Magnetic resonance: safety measures and biological effects

International Nuclear Information System (INIS)

Gordillo, I.; Lafuente, J.; Fernandez, C.; Barbero, M.J.; Cascon, E.

1997-01-01

The biological effects of electromagnetic fields is currently a subject of great controversy. For this reason, magnetic resonance imaging (MRI) and spectroscopy are constantly under investigation. The source of the risk in MRI is associated with the three types of electromagnetic radiation to which the patient is exposed: the static magnetic field, variable (gradient) magnetic fields and radiofrequency fields. Each is capable of producing significant biological effects when employed at sufficient intensity. Patients exposed to risk sources are those situated within the lines of force of the magnetic field, ellipsoid lines that are arranged around the magnet, representing the strength of the surrounding field. To date, at the intensity normally utilized in MRI(<2T) and respecting the field limit recommendations established by the US Food and Drug Administration (FDA) for clinical use of this technique no adverse secondary biological effects have been reported. The known biological effects and other possible secondary effects are reviewed, and the recommended safety measures are discussed. (Author)

Safety issues at the defense production reactors

International Nuclear Information System (INIS)

1987-01-01

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

Biological and haematological safety profile of oral amodiaquine ...

African Journals Online (AJOL)

Biological and haematological safety profile of oral amodiaquine and chloroquine in healthy volunteers with or without Plasmodium falciparum infection in northeast Tanzania. JJ Massaga, JP Lusingu, R Makunde, HM Malebo, MM Chile, JA Akida, MM Lemnge, AM Rønn, TG Theander, IC Bygbjerg, AY Kitua ...

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.

16 CFR 1115.8 - Compliance with product safety standards.

Science.gov (United States)

2010-01-01

... applicable mandatory consumer product safety standards and to report to the Commission any products which do.... 1115.8 Section 1115.8 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS SUBSTANTIAL PRODUCT HAZARD REPORTS General Interpretation § 1115.8 Compliance with...

Safety, efficacy, and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis

DEFF Research Database (Denmark)

Egeberg, A; Ottosen, M B; Gniadecki, R

2018-01-01

BACKGROUND: Real-life data on newer biologic and biosimilar agents for moderate-to-severe psoriasis are lacking. OBJECTIVES: To examine safety, efficacy, and time to discontinuation (drug survival) of biologics (adalimumab, etanercept, infliximab, secukinumab, and ustekinumab) and compare origina...... the long-term safety of novel biologics for psoriasis. This article is protected by copyright. All rights reserved....

DIVERSIFICATION OF A SAFETY FOOTWEAR PRODUCT

OpenAIRE

HARNAGEA Marta Cătălina; SECAN Cristina

2017-01-01

Product diversification is a usual strategy of footwear producers. As a requirement related to competitiveness in this domain, diversification can be done by practical application of some criteria. Considering this aspect, the paper proposes a research on the diversification in the case of a safety footwear product by modifying its component patterns, while keeping the initial shape of the product. Thus, starting from a safety shoe model, diversification was performed by changing the configur...

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...... in the specification material nor in their face-to-face meetings with the supplier. Safety aspects were not part of their work practice. On this basis, it was suggested that formal guidelines or procedures for integrating safety in the design of production lines would have no effect. Instead, the researchers set up...... 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...

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...... in the specification material nor in their face-to-face meetings with the supplier. Safety aspects were not part of their work practice. On this basis, it was suggested that formal guidelines or procedures for integrating safety in the design of production lines would have no effect. Instead, the researchers set up...

42 CFR 3.212 - Nonidentification of patient safety work product.

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Nonidentification of patient safety work product. 3... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.212 Nonidentification of patient safety work product. (a...

42 CFR 3.204 - Privilege of patient safety work product.

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Privilege of patient safety work product. 3.204... PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.204 Privilege of patient safety work product. (a) Privilege...

WebBio, a web-based management and analysis system for patient data of biological products in hospital.

Science.gov (United States)

Lu, Ying-Hao; Kuo, Chen-Chun; Huang, Yaw-Bin

2011-08-01

We selected HTML, PHP and JavaScript as the programming languages to build "WebBio", a web-based system for patient data of biological products and used MySQL as database. WebBio is based on the PHP-MySQL suite and is run by Apache server on Linux machine. WebBio provides the functions of data management, searching function and data analysis for 20 kinds of biological products (plasma expanders, human immunoglobulin and hematological products). There are two particular features in WebBio: (1) pharmacists can rapidly find out whose patients used contaminated products for medication safety, and (2) the statistics charts for a specific product can be automatically generated to reduce pharmacist's work loading. WebBio has successfully turned traditional paper work into web-based data management.

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... BIOLOGICAL PRODUCTS § 102.5 U.S. Veterinary Biological Product License. (a) Authorization to produce each biological product shall be specified on a U.S. Veterinary Biological Product License, issued by the...

Modified laminar flow biological safety cabinet.

Science.gov (United States)

McGarrity, G J; Coriell, L L

1974-10-01

Tests are reported on a modified laminar flow biological safety cabinet in which the return air plenum that conducts air from the work area to the high efficiency particulate air filters is under negative pressure. Freon gas released inside the cabinet could not be detected outside by a freon gas detection method capable of detecting 10(-6) cc/s. When T3 bacteriophage was aerosolized 5 cm outside the front opening in 11 tests, no phage could be detected inside the cabinet with the motor-filter unit in operation. An average of 2.8 x 10(5) plaque-forming units (PFU)/ft(3) (ca. 0.028 m(3)) were detected with the motor-filter unit not in operation, a penetration of 0.0%. Aerosolization 5 cm inside the cabinet yielded an average of 10 PFU/ft(3) outside the cabinet with the motor-filter unit in operation and an average of 4.1 x 10(5) PFU/ft(3) with the motor-filter unit not in operation, a penetration of 0.002%. These values are the same order of effectiveness as the positive-pressure laminar flow biological safety cabinets previously tested. The advantages of the negative-pressure return plenum design include: (i) assurance that if cracks or leaks develop in the plenum it will not lead to discharge of contaminated air into the laboratory; and (ii) the price is lower due to reduced manufacturing costs.

Design control considerations for biologic-device combination products.

Science.gov (United States)

Anderson, Dave; Liu, Roger; Anand Subramony, J; Cammack, Jon

2017-03-01

Combination products are therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. Historically, biologics development involved identifying efficacious doses administered to patients intravenously or perhaps by a syringe. Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery. For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products. As innovative as biologic-device combination products are, they can pose considerable development, regulatory, and commercialization challenges due to unique physicochemical properties and special clinical considerations (e.g., dosing volumes, frequency, co-medications, etc.) of the biologic medicine. A biologic-device combination product is a marriage between two partners with "cultural differences," so to speak. There are clear differences in the development, review, and commercialization processes of the biologic and the device. When these two cultures come together in a combination product, developers and reviewers must find ways to address the design controls and risk management processes of both the biologic and device, and knit them into a single entity with supporting product approval documentation. Moreover, digital medicine and connected health trends are pushing the boundaries of combination product development and regulations even further. Despite an admirable cooperation between industry and FDA in recent years, unique product configurations and design features have resulted in review challenges. These challenges have prompted agency reviewers to modernize consultation processes, while at the same time, promoting

Biosynthesis of therapeutic natural products using synthetic biology.

Science.gov (United States)

Awan, Ali R; Shaw, William M; Ellis, Tom

2016-10-01

Natural products are a group of bioactive structurally diverse chemicals produced by microorganisms and plants. These molecules and their derivatives have contributed to over a third of the therapeutic drugs produced in the last century. However, over the last few decades traditional drug discovery pipelines from natural products have become far less productive and far more expensive. One recent development with promise to combat this trend is the application of synthetic biology to therapeutic natural product biosynthesis. Synthetic biology is a young discipline with roots in systems biology, genetic engineering, and metabolic engineering. In this review, we discuss the use of synthetic biology to engineer improved yields of existing therapeutic natural products. We further describe the use of synthetic biology to combine and express natural product biosynthetic genes in unprecedented ways, and how this holds promise for opening up completely new avenues for drug discovery and production. Copyright © 2016 Elsevier B.V. All rights reserved.

Safety, security, and serving the public interest in synthetic biology.

Science.gov (United States)

Gronvall, Gigi Kwik

2018-03-21

This article describes what may be done by scientists and by the biotechnology industry, generally, to address the safety and security challenges in synthetic biology. Given the technical expertise requirements for developing sound policy options, as well as the importance of these issues to the future of the industry, scientists who work in synthetic biology should be informed about these challenges and get involved in shaping policies relevant to the field.

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.

Safety policy in the production of electricity

International Nuclear Information System (INIS)

Siddall, E.

1982-01-01

When safety is properly understood, defined and quantified, it can be seen that the development of our present industrial civilization has resulted in a progressive improvement in human safety. Increased safety has come with increased wealth in such close association that a high degree of cause-and-effect relationship must be considered. The quantitative relationship between wealth production and safety improvement is derived from different sources of evidence. When this is applied to the wealth production from electricity generation in a standard module of population in an advanced society, a safety benefit is indicated which exceeds the assessed direct risk associated with the electricity generation by orders of magnitude. It appears that a goal or policy intended to confer the greatest safety benefit to the population would result in attitudes and actions diametrically opposite to those which are conventional at the moment

Safety assessment of starch-based personal care products: Nanocapsules and pickering emulsions.

Science.gov (United States)

Marto, J; Pinto, P; Fitas, M; Gonçalves, L M; Almeida, A J; Ribeiro, H M

2018-03-01

The safety profile of the ingredients used in topical dosage forms and its evaluation is an issue of utmost importance. A suitable equilibrium between safety and efficacy is crucial before promoting a dermatological product. The aim of this work was to assess the safety and biological effects of starch-based vehicles (St-BV) used in such products. The hazard, exposure and dose-response assessment were used to characterize the risk of each ingredient. The EpiSkin™ assay and human repeat insult patch tests were performed to compare the theoretical safety assessment to in vitro and in vivo data. The efficacy of the St-BV was studied using biophysical measurements in human volunteers during 28 days, showing that all ingredients and their combinations were safe for the consumer. Tissue viability determined using the EpiSkin™ testing reached values between 84.0 ± 5.0% and 98.0 ± 8.6% after application of St-BV, which were considered as non-irritant to the skin. These observations were confirmed by the in vivo studies where the St-BV did not induce any sensitization on the volunteers, being safe for human use. Moreover, St-BV increased skin hydration and microcirculation, emerging as an attractive alternative to chemical raw materials. Copyright © 2018 Elsevier Inc. All rights reserved.

Adapting to Biology: Maintaining Container-Closure System Compatibility with the Therapeutic Biologic Revolution.

Science.gov (United States)

Degrazio, Dominick

Many pharmaceutical companies are transitioning their research and development drug product pipeline from traditional small-molecule injectables to the dimension of evolving therapeutic biologics. Important concerns associated with this changeover are becoming forefront, as challenges develop of varying complexity uncommon with the synthesis and production of traditional drugs. Therefore, alternative measures must be established that aim to preserve the efficacy and functionality of a biologic that might not be implemented for small molecules. Conserving protein stability is relative to perpetuating a net equilibrium of both intrinsic and extrinsic factors. Key to sustaining this balance is the ability of container-closure systems to maintain their compatibility with the ever-changing dynamics of therapeutic biologics. Failure to recognize and adjust the material properties of packaging components to support compatibility with therapeutic biologics can compromise patient safety, drug productivity, and biological stability. This review will examine the differences between small-molecule drugs and therapeutic biologics, lay a basic foundation for understanding the stability of therapeutic biologics, and demonstrate potential sources of container-closure systems' incompatibilities with therapeutic biologics at a mechanistic level. Many pharmaceutical companies are transitioning their research and development drug product pipeline from traditional small-molecule injectables to recombinantly derived therapeutic biologics. Concerns associated with this transformation are becoming prominent, as therapeutic biologics are uncharacteristic to small-molecule drugs. Maintaining the stability of a therapeutic biologic is a combination of balancing intrinsic factors and external elements within the biologic's microenvironment. An important aspect of this balance is relegated to the overall compatibility of primary, parenteral container-closure systems with therapeutic biologics

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

International Nuclear Information System (INIS)

Lasekan, Adeseye; Abu Bakar, Fatimah; Hashim, Dzulkifly

2013-01-01

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

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.

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.

33 CFR 147.847 - Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone.

Science.gov (United States)

2010-07-01

... Production, Storage, and Offloading System Safety Zone. 147.847 Section 147.847 Navigation and Navigable... ZONES § 147.847 Safety Zone; BW PIONEER Floating Production, Storage, and Offloading System Safety Zone. (a) Description. The BW PIONEER, a Floating Production, Storage and Offloading (FPSO) system, is in...

Safety policy in the production of electricity

International Nuclear Information System (INIS)

Siddall, E.

1983-01-01

When safety is properly understood, defined and quantified, it can be seen that the development of our present industrial civilization has resulted in a progressive and great improvement in human safety which is still continuing. Increased safety has come with increased wealth in such close association that a high degree of cause-and-effect relationship must be considered. The quantitative relationship between wealth production and safety improvement is derived from different sources of evidence. When this is applied to the wealth production from electricity generation in a standard module of population in an advanced society, a safety benefit is indicated which exceeds the assessed direct risk associated with the electricity generation by orders of magnitude. It appears that a goal or policy intended to confer the greatest safety benefit to the population would result in attitudes and actions diametrically opposite to those which are conventional at the moment

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.

Synthetic biology and occupational risk.

Science.gov (United States)

Howard, John; Murashov, Vladimir; Schulte, Paul

2017-03-01

Synthetic biology is an emerging interdisciplinary field of biotechnology that involves applying the principles of engineering and chemical design to biological systems. Biosafety professionals have done an excellent job in addressing research laboratory safety as synthetic biology and gene editing have emerged from the larger field of biotechnology. Despite these efforts, risks posed by synthetic biology are of increasing concern as research procedures scale up to industrial processes in the larger bioeconomy. A greater number and variety of workers will be exposed to commercial synthetic biology risks in the future, including risks to a variety of workers from the use of lentiviral vectors as gene transfer devices. There is a need to review and enhance current protection measures in the field of synthetic biology, whether in experimental laboratories where new advances are being researched, in health care settings where treatments using viral vectors as gene delivery systems are increasingly being used, or in the industrial bioeconomy. Enhanced worker protection measures should include increased injury and illness surveillance of the synthetic biology workforce; proactive risk assessment and management of synthetic biology products; research on the relative effectiveness of extrinsic and intrinsic biocontainment methods; specific safety guidance for synthetic biology industrial processes; determination of appropriate medical mitigation measures for lentiviral vector exposure incidents; and greater awareness and involvement in synthetic biology safety by the general occupational safety and health community as well as by government occupational safety and health research and regulatory agencies.

How Productive Is Workplace Health and Safety?

DEFF Research Database (Denmark)

Buhai, I. Sebastian; Cottini, Elena; Westergaard-Nielsen, Niels

2017-01-01

In this paper, we investigate the causal impact of workplace health and safety practices on firm performance, using Danish longitudinal matched employer–employee data merged with unique cross-sectional representative firm survey data on work environment conditions. We estimate standard production...... functions, augmented with workplace environment indicators, addressing both time-invariant and time-varying potentially relevant unobservables in the production process. We find positive and large productivity effects of improved physical dimensions of the health and safety environment, specifically...

42 CFR 3.208 - Continued protection of patient safety work product.

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Continued protection of patient safety work product... GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.208 Continued protection of patient safety work...

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...

Practices and Exploration on Competition of Molecular Biological Detection Technology among Students in Food Quality and Safety Major

Science.gov (United States)

Chang, Yaning; Peng, Yuke; Li, Pengfei; Zhuang, Yingping

2017-01-01

With the increasing importance in the application of the molecular biological detection technology in the field of food safety, strengthening education in molecular biology experimental techniques is more necessary for the culture of the students in food quality and safety major. However, molecular biology experiments are not always in curricula…

Agency perspectives on food safety for the products of animal biotechnology.

Science.gov (United States)

Howard, H J; Jones, K M; Rudenko, L

2012-08-01

Animal biotechnology represents one subset of tools among a larger set of technologies for potential use to meet increasing world demands for food. Assisted reproductive technologies (ART) such as artificial insemination and embryo transfer continue to make positive contributions in food animal production. The US Food and Drug Administration (FDA) performed a comprehensive risk assessment to identify potential food consumption or animal health risks associated with animal cloning, an emerging ART. At that time, FDA concluded that animal cloning posed no unique risks either to animal health or to food consumption, and food from animal clones and their sexually reproduced offspring required no additional federal regulation beyond that applicable to conventionally bred animals of the species examined. At this time, no new information has arisen that would necessitate a change in FDA's conclusions on food from animal clones or their sexually reproduced offspring. Use of recombinant DNA technologies to produce genetically engineered (GE) animals represents another emerging technology with potential to impact food animal production. In its regulation of GE animals, FDA follows a cumulative, risk-based approach to address scientific questions related to the GE animals. FDA evaluates data and information on the safety, effectiveness and stability of the GE event. FDA carries out its review at several levels (e.g. molecular biology, animal safety, food safety, environmental safety and claim validation). GE animal sponsors provide data to address risk questions for each level. This manuscript discusses FDA's role in evaluation of animal cloning and GE animals. © 2012 Blackwell Verlag GmbH.

21 CFR 610.11 - General safety.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 7 2010-04-01 2010-04-01 false General safety. 610.11 Section 610.11 Food and... GENERAL BIOLOGICAL PRODUCTS STANDARDS General Provisions § 610.11 General safety. A general safety test... for administration to humans. The general safety test is required in addition to other specific tests...

Safety issues at the defense production reactors

International Nuclear Information System (INIS)

1987-01-01

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

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.

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....... If a hazardous organism is found it means something, but absence in a limited number of samples is no guarantee of safety of a whole production batch. Finished product testing is often too little and too late. Therefore most attention should be focussed on management and control of the hazards in a more pro...

Radical production in biological systems

International Nuclear Information System (INIS)

Johnson, J.R.; Akabani, G.

1994-10-01

This paper describes our effort to develop a metric for radiation exposure that is more fundamental than adsorbed dose and upon which a metric for exposure to chemicals could be based. This metric is based on the production of radicals by the two agents. Radicals produced by radiation in biological systems commonly assumed to be the same as those produced in water despite the presence of a variety of complex molecules. This may explain why the extensive efforts to describe the relationship between energy deposition (track structure) and molecular damage to DNA, based on the spectrum of radicals produced, have not been successful in explaining simple biological effects such as cell killing. Current models assume that DNA and its basic elements are immersed in water-like media and only model the production and diffusion of water-based radicals and their interaction with DNA structures; these models lack the cross sections associated with each macro-component of DNA and only treat water-based radicals. It has been found that such models are not realistic because DNA is not immersed in pure water. A computer code capable of simulating electron tracks, low-energy electrons, energy deposition in small molecules, and radical production and diffusion in water like media has been developed. This code is still in at a primitive stage and development is continuing. It is being used to study radical production by radiation, and radical diffusion and interactions in simple molecular systems following their production. We are extending the code to radical production by chemicals to complement our PBPK modeling efforts. It therefore has been developed primarily for use with radionuclides that are in biological materials, and not for radiation fields

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

Science.gov (United States)

2015-07-08

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

75 FR 33312 - Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request...

Science.gov (United States)

2010-06-11

...] Indexing Structured Product Labeling for Human Prescription Drug and Biological Products; Request for... Biologics Evaluation and Research (CBER) are indexing certain categories of information in product labeling for use as terms to search repositories of approved prescription medical product structured product...

Packaging Evaluation Approach to Improve Cosmetic Product Safety

OpenAIRE

Benedetta Briasco; Priscilla Capra; Arianna Cecilia Cozzi; Barbara Mannucci; Paola Perugini

2016-01-01

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 packag...

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.

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.

Optimization of safety production supervision mode of coalmining enterprises

Energy Technology Data Exchange (ETDEWEB)

Zhou, M.; Xiao, Z. [China University of Mining and Technology, Xuzhou (China). School of Management

2005-12-01

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 focussing 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. 8 refs., 5 figs.

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.

Utilizing data consortia to monitor safety and effectiveness of biosimilars and their innovator products.

