel Development and Qualification program, at temperatures ranging from 1600 to 1800°C to determine fission product release at temperatures that bound reactor accident conditions. The PARFUME (PARticle FUel ModEl) code was used to predict the release of fission products silver, cesium, strontium, and krypton from fuel compacts containing tristructural isotropic (TRISO) coated particles during the safety tests, and the predicted values were compared with experimental results. Preliminary comparisons between PARFUME predictions and post-irradiation examination (PIE) results of the safety tests show different trends in the prediction of the fractional release depending on the species, and it leads to different conclusions regarding the diffusivities used in the modeling of fission product transport in TRISO-coated particles: • For silver, the diffusivity in silicon carbide (SiC) might be over-estimated by a factor of at least 102 to 103 at 1600°C and 1700°C, and at least 10 to 102 at 1800°C. The diffusivity of silver in uranium oxy-carbide (UCO) might also be over-estimated, but the available data are insufficient to allow definitive conclusions to be drawn. • For cesium, the diffusivity in UCO might be over-estimated by a factor of at least 102 to 103 at 1600°C, 105 at 1700°C, and 103 at 1800°C. The diffusivity of cesium in SiC might also over-estimated, by a factor of 10 at 1600°C and 103 at 1700°C, based upon the comparisons between calculated and measured release fractions from intact particles. There is no available estimate at 1800°C since all the compacts heated up at 1800°C contain particles with failed SiC layers whose release dominates the release from intact particles. • For strontium, the diffusivity in SiC might be over-estimated by a factor of 10 to 102 at 1600 and 1700°C, and 102 to 103 at 1800°C. These

  10. 医院输血科生物安全管理现状及对策%Current management of biological safety in hospital blood transfusion and countermeasures

    Institute of Scientific and Technical Information of China (English)

    吴争胜; 蒋璐茜; 陈秉宇

    2011-01-01

    目的 根据浙江省输血科(血库)生物安全建设的现状,探讨进行规范化管理的方法. 方法 随机调查浙江省30所医院输血科(血库)存在的生物安全隐患,探讨制定切实可行的管理措施. 结果 综合性医院输血科生物安全管理方面存在诸多隐患,其中管理制度、操作规程等完善的合格率仅60.0%,66.7%输血科工作区布局不够合理、工作人员感染防范意识较差、医疗废弃物处理不规范等,个人防护的基本配置>90.0%,但实际使用率欠佳. 结论 必须严格执行生物安全的法律法规,制定和健全规章制度,才能确保输血科生物安全,有效预防与控制医院感染.%OBJECTIVE To approach standardized management of biological safety in blood transfusion based upon the present situation in this field in Zhejiang.METHODS A randomized survey of hidden hazardous factors threatening biological safety was conducted among the departments of blood transfusion in 30 hospitals and the data were statistically analyzed.RESULTS Several risky issues were found in the management of blood transfusion and biological safety.The qualified rate of supervising system and operating rules was only 60.0 %, unreasonable layout of workspace, poor awareness of prevention of infection, inadequate disposition of medical wastes accounted for 66.7%, staff's body sheltering was equipped over 90.0%, but the actual using rate was unexpectedly low.CONCLUSION In order to ensure the biological safety in blood transfusion and effective prevention and control of hospital infection, the relevant laws and regulations concerning biological safety should be established and strictly carried out.

  11. Gamma irradiation induced disintegration of waste activated sludge for biological hydrogen production

    Science.gov (United States)

    Yin, Yanan; Wang, Jianlong

    2016-04-01

    In this paper, gamma irradiation was applied for the disintegration and dissolution of waste activated sludge produced during the biological wastewater treatment, and the solubilized sludge was used as substrate for bio-hydrogen production. The experimental results showed that the solubilization of waste activated sludge was 53.7% at 20 kGy and pH=12, and the SCOD, polysaccharides, protein, TN and TP contents in the irradiated sludge solutions was 3789.6 mg/L, 268.3 mg/L, 1881.5 mg/L, 132.3 mg/L and 80.4 mg/L, respectively. The irradiated sludge was used for fermentative hydrogen production, and the hydrogen yield was 10.5±0.7 mL/g SCODconsumed. It can be concluded that the irradiated waste activated sludge could be used as a low-cost substrate for fermentative hydrogen production.