Science.gov (United States)

Baldziki, Mike; Brown, Jeff; Chan, Hungching; Cheetham, T Craig; Conn, Thomas; Daniel, Gregory W; Hendrickson, Mark; Hilbrich, Lutz; Johnson, Ayanna; Miller, Steven B; Moore, Tom; Motheral, Brenda; Priddy, Sarah A; Raebel, Marsha A; Randhawa, Gurvaneet; Surratt, Penny; Walraven, Cheryl; White, T Jeff; Bruns, Kevin; Carden, Mary Jo; Dragovich, Charlie; Eichelberger, Bernadette; Rosato, Edith; Sega, Todd

2015-01-01

The Biologics Price Competition and Innovation Act, introduced as part of the Affordable Care Act, directed the FDA to create an approval pathway for biologic products shown to be biosimilar or interchangeable with an FDA-approved innovator drug. These biosimilars will not be chemically identical to the reference agent. Investigational studies conducted with biosimilar agents will likely provide limited real-world evidence of their effectiveness and safety. How do we best monitor effectiveness and safety of biosimilar products once approved by the FDA and used more extensively by patients? To determine the feasibility of developing a distributed research network that will use health insurance plan and health delivery system data to detect biosimilar safety and effectiveness signals early and be able to answer important managed care pharmacy questions from both the government and managed care organizations. Twenty-one members of the AMCP Task Force on Biosimilar Collective Intelligence Systems met November 12, 2013, to discuss issues involved in designing this consortium and to explore next steps. The task force concluded that a managed care biosimilars research consortium would be of significant value. Task force members agreed that it is best to use a distributed research network structurally similar to existing DARTNet, HMO Research Network, and Mini-Sentinel consortia. However, for some surveillance projects that it undertakes, the task force recognizes it may need supplemental data from managed care and other sources (i.e., a "hybrid" structure model). The task force believes that AMCP is well positioned to lead the biosimilar-monitoring effort and that the next step to developing a biosimilar-innovator collective intelligence system is to convene an advisory council to address organizational governance.

[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.

Synthetic biology advances for pharmaceutical production

Science.gov (United States)

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. PMID:25744872

42 CFR 3.206 - Confidentiality of patient safety work product.

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Confidentiality of patient safety work product. 3... individually identifiable health information in such patient safety work product, the direct identifiers listed at 45 CFR 164.514(e)(2) have been removed. (5) Disclosure of nonidentifiable patient safety work...

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

Relevance of microbial finished product testing in food safety management

NARCIS (Netherlands)

Zwietering, M.H.; Jacxsens, L.; Membre, J.M.; Nauta, M.; Peterz, M.

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.

DIVERSIFICATION OF A SAFETY FOOTWEAR PRODUCT

Directory of Open Access Journals (Sweden)

HARNAGEA Marta Cătălina

2017-05-01

Full Text Available Product diversification is a usual strategy of footwear producers. As a requirement related to competitiveness in this domain, diversification can be done by practical application of some criteria. Considering this aspect, the paper proposes a research on the diversification in the case of a safety footwear product by modifying its component patterns, while keeping the initial shape of the product. Thus, starting from a safety shoe model, diversification was performed by changing the configuration in the joining area of two patterns of the product. By joining the tongue with the bellows tongue, the upper with the quarter, the heel counter with the quarter and the collar and heel counter with quarter has resulted a family of models characterized by a reduction of the number of patterns in the product. The size of the set presents a significant influence on the theoretical nesting factor and implicitly on the size of the wastes. The analysis of the resulting new model types lead to highlighting the influence of the patterns number of the uppers and the area of the set on the usage index of the leather surface when cutting the parts and on the specific consumption.

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.

EFSA Panel on Biological Hazards (BIOHAZ); Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2011 update)

DEFF Research Database (Denmark)

Hald, Tine

) assessment was developed by EFSA for its own use to provide a generic risk assessment approach applicable across EFSA’s scientific Panels, for biological agents notified for intentional use in the whole food chain. The safety of unambiguously defined biological agents at the highest taxonomic unit......EFSA is requested to assess the safety of a broad range of biological agents (including microorganisms and viruses) in the context of notifications for market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified presumption of safety (QPS...

Obtaining and application of increased food and biological value iodinated products from lentils sprouted grain

Directory of Open Access Journals (Sweden)

L. V. Antipova

2017-01-01

Full Text Available The choice of research direction is related to the actual problem of production and distribution of functional purpose food products due to the spread of nutritional diseases and the lack of micronutrients in ordinary people and athletes diet. As an object for enrichment with iodine, it was suggested to use lentils, which is famous for its high protein content, low lipid and oligosaccharide content, and low inhibitory effect. The iodine accumulation occurs during germination, due to the use of a nutrient solution of the iodine inorganic form. In addition, the biochemical composition of the grain and the biological value of lentils are significantly improved: an increase in the content of total amino acids and vitamins is found to be 1.5-2.0 times, a mass fraction of the oligosaccharide fraction is observed. To determine the effect of technological processing on the degree of iodine conservation in lentils the grains were exposed to the following impact: grinding, extrusion, frying. An insignificant decrease in the amount of iodine during extrusion was noted and more significant one - during grinding. The obtained results of the determination of biological safety by the method of studying the effect of the investigated product on the growth response of ciliates allowed to confirm the safety of both fresh and dried sprouted grain of lentils. When studying the microbiology of grain by sowing on agarized selective diagnostic environments with subsequent identification of the qualitative and quantitative composition of microflora, including colony-forming units, deviations from the normative indices were not revealed. Experimental production of the extrudate was carried out, possible ways of its use in meat systems for improving the functional and technological properties of minced meat, as well as for independent use as snacks for the nutrition of athletes were suggested.

Cardiovascular safety of biologic therapies for the treatment of RA.

Science.gov (United States)

Greenberg, Jeffrey D; Furer, Victoria; Farkouh, Michael E

2011-11-15

Cardiovascular disease represents a major source of extra-articular comorbidity in patients with rheumatoid arthritis (RA). A combination of traditional cardiovascular risk factors and RA-related factors accounts for the excess risk in RA. Among RA-related factors, chronic systemic inflammation has been implicated in the pathogenesis and progression of atherosclerosis. A growing body of evidence--mainly derived from observational databases and registries--suggests that specific RA therapies, including methotrexate and anti-TNF biologic agents, can reduce the risk of future cardiovascular events in patients with RA. The cardiovascular profile of other biologic therapies for the treatment of RA has not been adequately studied, including of investigational drugs that improve systemic inflammation but alter traditional cardiovascular risk factors. In the absence of large clinical trials adequately powered to detect differences in cardiovascular events between biologic drugs in RA, deriving firm conclusions on cardiovascular safety is challenging. Nevertheless, observational research using large registries has emerged as a promising approach to study the cardiovascular risk of emerging RA biologic therapies.

A primer of drug safety surveillance: an industry perspective. Part II: Product labeling and product knowledge.

Science.gov (United States)

Allan, M C

1992-01-01

To place the fundamentals of clinical drug safety surveillance in a conceptual framework that will facilitate understanding and application of adverse drug event data to protect the health of the public and support a market for pharmaceutical manufacturers' products. Part II of this series discusses specific issues regarding product labeling, such as developing the labeling, changing the labeling, and the legal as well as commercial ramifications of the contents of the labeling. An adverse event report scenario is further analyzed and suggestions are offered for maintaining the product labeling as an accurate reflection of the drug safety surveillance data. This article also emphasizes the necessity of product knowledge in adverse event database management. Both scientific and proprietary knowledge are required. Acquiring product knowledge is a part of the day-to-day activities of drug safety surveillance. A knowledge of the history of the product may forestall adverse publicity, as shown in the illustration. This review uses primary sources from the federal laws (regulations), commentaries, and summaries. Very complex topics are briefly summarized in the text. Secondary sources, ranging from newspaper articles to judicial summaries, illustrate the interpretation of adverse drug events and opportunities for drug safety surveillance intervention. The reference materials used were articles theoretically or practically applicable in the day-to-day practice of drug safety surveillance. The role of clinical drug safety surveillance in product monitoring and drug development is described. The process of drug safety surveillance is defined by the Food and Drug Administration regulations, product labeling, product knowledge, and database management. Database management is subdivided into the functions of receipt, retention, retrieval, and review of adverse event reports. Emphasis is placed on the dynamic interaction of the components of the process. Suggestions are offered

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.

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.

The influence of farmland pollution on the quality and safety of agricultural products

Science.gov (United States)

Ma, Z. L.; Li, L. Y.; Ye, C.; Lin, X. Y.; B, C.; Wei

2018-02-01

The quality and safety of agricultural products is not only a major livelihood issues for people’s health, but also the main barriers to international trade of agricultural products nowadays. The soil is the foundation to the production of agricultural products and the guarantee of agricultural development. The farmland soil quality is directly related to the quality and safety of agricultural products. Our country’s soil has been polluted by a series of pollution, Such as the excessive discharge of industrial wastes, the encroachment of household waste, and the unreasonable use of pesticides and fertilizers. Soil degradation is a serious threat to the quality and safety of agricultural products, so eliminating soil degradation is the fundamental way out for quality and safety of agricultural products. By analyzing problems of the quality and safety of agricultural products in our country, and exploring the farmland soil influence on the quality and safety of agricultural products. This article provides a reference for improving the control level of quality and safety of agricultural products and the farmland soil quality.

Yeast synthetic biology toolbox and applications for biofuel production.

Science.gov (United States)

Tsai, Ching-Sung; Kwak, Suryang; Turner, Timothy L; Jin, Yong-Su

2015-02-01

Yeasts are efficient biofuel producers with numerous advantages outcompeting bacterial counterparts. While most synthetic biology tools have been developed and customized for bacteria especially for Escherichia coli, yeast synthetic biological tools have been exploited for improving yeast to produce fuels and chemicals from renewable biomass. Here we review the current status of synthetic biological tools and their applications for biofuel production, focusing on the model strain Saccharomyces cerevisiae We describe assembly techniques that have been developed for constructing genes, pathways, and genomes in yeast. Moreover, we discuss synthetic parts for allowing precise control of gene expression at both transcriptional and translational levels. Applications of these synthetic biological approaches have led to identification of effective gene targets that are responsible for desirable traits, such as cellulosic sugar utilization, advanced biofuel production, and enhanced tolerance against toxic products for biofuel production from renewable biomass. Although an array of synthetic biology tools and devices are available, we observed some gaps existing in tool development to achieve industrial utilization. Looking forward, future tool development should focus on industrial cultivation conditions utilizing industrial strains. © FEMS 2015. All rights reserved. For permissions, please e-mail: journals.permission@oup.com.

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

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...

Hydrogen production from biomass by biological systems

International Nuclear Information System (INIS)

Sharifan, H.R.; Qader, S.

2009-01-01

Hydrogen gas is seen as a future energy carrier, not involved in 'greenhouse' gas and its released energy in combustion can be converted to electric power. Biological system with low energy can produce hydrogen compared to electrochemical hydrogen production via solar battery-based water splitting which requires the use of solar batteries with high energy requirements. The biological hydrogen production occurs in microalgae and cyanobacteria by photosynthesis. They consume biochemical energy to produce molecular hydrogen. Hydrogen in some algae is an anaerobic production in the absence of light. In cyanobacteria the hydrogen production simultaneously happens with nitrogen fixation, and also catalyzed by nitrogenase as a side reaction. Hydrogen production by photosynthetic bacteria is mediated by nitrogenase activity, although hydrogenases may be active for both hydrogen production and hydrogen uptake under some conditions. Genetic studies on photosynthetic microorganisms have markedly increased in recent times, relatively few genetic engineering studies have focused on altering the characteristics of these microorganisms, particularly with respect to enhancing the hydrogen-producing capabilities of photosynthetic bacteria and cyanobacteria. (author)

The Traceability and Safety of Fishery Products

OpenAIRE

Gheorghe Adrian ZUGRAVU; Ionica SOARE

2012-01-01

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 ...

Environmental, health and safety issues related to the production and use of CdTe photovoltaic modules

International Nuclear Information System (INIS)

Moskowitz, P.D.

1992-01-01

This paper examines environmental, health and safety issues associated with the production and use of CdTe photovoltaic modules. Handling of Cd and Te in photovoltaic production can present hazards to health, safety and the environment. Prior recognition of these hazards can allow device manufacturers time to implement appropriate hazard management strategies. The most important health hazards are probably related to chronic low-level exposures to Cd, especially to workers in manufacturing facilities. Because of the long latency period associated with the development of health effects arising from such exposures, and the availability of environmental and biomonitoring protocols, such hazards can be monitored and controlled. The true hazard presented by CdTe is very uncertain because characterizations of its inherent biological toxicity are based on extrapolation of data from other Cd compounds. Technical and institutional mechanisms for the recycling of spent CdTe modules may be needed to ensure public acceptance of this material option and to eliminate expensive disposal costs. (author)

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

International Nuclear Information System (INIS)

Pang Liefen

2012-01-01

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)

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.

A novel melittin nano-liposome exerted excellent anti-hepatocellular carcinoma efficacy with better biological safety

Directory of Open Access Journals (Sweden)

Jie Mao

2017-03-01

Full Text Available Abstract Melittin is the main effective component of bee venom and has extensive biological functions; however, serious side effects have restricted its clinical application. Preclinical and clinical studies showed that the main adverse events were allergic reaction and pain at the administration site. To decrease the toxicity, we prepared melittin nano-liposomes by encapsulating melittin with poloxamer 188 and explored the inhibitory activities on liver cancer together with biological safety. Here, we showed that melittin nano-liposomes significantly inhibited the survival of hepatocellular carcinoma (HCC cells in vitro and prominently suppressed the growth of subcutaneous and orthotopic HCC transplantation tumors in vivo. It was important that it induced less inflammation and allergy in mice compared with melittin. Overall, melittin nano-liposomes would have a better application in HCC therapy due to its significant anti-tumor activity and better biological safety.

A novel melittin nano-liposome exerted excellent anti-hepatocellular carcinoma efficacy with better biological safety.

Science.gov (United States)

Mao, Jie; Liu, Shujun; Ai, Min; Wang, Zhuo; Wang, Duowei; Li, Xianjing; Hu, Kaiyong; Gao, Xinghua; Yang, Yong

2017-03-20

Melittin is the main effective component of bee venom and has extensive biological functions; however, serious side effects have restricted its clinical application. Preclinical and clinical studies showed that the main adverse events were allergic reaction and pain at the administration site. To decrease the toxicity, we prepared melittin nano-liposomes by encapsulating melittin with poloxamer 188 and explored the inhibitory activities on liver cancer together with biological safety. Here, we showed that melittin nano-liposomes significantly inhibited the survival of hepatocellular carcinoma (HCC) cells in vitro and prominently suppressed the growth of subcutaneous and orthotopic HCC transplantation tumors in vivo. It was important that it induced less inflammation and allergy in mice compared with melittin. Overall, melittin nano-liposomes would have a better application in HCC therapy due to its significant anti-tumor activity and better biological safety.

Production of a biological surfactant

Directory of Open Access Journals (Sweden)

N. Gladys Rosero

2002-01-01

Full Text Available This paper summarizes the scale up work performed at the Colombian Petroleum Institute on a process to produce at pilot plant level a biosurfactant of the rhamnolipid type. By examination of both the activation conditions of the microorganism and design aspects of the broth, a stable condition was achieved which consistently triggers the production mechanisms and thus it was obtained a significant increment in biosurfactant productivity. The biological surfactant exhibited high efficiency in applications such as hydrocarbon biodegradation in saline environments, corrosion inhibition, and crude oil recovery from storage tank bottom sludges.

9 CFR 114.17 - Rebottling of biological products.

Science.gov (United States)

2010-01-01

... reports of all tests conducted on the rebottled product shall be submitted to Animal and Plant Health... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Rebottling of biological products. 114.17 Section 114.17 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT...

Biological hydrogen production by moderately thermophilic anaerobic bacteria

International Nuclear Information System (INIS)

HP Goorissen; AJM Stams

2006-01-01

This study focuses on the biological production of hydrogen at moderate temperatures (65-75 C) by anaerobic bacteria. A survey was made to select the best (moderate) thermophiles for hydrogen production from cellulolytic biomass. From this survey we selected Caldicellulosiruptor saccharolyticus (a gram-positive bacterium) and Thermotoga elfii (a gram-negative bacterium) as potential candidates for biological hydrogen production on mixtures of C 5 -C 6 sugars. Xylose and glucose were used as model substrates to describe growth and hydrogen production from hydrolyzed biomass. Mixed substrate utilization in batch cultures revealed differences in the sequence of substrate consumption and in catabolites repression of the two microorganisms. The regulatory mechanisms of catabolites repression in these microorganisms are not known yet. (authors)

Part I. Fuel-motion diagnostics in support of fast-reactor safety experiments. Part II. Fission product detection system in support of fast reactor safety experiments

International Nuclear Information System (INIS)

Devolpi, A.; Doerner, R.C.; Fink, C.L.; Regis, J.P.; Rhodes, E.A.; Stanford, G.S.; Braid, T.H.; Boyar, R.E.

1986-05-01

In all destructive fast-reactor safety experiments at TREAT, fuel motion and cladding failure have been monitored by the fast-neutron/gamma-ray hodoscope, providing experimental results that are directly applicable to design, modeling, and validation in fast-reactor safety. Hodoscope contributions to the safety program can be considered to fall into several groupings: pre-failure fuel motion, cladding failure, post-failure fuel motion, steel blockages, pretest and posttest radiography, axial-power-profile variations, and power-coupling monitoring. High-quality results in fuel motion have been achieved, and motion sequences have been reconstructed in qualitative and quantitative visual forms. A collimated detection system has been used to observe fission products in the upper regions of a test loop in the TREAT reactor. Particular regions of the loop are targeted through any of five channels in a rotatable assembly in a horizontal hole through the biological shield. A well-type neutron detector, optimized for delayed neutrons, and two GeLi gamma ray spectrometers have been used in several experiments. Data are presented showing a time history of the transport of Dn emitters, of gamma spectra identifying volatile fission products deposited as aerosols, and of fission gas isotopes released from the coolant

Evaluation of DoD Biological Safety and Security Implementation

Science.gov (United States)

2016-04-27

advanced development, efficient production, and timely distribution. Critical Reagent Program products include antibodies, inactivated antigens , genomic...effects to the economy, communicability, low infectious dose, and a history of or current interest in weaponization based on threat reporting. The...unwarranted by the threat. Recommendation #3. Biological Personnel Reliability Program [BPRP] Maintain use of the BPRP tailored to bio -defense work; balance

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

Immunogenicity of biologically-derived therapeutics: assessment and interpretation of nonclinical safety studies.

Science.gov (United States)

Ponce, Rafael; Abad, Leslie; Amaravadi, Lakshmi; Gelzleichter, Thomas; Gore, Elizabeth; Green, James; Gupta, Shalini; Herzyk, Danuta; Hurst, Christopher; Ivens, Inge A; Kawabata, Thomas; Maier, Curtis; Mounho, Barbara; Rup, Bonita; Shankar, Gopi; Smith, Holly; Thomas, Peter; Wierda, Dan

2009-07-01

An evaluation of potential antibody formation to biologic therapeutics during the course of nonclinical safety studies and its impact on the toxicity profile is expected under current regulatory guidance and is accepted standard practice. However, approaches for incorporating this information in the interpretation of nonclinical safety studies are not clearly established. Described here are the immunological basis of anti-drug antibody formation to biopharmaceuticals (immunogenicity) in laboratory animals, and approaches for generating and interpreting immunogenicity data from nonclinical safety studies of biotechnology-derived therapeutics to support their progression to clinical evaluation. We subscribe that immunogenicity testing strategies should be adapted to the specific needs of each therapeutic development program, and data generated from such analyses should be integrated with available clinical and anatomic pathology, pharmacokinetic, and pharmacodynamic data to properly interpret nonclinical studies.

9 CFR 114.18 - Reprocessing of biological products.

Science.gov (United States)

2010-01-01

... for all tests conducted shall be submitted to Animal and Plant Health Inspection Service. The licensee... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Reprocessing of biological products. 114.18 Section 114.18 Animals and Animal Products ANIMAL AND PLANT HEALTH INSPECTION SERVICE...

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...... and studies of documents. A questionnaire regarding product development tasks and occupational safety and health were distributed to 30 design and production engineers. A total of 27 completed the questionnaire corresponding to a response rate of 90 per cent.......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 health into the development process, especially the efforts and attitudes of design and production engineers', and (iii) to identify key actors'reflections on how to improve this integration. The study was based on qualitative as well as quantitative methods including interviews, questionnaires...

42 CFR 3.210 - Required disclosure of patient safety work product to the Secretary.

Science.gov (United States)

2010-10-01

... 42 Public Health 1 2010-10-01 2010-10-01 false Required disclosure of patient safety work product... HUMAN SERVICES GENERAL PROVISIONS PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT Confidentiality and Privilege Protections of Patient Safety Work Product § 3.210 Required disclosure of patient...

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.

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.

Linking neuroethology to the chemical biology of natural products

DEFF Research Database (Denmark)

Olivera, Baldomero M.; Raghuraman, Shrinivasan; Schmidt, Eric W.

2017-01-01

From a biological perspective, a natural product can be defined as a compound evolved by an organism for chemical interactions with another organism including prey, predator, competitor, pathogen, symbiont or host. Natural products hold tremendous potential as drug leads and have been extensively...... a better understanding of the evolution, biology and biochemistry of natural products will facilitate both neuroscience and the potential for drug leads. The larger goal is to establish a new sub-discipline in the broader field of neuroethology that we refer to as “Chemical Neuroethology”, linking...... the substantial work carried out by chemists on natural products with accelerating advances in neuroethology....

Extracellular membrane vesicles in blood products-biology and clinical relevance

Directory of Open Access Journals (Sweden)

Emilija Krstova Krajnc

2016-01-01

Full Text Available Extracellular membrane vesicles are fragments shed from plasma membranes off all cell types that are undergoing apoptosis or are being subjected to various types of stimulation or stress.  Even in the process of programmed cell death (apoptosis, cell fall apart of varying size vesicles. They expose phosphatidylserine (PS on the outer leaflet of their membrane, and bear surface membrane antigens reflecting their cellular origin. Extracellular membrane vesicles have been isolated from many types of biological fluids, including serum, cerebrospinal fluid, urine, saliva, tears and conditioned culture medium. Flow cytometry is one of the many different methodological approaches that have been used to analyze EMVs. The method attempts to characterize the EMVs cellular origin, size, population, number, and structure. EMVs are present and accumulate in blood products (erythrocytes, platelets as well as in fresh frozen plasma during storage. The aim of this review is to highlight the importance of extracellular vesicles as a cell-to-cell communication system and the role in the pathogenesis of different diseases. Special emphasis will be given to the implication of extracellular membrane vesicles in blood products and their clinical relevance. Although our understanding of the role of  EMVs in disease is far from comprehensive, they display promise as biomarkers for different diseases in the future and also as a marker of quality and safety in the quality control of blood products.

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... to license control. (a) If a drug has an approved license under section 351 of the Public Health.... (b) To obtain marketing approval for radioactive biological products for human use, as defined in...

78 FR 60884 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Science.gov (United States)

2013-10-02

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Immunoregulation, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics...

76 FR 44016 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Science.gov (United States)

2011-07-22

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research...

Food safety of milk and dairy product of dairy cattle from heavy metal contamination

Science.gov (United States)

Harlia, E.; Rahmah, KN; Suryanto, D.

2018-01-01

Food safety of milk and dairy products is a prerequisite for consumption, which must be free from physical, biological and chemical contamination. Chemical contamination of heavy metals Pb (Plumbum/Lead) and Cd (Cadmium) is generally derived from the environment such as from water, grass, feed additives, medicines and farm equipment. The contamination of milk and dairy products can affect quality and food safety for human consumption. The aim of this research is to investigate contamination of heavy metals Pb and Cd on fresh milk, pasteurized milk, and dodol milk compared with the Maximum Residue Limits (MRL). The methods of this researched was through case study and data obtained analyzed descriptively. Milk samples were obtained from Bandung and surrounding areas. The number of samples used was 30 samples for each product: 30 samples of fresh milk directly obtained from dairy farm, 30 samples of pasteurized milk obtained from street vendors and 30 samples of dodol milk obtained from home industry. Parameters observed were heavy metal residues of Pb and Cd. The results showed that: 1) approximately 83% of fresh milk samples were contaminated by Pb which 57% samples were above MRL and 90% samples were contaminated by Cd above MRL; 2) 67% of pasteurized milk samples were contaminated by Pb below MRL; 3) 60% of dodol milk samples were contaminated by Pb and Cd above MRL.

9 CFR 101.3 - Biological products and related terms.

Science.gov (United States)

2010-01-01

... as required by the regulations. (e) Released product. A finished product released for marketing after... total quantity of completed product which has been thoroughly mixed in a single container and identified... 9 Animals and Animal Products 1 2010-01-01 2010-01-01 false Biological products and related terms...

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

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.

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

Science.gov (United States)

2012-01-25

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The...

The Trends and their Impact on Fishery Products Safety and Quality

Directory of Open Access Journals (Sweden)

Gheorghe Adrian ZUGRAVU

2012-11-01

Full Text Available The paper follows two main objectives: to understand consumers’ perception of safety 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.

Biologicals versus biosimilars the future ahead

Directory of Open Access Journals (Sweden)

A Singhal

2015-01-01

Full Text Available Biosimilars are highly similar versions of already authorized innovator biological therapies. They demonstrate no clinically meaningful difference with their innovator products in terms of efficacy, safety and quality characteristics and biological activity. Biosimilars have demonstrated growing acceptance and use, especially in the developing countries due to severe cost constraints. Global market for Indian non-innovator products is approximately worth USD 1.5 Billion/annum with an annual growth rate of 27%. Estimated exports of Indian biopharmaceutical products have been increasing at a rate of 47%. In India, there is a good acceptance of non-innovator healthcare products amongst healthcare professionals and patients. Several home grown biopharmaceutical industries are now actively developing and marketing non innovator products in India.

Efficacy and Safety of Pomegranate Medicinal Products for Cancer

Science.gov (United States)

Vlachojannis, Christian

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

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

Science.gov (United States)

2012-04-25

...] Draft Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; Availability AGENCY: Food and... safety assessment of nanomaterials in cosmetic products. This guidance is intended to assist industry in... Cosmetic Products.'' The draft guidance is intended to assist industry in identifying the potential safety...

Nutrient availability limits biological production in Arctic sea ice melt ponds

DEFF Research Database (Denmark)

Sørensen, Heidi Louise; Thamdrup, Bo; Jeppesen, Erik

2017-01-01

nutrient limitation in melt ponds. We also document that the addition of nutrients, although at relative high concentrations, can stimulate biological productivity at several trophic levels. Given the projected increase in first-year ice, increased melt pond coverage during the Arctic spring and potential......Every spring and summer melt ponds form at the surface of polar sea ice and become habitats where biological production may take place. Previous studies report a large variability in the productivity, but the causes are unknown. We investigated if nutrients limit the productivity in these first...... additional nutrient supply from, e.g. terrestrial sources imply that biological activity of melt ponds may become increasingly important for the sympagic carbon cycling in the future Arctic....

Postharvest biology and technology research and development ...

African Journals Online (AJOL)

STORAGESEVER

2008-09-03

Sep 3, 2008 ... The applications of biological control agents in pre- and post-harvest operations and .... production, with regards to food safety, operator health and the ... and to work out sustainable compliance modalities for small-scale ...

Biocomes: new biological products for sustainable farming and forestry

NARCIS (Netherlands)

Teixidó, N.; Cal, de A.L.; Usall, J.; Guijarro, B.; Larena, I.; Torres, R.; Abadias, M.; Köhl, J.

2016-01-01

The growing interest in biological control has been reflected during last decades in a big number of scientific publications, books and symposia. However, biocontrol commercial application at a European level is limited and biological control products are not currently available for the control of

Design of agricultural product quality safety retrospective supervision system of Jiangsu province

Science.gov (United States)

Wang, Kun

2017-08-01

In store and supermarkets to consumers can trace back agricultural products through the electronic province card to query their origin, planting, processing, packaging, testing and other important information and found that the problems. Quality and safety issues can identify the responsibility of the problem. This paper designs a retroactive supervision system for the quality and safety of agricultural products in Jiangsu Province. Based on the analysis of agricultural production and business process, the goal of Jiangsu agricultural product quality safety traceability system construction is established, and the specific functional requirements and non-functioning requirements of the retroactive system are analyzed, and the target is specified for the specific construction of the retroactive system. The design of the quality and safety traceability system in Jiangsu province contains the design of the overall design, the trace code design and the system function module.

[Evaluation of the safety of innovative drugs against viruses and infectious agents].

Science.gov (United States)

Kobayashi, Tetsu; Yusa, Keisuke; Kawasaki, Nana

2013-01-01

Recently, several novel cellular therapy products and biological drugs are being developed to treat various previously untreatable diseases. One of the most important issues regarding these innovations is how to ensure safety over infectious agents, including viruses and prions, in the earliest treatments with these products. The object of this study is a risk assessment of cases of human infectious with the agents and to present a sample risk management plan based on a collaboration among the National Institute of Health Sciences, universities, marketing authorization holders, and scientific societies. There are three subjects of study: (1) the viral safety of cellular therapy products, (2) the viral safety of biological drugs, and (3) the safety of prions. In this report, we describe the objects of the study, the project members, the study plan outline, and the ongoing plans. The results of the viral risk identification and the risk analysis of cellular therapy products will also be described, based on a review of the literature and case reports obtained during the first year of this project.

Safety issues of nuclear production of hydrogen

International Nuclear Information System (INIS)

Piera, Mireia; Martinez-Val, Jose M.; Jose Montes, Ma

2006-01-01

Hydrogen is not an uncommon issue in Nuclear Safety analysis, particularly in relation to severe accidents. On the other hand, hydrogen is a household name in the chemical industry, particularly in oil refineries, and is also a well known chemical element currently produced by steam reforming of natural gas, and other methods (such as coal gasification). In the not-too-distant future, hydrogen will have to be produced (by chemical reduction of water) using renewable and nuclear energy sources. In particular, nuclear fission seems to offer the cheapest way to provide the primary energy in the medium-term. Safety principles are fundamental guidelines in the design, construction and operation both of hydrogen facilities and nuclear power plants. When these two technologies are integrated, a complete safety analysis must consider not only the safety practices of each industry, but any interaction that could be established between them. In particular, any accident involving a sudden energy release from one of the facilities can affect the other. Release of dangerous substances (chemicals, radiotoxic effluents) can also pose safety problems. Although nuclear-produced hydrogen facilities will need specific approaches and detailed analysis on their safety features, a preliminary approach is presented in this paper. No significant roadblocks are identified that could hamper the deployment of this new industry, but some of the hydrogen production methods will involve very demanding safety standards

Versatile and on-demand biologics co-production in yeast.

Science.gov (United States)

Cao, Jicong; Perez-Pinera, Pablo; Lowenhaupt, Ky; Wu, Ming-Ru; Purcell, Oliver; de la Fuente-Nunez, Cesar; Lu, Timothy K

2018-01-08

Current limitations to on-demand drug manufacturing can be addressed by technologies that streamline manufacturing processes. Combining the production of two or more drugs into a single batch could not only be useful for research, clinical studies, and urgent therapies but also effective when combination therapies are needed or where resources are scarce. Here we propose strategies to concurrently produce multiple biologics from yeast in single batches by multiplexing strain development, cell culture, separation, and purification. We demonstrate proof-of-concept for three biologics co-production strategies: (i) inducible expression of multiple biologics and control over the ratio between biologic drugs produced together; (ii) consolidated bioprocessing; and (iii) co-expression and co-purification of a mixture of two monoclonal antibodies. We then use these basic strategies to produce drug mixtures as well as to separate drugs. These strategies offer a diverse array of options for on-demand, flexible, low-cost, and decentralized biomanufacturing applications without the need for specialized equipment.

Quality and Safety Aspects of Cereals (Wheat) and Their Products.

Science.gov (United States)

Varzakas, Theo

2016-11-17

Cereals and, most specifically, wheat are described in this chapter highlighting on their safety and quality aspects. Moreover, wheat quality aspects are adequately addressed since they are used to characterize dough properties and baking quality. Determination of dough properties is also mentioned and pasta quality is also described in this chapter. Chemometrics-multivariate analysis is one of the analyses carried out. Regarding production weighing/mixing of flours, kneading, extruded wheat flours, and sodium chloride are important processing steps/raw materials used in the manufacturing of pastry products. Staling of cereal-based products is also taken into account. Finally, safety aspects of cereal-based products are well documented with special emphasis on mycotoxins, acrylamide, and near infrared methodology.

Systems biology solutions for biochemical production challenges

DEFF Research Database (Denmark)

Hansen, Anne Sofie Lærke; Lennen, Rebecca M; Sonnenschein, Nikolaus

2017-01-01

There is an urgent need to significantly accelerate the development of microbial cell factories to produce fuels and chemicals from renewable feedstocks in order to facilitate the transition to a biobased society. Methods commonly used within the field of systems biology including omics...... characterization, genome-scale metabolic modeling, and adaptive laboratory evolution can be readily deployed in metabolic engineering projects. However, high performance strains usually carry tens of genetic modifications and need to operate in challenging environmental conditions. This additional complexity...... compared to basic science research requires pushing systems biology strategies to their limits and often spurs innovative developments that benefit fields outside metabolic engineering. Here we survey recent advanced applications of systems biology methods in engineering microbial production strains...

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

Science.gov (United States)

2013-04-05

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function..., Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. FDA intends to...

Laboratory Safety in the Biology Lab.

Science.gov (United States)

Ritch, Donna; Rank, Jane

2001-01-01

Reports on a research project to determine if students possess and comprehend basic safety knowledge. Shows a significant increase in the amount of safety knowledge gained when students are exposed to various topics in laboratory safety and are held accountable for learning the information as required in a laboratory safety course. (Author/MM)

Biological risks associated with consumption of reptile products

DEFF Research Database (Denmark)

Magnino, S.; Colin, P.; Dei-Cas, E.

2009-01-01

recently increased in some areas of the world. Biological risks associated with the consumption of products from both farmed and wild reptile meat and eggs include infections caused by bacteria (Salmonella spp., Vibrio spp.). parasites (Spirometra, Trichinella, Gnathostoma, pentastomids), as well...... to increase the occurrence of biological hazards in reptile meat. Application of GHP, GMP and HACCP procedures, respectively at farm and slaughterhouse level, is crucial for controlling the hazards.......The consumption of a wide variety of species of reptiles caught from the wild has been an important source of protein for humans world-wide for millennia. Terrapins. snakes, lizards, crocodiles and iguanas are now farmed and the consumption and trade of their meat and other edible products have...

Screening-Level Safety Assessment of Personal Care Product Constituents Using Publicly Available Data

Directory of Open Access Journals (Sweden)

Ernest S. Fung

2018-06-01

Full Text Available Organizations recommend evaluating individual ingredients when assessing the safety of personal care or cosmetic products. The goal of this study was to present a screening-level safety assessment methodology to evaluate the safety of a product by identifying individual ingredients, determining their frequency of use in on-market products, and examining published safe-level-of-use information for each ingredient. As a case study, we evaluated WEN by Chaz Dean (WCD cleansing conditioners since there have been claims of adverse health effects associated with product use. We evaluated 30 ingredients in three on-market WCD cleansing conditioners. We then analyzed the National Library of Medicine’s Household Products Database and the Environmental Working Group’s (EWG Skin Deep Cosmetic Database, two of the largest publicly available databases, for other on-market personal care and cosmetic products that contained these ingredients. Safe-level-of-use information for each ingredient was obtained by reviewing peer-reviewed literature, the Food and Drug Administration’s (FDA generally recognized as safe (GRAS database, available Cosmetic Ingredient Review (CIR publications, and available product safety publications. The results of this analysis showed that more than 20,000 personal care and cosmetic products contained one or more of the evaluated ingredients used in WCD cleaning conditioners. Published safety information was available for 21 of the 30 evaluated ingredients: seven identified ingredients were designated as GRAS by the FDA and 16 ingredients had safe-level-of-use information available from the CIR. This study presents a screening-level safety assessment methodology that can serve as an initial screening tool to evaluate the safety of an ingredient intended for use in personal care and cosmetic products before a product is launched onto the market. This study provides evidence that the evaluated WCD cleansing conditioner ingredients

MANAGING PRODUCT SAFETY SYSTEM HACCP ON THE EXAMPLE OF BEET-SUGAR PRODUCTION

Directory of Open Access Journals (Sweden)

V. A. Golybin

2015-01-01

Full Text Available The most effective safety management system of food production in all industrialized countries in the world recognized by the system based on the principles of HACCP. In Russia, the conformity assessment carried out by the HACCP system certification. The essence of the HACCP system is to identify and control the critical points. Critical Control Point – this is the stage of the process, which is subject to control for hazard identification and risk management in order to avoid the production of unsafe products. Implementation of HACCP system allows to tighten and coordinate the quality control system, which will improve the competitiveness of the products produced in the sugar market in Russia and abroad. In the early stages of food production HACCP system to prevent the occurrence of danger. It is based on the preventive approach to ensuring quality and safety in the production process, and can also be used in the development of new products. HACCP system is based on seven main principles to ensure the implementation and management of the system in production. 1. Creation of a working group of the coordinator and the technical secretary and various consultants. 2. Information on materials and products, in this case of sugar beet and sugar. 3. Information about the production. 4. Risk analysis of the available chemical, physical and microbiological factors. To determine the critical control points according to the results obtained for each factor is determined by a special chart the extent of its accounting. The need to consider the potential hazard is determined by the order in which area it has got. 5. The production program of mandatory preliminary activities in the production of sugar. 6. Determination of critical control points. 7. Making worksheets HACCP. It is shown that the use of HACCP in sugar beet production has several advantages.

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.

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.

A proposal for safety design philosophy of HTGR for coupling hydrogen production plant

International Nuclear Information System (INIS)

Sato, Hiroyuki; Ohashi, Hirofumi; Tazawa, Yujiro; Imai, Yoshiyuki; Nakagawa, Shigeaki; Tachibana, Yukio; Kunitomi, Kazuhiko

2013-06-01

Japan Atomic Energy Agency (JAEA) has been conducting research and development for hydrogen production utilizing heat from High Temperature Gas-cooled Reactors (HTGRs). Towards the realization of nuclear hydrogen production, coupled hydrogen production plants should not be treated as an extension of a nuclear plant in order to open the door for the entry of non-nuclear industries as well as assuring reactor safety against postulated abnormal events initiated in the hydrogen production plants. Since hydrogen production plant utilizing nuclear heat has never been built in the world, little attention has been given to the establishment of a safety design for such system including the High Temperature engineering Test Reactor (HTTR). In the present study, requirements in order to design, construct and operate hydrogen production plants under conventional chemical plant standards are identified. In addition, design considerations for safety design of nuclear facility are suggested. Furthermore, feasibility of proposed safety design and design considerations are evaluated. (author)

In situ biomolecule production by bacteria; a synthetic biology approach to medicine.

Science.gov (United States)

Flores Bueso, Yensi; Lehouritis, Panos; Tangney, Mark

2018-04-10

The ability to modify existing microbiota at different sites presents enormous potential for local or indirect management of various diseases. Because bacteria can be maintained for lengthy periods in various regions of the body, they represent a platform with enormous potential for targeted production of biomolecules, which offer tremendous promise for therapeutic and diagnostic approaches for various diseases. While biological medicines are currently limited in the clinic to patient administration of exogenously produced biomolecules from engineered cells, in situ production of biomolecules presents enormous scope in medicine and beyond. The slow pace and high expense of traditional research approaches has particularly hampered the development of biological medicines. It may be argued that bacterial-based medicine has been "waiting" for the advent of enabling technology. We propose that this technology is Synthetic Biology, and that the wait is over. Synthetic Biology facilitates a systematic approach to programming living entities and/or their products, using an approach to Research and Development (R&D) that facilitates rapid, cheap, accessible, yet sophisticated product development. Full engagement with the Synthetic Biology approach to R&D can unlock the potential for bacteria as medicines for cancer and other indications. In this review, we describe how by employing Synthetic Biology, designer bugs can be used as drugs, drug-production factories or diagnostic devices, using oncology as an exemplar for the concept of in situ biomolecule production in medicine. Copyright © 2018 Elsevier B.V. All rights reserved.