  12. Berry productivity estimation of biological(botanical) reservations 'Milevichsky' and 'Zalyuchitsky'

    International Nuclear Information System (INIS)

    The necessity of creation of local status biological (botanical) reservations in Zhitkovichi district is scientifically substantiated on he basis of performed investigations and analysis of location nature conditions of declared reservations, their nature potential and on the estimation of productivity of wild berr plantation and radiation situation. Forest districts of these reservations have high productivity of wild bilberries and great bilberry and natural background radiation. The specific radiation activity of bilverries collected in the foregoing districts of Milevichi and Zalyutichi forestry does not exceed 60 Bk/kg, that is less than 30% of the permissible rate. Main recommendations were developed for protection and utilization of reservations, for conservation of the conditions required for growing forests with optimum characteristics, which promote vegetation and high productivity of wild berry reservations

  13. Method for assessing the impact of emission gasses on physiology and productivity in biological methanogenesis.

    Science.gov (United States)

    Seifert, A H; Rittmann, S; Bernacchi, S; Herwig, C

    2013-05-01

    This contribution presents a method for quantification of the impact of emission gasses on the methane production with hydrogenotrophic methanogenic archaea. The developed method allows a robust quantification of the influence of real gasses on the volumetric productivity of methanogenic cultures by uncoupling physiological and mass transfer effects. This is achieved over reference experiments with pure H2 and CO2, simulating the mass transfer influence of the non-convertible side components by addition of N2 to the reactant stream. Furthermore, this method was used to examine the performance of Methanothermobacter marburgensis on different emission gasses. None of the present side components had a negative effect on the volumetric methane production rate. The presented method showed to be ready to use as a generic tool for feasibility studies and quantification of the physiological impact regarding the use of exhaust gasses as reactant gas for the biological methanogenesis. PMID:23582218

  14. Application of Evolutionary Encryption 2D Barcode Generation Technology in Agricultural Product Quality and Safety Traceability System

    Institute of Scientific and Technical Information of China (English)

    Xiaojun; ZHONG; Zhijie; LAI; Yan; CHEN; Jianxin; QIAN; Xiaocong; HONG; Caiyi; LI

    2014-01-01

    Two-dimensional(2D) barcode technology is an electronic tagging technology based on combination of computer and optical technology. It is an important way of information collection and input. 2D barcode technology has been widely used in various fields of logistics,production automation,and e-commerce,but it also has brought about a series of safety problems. Based on evolutionary encryption technology,this paper improved algorithm of traditional 2D barcode generation,to improve forgery- proof performance of 2D barcode. This algorithm is applied to agricultural products quality and safety traceability system and the results show that it is effective.

  15. Enzyme and metabolic engineering for the production of novel biopolymers: crossover of biological and chemical processes.

    Science.gov (United States)

    Matsumoto, Ken'ichiro; Taguchi, Seiichi

    2013-12-01

    The development of synthetic biology has transformed microbes into useful factories for producing valuable polymers and/or their precursors from renewable biomass. Recent progress at the interface of chemistry and biology has enabled the production of a variety of new biopolymers with properties that substantially differ from their petroleum-derived counterparts. This review touches on recent trials and achievements in the field of biopolymer synthesis, including chemo-enzymatically synthesized aliphatic polyesters, wholly biosynthesized lactate-based polyesters, polyhydroxyalkanoates and other unusual bacterially synthesized polyesters. The expanding diversities in structure and the material properties of biopolymers are key for exploring practical applications. The enzyme and metabolic engineering approaches toward this goal are discussed by shedding light on the successful case studies.

  16. The prospects of synthetic biology for the production of fuel from biomass

    International Nuclear Information System (INIS)

    When applied to engineering the metabolism of microorganisms, synthetic biology produces a broad spectrum of biomolecules from carbohydrates and, in the near future, from the biomass in general. The markets for biofuels and for chemicals are thus hooked up through a common technological core. Synthetic biology also opens new possibilities for switching from different types of biomass to different products, thus allowing for more flexibility in development strategies and eventually in industrial operations. This opening is welcomed even though the economic and societal environments hardly favors biofuels. A few more years of research and development are needed to bring these new possibilities to industrial maturity. Advanced biofuels will pass the threshold at which they become profitable and will no longer need subsidies. (author)

  17. The reduction of biological production induced by mesoscale mixing: a modelling study in the Benguela upwelling

    CERN Document Server

    Hernández-Carrasco, Ismael; Hernández-García, Emilio; Garçon, Veronique; López, Cristóbal