MANAGEMENT OF QUALITY AND SAFETY OF FOOD PRODUCTS OF ANIMAL ORIGIN

Directory of Open Access Journals (Sweden)

Goryana Yonkova

2016-12-01

Full Text Available Bulgaria is famous not only in Europe but throughout the world, except for its rich natural and cultural heritage, but also traditional dairy products (yogurt and cheese - cow, sheep, buffalo and goats; yellow cheese, honey and bee products, rose oil. To be competitive on national and international markets, food production must meet the requirements for quality assurance and food safety. The article presents the key economic indicators and threats related to quality management and safety of food products of animal origin in relation to the conservation of components of the environment and human health.

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 biologica...... for these situations will contribute to ensuring that stored food products are protected from insect and mite pests using techniques that are safe for consumers, workers and the environment.......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...

76 FR 13646 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Science.gov (United States)

2011-03-14

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Polysaccharides, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review...

Using resources for scientific-driven pharmacovigilance: from many product safety documents to one product safety master file.

Science.gov (United States)

Furlan, Giovanni

2012-08-01

Current regulations require a description of the overall safety profile or the specific risks of a drug in multiple documents such as the Periodic and Development Safety Update Reports, Risk Management Plans (RMPs) and Signal Detection Reports. In a resource-constrained world, the need for preparing multiple documents reporting the same information results in shifting the focus from a thorough scientific and medical evaluation of the available data to maintaining compliance with regulatory timelines. Since the aim of drug safety is to understand and characterize product issues to take adequate risk minimization measures rather than to comply with bureaucratic requirements, there is the need to avoid redundancy. In order to identify core drug safety activities that need to be undertaken to protect patient safety and reduce the number of documents reporting the results of these activities, the author has reviewed the main topics included in the drug safety guidelines and templates. The topics and sources that need to be taken into account in the main regulatory documents have been found to greatly overlap and, in the future, as a result of the new Periodic Safety Update Report structure and requirements, in the author's opinion this overlap is likely to further increase. Many of the identified inter-document differences seemed to be substantially formal. The Development Safety Update Report, for example, requires separate presentation of the safety issues emerging from different sources followed by an overall evaluation of each safety issue. The RMP, instead, requires a detailed description of the safety issues without separate presentation of the evidence derived from each source. To some extent, however, the individual documents require an in-depth analysis of different aspects; the RMP, for example, requires an epidemiological description of the indication for which the drug is used and its risks. At the time of writing this article, this is not specifically

Safety and efficacy of personal care products containing colloidal oatmeal.

Science.gov (United States)

Criquet, Maryline; Roure, Romain; Dayan, Liliane; Nollent, Virginie; Bertin, Christiane

2012-01-01

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. 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. 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. 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.

76 FR 55397 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Science.gov (United States)

2011-09-07

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research and Review, Center...

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.

Safety and risk assessment of ceramide 3 in cosmetic products.

Science.gov (United States)

Choi, Seul Min; Lee, Byung-Mu

2015-10-01

Ceramide 3 is used mainly as a moisturizer in various cosmetic products. Although several safety studies on formulations containing pseudo-ceramide or ceramide have been conducted at the preclinical and clinical levels for regulatory approval, no studies have evaluated the systemic toxicity of ceramide 3. To address this issue, we conducted a risk assessment and comprehensive toxicological review of ceramide and pseudo-ceramide. We assumed that ceramide 3 is present in various personal and cosmetic products at concentrations of 0.5-10%. Based on previously reported exposure data, the margin of safety (MOS) was calculated for product type, use pattern, and ceramide 3 concentration. Lipsticks with up to 10% ceramide 3 (MOS = 4111) are considered safe, while shampoos containing 0.5% ceramide 3 (MOS = 148) are known to be safe. Reported MOS values for body lotion applied to the hands (1% ceramide 3) and back (5% ceramide 3) were 103 and 168, respectively. We anticipate that face cream would be safe up to a ceramide 3 concentration of 3% (MOS = 149). Collectively, the MOS approach indicated no safety concerns for cosmetic products containing less than 1% ceramide 3. Copyright © 2015 Elsevier Ltd. All rights reserved.

The European space suit, a design for productivity and crew safety

Science.gov (United States)

Skoog, A. Ingemar; Berthier, S.; Ollivier, Y.

In order to fulfil the two major mission objectives, i.e. support planned and unplanned external servicing of the COLUMBUS FFL and support the HERMES vehicle for safety critical operations and emergencies, the European Space Suit System baseline configuration incorporates a number of design features, which shall enhance the productivity and the crew safety of EVA astronauts. The work in EVA is today - and will be for several years - a manual work. Consequently, to improve productivity, the first challenge is to design a suit enclosure which minimizes movement restrictions and crew fatigue. It is covered by the "ergonomic" aspect of the suit design. Furthermore, it is also necessary to help the EVA crewmember in his work, by giving him the right information at the right time. Many solutions exist in this field of Man-Machine Interface, from a very simple system, based on cuff check lists, up to advanced systems, including Head-Up Displays. The design concept for improved productivity encompasses following features: • easy donning/doffing thru rear entry, • suit ergonomy optimisation, • display of operational information in alpha-numerical and graphical from, and • voice processing for operations and safety critical information. Concerning crew safety the major design features are: • a lower R-factor for emergency EVA operations thru incressed suit pressure, • zero prebreath conditions for normal operations, • visual and voice processing of all safety critical functions, and • an autonomous life support system to permit unrestricted operations around HERMES and the CFFL. The paper analyses crew safety and productivity criteria and describes how these features are being built into the design of the European Space Suit System.

Systems biology solutions for biochemical production challenges.

Science.gov (United States)

Hansen, Anne Sofie Lærke; Lennen, Rebecca M; Sonnenschein, Nikolaus; Herrgård, Markus J

2017-06-01

There is an urgent need to significantly accelerate the development of microbial cell factories to produce fuels and chemicals from renewable feedstocks in order to facilitate the transition to a biobased society. Methods commonly used within the field of systems biology including omics characterization, genome-scale metabolic modeling, and adaptive laboratory evolution can be readily deployed in metabolic engineering projects. However, high performance strains usually carry tens of genetic modifications and need to operate in challenging environmental conditions. This additional complexity compared to basic science research requires pushing systems biology strategies to their limits and often spurs innovative developments that benefit fields outside metabolic engineering. Here we survey recent advanced applications of systems biology methods in engineering microbial production strains for biofuels and -chemicals. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

Milk kefir: composition, microbial cultures, biological activities, and related products.

Science.gov (United States)

Prado, Maria R; Blandón, Lina Marcela; Vandenberghe, Luciana P S; Rodrigues, Cristine; Castro, Guillermo R; Thomaz-Soccol, Vanete; Soccol, Carlos R

2015-01-01

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.

Ionizing radiation for sterilization of medical products and biological tissues

Energy Technology Data Exchange (ETDEWEB)

Kumar, S K; Raghevendrarao, M K [Bhabha Atomic Research Centre, Bombay (India). Library and Technical Information Section

1975-10-01

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.

Hormones in international meat production: biological, sociological and consumer issues.

Science.gov (United States)

Galbraith, Hugh

2002-12-01

proliferation in cells maintaining receptivity. Mathematical models describing quantitative relationships between consumption of small amounts of oestrogens in meat in addition to greater concentrations from endogenous production, chemical stoichiometry at cellular level and human pathology have not been developed. Such an approach will be necessary to establish 'molecular materiality' of the additional hormone intake as a component of relative risk assessment. The other hormones, although generally less well researched, are similarly subject to a range of tests to determine potentially adverse effects. The resulting limited international consensus relates to the application of the 'precautionary principle' and non-acceptance by the European Commission of the recommendations of the Codex Alimentarius Commission, which determined that meat from cattle, hormone-treated according to good practice, was safe for human consumers. The present review considers the hormone issue in the context of current international social methodology and regulation, recent advances in knowledge of biological activity of hormones and current status of science-based evaluation of food safety and risk for human consumers.

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....

Safety considerations and countermeasures against fire and explosion at an HTGR-hydrogen production system. Proposal of safety design concept

International Nuclear Information System (INIS)

Nishihara, T.; Hada, K.; Shibata, T.; Shiozawa, S.

1996-01-01

Establishment of safety design concept and countermeasures against fire and explosion accidents is among key safety-related issues in an HTGR-hydrogen production system. We propose the different safety design concepts depending upon the origin of fire and explosion which may happen in the HTGR-hydrogen production plant. Against fire and explosion originated outside the reactor building (R/B), namely in the area of hydrogen production plant, the safety design concept is primarily to take a safe distance for preventing the damage on safety-related items or a proof wall if necessary. Because the hydrogen production plant is designed in the same safety level as a conventional chemical plant. The safe distance is proposed to limit an incident overpressure to 10 kPa so as not to suffer any damage on the items and to limit a wall-averaged temperature of concrete structures of the R/B to 175degC according to the current regulation. On the other hand, against a potential possibility of explosion originated inside the R/B, the safety design concept is to minimize the possibility of explosion low enough to assume no occurrence inside the R/B. That is, the measure is to exclude a simultaneous failure of a secondary helium piping and an endothermic chemical reactor. Furthermore, in severe accident condition in which the explosion may be postulated a priori, an incidental overpressure of explosion inside the reactor containment vessel (C/V) should be limited so as not to fail the C/V through restricting the amount of combustible gas ingress into the C/V by means of a combination of C/V isolation valve installed in the helium piping and emergency shut off valve in the process feed gas line. (author)

Uranium Production Safety Assessment Team. UPSAT. An international peer review service for uranium production facilities

International Nuclear Information System (INIS)

1996-01-01

The IAEA Uranium Production Safety Assessment Team (UPSAT) programme is designed to assist Member States to improve the safe operation of uranium production facilities. This programme facilitates the exchange of knowledge and experience between team members and industry personnel. An UPSAT mission is an international expert review, conducted outside of any regulatory framework. The programme is implemented in the spirit of voluntary co-operation to contribute to the enhancement of operational safety and practices where it is most effective, at the facility itself. An UPSAT review supplements other facility and regulatory efforts which may have the same objective

Long-term safety and efficacy of biosimilar infliximab among patients with inflammatory arthritis switched from reference product

Directory of Open Access Journals (Sweden)

Abdalla A

2017-03-01

Full Text Available Abuelmagd Abdalla, Niamh Byrne, Richard Conway, Thomas Walsh, Geraldine Mannion, Michael Hanly, Miriam O’Sullivan, Ann Maria Curran, John J Carey Department of Rheumatology, Galway University Hospitals, Galway, Ireland Purpose: To evaluate the efficacy and safety of the biosimilar infliximab in adult patients with inflammatory arthritis switched from reference product in our center. Patients and methods: In April 2014, patients attending our rheumatology service for infliximab infusions were switched from reference product to the biosimilar infliximab following consent and hospital approval. Results: Around 34 patients with inflammatory arthritis were switched from reference product to biosimilar infliximab in 2014: 50% female, mean age 55 years (standard deviation=12.9, mean disease duration 14.79 years (9.7, median duration on infliximab 57 months, and two-thirds on oral disease-modifying antirheumatic drugs. There was no difference in efficacy or safety in the first 6 months of therapy. By the end of 2015, the mean follow-up on biosimilar infliximab was 15.8 (standard deviation=6.3 months. Our results showed no significant difference in Health Assessment Questionnaire score, patient global assessment of disease activity, number of disease flares, or the medication dose between the originator and the biosimilar infliximab. However, reported pain and C-reactive protein values were significantly higher during the longer follow-up period (p=0.043, 0.001 respectively. There was no significant difference in the number of adverse events or infusion reactions during follow-up periods. Only five (14.7% patients discontinued the biosimilar infliximab. Conclusion: Our patients experienced similar efficacy and safety for managing their arthritis with the biosimilar infliximab as the reference product infliximab, but at a much lower cost. Keywords: biologic therapy, rheumatic diseases, biosimilar exchange, infliximab, adult

Food Safety and Nutrition Information for Kids and Teens

Science.gov (United States)

... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Food Home Food Resources for You Consumers Kids & Teens ... More sharing options Linkedin Pin it Email Print Food Safety & Nutrition Information for Kids and Teens Fun & ...

Biologic agents therapy for Saudi children with rheumatic diseases: indications and safety.

Science.gov (United States)

Al-Mayouf, Sulaiman M; Alenazi, Abdullatif; AlJasser, Hind

2016-06-01

To report the indications and safety of biologic agents in childhood rheumatic diseases at a tertiary hospital. Children with rheumatic diseases treated with biologic agents at King Faisal Specialist Hospital and Research Center, Riyadh, Saudi Arabia, from January 2001 to December 2011 were included. All patients were reviewed for: demographic characteristics, diagnosis, concomitant treatment and indications of using biologic agents, age at start of therapy and side effects during the treatment period. In all, 134 children (89 female) with various rheumatic diseases were treated with biologic agents. Mean age at starting biologic treatment was 9.3 (4.25-14) years and mean therapy duration was 14.7 (3-88) months. Juvenile idiopathic arthritis (JIA) was the most frequent diagnosis (70.1%) followed by systemic lupus erythematosus (12.7%) and vasculitis (4.5%). All patients received concomitant therapy (corticosteroids and disease-modifying antirheumatic drugs). In total, 273 treatments with biologic agents were used, (95 etanercept, 52 rituximab, 47 adalimumab, 37 infliximab, 23 anakinra, 10 tocilizumab and nine abatacept). Therapy was switched to another agent in 57 (42.5%) patients, mainly because of inefficacy (89.4%) or adverse event (10.6%). A total of 95 (34.8%) adverse events were notified; of these, the most frequent were infusion-related reactions (33.7%) followed by infections (24.2%) and autoantibody positivity (10.6%). One patient developed macrophage activation syndrome. Biologic agents were used in children with a range of rheumatic diseases. Of these, the most frequent was JIA. Off-label use of biologic agents in our cohort is common. These agents seem safe. However, they may associated with various adverse events. Sequential therapy seems well tolerated. However, this should be carefully balanced and considered on an individual basis. © 2014 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

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.

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.

The Effect of Safety Costs on Productivity and Quality: A Case Study of Five Steel Companies in Ahvaz

Directory of Open Access Journals (Sweden)

Gholamabbas Shirali

2016-10-01

Full Text Available Background The implementation of a safety program is one of the most effective factors in increasing productivity. A look to safety from the perspective of efficiency can indicate necessary investment in safety for all, especially the managers of companies. Objectives The aim of this study was to evaluate the effect of safety costs on some indicators of productivity and quality in industrial companies. Methods This study was a retrospective analysis and was implemented in five steel companies in Ahvaz. The data relating to the safety costs such as staffing costs and total safety costs, and productivity and quality indicators were collected in five years. This information and data were collected according to statistics from documents and archives of safety, accounting, and production sectors of companies. Costs as well as numbers and figures of variables were expressed in the form of per capita and percentage to make the data comparable. Linear and generalized regression models and Wald Chi-Square test were used by the SPSS 22 software to determine the relationships between them. Results Safety costs such as capita labor safety costs and capita total safety costs or percentage safety labor costs to labor costs, showed a significant positive effect on labor productivity, labor competitiveness, total factor productivity, quality index and production rates (in some cases, P = 0.001. Conclusions The total safety cost and safety labor compensation generally, regardless of the nature and quality of the safety management system, can impact productivity, quality and quantity of production in addition to other factors of production. Surely if safety programs are targeted and codified, the effect of the investment will be doubled.

Usage, biological activity, and safety of selected botanical dietary supplements consumed in the United States

Directory of Open Access Journals (Sweden)

P. Annécie Benatrehina

2018-04-01

Full Text Available In view of the continuous growth of the botanical dietary supplement industry and the increased popularity of lesser known or exotic botanicals, recent findings are described on the phytochemical composition and biological activities of five selected fruits consumed in the United States, namely, açaí, noni, mangosteen, black chokeberry, and maqui berry. A review of the ethnomedicinal uses of these plants has revealed some similarities ranging from wound-healing to the treatment of fever and infectious diseases. Laboratory studies on açaí have shown both its antioxidant and anti-inflammatory activities in vitro, and more importantly, its neuroprotective properties in animals. Anthraquinones and iridoid glucosides isolated from noni fruit induce the phase II enzyme quinone reductase (QR, and noni fruit juice exhibited antitumor and antidiabetic activities in certain animal models. Antitumorigenic effects of mangosteen in animal xenograft models of human cancers have been attributed to its xanthone content, and pure α-mangostin was shown to display antineoplastic activity in mice despite a reported low oral bioavailability. Work on the less extensively investigated black chokeberry and maqui berry has focused on recent isolation studies and has resulted in the identification of bioactive secondary metabolites with QR-inducing and hydroxyl-radical scavenging properties. On the basis of the safety studies and toxicity case reports described herein, these fruits may be generally considered as safe. However, cases of adulteration found in a commercialized açaí product and some conflicting results from mangosteen safety studies warrant further investigation on the safety of these marketed botanical dietary supplements. Keywords: Açaí, Noni, Mangosteen, Black chokeberry, Maqui berry

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

Efficacy and Safety of Pomegranate Medicinal Products for Cancer

OpenAIRE

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 ...

Preliminary safety analysis of the HTTR-IS nuclear hydrogen production system

International Nuclear Information System (INIS)

Sato, Hiroyuki; Ohashi, Hirofumi; Tazawa, Yujiro; Tachibana, Yukio; Sakaba, Nariaki

2010-06-01

Japan Atomic Energy Agency is planning to demonstrate hydrogen production by thermochemical water-splitting IS process utilizing heat from the high-temperature gas-cooled reactor HTTR (HTTR-IS system). The previous study identified that the HTTR modification due to the coupling of hydrogen production plant requires an additional safety review since the scenario and quantitative values of the evaluation items would be altered from the original HTTR safety review. Hence, preliminary safety analyses are conducted by using the system analysis code. Calculation results showed that evaluation items such as a coolant pressure, temperatures of heat transfer tubes at the pressure boundary, etc., did not exceed allowable values. Also, the peak fuel temperature did not exceed allowable value and therefore the reactor core was not damaged and cooled sufficiently. This report compiles calculation conditions, event scenarios and the calculation results of the preliminary safety analysis. (author)

Environmental contamination by cyclophosphamide preparation: Comparison of conventional manual production in biological safety cabinet and robot-assisted production by APOTECAchemo.

Science.gov (United States)

Schierl, Rudolf; Masini, Carla; Groeneveld, Svenja; Fischer, Elke; Böhlandt, Antje; Rosini, Valeria; Paolucci, Demis

2016-02-01

The aim of this study was to compare environmental contamination of cyclophosphamide (CP) during 1 week of drug compounding by conventional manual procedure in a biological safety cabinet (BSC) with laminar airflow and a new robotic drug preparation system (APOTECAchemo). During four consecutive days, similar numbers of infusion bags with cyclophosphamide were prepared with both techniques in a cross-over design. Wipe samples (49 for BSC, 50 for APOTECAchemo) were taken at several locations (gloves, infusion bags, trays, BSC-benches, floor) in the pharmacy and analyzed for CP concentrations by GC-MSMS (LOD 0.2 ng/sample). The detection rate was 70% in the BSC versus 15% in APOTECAchemo. During manual preparation of admixtures using BSC contamination with CP was below 0.001 ng/cm(2) at most locations, but significant on gloves (0.0004-0.0967 ng/cm(2)) and the majority (70%) of infusion bags (preparation by APOTECAchemo, gloves (1 of 8: 0.0007 ng/cm(2)) and infusion bags (3 of 20: 0.0005, 0.0019, 0.0094 ng/cm(2)) were considerably less contaminated. Residual contamination was found on the surfaces under the dosing device in the compounding area (0.0293-0.1603 ng/cm(2)) inside the robotic system. Compared to outcomes of other studies, our results underline good manufacturing procedures in this pharmacy with low contamination for both techniques (BSC and APOTECAchemo). Comparison of both preparation procedures validated that contamination of infusion bags was much lower by using the robotic system. © The Author(s) 2014.

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

OpenAIRE

Ma, Liping; Hao, Bianqing; Qiao, Xiongwu

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 fertili...

77 FR 42319 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Science.gov (United States)

2012-07-18

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... consideration of the appropriateness of cell lines derived from human tumors for vaccine manufacture. FDA...

75 FR 59729 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Science.gov (United States)

2010-09-28

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug... public. Name of Committee: Vaccines and Related Biological Products Advisory Committee. General Function... vaccines for a post-exposure prophylaxis indication using the animal rule. On November 17, 2010, the...

49 CFR 236.907 - Product Safety Plan (PSP).

Science.gov (United States)

2010-10-01

... addressed during the life cycle of the product, including maximum threshold limits for each hazard (for... accordance with other criteria if demonstrated to the satisfaction of the Associate Administrator for Safety... contractor employees and supervisors necessary to ensure the safe and proper installation, implementation...

Safety assessment of VHTR hydrogen production system against fire, explosion and acute toxicity

International Nuclear Information System (INIS)

Murakami, Tomoyuki; Nishihara, Tetsuo; Kunitomi, Kazuhiko

2008-01-01

The Japan Atomic Energy Agency has been developing a nuclear hydrogen production system by using heat from the Very High Temperature Reactor (VHTR). This system will handle a large amount of combustible gas and toxic gas. The risk from fire, explosion and acute toxic exposure caused by an accident involving chemical material release in a hydrogen production system is assessed. It is important to ensure the safety of the nuclear plant, and the risks for public health should be sufficiently small. This report provides the basic policy for the safety evaluation in cases of accident involving fire, explosion and toxic material release in a hydrogen production system. Preliminary safety analysis of a commercial-sized VHTR hydrogen production system, GTHTR300C, is performed. This analysis provides us with useful information on the separation distance between a nuclear plant and a hydrogen production system and a prospect that an accident in a hydrogen production system does not significantly increase the risks of the public. (author)

The TESS database. Use in product safety assessment.

Science.gov (United States)

Litovitz, T

1998-01-01

The Toxic Exposure Surveillance System or TESS is a comprehensive poisoning surveillance database maintained by the American Association of Poison Control Centers. It now includes data on more than 20.3 million human poison exposures reported to US poison centres. TESS data are submitted by 67 of the 75 US poison control centres, covering 87% of the US population. Reports to US poison centres included in TESS originate both from the general public and from health professionals (12.9%) and include both patients managed at home or at the site of the exposure (73.6%) and those managed in hospitals, emergency departments, or other healthcare facilities (22.8%). TESS data are used by the pharmaceutical industry to monitor or defend product safety, by regulatory agencies proposing new regulations or considering new approvals or over-the-counter switches, and by clinical researchers attempting to characterise toxicity profiles or determine treatment protocols. TESS is a key component of an effective post-marketing surveillance programme, allowing early identification of previously unsuspected hazards, and early changes in formulations, labelling, or packaging when needed, thereby minimising injuries, deaths and product liability. Deaths, severe outcomes and comparisons of poisoning outcomes and hospitalisation rates between products or product categories are used to identify safety outliers. TESS data for each case of poisoning include identification of the substances implicated (including brand and formulation where known), patient age, outcome, specific clinical effects, exposure route, reason for the exposure (unintentional, suicidal, therapeutic error, etc.), antidotes used and the level of healthcare intervention utilised. Pharmaceuticals are implicated in 42% of TESS poisoning cases. About 53% of all cases of poisoning occur in children under 6 years of age. Of the more than 2.1 million cases reported to TESS in 1996, 123,095 (5.7%) were therapeutic errors and 32

Synthetic and systems biology for microbial production of commodity chemicals.

Science.gov (United States)

Chubukov, Victor; Mukhopadhyay, Aindrila; Petzold, Christopher J; Keasling, Jay D; Martín, Héctor García

2016-01-01

The combination of synthetic and systems biology is a powerful framework to study fundamental questions in biology and produce chemicals of immediate practical application such as biofuels, polymers, or therapeutics. However, we cannot yet engineer biological systems as easily and precisely as we engineer physical systems. In this review, we describe the path from the choice of target molecule to scaling production up to commercial volumes. We present and explain some of the current challenges and gaps in our knowledge that must be overcome in order to bring our bioengineering capabilities to the level of other engineering disciplines. Challenges start at molecule selection, where a difficult balance between economic potential and biological feasibility must be struck. Pathway design and construction have recently been revolutionized by next-generation sequencing and exponentially improving DNA synthesis capabilities. Although pathway optimization can be significantly aided by enzyme expression characterization through proteomics, choosing optimal relative protein expression levels for maximum production is still the subject of heuristic, non-systematic approaches. Toxic metabolic intermediates and proteins can significantly affect production, and dynamic pathway regulation emerges as a powerful but yet immature tool to prevent it. Host engineering arises as a much needed complement to pathway engineering for high bioproduct yields; and systems biology approaches such as stoichiometric modeling or growth coupling strategies are required. A final, and often underestimated, challenge is the successful scale up of processes to commercial volumes. Sustained efforts in improving reproducibility and predictability are needed for further development of bioengineering.

Layoffs and tradeoffs: production, quality, and safety demands under the threat of job loss.

Science.gov (United States)

Probst, Tahira M

2002-07-01

Employees often face a conflict between production targets, quality assurance, and adherence to safety policies. In a time when layoffs are on the rise, it is important to understand the effects of employee job insecurity on these potentially competing demands. A laboratory experiment manipulated the threat of layoffs in a simulated organization and assessed its effect on employee productivity, product quality, and adherence to safety policies. Results suggest that student participants faced with the threat of layoffs were more productive, yet violated more safety rules and produced lower quality outputs, than participants in the control condition. Implications for organizations contemplating layoffs and directions for future research are discussed.

77 FR 63839 - Vaccines and Related Biological Products Advisory Committee; Notice of Meeting

Science.gov (United States)

2012-10-17

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide...) Virus Monovalent Vaccine manufactured by GlaxoSmithKline. On November 15, 2012, the committee will meet...

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

Science.gov (United States)

2010-01-19

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... virus vaccine for the 2010 - 2011 influenza season. FDA intends to make background material available to...

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

Science.gov (United States)

2011-01-20

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... the influenza virus vaccine for the 2011-2012 influenza season. The committee will also hear an update...

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

Science.gov (United States)

2013-01-25

...] Vaccines and Related Biological Products Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Vaccines and Related Biological Products Advisory Committee. General Function of the Committee: To provide... virus vaccine for the 2013- 2014 influenza season. FDA intends to make background material available to...

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.

Biological Agents

Science.gov (United States)

... E-Tools Safety and Health Topics / Biological Agents Biological Agents This page requires that javascript be enabled ... 202) 693-2300 if additional assistance is required. Biological Agents Menu Overview In Focus: Ebola Frederick A. ...

77 FR 47397 - Request for Nominations of Specific Drug/Biologic Product(s) That Could Be Brought Before the...

Science.gov (United States)

2012-08-08

... decision-making processes. Significant public health and safety issues are brought before these committees... future pediatric product development by focusing on products whose development would benefit the most...

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

Science.gov (United States)

2012-02-22

... CONSUMER PRODUCT SAFETY COMMISSION 16 CFR Chapter II Acceptance of ASTM F963-11 as a Mandatory... have accepted the revised ASTM F963-11 standard titled, Standard Consumer Safety Specifications for Toy Safety. Pursuant to section 106 of the Consumer Product Safety Improvement Act of 2008, ASTM F963-11 will...

Advanced glycation end-products: a biological consequence of lifestyle contributing to cancer disparity

OpenAIRE

Turner, David P.

2015-01-01

Low income, poor diet, obesity and a lack of exercise are inter-related lifestyle factors that can profoundly alter our biological make-up to increase cancer risk, growth and development. We recently reported a potential mechanistic link between carbohydrate derived metabolites and cancer which may provide a biological consequence of lifestyle that can directly impact tumor biology. Advanced glycation end-products (AGEs) are reactive metabolites produced as a by-product of sugar metabolism. F...

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.

Fundamental philosophy on the safety design of the HTTR-IS hydrogen production system

International Nuclear Information System (INIS)

Ohashi, Kazutaka; Nishihara, Tetsuo; Kunitomi, Kazuhiko

2007-01-01

Japan Atomic Energy Agency (JAEA) has been conducting an R and D work on the VHTR reactor system and IS hydrogen production system to realize hydrogen production using nuclear heat. As a part of this activity, JAEA is planning to connect an IS test system to the High Temperature Engineering Test Reactor (HTTR) to demonstrate its technical feasibility. This paper proposes a fundamental philosophy on the safety design of the HTTR-IS hydrogen production system including the methodology to select postulated abnormal events and its event sequences and to define safety functions of the IS system to ensure the reactor safety. Also the measure to clarify the IS system as non-reactor system is proposed. (author)

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

Biological effects of electromagnetic fields and recently updated safety guidelines for strong static magnetic fields

International Nuclear Information System (INIS)

Yamaguchi-Sekino, Sachiko; Sekino, Masaki; Ueno, Shoogo

2011-01-01

Humans are exposed daily to artificial and naturally occurring magnetic fields that originate from many different sources. We review recent studies that examine the biological effects of and medical applications involving electromagnetic fields, review the properties of static and pulsed electromagnetic fields that affect biological systems, describe the use of a pulsed electromagnetic field in combination with an anticancer agent as an example of a medical application that incorporates an electromagnetic field, and discuss the recently updated safety guidelines for static electromagnetic fields. The most notable modifications to the 2009 International Commission on Non-Ionizing Radiation Protection guidelines are the increased exposure limits, especially for those who work with or near electromagnetic fields (occupational exposure limits). The recommended increases in exposure were determined using recent scientific evidence obtained from animal and human studies. Several studies since the 1994 publication of the guidelines have examined the effects on humans after exposure to high static electromagnetic fields (up to 9.4 tesla), but additional research is needed to ascertain further the safety of strong electromagnetic fields. (author)

Hazard identification and risk assessment for biologics targeting the immune system.

Science.gov (United States)

Weir, Andrea B

2008-01-01

Biologic pharmaceuticals include a variety of products, such as monoclonal antibodies, fusion proteins and cytokines. Products in those classes include immunomodulatory biologics, which are intended to enhance or diminish the activity of the immune system. Immunomodulatory biologics have been approved by the U.S. FDA for a variety of indications, including cancer and inflammatory conditions. Prior to gaining approval for marketing, sponsoring companies for all types of products must demonstrate a product's safety in toxicology studies conducted in animals and show safety and efficacy in clinical trials conducted in patients. The overall goal of toxicology studies, which applies to immunomodulatory and other product types, is to identify the hazards that products pose to humans. Because biologics are generally highly selective for specific targets (receptors/epitopes), conducting toxicology studies in animal models with the target is essential. Such animals are referred to as pharmacologically relevant. Endpoints routinely included in toxicology studies, such as hematology, organ weight and histopathology, can be used to assess the effect of a product on the structure of the immune system. Additionally, specialized endpoints, such as immunophenotyping and immune function tests, can be used to define effects of immunomodulatory products on the immune system. Following hazard identification, risks posed to patients are assessed and managed. Risks can be managed through clinical trial design and risk communication, a practice that applies to immunomodulatory and other product types. Examples of risk management in clinical trial design include establishing a safe starting dose, defining the appropriate patient population and establishing appropriate patient monitoring. Risk communication starts during clinical trials and continues after product approval. A combination of hazard identification, risk assessment and risk management allows for drug development to proceed

Production of biological nanoparticles from bovine serum albumin ...

African Journals Online (AJOL)

Production of biological nanoparticles from bovine serum albumin for drug delivery. ... Bovine serum albumin (BSA) was used for generation of nanoparticles in a drug delivery system. ... The impact of protein concentration and additional rate of organic solvent (i.e. ethanol) upon the particle ... AJOL African Journals Online.

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

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

EFSA BIOHAZ Panel (EFSA Panel on Biological Hazards), 2013. Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2013 update)

DEFF Research Database (Denmark)

Licht, Tine Rask; Baggesen, Dorte Lau

EFSA is requested to assess the safety of a broad range of biological agents in the context of notifications for market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified presumption of safety (QPS) assessment was developed to provide...... a harmonised generic pre-assessment to support safety risk assessments performed by EFSA’s scientific Panels. The safety of unambiguously defined biological agents (at the highest taxonomic unit appropriate for the purpose for which an application is intended), and the completeness of the body of knowledge...... is the one in the most recently published scientific opinion. The 2013 update reviews previously assessed microorganisms including bacteria, yeasts, filamentous fungi, oomycetes and viruses used for plant protection purposes. All taxonomic units previously recommended for the QPS list had their status...

Synthetic biology approaches for the production of plant metabolites in unicellular organisms.

Science.gov (United States)

Moses, Tessa; Mehrshahi, Payam; Smith, Alison G; Goossens, Alain

2017-07-10

Synthetic biology is the repurposing of biological systems for novel objectives and applications. Through the co-ordinated and balanced expression of genes, both native and those introduced from other organisms, resources within an industrial chassis can be siphoned for the commercial production of high-value commodities. This developing interdisciplinary field has the potential to revolutionize natural product discovery from higher plants, by providing a diverse array of tools, technologies, and strategies for exploring the large chemically complex space of plant natural products using unicellular organisms. In this review, we emphasize the key features that influence the generation of biorefineries and highlight technologies and strategic solutions that can be used to overcome engineering pitfalls with rational design. Also presented is a succinct guide to assist the selection of unicellular chassis most suited for the engineering and subsequent production of the desired natural product, in order to meet the global demand for plant natural products in a safe and sustainable manner. © The Author 2017. Published by Oxford University Press on behalf of the Society for Experimental Biology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

European Legal Developments in Product Liability and Product Safety and the Total Quality Management Approach

NARCIS (Netherlands)

Brack, Antoni; 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

Impact of rent-seeking on productivity in Chinese coal mine safety supervision: A simulation study

International Nuclear Information System (INIS)

Chen, Hong; Feng, Qun; Zhu, Dandan; Han, Shuai; Long, Ruyin

2016-01-01

During the “golden decade” (2001–2011) of the coal industry in China, rent-seeking increased in coal mine safety supervision alongside significant improvements in coal mine safety status and increased economic benefits in the coal industry. To explore this internal relationship, we developed a Matlab simulation system and simulated the impact of rent-seeking from each level of the supervision department on coal mine productivity in different scenarios. The results showed the following. (1) Rent-seeking had no significant influence on the average level of material productivity but it had an adverse effect on the average level of mental productivity. Due to the effects of rent-seeking, productivity tended to exhibit unstable and destructive fluctuations, and rent-seeking had the dual effect of promoting and restraining productivity in a wide range with a high frequency. (2) In the supervision scenario, supervision by the high-level department was efficient, and productivity was promoted more by the national and provincial supervision department. (3) In the rent-seeking scenario, each level of the department had an intensity threshold above which coal mine accidents occurred. We also propose suggestions that focuses on the improved supervision of Chinese coal mine safety in three areas based on the “new normal” safety concept. - Highlights: •We discussed rent-seeking behavior in Chinese coal mine safety supervision. •We explored the characteristics of coal mine productivity. •We investigated the impact of rent-seeking on coal mine productivity in three scenarios. •We found rent-seeking led to great fluctuations in productivity with a dual effect. •We proposed a model strategy for Chinese coal mine safety supervision in three areas.

Workshop on Indian Chemical Industry: perspectives on safety, cleaner production and environment production

NARCIS (Netherlands)

Ham, J.M.

1996-01-01

A Workshop on "Indian Chemical Industry: Perspectives on Safety, Cleaner Production and Environmental Protection" was held on 3, 4 and 5 January 1996, in Bombay, India. The main objective of the workshop, which was organised jointly by the Government of India, UNIDO/UNDP and the Indian Chemical

IINFLUENCE OF FREEZING AND PROLONGED STORAGE OF EXPRESSED BREAST MILK ON ITS NUTRITIVE, BIOLOGICAL VALUES AND MICROBIOLOGICAL SAFETY

Directory of Open Access Journals (Sweden)

O. L. Lukoyanova

2011-01-01

Full Text Available Evaluation of prolonged storage of breast milk safety for nutrition of newborns remains actual problem of modern nutritiology. Objectives: to evaluate an influence of freezing and prolonged storage of expressed breast milk on its nutritive, biological values and microbiological safety. Methods: samples of expressed breast milk (native samples and after 1 and 3 months of storage in containers Philips AVENT in t -18°С were analyzed; levels of secretory IgA, lysozyme, transforming growth factor (TGF β1, potassium, calcium, magnesium, pH, buffer capacity and bacterial cells were detected. Results: there is no statistically significant influence of low temperature and prolonged storage of expressed breast milk on levels of secretory IgA, lysozyme, TGF β1 and bacterial cells. Potassium and calcium levels significantly decreased (on about 10% and 20% accordingly, pH increased, and buffer capacity of milk lowered after freezing during 3 months. Conclusion: children’s feeding with native and expressed breast milk defrosted after 3 months of storage is equal in nutritive and biological values and microbiological safety.

The Use of Alternative Raw Material in Production of Pastry Products as a Progressive Direction in Creating the Products of High Biological Value

Directory of Open Access Journals (Sweden)

Janа Bachinska

2017-02-01

Full Text Available This paper examines the impact of the use of alternative vegetable raw materials in the manufacture of pastry products with high biological value; it presents the results of evaluation of commodity of the developed products and compares them with the main samples presented in Kharkiv trade network. The feasibility of using a mixture of fiber and pumpkin seeds in the technology of pastry production to extend the range of confectionery products of high biological value and products with reduced calories has been proved. Adding the mixture of fiber and pumpkin seeds to biscuits and cakes positively affected the chemical composition of the ready-made product, saturating it with useful and necessary to human body mineral elements, vitamins, dietary fiber.

Biologic and Conventional Systemic Therapies Show Similar Safety and Efficacy in Elderly and Adult Patients With Moderate to Severe Psoriasis.

Science.gov (United States)

Garber, Caren; Plotnikova, Natalia; Au, Shiu-chung; Sorensen, Eric P; Gottlieb, Alice

2015-08-01

Despite the aging population, few studies have documented the treatment of geriatric psoriasis. The purpose of this study is to compare the efficacy, safety, and prescribing patterns of biologics and conventional systemic medications in elderly versus adult psoriasis. All patient visits coded for psoriasis or psoriatic arthritis (ICD-9 696.1 or 696.0) at the Tufts Medical Center General Dermatology Clinic from January 1, 2008, to March 1, 2015 were included in this retrospective cohort study. The outcome measure used was the validated simple-measure for assessing psoriasis activity (S-MAPA), the product of the physician's global assessment and the body surface area. 194 patients who underwent 278 treatment courses were included in the study. 48 patients were included in the elderly cohort (≥ 65 years old) and 146 in the adult cohort (18-64 years old). There was no significant difference in S-MAPA improvement at 12 weeks between the two cohorts when treated with biologics (42.92% improvement in adults, 48.77% in elderly; P=0.498) or conventional systemics (43.96% and 51.82%, respectively; P=0.448). Within the elderly cohort, there was no significant difference in efficacy of biologics versus conventional systemics at any time point. Topical prescription rates were significantly higher in the elderly cohort ( P=0.004) while biologic prescription rates were significantly lower ( P=0.014) despite the same baseline S-MAPA in both age groups. For both biologics and conventional systemics, there was no statistically significant intergroup difference in the rate of adverse events ( P=0.322 for biologics; P=0.581 for conventional systemics) or infection ( P=0.753 for biologics; P=0.828 for conventional systemics). Within the elderly cohort, there was a higher rate of adverse events with conventional systemic treatment than with biologic treatment ( P=0.033). This study provides preliminary evidence to suggest that biologic and conventional systemic therapies are similarly

Toward an understanding of the impact of production pressure on safety performance in construction operations.

Science.gov (United States)

Han, Sanguk; Saba, Farzaneh; Lee, Sanghyun; Mohamed, Yasser; Peña-Mora, Feniosky

2014-07-01

It is not unusual to observe that actual schedule and quality performances are different from planned performances (e.g., schedule delay and rework) during a construction project. Such differences often result in production pressure (e.g., being pressed to work faster). Previous studies demonstrated that such production pressure negatively affects safety performance. However, the process by which production pressure influences safety performance, and to what extent, has not been fully investigated. As a result, the impact of production pressure has not been incorporated much into safety management in practice. In an effort to address this issue, this paper examines how production pressure relates to safety performance over time by identifying their feedback processes. A conceptual causal loop diagram is created to identify the relationship between schedule and quality performances (e.g., schedule delays and rework) and the components related to a safety program (e.g., workers' perceptions of safety, safety training, safety supervision, and crew size). A case study is then experimentally undertaken to investigate this relationship with accident occurrence with the use of data collected from a construction site; the case study is used to build a System Dynamics (SD) model. The SD model, then, is validated through inequality statistics analysis. Sensitivity analysis and statistical screening techniques further permit an evaluation of the impact of the managerial components on accident occurrence. The results of the case study indicate that schedule delays and rework are the critical factors affecting accident occurrence for the monitored project. Copyright © 2013 Elsevier Ltd. All rights reserved.