    2013-01-01

    Recent studies, both based on remote sensed data and coupled models, showed a reduction of biological productivity due to vigorous horizontal mixing in upwelling systems. In order to better understand this phenomenon, we have considered a system of oceanic flow in the Benguela area coupled with a simple biogeochemical model of Nutrient-Phyto-Zooplankton (NPZ) type. For the flow three different surface velocity fields are considered: one derived from satellite altimetry data, and the other two from a regional numerical model at two different spatial resolutions. We computed horizontal particle dispersion in terms of Lyapunov Exponents, and analyzed their correlations with phytoplankton concentrations. Our modelling approach confirms that in the south Benguela, there is a reduction of biological activity when stirring is increased. Two-dimensional offshore advection seems to be the dominant process involved. In the northern area, other factors not taken into account in our simulation are influencing the ecosyst...

  18. Innovation in biological production and upgrading of methane and hydrogen for use as gaseous transport biofuel.

    Science.gov (United States)

    Xia, Ao; Cheng, Jun; Murphy, Jerry D

    2016-01-01

    Biofuels derived from biomass will play a major role in future renewable energy supplies in transport. Gaseous biofuels have superior energy balances, offer greater greenhouse gas emission reductions and produce lower pollutant emissions than liquid biofuels. Biogas derived through fermentation of wet organic substrates will play a major role in future transport systems. Biogas (which is composed of approximately 60% methane/hydrogen and 40% carbon dioxide) requires an upgrading process to reduce the carbon dioxide content to less than 3% before it is used as compressed gas in transport. This paper reviews recent developments in fermentative biogas production and upgrading as a transport fuel. Third generation gaseous biofuels may be generated using marine-based algae via two-stage fermentation, cogenerating hydrogen and methane. Alternative biological upgrading techniques, such as biological methanation and microalgal biogas upgrading, have the potential to simultaneously upgrade biogas, increase gaseous biofuel yield and reduce carbon dioxide emission. PMID:26724182

  19. Removal of disinfection by-product formation potentials by biologically assisted GAC treatment

    Institute of Scientific and Technical Information of China (English)

    2006-01-01

    The object of this paper is to evaluate the removal of disinfection by-products formation potential by artificially intensified biological activated carbon(BAC) process which is developed on the basis of traditional ozone granular activated carbon (GAC). The results show that 23.1% of trihalomethane formation potential (THMFP) and 68% of haloacetic acid formation potential (HAAFP) can be removed by BAC,respectively. Under the same conditions, the removal rates of the same substances were 12.2% and 13-25 % respectively only by GAC process. Compared with GAC, the high removal rates of the two formed potential substances were due to the increasing of bioactivity of the media and the synergistic capabilities of biological degradation cooperating with activated carbon adsorption of organic compounds. BAC process has some advantages such as long backwashing cycle time, low backwashing intensity and prolonged activated carbon lifetime, etc.

  20. The future coastal ocean: the impact of increased stratification on biological production and carbon cycling

    Science.gov (United States)

    Lachkar, Z.; Gruber, N.

    2012-04-01

    Eastern boundary upwelling systems (EBUS) are regions of intense biogeochemical cycling and air-sea CO2 exchange. EBUS are particularly sensitive to changes in vertical stratification induced by upper ocean warming. However, neither the biological response to such physical perturbation nor the extent to which air-sea CO2 exchange might be altered under increased stratification are well understood. Here, we investigate the vulnerability of EBUS to such changes by conducting eddy-resolving simulations with the Regional Oceanic Modeling System (ROMS) coupled to a state-of-the art ecosystem model for the California and the Canary Current Systems. We examine how potential changes in stratification might affect the productivity in both upwelling systems and explore related changes in air-sea CO2 fluxes and biological pump efficiency. A particular focus of our analyses is on the role of local vs large scale changes in stratification. Overall, our initial results show for both EBUS a substantial increase of the CO2 outgassing with only a relatively modest change in productivity. We also found that identical changes in the vertical stratification lead to contrasting biological responses within and between these two EBUS characterized with only modestly different physical and environmental conditions. This is essentially due to varying initial temperature and nutrient conditions in addition to factors associated with the nearshore-offshore exchange timescales such as the shelf topography and the level of mesoscale eddy activity which differ substantially between the two EBUS. Finally, our results show that the depth of the maximum warming as well as the vertical penetration of the warm temperature anomaly play a key role in controlling the magnitude of the biological response in each EBUS.