Construction of Traceability System for Quality Safety of Cereal and Oil Products

Science.gov (United States)

Zheng, Huoguo; Liu, Shihong; Meng, Hong; Hu, Haiyan

After several significant food safety incident, global food industry and governments in many countries are putting increasing emphasis on establishment of food traceability systems. Food traceability has become an effective way in food quality and safety management. The traceability system for quality safety of cereal and oil products was designed and implemented with HACCP and FMECA method, encoding, information processing, and hardware R&D technology etc, according to the whole supply chain of cereal and oil products. Results indicated that the system provide not only the management in origin, processing, circulating and consuming for enterprise, but also tracing service for customers and supervisor by means of telephone, internet, SMS, touch machine and mobile terminal.

PERSPECTIVES FOR DEVELOPMENT OF THE BIOLOGIC PLUM PRODUCTION IN BULGARIA

Directory of Open Access Journals (Sweden)

Ivanka Vitanova

2014-03-01

Full Text Available The Bulgarian plum cultivars Gabrovska, Nevena, Strinava, Guliaeva and Balvanska slava, breeding in the Plum Experimental Station in the town of Dryanovo and the introduced cultivars Stanley, Chachanska lepotitsa, Opal, Malvazinka, Hramova renkloda, Tuleu timpuriu, Althan’s Gage, Pacific, Mirabell de Nancy, Anna Schpet and Jojo, what are high productive and are tolerant to sharka and other important economic plum diseases are suitable for the biologic plum production. The organic fertilization is a basic element of the technology for the biologic plum production. The fertilization with manure and the green manure with a winter green peas and with a peas-rye mix increased the humus content, influenced positive action on the supplying of the plum plants with the main nutrient macro elements, increased the yield and to be able apply successfully in the plum orchards and at not irrigation conditions.

Understanding safety and production risks in rail engineering planning and protection.

Science.gov (United States)

Wilson, John R; Ryan, Brendan; Schock, Alex; Ferreira, Pedro; Smith, Stuart; Pitsopoulos, Julia

2009-07-01

Much of the published human factors work on risk is to do with safety and within this is concerned with prediction and analysis of human error and with human reliability assessment. Less has been published on human factors contributions to understanding and managing project, business, engineering and other forms of risk and still less jointly assessing risk to do with broad issues of 'safety' and broad issues of 'production' or 'performance'. This paper contains a general commentary on human factors and assessment of risk of various kinds, in the context of the aims of ergonomics and concerns about being too risk averse. The paper then describes a specific project, in rail engineering, where the notion of a human factors case has been employed to analyse engineering functions and related human factors issues. A human factors issues register for potential system disturbances has been developed, prior to a human factors risk assessment, which jointly covers safety and production (engineering delivery) concerns. The paper concludes with a commentary on the potential relevance of a resilience engineering perspective to understanding rail engineering systems risk. Design, planning and management of complex systems will increasingly have to address the issue of making trade-offs between safety and production, and ergonomics should be central to this. The paper addresses the relevant issues and does so in an under-published domain - rail systems engineering work.

Executing effective road safety advertising: are big production budgets necessary?

Science.gov (United States)

Donovan, R J; Jalleh, G; Henley, N

1999-05-01

Twelve (12) road safety television commercials (TVCs) ranging in production costs from $A15,000 to $A250,000 (current prices) were evaluated using standard advertising pre-test procedures. The twelve ads covered four road safety behaviours (speeding; drink driving; fatigue; and inattention), and included a variety of executional types within and across behaviours. One ad in each of the four behaviours was an expensive TAC and ($A200,000 or more). The testing procedure assessed respondents' self-reported impact of the ad on their future intentions to comply with the road safety behavior advocated in the ad. Just under 1000 appropriately screened motor vehicle drivers license holders were recruited via street intercept methods and randomly allocated to one of the twelve and exposure conditions. The results showed that while the two best performing ads were highly dramatic TAC ads showing graphic crash scenes, these were also the most expensive ads to produce, and, being 60 and 90 s, the most expensive to air. In several cases, 30 s low cost talking heads testimonials performed equally as well as their far more expensive counterparts. We conclude that big production budgets may not be necessary to create effective road safety advertising.

Molecular biology in studies of oceanic primary production

International Nuclear Information System (INIS)

LaRoche, J.; Falkowski, P.G.; Geider, R.

1992-01-01

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

The balance between safety and productivity and its relationship with human factors and safety awareness and communication in aircraft manufacturing

NARCIS (Netherlands)

Karanikas, N.; Melis, Damien Jose; Kourousis, Kyriakos

2017-01-01

Background: This paper presents the findings of a pilot research survey which assessed the degree of balance between safety and productivity, and its relationship with awareness and communication of human factors and safety rules in the aircraft manufacturing environment. Methods: The study was

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

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...... 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...

MODERN TECHNOLOGICAL SOLUTIONS USED IN THE PRODUCTION OF BAKERY PRODUCTS WITH HIGH BIOLOGICAL VALUE

OpenAIRE

Marta Brodowska; Dominika Guzek; Agnieszka Wierzbicka

2014-01-01

Biological value of the food products is a result of the presence of bioactive substances and the proportions of the components. Technological development allows to optimize and accelerate the processes of bread production and increase value of food. Bakery industry used whole grains and pseudocereals as additional source of active compounds, biotechnological techniques as using appropriate yeast strain and encapsulation, which provide protection of substance and their controlled release in p...

Biological production of hydroxylated aromatics : Optimization strategies for Pseudomonas putida S12

NARCIS (Netherlands)

Verhoef, A.

2010-01-01

To replace environmentally unfriendly petrochemical production processes, the demand for bio-based production of organic chemicals is increasing. This thesis focuses on the biological production of hydroxylated aromatics from renewable substrates by engineered P. putida S12 including several cases

78 FR 19492 - Draft Guidance for Industry on Formal Meetings Between FDA and Biosimilar Biological Product...

Science.gov (United States)

2013-04-01

..., or Office of Communication, Outreach, and Development (HFM-40), Center for Biologics Evaluation and... biological product. This draft guidance describes the Agency's current thinking on how it intends to... review of biosimilar biological products. Because these meetings often will represent critical points in...

The Product Quality Research Institute (PQRI) Leachables and Extractables Working Group Initiatives for Parenteral and Ophthalmic Drug Product (PODP).

Science.gov (United States)

Paskiet, Diane; Jenke, Dennis; Ball, Douglas; Houston, Christopher; Norwood, Daniel L; Markovic, Ingrid

2013-01-01

The Product Quality Research Institute (PQRI) is a non-profit consortium of organizations working together to generate and share timely, relevant, and impactful information that advances drug product quality and development. The collaborative activities of PQRI participants have, in the case of orally inhaled and nasal drug products (OINDPs), resulted in comprehensive and widely-accepted recommendations for leachables assessments to help ensure patient safety with respect to this class of packaged drug products. These recommendations, which include scientifically justified safety thresholds for leachables, represent a significant milestone towards establishing standardized approaches for safety qualification of leachables in OINDP. To build on the success of the OINDP effort, PQRI's Parenteral and Ophthalmic Drug Products (PODP) Leachables and Extractables Working Group was formed to extrapolate the OINDP threshold concepts and best practice recommendations to other dosage forms with high concern for interaction with packaging/delivery systems. This article considers the general aspects of leachables and their safety assessment, introduces the PODP Work Plan and initial study Protocol, discusses the laboratory studies being conducted by the PODP Chemistry Team, outlines the strategy being developed by the PODP Toxicology Team for the safety qualification of PODP leachables, and considers the issues associated with application of the safety thresholds, particularly with respect to large-volume parenterals. Lastly, the unique leachables issues associated with biologics are described. The Product Quality Research Institute (PQRI) is a non-profit consortium involving industry organizations, academia, and regulatory agencies that together provide recommendations in support of regulatory guidance to advance drug product quality. The collaborative activities of the PQRI Orally Inhaled and Nasal Drug Products Leachables and Extractables Working Group resulted in a

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.

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.

Waste water biological purification plants of dairy products industry and energy management

Science.gov (United States)

Stepanov, Sergey; Solkina, Olga; Stepanov, Alexander; Zhukova, Maria

2017-10-01

The paper presents results of engineering and economical comparison of waste water biological purification plants of dairy products industry. Three methods of purification are compared: traditional biological purification with the use of secondary clarifiers and afterpurification through granular-bed filters, biomembrane technology and physical-and-chemical treatment together with biomembrane technology for new construction conditions. The improvement of the biological purification technology using nitro-denitrification and membrane un-mixing of sludge mixture is a promising trend in this area. In these calculations, an energy management which is widely applied abroad was used. The descriptions of the three methods are illustrated with structural schemes. Costs of equipment and production areas are taken from manufacturers’ data. The research is aimed at an engineering and economical comparison of new constructions of waste water purification of dairy products industry. The experiment demonstrates advantages of biomembrane technology in waste water purification. This technology offers prospects of 122 million rubles cost saving during 25 years of operation when compared with of the technology of preparatory reagent flotation and of 13.7 million rubles cost saving compared to the option of traditional biological purification.

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 REGULATIONS SUBSTANTIAL PRODUCT HAZARD REPORTS General Interpretation § 1115.5 Reporting of failures to comply...

Safety and efficacy of personal care products containing colloidal oatmeal

OpenAIRE

Criquet, Maryline; Roure, Romain; Dayan, Liliane; Nollent, Virginie; Bertin, Christiane

2012-01-01

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 vu...

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).

Safety assessment for the IS process in a hydrogen production facility

International Nuclear Information System (INIS)

Cho, Nam Chul

2005-08-01

A substitute energy development have been required due to the dry up of the fossil fuel and an environmental problem. Consequently, among substitute energy to be discussed, producing hydrogen from water which does not release carbon is a very promising technology. Also, Iodine-Sulfur(IS) thermochemical water decomposition is one of the promising process which is used to produce hydrogen efficiently using the high temperature gas-cooled reactor(HTGR) as an energy source that is possible to supply heat over 1000 .deg. C. In this study, to make a safety assessment of the hydrogen production using the IS process, an initiating events analysis and an accident scenario modeling considering the relief system were carried out. A method for initiating event identification used the Master Logic Diagram(MLD) that is logical and deductive. As a result, 9 initiating events that cause a leakage of the chemical material were identified. 6 accident scenario based on the initiating event are identified and quantified to the event trees. The frequency of the chemical material leakage produced by IS process is estimated relatively high to the value of 1.22x10 -4 /y. Therefore, it requires more effort on safety of the hydrogen production which can be considered as a part of the nuclear system and safety management research to increase social acceptability. Moreover, these methods will be helpful to the safety assessment of the hydrogen production system of the IS process in general

The Trends and their Impact on Fishery Products Safety and Quality

OpenAIRE

Gheorghe Adrian ZUGRAVU; Maria Magdalena TUREK RAHOVEANU

2012-01-01

The paper follows two main objectives: to understand consumers’ perception of safety 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 ar...

Reusing salad from salad bars – simulating the effects on product loss, microbial safety and product quality

NARCIS (Netherlands)

Tromp, S.O.; Rijgersberg, H.; Franz, E.

2012-01-01

The goal of this study is to model the effects of reusing salad from salad bars to reduce product loss, while keeping microbial safety and product quality at acceptable levels. We, therefore, expand our previously developed simulation model by incorporating reuse strategies and a quality decay

Presence and biological activity of antibiotics used in fuel ethanol and corn co-product production.

Science.gov (United States)

Compart, D M Paulus; Carlson, A M; Crawford, G I; Fink, R C; Diez-Gonzalez, F; Dicostanzo, A; Shurson, G C

2013-05-01

Antibiotics are used in ethanol production to control bacteria from competing with yeast for nutrients during starch fermentation. However, there is no published scientific information on whether antibiotic residues are present in distillers grains (DG), co-products from ethanol production, or whether they retain their biological activity. Therefore, the objectives of this study were to quantify concentrations of various antibiotic residues in DG and determine whether residues were biologically active. Twenty distillers wet grains and 20 distillers dried grains samples were collected quarterly from 9 states and 43 ethanol plants in the United States. Samples were analyzed for DM, CP, NDF, crude fat, S, P, and pH to describe the nutritional characteristics of the samples evaluated. Samples were also analyzed for the presence of erythromycin, penicillin G, tetracycline, tylosin, and virginiamycin M1, using liquid chromatography and mass spectrometry. Additionally, virginiamycin residues were determined, using a U.S. Food and Drug Administration-approved bioassay method. Samples were extracted and further analyzed for biological activity by exposing the sample extracts to 10(4) to 10(7) CFU/mL concentrations of sentinel bacterial strains Escherichia coli ATCC 8739 and Listeria monocytogenes ATCC 19115. Extracts that inhibited bacterial growth were considered to have biological activity. Physiochemical characteristics varied among samples but were consistent with previous findings. Thirteen percent of all samples contained low (≤1.12 mg/kg) antibiotic concentrations. Only 1 sample extract inhibited growth of Escherichia coli at 10(4) CFU/mL, but this sample contained no detectable concentrations of antibiotic residues. No extracts inhibited Listeria monocytogenes growth. These data indicate that the likelihood of detectable concentrations of antibiotic residues in DG is low; and if detected, they are found in very low concentrations. The inhibition in only 1 DG

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

37 CFR 1.779 - Calculation of patent term extension for a veterinary biological product.

Science.gov (United States)

2010-07-01

... period beginning on the date the authority to prepare an experimental biological product under the Virus... diligence; (iii) One-half the number of days remaining in the period defined by paragraph (c)(1) of this... experimental biological product under the Virus-Serum-Toxin Act was submitted before November 16, 1988, by— (A...

Safety and preliminary evidence of biologic efficacy of a mammaglobin-a DNA vaccine in patients with stable metastatic breast cancer.

Science.gov (United States)

Tiriveedhi, Venkataswarup; Tucker, Natalia; Herndon, John; Li, Lijin; Sturmoski, Mark; Ellis, Matthew; Ma, Cynthia; Naughton, Michael; Lockhart, A Craig; Gao, Feng; Fleming, Timothy; Goedegebuure, Peter; Mohanakumar, Thalachallour; Gillanders, William E

2014-12-01

Mammaglobin-A (MAM-A) is overexpressed in 40% to 80% of primary breast cancers. We initiated a phase I clinical trial of a MAM-A DNA vaccine to evaluate its safety and biologic efficacy. Patients with breast cancer with stable metastatic disease were eligible for enrollment. Safety was monitored with clinical and laboratory assessments. The CD8 T-cell response was measured by ELISPOT, flow cytometry, and cytotoxicity assays. Progression-free survival (PFS) was described using the Kaplan-Meier product limit estimator. Fourteen subjects have been treated with the MAM-A DNA vaccine and no significant adverse events have been observed. Eight of 14 subjects were HLA-A2(+), and the CD8 T-cell response to vaccination was studied in detail. Flow cytometry demonstrated a significant increase in the frequency of MAM-A-specific CD8 T cells after vaccination (0.9% ± 0.5% vs. 3.8% ± 1.2%; P cells (41 ± 32 vs. 215 ± 67 spm; P cell responses, and preliminary evidence suggests improved PFS. Additional studies are required to define the potential of the MAM-A DNA vaccine for breast cancer prevention and/or therapy. ©2014 American Association for Cancer Research.

Playground Safety

Science.gov (United States)

... Prevention Fall Prevention Playground Safety Poisoning Prevention Road Traffic Safety Sports Safety Get Email Updates To receive ... at the Consumer Product Safety Commission’s Playground Safety website . References U.S. Consumer Product Safety Commission. Injuries and ...

MODERN TECHNOLOGICAL SOLUTIONS USED IN THE PRODUCTION OF BAKERY PRODUCTS WITH HIGH BIOLOGICAL VALUE

Directory of Open Access Journals (Sweden)

Marta Brodowska

2014-06-01

Full Text Available Biological value of the food products is a result of the presence of bioactive substances and the proportions of the components. Technological development allows to optimize and accelerate the processes of bread production and increase value of food. Bakery industry used whole grains and pseudocereals as additional source of active compounds, biotechnological techniques as using appropriate yeast strain and encapsulation, which provide protection of substance and their controlled release in production of functional bread. The adding to bread fruits, vegetables and condiments may increase content of vitamin, minerals, dietary fiber and other bioactive compounds.

Biological hydrogen production by dark fermentation: challenges and prospects towards scaled-up production.

Science.gov (United States)

RenNanqi; GuoWanqian; LiuBingfeng; CaoGuangli; DingJie

2011-06-01

Among different technologies of hydrogen production, bio-hydrogen production exhibits perhaps the greatest potential to replace fossil fuels. Based on recent research on dark fermentative hydrogen production, this article reviews the following aspects towards scaled-up application of this technology: bioreactor development and parameter optimization, process modeling and simulation, exploitation of cheaper raw materials and combining dark-fermentation with photo-fermentation. Bioreactors are necessary for dark-fermentation hydrogen production, so the design of reactor type and optimization of parameters are essential. Process modeling and simulation can help engineers design and optimize large-scale systems and operations. Use of cheaper raw materials will surely accelerate the pace of scaled-up production of biological hydrogen. And finally, combining dark-fermentation with photo-fermentation holds considerable promise, and has successfully achieved maximum overall hydrogen yield from a single substrate. Future development of bio-hydrogen production will also be discussed. Copyright © 2011 Elsevier Ltd. All rights reserved.

Dynamic modeling of the tradeoff between productivity and safety in critical engineering systems

International Nuclear Information System (INIS)

Cowing, Michelle M.; Elisabeth Pate-Cornell, M.; Glynn, Peter W.

2004-01-01

Short-term tradeoffs between productivity and safety often exist in the operation of critical facilities such as nuclear power plants, offshore oil platforms, or simply individual cars. For example, interruption of operations for maintenance on demand can decrease short-term productivity but may be needed to ensure safety. Operations are interrupted for several reasons: scheduled maintenance, maintenance on demand, response to warnings, subsystem failure, or a catastrophic accident. The choice of operational procedures (e.g. timing and extent of scheduled maintenance) generally affects the probabilities of both production interruptions and catastrophic failures. In this paper, we present and illustrate a dynamic probabilistic model designed to describe the long-term evolution of such a system through the different phases of operation, shutdown, and possibly accident. The model's parameters represent explicitly the effects of different components' performance on the system's safety and reliability through an engineering probabilistic risk assessment (PRA). In addition to PRA, a Markov model is used to track the evolution of the system and its components through different performance phases. The model parameters are then linked to different operations strategies, to allow computation of the effects of each management strategy on the system's long-term productivity and safety. Decision analysis is then used to support the management of the short-term trade-offs between productivity and safety in order to maximize long-term performance. The value function is that of plant managers, within the constraints set by local utility commissions and national (e.g. energy) agencies. This model is illustrated by the case of outages (planned and unplanned) in nuclear power plants to show how it can be used to guide policy decisions regarding outage frequency and plant lifetime, and more specifically, the choice of a reactor tripping policy as a function of the state of the

Benchmarking road safety of U.S. states: a DEA-based Malmquist productivity index approach.

Science.gov (United States)

Egilmez, Gokhan; McAvoy, Deborah

2013-04-01

In this study, a DEA based Malmquist index model was developed to assess the relative efficiency and productivity of U.S. states in decreasing the number of road fatalities. Even though the national trend in fatal crashes has reached to the lowest level since 1949 (Traffic Safety Annual Assessment Highlights, 2010), a state-by-state analysis and comparison has not been studied considering other characteristics of the holistic national road safety assessment problem in any work in the literature or organizational reports. In this study, a DEA based Malmquist index model was developed to assess the relative efficiency and productivity of 50 U.S. states in reducing the number of fatal crashes. The single output, fatal crashes, and five inputs were aggregated into single road safety score and utilized in the DEA-based Malmquist index mathematical model. The period of 2002-2008 was considered due to data availability for the inputs and the output considered. According to the results, there is a slight negative productivity (an average of -0.2 percent productivity) observed in the U.S. on minimizing the number of fatal crashes along with an average of 2.1 percent efficiency decline and 1.8 percent technological improvement. The productivity in reducing the fatal crashes can only be attributed to the technological growth since there is a negative efficiency growth is occurred. It can be concluded that even though there is a declining trend observed in the fatality rates, the efficiency of states in utilizing societal and economical resources towards the goal of zero fatality is not still efficient. More effective policy making towards increasing safety belt usage and better utilization of safety expenditures to improve road condition are derived as the key areas to focus on for state highway safety agencies from the scope of current research. Published by Elsevier Ltd.

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.

Natural product synthesis at the interface of chemistry and biology

Science.gov (United States)

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 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. PMID:25043880

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.

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... from lead limits under section 101 of the Consumer Product Safety Improvement Act for certain electronic devices. (a) The Consumer Product Safety Improvement Act (CPSIA) provides for specific lead limits...

Natural infection of cattle with an atypical 'HoBi'-like pestivirus--implications for BVD control and for the safety of biological products.

Science.gov (United States)

Ståhl, Karl; Kampa, Jaruwan; Alenius, Stefan; Persson Wadman, Annie; Baule, Claudia; Aiumlamai, Suneerat; Belák, Sándor

2007-01-01

During a study on Bovine Viral Diarrhoea (BVD) epidemiology in Thailand, a pestivirus was detected in serum from a calf. Comparative nucleotide sequence analysis showed that this virus was closely related to a recently described atypical pestivirus (D32/00_'HoBi') that was first isolated from a batch of foetal calf serum collected in Brazil. The results from virus neutralisation tests performed on sera collected from cattle in the herd of the infected calf, showed that these cattle had markedly higher antibody titres against the atypical pestivirus 'HoBi' than against Bovine Viral Diarrhoea Virus types 1 and 2, or Border Disease Virus. The results also supported, consequently, the results from the molecular analysis, and demonstrated that a 'HoBi'-like pestivirus had been introduced to, and was now circulating in the herd. This study is the first to report a natural infection in cattle with a virus related to this atypical pestivirus, and it suggests that this group of pestiviruses may already be spread in cattle populations. The findings have implications for BVD control and for the biosafety of vaccines and other biological products produced with foetal calf serum. Consequently, these atypical pestiviruses should be included in serological assays, and any diagnostic assay aimed at detection of pestiviruses in biological products or animals should be tested for its ability to detect them.

UPSAT guidelines. 1996 edition. Reference document for IAEA Uranium Productions Safety Assessment Teams (UPSATs)

International Nuclear Information System (INIS)

1996-05-01

The IAEA Uranium Production Safety Assessment Team (UPSAT) programme provides advice and assistance to Member States to enhance the safety and environmental performance of uranium production facilities during construction, commissioning and operation. Sound design and construction are prerequisite for the safe and environmentally responsible operation of uranium mines and mills. However, the safety of the facility depends ultimately on sound policies, procedures and practices; on the capability and reliability of the construction, commissioning and operating personnel; on comprehensive instructions; and on adequate resources. A positive attitude and conscientiousness on the part of the management and staff in discharging their responsibilities is important to safety. The UPSAT guidelines have been developed in the following areas: (1) management, organization and administration; (2) training and qualification; (3) operation (4) maintenance; (5) safety, fire protection, emergency planning, and preparedness; (6) radiation protection; (7) environmental monitoring programme; (8) construction management; (9) commissioning and decommissioning

Patient Drug Safety Reporting: Diabetes Patients' Perceptions of Drug Safety and How to Improve Reporting of Adverse Events and Product Complaints.

Science.gov (United States)

Patel, Puja; Spears, David; Eriksen, Betina Østergaard; Lollike, Karsten; Sacco, Michael

2018-03-01

Global health care manufacturer Novo Nordisk commissioned research regarding awareness of drug safety department activities and potential to increase patient feedback. Objectives were to examine patients' knowledge of pharmaceutical manufacturers' responsibilities and efforts regarding drug safety, their perceptions and experiences related to these efforts, and how these factors influence their thoughts and behaviors. Data were collected before and after respondents read a description of a drug safety department and its practices. We conducted quantitative survey research across 608 health care consumers receiving treatment for diabetes in the United States, Germany, United Kingdom, and Italy. This research validated initial, exploratory qualitative research (across 40 comparable consumers from the same countries) which served to guide design of the larger study. Before reading a drug safety department description, 55% of respondents were unaware these departments collect safety information on products and patients. After reading the description, 34% reported the department does more than they expected to ensure drug safety, and 56% reported "more confidence" in the industry as a whole. Further, 66% reported themselves more likely to report an adverse event or product complaint, and 60% reported that they were more likely to contact a drug safety department with questions. The most preferred communication methods were websites/online forums (39%), email (27%), and telephone (25%). Learning about drug safety departments elevates consumers' confidence in manufacturers' safety efforts and establishes potential for patients to engage in increased self-monitoring and reporting. Study results reveal potentially actionable insights for the industry across patient and physician programs and communications.

77 FR 51912 - Safety Zone; Tom Lyons Productions Fireworks, Long Island Sound, Sands Point, NY

Science.gov (United States)

2012-08-28

... DEPARTMENT OF HOMELAND SECURITY Coast Guard 33 CFR Part 165 [Docket Number USCG-2012-0618] RIN 1625-AA00 Safety Zone; Tom Lyons Productions Fireworks, Long Island Sound, Sands Point, NY AGENCY.... 165.T01-0618 to read as follows: Sec. 165.T01-0618 Safety Zone; Tom Lyons Productions Fireworks, Long...

Biological effects induced by low amounts of nuclear fission products

International Nuclear Information System (INIS)

Vasilenko, I.Ya.; Shishkin, V.F.; Khudyakova, N.V.

1991-01-01

The review deals with the problem of biological hazard of low radiation doses for animals and human beings taking into the danger of internal and external irradiation by nuclear fission products under conditions of enhancing anthropogenic radiation contamination of biosphere. An attention is paid to the estimation of life span carcinogenesis, genetic and delayed effects. A conclusion is made on a necessity of multiaspect investigation of biological importance of low radiation doses taking into account modifying effects of other environmental factors

Modeling issues associated with production reactor safety assessment

International Nuclear Information System (INIS)

Stack, D.W.; Thomas, W.R.

1990-01-01

This paper describes several Probabilistic Safety Assessment (PSA) modeling issues that are related to the unique design and operation of the production reactors. The identification of initiating events and determination of a set of success criteria for the production reactors is of concern because of their unique design. The modeling of accident recovery must take into account the unique operation of these reactors. Finally, a more thorough search and evaluation of common-cause events is required to account for combinations of unique design features and operation that might otherwise not be included in the PSA. It is expected that most of these modeling issues also would be encountered when modeling some of the other more unique reactor and nonreactor facilities that are part of the DOE nuclear materials production complex. 9 refs., 2 figs

A Review of the Poultry Meat Production Industry for Food Safety in Indonesia

Science.gov (United States)

Wahyono, N. D.; Utami, M. M. D.

2018-01-01

Poultry meat is an indispensable source of animal protein in human growth and development, so it is in great demand by people all over the world. Poultry meat has several advantages, namely the quality of nutrition is good enough, delicious taste, relatively affordable price, easy to get and accepted all levels of society with diverse backgrounds. The era of globalization requires competitive products, such as chicken meat in Indonesia, the current chicken meat industry is not only based on high production capacity and decreased production costs but also chicken products are safe to eat. As a consequence of trade liberalization, the poultry industry faces the threat of competition with cheaper products with better quality. The food safety of chicken meat starts from the farm, processing process until consumed. Food safety is a requirement of food products that must be handled by involving government, industry and consumers.

Sustained climate warming drives declining marine biological productivity

Science.gov (United States)

Moore, J. Keith; Fu, Weiwei; Primeau, Francois; Britten, Gregory L.; Lindsay, Keith; Long, Matthew; Doney, Scott C.; Mahowald, Natalie; Hoffman, Forrest; Randerson, James T.

2018-03-01

Climate change projections to the year 2100 may miss physical-biogeochemical feedbacks that emerge later from the cumulative effects of climate warming. In a coupled climate simulation to the year 2300, the westerly winds strengthen and shift poleward, surface waters warm, and sea ice disappears, leading to intense nutrient trapping in the Southern Ocean. The trapping drives a global-scale nutrient redistribution, with net transfer to the deep ocean. Ensuing surface nutrient reductions north of 30°S drive steady declines in primary production and carbon export (decreases of 24 and 41%, respectively, by 2300). Potential fishery yields, constrained by lower–trophic-level productivity, decrease by more than 20% globally and by nearly 60% in the North Atlantic. Continued high levels of greenhouse gas emissions could suppress marine biological productivity for a millennium.

Basic principles on the safety evaluation of the HTGR hydrogen production system

International Nuclear Information System (INIS)

Ohashi, Kazutaka; Nishihara, Tetsuo; Tazawa, Yujiro; Tachibana, Yukio; Kunitomi, Kazuhiko

2009-03-01

As HTGR hydrogen production systems, such as HTTR-IS system or GTHTR300C currently being developed by Japan Atomic Energy Agency, consists of nuclear reactor and chemical plant, which are without a precedent in the world, safety design philosophy and regulatory framework should be newly developed. In this report, phenomena to be considered and events to be postulated in the safety evaluation of the HTGR hydrogen production systems were investigated and basic principles to establish acceptance criteria for the explosion and toxic gas release accidents were provided. Especially for the explosion accident, quantitative criteria to the reactor building are proposed with relating sample calculation results. It is necessary to treat abnormal events occurred in the hydrogen production system as an 'external events to the nuclear plant' in order to classify the hydrogen production system as no-nuclear facility' and basic policy to meet such requirement was also provided. (author)

Aspects of the political economy of development and synthetic biology.

Science.gov (United States)

Wellhausen, Rachel; Mukunda, Gautam

2009-12-01

What implications might synthetic biology's potential as a wholly new method of production have for the world economy, particularly developing countries? Theories of political economy predict that synthetic biology can shift terms of trade and displace producers in developing countries. Governments, however, retain the ability to mitigate negative changes through social safety nets and to foster adaptation to some changes through research, education and investment. We consider the effects the synthetic production of otherwise naturally derived molecules are likely to have on trade and investment, particularly in developing countries. Both rubber in Malaysia and indigo dyes in India provide historical examples of natural molecules that faced market dislocations from synthetic competitors. Natural rubber was able to maintain significant market share, while natural indigo vanished from world markets. These cases demonstrate the two extremes of the impact synthetic biology might have on naturally derived products. If developing countries can cushion the pain of technological changes by providing producers support as they retool or exit, the harmful effects of synthetic biology can be mitigated while its benefits can still be captured.

The Effect of Product Safety Courses on the Adoption and Outcomes of LESS Surgery

OpenAIRE

Toomey, Paul G.; Ross, Sharona B.; Choung, Edward; Donn, Natalie; Vice, Michelle; Luberice, Kenneth; Albrink, Michael; Rosemurgy, Alexander S.

2015-01-01

Background and Objectives: As technology in surgery evolves, the medical instrument industry is inevitability involved in promoting the use and appropriate (ie, effective and safe) application of its products. This study was undertaken to evaluate industry-supported product safety courses in laparoendoscopic single-site (LESS) surgery, by using the metrics of surgeons' adoption of the technique, safety of the procedure, and surgeons' perception of the surgery. Methods: LESS surgery courses th...

Phytosterol oxidation products in enriched foods: Occurrence, exposure, and biological effects.

Science.gov (United States)

Scholz, Birgit; Guth, Sabine; Engel, Karl-Heinz; Steinberg, Pablo

2015-07-01

Hypercholesterolemia is an important risk factor for the development of cardiovascular diseases. Dietary intake of phytosterols/phytostanols and their fatty acid esters results in a reduction of the LDL and total plasma cholesterol levels. Therefore, these constituents are added to a broad spectrum of foods. As in the case of cholesterol, thermo-oxidative treatment of phytosterols may result in the formation of phytosterol oxidation products (POPs), i.e. keto-, hydroxy-, and epoxy-derivatives. This review summarizes and evaluates the current knowledge regarding POPs in the light of the potentially increasing dietary exposure to these constituents via the consumption of foods enriched with phytosterols/phytostanols and their esters. Data on the occurrence of POPs and approaches to assess the potential intake of POPs resulting from the consumption of enriched foods are described. The knowledge on the uptake of POPs and the presently available data on the impact of the consumption of enriched foods on the levels of POPs in humans are discussed. Biological effects of POPs, such as potential proatherogenic properties or the loss of the cholesterol-lowering effects compared to nonoxidized phytosterols, are discussed. Finally, knowledge gaps are outlined and recommendations for further research needed for a safety assessment of POPs are presented. © 2015 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

[Side effects of biologic therapies in psoriasis].

Science.gov (United States)

Altenburg, A; Augustin, M; Zouboulis, C C

2018-04-01

The introduction of biologics has revolutionized the treatment of moderate to severe plaque psoriasis. Due to the continuous expansion of biological therapies for psoriasis, it is particularly important to acknowledge efficacy and safety of the compounds not only in clinical trials but also in long-term registry-based observational studies. Typical side effects and significant risks of antipsoriatic biologic therapies considering psoriatic control groups are presented. A selective literature search was conducted in PubMed and long-term safety studies of the psoriasis registries PsoBest, PSOLAR and BADBIR were evaluated. To assess the long-term safety of biologics, the evaluation of the course of large patient cohorts in long-term registries is of particular medical importance. Newer biologic drugs seem to exhibit a better safety profile than older ones.

Chemical Biology of Microbial Anticancer Natural Products

DEFF Research Database (Denmark)

Bladt, Tanja Thorskov; Gotfredsen, Charlotte Held

than 100 years. New natural products (NPs) are continually discovered and with the increase in selective biological assays, previously described compounds often also display novel bioactivities, justifying their presence in novel screening efforts. Screening and discovery of compounds with activity...... towards chronic lymphocytic leukemia (CLL) cells is crucial since CLL is considered as an incurable disease. To discover novel agents that targets CLL cells is complicated. CLL cells rapidly undergo apoptosis in vitro when they are removed from their natural microenvironment, even though they are long...

[Storage of plant protection products in farms: minimum safety requirements].

Science.gov (United States)

Dutto, Moreno; Alfonzo, Santo; Rubbiani, Maristella

2012-01-01

Failure to comply with requirements for proper storage and use of pesticides in farms can be extremely hazardous and the risk of accidents involving farm workers, other persons and even animals is high. There are still wide differences in the interpretation of the concept of "securing or making safe", by workers in this sector. One of the critical points detected, particularly in the fruit sector, is the establishment of an adequate storage site for plant protection products. The definition of "safe storage of pesticides" is still unclear despite the recent enactment of Legislative Decree 81/2008 regulating health and work safety in Italy. In addition, there are no national guidelines setting clear minimum criteria for storage of plant protection products in farms. The authors, on the basis of their professional experience and through analysis of recent legislation, establish certain minimum safety standards for storage of pesticides in farms.

Nonclinical safety strategies for stem cell therapies

Energy Technology Data Exchange (ETDEWEB)

Sharpe, Michaela E., E-mail: michaela_sharpe@yahoo.com [Investigative Toxicology, Drug Safety Research and Development, Pfizer Ltd, Ramsgate Road, Sandwich, CT13 9NJ (United Kingdom); Morton, Daniel [Exploratory Drug Safety, Drug Safety Research and Development, Pfizer Inc, Cambridge, 02140 (United States); Rossi, Annamaria [Investigative Toxicology, Drug Safety Research and Development, Pfizer Ltd, Ramsgate Road, Sandwich, CT13 9NJ (United Kingdom)

2012-08-01

Recent breakthroughs in stem cell biology, especially the development of the induced pluripotent stem cell techniques, have generated tremendous enthusiasm and efforts to explore the therapeutic potential of stem cells in regenerative medicine. Stem cell therapies are being considered for the treatment of degenerative diseases, inflammatory conditions, cancer and repair of damaged tissue. The safety of a stem cell therapy depends on many factors including the type of cell therapy, the differentiation status and proliferation capacity of the cells, the route of administration, the intended clinical location, long term survival of the product and/or engraftment, the need for repeated administration, the disease to be treated and the age of the population. Understanding the product profile of the intended therapy is crucial to the development of the nonclinical safety study design.

Nonclinical safety strategies for stem cell therapies

International Nuclear Information System (INIS)

Sharpe, Michaela E.; Morton, Daniel; Rossi, Annamaria

2012-01-01

Recent breakthroughs in stem cell biology, especially the development of the induced pluripotent stem cell techniques, have generated tremendous enthusiasm and efforts to explore the therapeutic potential of stem cells in regenerative medicine. Stem cell therapies are being considered for the treatment of degenerative diseases, inflammatory conditions, cancer and repair of damaged tissue. The safety of a stem cell therapy depends on many factors including the type of cell therapy, the differentiation status and proliferation capacity of the cells, the route of administration, the intended clinical location, long term survival of the product and/or engraftment, the need for repeated administration, the disease to be treated and the age of the population. Understanding the product profile of the intended therapy is crucial to the development of the nonclinical safety study design.

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.

Safety assessment of personal care products/cosmetics and their ingredients

International Nuclear Information System (INIS)

Nohynek, Gerhard J.; Antignac, Eric; Re, Thomas; Toutain, Herve

2010-01-01

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

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

Dermal safety assessment of Arm & Hammer laundry products formulated for sensitive skin.

Science.gov (United States)

Frederick, Douglas M; Vorwerk, Linda; Gupta, Archana; Ghassemi, Annahita

2017-09-01

The prevalence of sensitive skin among the general population in industrialized countries is reported to be over 50%. Sensitive skin subjects often report significant reactions to contact with cosmetics, soaps and other consumer products. This paper describes the overall skin compatibility and mildness program for a newly developed, lightly fragranced, colorant free laundry product (i.e. Arm & Hammer™ Sensitive Skin plus Skin-Friendly Fresh Scent), specially formulated for individuals with sensitive skin. The skin mildness of the product was compared to Arm & Hammer™ Free & Clear liquid laundry detergent with no fragrance or colorant, and an established history of safe use by sensitive skin consumers. The test material was a liquid laundry product with a light scent formulated for sensitive skin consumers (Arm & Hammer™ Sensitive Skin plus Skin-Friendly Fresh Scent). The product was compared to commercially marketed products for sensitive skin with a history of skin safety in the marketplace, including: a very similar product formulation (Arm & Hammer™ Free & Clear with no fragrance), and several selected competitors' products. Studies were conducted among individuals with self-assessed sensitive skin (based on a questionnaire) using standard protocols for the Human Repeat Insult Patch Test (HRIPT), 10-Day Cumulative Irritation, the Wrist Band Wear test, and the Safety In-Use testing. Responses in all protocols were evaluated by visual scoring of potential dermatologic reactions, and recording any sensory effects at the time of the examination. In addition, sensory effects collected from panelists' daily diaries were also evaluated. The HRIPT confirmed that neither the fragrance alone, nor the product formulation with fragrance, induced contact sensitization in sensitive skin subjects. The 10-Day cumulative irritation study conducted using sensitive skin subjects showed highly favorable skin compatibility, and the test product was comparable to the control

Safety aspects of the production of foods and food ingredients from insects.

Science.gov (United States)

Schlüter, Oliver; Rumpold, Birgit; Holzhauser, Thomas; Roth, Angelika; Vogel, Rudi F; Quasigroch, Walter; Vogel, Stephanie; Heinz, Volker; Jäger, Henry; Bandick, Nils; Kulling, Sabine; Knorr, Dietrich; Steinberg, Pablo; Engel, Karl-Heinz

2017-06-01

At present, insects are rarely used by the European food industry, but they are a subject of growing interest as an alternative source of raw materials. The risks associated with the use of insects in the production of foods and food ingredients have not been sufficiently investigated. There is a lack of scientifically based knowledge of insect processing to ensure food safety, especially when these processes are carried out on an industrial scale. This review focuses on the safety aspects that need to be considered regarding the fractionation of insects for the production of foods and food ingredients. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Safety evaluation for packaging (onsite) product removal can containers

International Nuclear Information System (INIS)

Burnside, M.E.

1998-01-01

Six Product Removal (PR) Cans and Containers are located within the Plutonium Finishing Plant. Each can is expected to contain a maximum of 3 g of residual radioactive material, consisting mainly of plutonium isotopes. The PR Can Containers were previously authorized by HNF-SD-TP-SEP-064, Rev. 0 (Boettger 1997), for the interarea transport of up to 3 g of plutonium. The purpose of this safety evaluation for packaging is to allow the transport of six PR Cans with their Containers from the Plutonium Finishing Plant to the 233 S Evaporator Facility. This safety evaluation for packaging is authorized for use until April 29, 1999, or until the shipment is made, whichever happens first

Update of the list of QPS‐recommended biological agents intentionally added to food or feed as notified to EFSA 4: suitability of taxonomic units notified to EFSA until March 2016

OpenAIRE

EFSA Panel on Biological Hazards (BIOHAZ); Allende, Ana; Bolton, Declan; Chemaly, Marianne; Davies, Robert; Fernandez Escamez, Pablo Salvador; Girones, Rosina; Herman, Lieve; Koutsoumanis, Konstantinos; Lindqvist, Roland; Nørrung, Birgit; Ricci, Antonia; Robertson, Lucy; Ru, Giuseppe; Sanaa, Moez

2016-01-01

EFSA was requested to assess the safety of a broad range of biological agents in the context of notifications for market authorisation as sources of food and feed additives, enzymes and plant protection products. The qualified presumption of safety (QPS) assessment was developed to provide a harmonised generic preassessment to support safety risk assessments performed by EFSA's scientific Panels. The safety of unambiguously defined biological agents (at the highest taxonomic unit appropriate ...

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...

International trade standards for commodities and products derived from animals: the need for a system that integrates food safety and animal disease risk management.

Science.gov (United States)

Thomson, G R; Penrith, M-L; Atkinson, M W; Thalwitzer, S; Mancuso, A; Atkinson, S J; Osofsky, S A

2013-12-01

A case is made for greater emphasis to be placed on value chain management as an alternative to geographically based disease risk mitigation for trade in commodities and products derived from animals. The geographic approach is dependent upon achievement of freedom in countries or zones from infectious agents that cause so-called transboundary animal diseases, while value chain-based risk management depends upon mitigation of animal disease hazards potentially associated with specific commodities or products irrespective of the locality of production. This commodity-specific approach is founded on the same principles upon which international food safety standards are based, viz. hazard analysis critical control points (HACCP). Broader acceptance of a value chain approach enables animal disease risk management to be combined with food safety management by the integration of commodity-based trade and HACCP methodologies and thereby facilitates 'farm to fork' quality assurance. The latter is increasingly recognized as indispensable to food safety assurance and is therefore a pre-condition to safe trade. The biological principles upon which HACCP and commodity-based trade are based are essentially identical, potentially simplifying sanitary control in contrast to current separate international sanitary standards for food safety and animal disease risks that are difficult to reconcile. A value chain approach would not only enable more effective integration of food safety and animal disease risk management of foodstuffs derived from animals but would also ameliorate adverse environmental and associated socio-economic consequences of current sanitary standards based on the geographic distribution of animal infections. This is especially the case where vast veterinary cordon fencing systems are relied upon to separate livestock and wildlife as is the case in much of southern Africa. A value chain approach would thus be particularly beneficial to under-developed regions of

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.

Biological sludge solubilisation for reduction of excess sludge production in wastewater treatment process.

Science.gov (United States)

Yamaguchi, T; Yao, Y; Kihara, Y

2006-01-01

A novel sludge disintegration system (JFE-SD system) was developed for the reduction of excess sludge production in wastewater treatment plants. Chemical and biological treatments were applied to disintegrate excess sludge. At the first step, to enhance biological disintegration, the sludge was pretreated with alkali. At the second step, the sludge was disintegrated by biological treatment. Many kinds of sludge degrading microorganisms integrated the sludge. The efficiency of the new sludge disintegration system was confirmed in a full-scale experiment. The JFE-SD system reduced excess sludge production by approximately 50% during the experimental period. The quality of effluent was kept at quite a good level. Economic analysis revealed that this system could significantly decrease the excess sludge treatment cost.

Systems Biology of Microbial Exopolysaccharides Production.

Science.gov (United States)

Ates, Ozlem

2015-01-01

Exopolysaccharides (EPSs) 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 toward 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.

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.

Implementation of Plasma Fractionation in Biological Medicines Production

OpenAIRE

Mousavi Hosseini, Kamran; Ghasemzadeh, Mehran

2016-01-01

Context The major motivation for the preparation of the plasma derived biological medicine was the treatment of casualties from the Second World War. Due to the high expenses for preparation of plasma derived products, achievement of self-sufficiency in human plasma biotechnological industry is an important goal for developing countries. Evidence Acquisition The complexity of the blood plasma was first revealed by the Nobel Prize laureate, Arne Tiselius and Theodor Svedberg, which resulted in...

Formation of secondary products in water purification. ; Toxicological evaluation of mutagenic chlorination by-products during drinking water treatment. Josui shori ni okeru fukuseiseibutsu. ; Josui shori ni okeru hen'i genseibusshitsu no dokusei hyoka

Energy Technology Data Exchange (ETDEWEB)

Nakamuro, K [Setsunan Univ., Osaka (Japan). Faculty of Pharmaceutical Sciences; Sayato, Y [Setsunan Univ., Osaka (Japan)

1993-12-10

The biological effects of acute toxicity, chronic toxicity, carcinogenicity, etc. of chlorination by-products detected in drinking water in Japan are discussed. The biological effects of representative chlorination by-products such as trihalomethane, haloacetic acid, haloaldehyde, haloacetonitrile, chlorophenol, chloropicrin, etc. as well as the evaluation of mutagenicity in drinking water purification process, for which Ames Salmonella/microsome assay is used for safety evaluation of drinking water, are discussed. The extent of the contribution of mutagenicity of chlorination disinfection by-products to the mutagenicity of drinking water is investigated. It must be admitted that biological evaluation of the safety of water quality is impossible currently by using only the known chemical substances contained in drinking water. The effects of chlorination and ozone treatment which are often applied to drinking water treatment are different each other. 58 refs., 1 fig., 4 tabs.

No longer "if," but "when": the coming abbreviated approval pathway for follow-on biologics.

Science.gov (United States)

Kelly, Jeremiah J; David, Michael

2009-01-01

Abbreviated approval of follow-on biologics involves answering complex scientific, legal, and policy questions. The Food and Drug Administration (FDA or the Agency) asserts that it lacks the statutory authority to approve follow-on versions of biologics licensed under Section 351 of the Public Health Service Act (PHSA). Despite persuasive arguments to the contrary the one hundred and tenth Congress entertained four legislative proposals to give FDA this authority, each markedly different. It is no longer a question of "if," but "when" FDA will receive authority to review and license abbreviated applications for follow-on biologics. Any legislation in the one hundred and eleventh Congress must determine: (1) if FDA should be granted authority to develop an abbreviated pathway through rulemaking or guidance; (2) if human clinical trials should be mandatory or discretionary; (3) the feasibility of interchangeability determinations in light of patient safety concerns; (4) the duration of marketing exclusivity for associated products; (5) which products are eligible for follow-on approval; and (6) the degree to which uniformity is achievable between the FD&C Act and the PHSA. This paper recommends the one hundred and eleventh Congress strike a balance between patient safety, incentives for product innovation, price competition, and the need for a flexible, transparent process that capitalizes on FDA's growing expertise with follow-on biologics approvals under Section 505(b)(2) of the FD&C Act.

Assessment of radiation safety awareness and attitude toward biological effect of radiation for employees in nuclear workplace

International Nuclear Information System (INIS)

Youngchuay, U.; Jetawattana, S.; Toeypho, V.; Eso, J.

2016-01-01

This study demonstrated a potential relevance of data pertaining to the interaction of awareness in radiation biology and their attitude towards radiation hazards. The obtained information is useful in ascertaining the effectiveness of the ongoing radiation safety program and will be further used to determine the relationships between the radiation effective dose and cytogenetic approach in these groups of workers. (author)

Microbiological quality and safety assessment of lettuce production in Brazil.

Science.gov (United States)

Ceuppens, Siele; Hessel, Claudia Titze; de Quadros Rodrigues, Rochele; Bartz, Sabrina; Tondo, Eduardo César; Uyttendaele, Mieke

2014-07-02

The microbiological quality and safety of lettuce during primary production in Brazil were determined by enumeration of hygiene indicators Escherichia coli, coliforms and enterococci and detection of enteric pathogens Salmonella and E. coli O157:H7 in organic fertilizers, soil, irrigation water, lettuce crops, harvest boxes and worker's hands taken from six different lettuce farms throughout the crop growth cycle. Generic E. coli was a suitable indicator for the presence of Salmonella and E. coli O157:H7, while coliforms and enterococci were not. Few pathogens were detected: 5 salmonellae and 2 E. coli O157:H7 from 260 samples, of which only one was lettuce and the others were manure, soil and water. Most (5/7) pathogens were isolated from the same farm and all were from organic production. Statistical analysis revealed the following environmental and agro-technical risk factors for increased microbial load and pathogen prevalence in lettuce production: high temperature, flooding of lettuce fields, application of contaminated organic fertilizer, irrigation with water of inferior quality and large distances between the field and toilets. Control of the composting process of organic fertilizers and the irrigation water quality appear most crucial to improve and/or maintain the microbiological quality and safety during the primary production of lettuce. Copyright © 2014 Elsevier B.V. All rights reserved.

Photochemical versus biological production of methyl iodide during Meteor 55

Science.gov (United States)

Richter, U.; Wallace, D.

2003-04-01

The flux of methyl iodide from sea to air represents the largest flux of iodine from the ocean to the atmosphere. Surface water concentrations and hence fluxes are particularly high in tropical regions. This flux may be responsible for the enrichment of iodine in the marine aerosol and may contribute to important processes in the marine boundary layer, including particle formation. Methyl iodide is commonly referred to as a biogenic gas, with both macroalgae and phytoplankton identified as important sources. On the other hand experimental and field data have shown the importance of photochemical production that is not necessarily associated directly with biological activity. During the Meteor cruise 55 along 11°N in the tropical Atlantic Ocean, a series of experiments were conducted to examine the biological vs. photochemical production of methyl iodide. A total of eight separate experiments were conducted. Production of CH3I in quartz glass flasks during 24 hour incubations (dark and natural sunlight) was measured under three experimental treatments: untreated seawater, filtered seawater (0.1 um pore size filter to exclude most phytoplankton and bacteria), and seawater that was poisoned with mercuric chloride. There were two clear findings from these experiments: (1) methyl iodide production was significantly higher in all the incubations that were exposed to the light than in the dark incubations; (2) there was no significant difference between CH3I production under the three experimental treatments. These results argue very strongly for the primary importance of photochemical production of CH3I as opposed to biogenic production at least for the tropical open ocean surface waters. Further experiments are required to investigate the reactants involved, their sources, the wavelength and depth dependence of production, etc. as well as (possibly related) sink processes.

Very-large-scale production of antibodies in plants: The biologization of manufacturing.

Science.gov (United States)

Buyel, J F; Twyman, R M; Fischer, R

2017-07-01

Gene technology has facilitated the biologization of manufacturing, i.e. the use and production of complex biological molecules and systems at an industrial scale. Monoclonal antibodies (mAbs) are currently the major class of biopharmaceutical products, but they are typically used to treat specific diseases which individually have comparably low incidences. The therapeutic potential of mAbs could also be used for more prevalent diseases, but this would require a massive increase in production capacity that could not be met by traditional fermenter systems. Here we outline the potential of plants to be used for the very-large-scale (VLS) production of biopharmaceutical proteins such as mAbs. We discuss the potential market sizes and their corresponding production capacities. We then consider available process technologies and scale-down models and how these can be used to develop VLS processes. Finally, we discuss which adaptations will likely be required for VLS production, lessons learned from existing cell culture-based processes and the food industry, and practical requirements for the implementation of a VLS process. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Diagnostic and proposal for use of safety inventory into finished products for a plastics company

Directory of Open Access Journals (Sweden)

Elpidio Oscar Benitez Nara

2013-02-01

Full Text Available The stock is essential for companies. Thinking about it, it is increasingly necessary to develop techniques that seek to reduce inventory levels making them suitable to the company structure and satisfactorily meet the needs of increasingly demanding customers while maintaining the service level. The safety stock is derived from various uncertainties such as shortage of raw materials and difficulties in producing variations in sales projections thus scaling of this safety stock is a most difficult task to perform. In this sense, the present study aims to demonstrate the Inventory Management structure acceptable to a company that seeks to reduce capital invested in stocks as well as a for continuous review reorder point. The research was developed through an analysis of the current policy Inventories of the company, where we sought the most representative products of the product line. For these products it was necessary future sales forecasts for the annual period where it was possible to scale according to company politic Inventories of the average stocks of these products in order to compare with the stocks of securities calculated using specific equations. Then, using the equations it was also defined the point of application of all the studied products was defined, as a model for continuous revision product line studied. Finally the proposed method for use of safety stock techniques showed good results as a reduction of approximately 43% of capital invested in safety stock if compared to current Inventories policy of the company.

PCMO L01-Setting Specifications for Biological Investigational Medicinal Products.

Science.gov (United States)

Krause, Stephan O

2015-01-01

This paper provides overall guidance and best practices for the setting of specifications for clinical biological drug substances and drug products within the framework of ICH guidelines on pharmaceutical development [Q8(R2) and Q11], quality risk management (Q9), and quality systems (Q10). A review is provided of the current regulatory expectations for the specification setting process as part of a control strategy during product development, pointing to existing challenges for the investigational new drug/investigational medicinal product dossier (IND/IMPD) sponsor. A case study illustrates how the investigational medicinal product specification revision process can be managed within a flexible quality system, and how specifications can be set and justified for early and late development stages. This paper provides an overview for the setting of product specifications for investigational medicinal products used in clinical trials. A case study illustrates how product specifications of investigational medicinal products can be justified and managed within a modern product quality system. © PDA, Inc. 2015.

RFID in the blood supply chain--increasing productivity, quality and patient safety.

Science.gov (United States)

Briggs, Lynne; Davis, Rodeina; Gutierrez, Alfonso; Kopetsky, Matthew; Young, Kassandra; Veeramani, Raj

2009-01-01

As part of an overall design of a new, standardized RFID-enabled blood transfusion medicine supply chain, an assessment was conducted for two hospitals: the University of Iowa Hospital and Clinics (UIHC) and Mississippi Baptist Health System (MBHS). The main objectives of the study were to assess RFID technological and economic feasibility, along with possible impacts to productivity, quality and patient safety. A step-by-step process analysis focused on the factors contributing to process "pain points" (errors, inefficiency, product losses). A process re-engineering exercise produced blueprints of RFID-enabled processes to alleviate or eliminate those pain-points. In addition, an innovative model quantifying the potential reduction in adverse patient effects as a result of RFID implementation was created, allowing improvement initiatives to focus on process areas with the greatest potential impact to patient safety. The study concluded that it is feasible to implement RFID-enabled processes, with tangible improvements to productivity and safety expected. Based on a comprehensive cost/benefit model, it is estimated for a large hospital (UIHC) to recover investment from implementation within two to three years, while smaller hospitals may need longer to realize ROI. More importantly, the study estimated that RFID technology could reduce morbidity and mortality effects substantially among patients receiving transfusions.

MICROBIOLOGICAL SAFETY BIBLIOGRAPHY

Science.gov (United States)

More than a thousand articles on biological safety in infectious disease laboratories are listed for the use of supervisors responsible for the safety of laboratory personnel. An author index is included.

Advanced glycation end-products: a biological consequence of lifestyle contributing to cancer disparity.

Science.gov (United States)

Turner, David P

2015-05-15

Low income, poor diet, obesity, and a lack of exercise are interrelated lifestyle factors that can profoundly alter our biologic make up to increase cancer risk, growth, and development. We recently reported a potential mechanistic link between carbohydrate-derived metabolites and cancer, which may provide a biologic consequence of lifestyle that can directly affect tumor biology. Advanced glycation end-products (AGE) are reactive metabolites produced as a by-product of sugar metabolism. Failure to remove these highly reactive metabolites can lead to protein damage, aberrant cell signaling, increased stress responses, and decreased genetic fidelity. Critically, AGE accumulation is also directly affected by our lifestyle choices and shows a race-specific, tumor-dependent pattern of accumulation in cancer patients. This review will discuss the contribution of AGEs to the cancer phenotype, with a particular emphasis on their biologic links with the socioeconomic and environmental risk factors that drive cancer disparity. Given the potential benefits of lifestyle changes and the potential biologic role of AGEs in promoting cancer, opportunities exist for collaborations affecting basic, translational, epidemiologic, and cancer prevention initiatives. ©2015 American Association for Cancer Research.

Occupational Health and Safety: reflection on potential risks and the safety handling of nanomaterials

Directory of Open Access Journals (Sweden)

Guilherme Frederico Bernardo Lenz e Silva

2013-11-01

Full Text Available Every day the nanotechnology, that refers to a field whose theme is the control of matter on an atomic and molecular scale working with nanometric structures (<100 nm, is more present in the development of products and industrial processes. The particle manipulation of nanometric structures has created opportunities in the development of new products and materials. However, synthesis, handling, storage, stabilization and the incorporation of these materials, with nanometric dimensions, demand a new perspective of analysis and evaluation of old manufacturing processes, procedures and industrial devices, in order to guarantee collective and individual protection to workers and society. With the increasing of scale and production of nanoestrutuctured materials, a big part of labour community starts to be in contact with different nanomaterials (forms and ways. In this work the main aspects and involved risks of manufacture, storage, synthesis, stabilization and incorporation of nanomaterials on new products are evaluated in order to reduce, decrease and eliminate chemical, physical and biological risks for the employees. A bibliographic review was conducted about risk, safety and nanotechnology based on available English literature focusing safety and environmental agencies from different countries such as USA, Canada, EU (France, UK, Germany, Den-mark, Australia and Japan.

A consilience model to describe N2O production during biological N removal

DEFF Research Database (Denmark)

Domingo Felez, Carlos; Smets, Barth F.

2016-01-01

Nitrous oxide (N2O), a potent greenhouse gas, is produced during biological nitrogen conversion in wastewater treatment operations. Complex mechanisms underlie N2O production by autotrophic and heterotrophic organisms, which continue to be unravelled. Mathematical models that describe nitric oxide...... (NO) and N2O dynamics have been proposed. Here, a first comprehensive model that considers all relevant NO and N2O production and consumption mechanisms is proposed. The model describes autotrophic NO production by ammonia oxidizing bacteria associated with ammonia oxidation and with nitrite reduction......, followed by NO reduction to N2O. It also considers NO and N2O as intermediates in heterotrophic denitrification in a 4-step model. Three biological NO and N2O production pathways are accounted for, improving the capabilities of existing models while not increasing their complexity. Abiotic contributions...

Radioactivity in consumer products : radiation safety and regulatory appraisal

International Nuclear Information System (INIS)

Murthy, B.K.S.; Venkataraman, G.; Subrahmanym, P.

1993-01-01

Use of radioactive materials in consumer products is in vogue almost since the discovery of radioactivity. There has been a rapid growth in the use of radioactive material in various consumer products such as Ionization Chamber Smoke Detectors (ICSD), Static eliminators, etc. In addition, there are certain manufacturing processes wherein the Naturally Occurring Radioactive Material (NORM) get incorporated in the consumer products. Certain phosphatic fertilizers, titanium dioxide pigments, phospho gypsum plaster boards are some examples in this category. The manufacture and use of these products result in radiation dose to the public apart from radiation exposure to the personnel involved in the manufacturing process. Appropriate radiation control measures have to be taken in the design, manufacture and use of consumer products to ensure that the radiation doses to the public and the population at large do not exceed the relevant limits. While appropriate regulatory controls and surveillance are established for manufacture and use of certain products, these are still to be recognised and established in respect of certain other processes and products. The current status of radiation safety and regulatory control and the lack of these in respect of some products are discussed in this paper. (author). 5 refs

Urine: Waste product or biologically active tissue?

Science.gov (United States)

2018-03-01

Historically, urine has been viewed primarily as a waste product with little biological role in the overall health of an individual. Increasingly, data suggest that urine plays a role in human health beyond waste excretion. For example, urine might act as an irritant and contribute to symptoms through interaction with-and potential compromise of-the urothelium. To explore the concept that urine may be a vehicle for agents with potential or occult bioactivity and to discuss existing evidence and novel research questions that may yield insight into such a role, the National Institute of Diabetes and Digestive and Kidney Disease invited experts in the fields of comparative evolutionary physiology, basic science, nephrology, urology, pediatrics, metabolomics, and proteomics (among others) to a Urinology Think Tank meeting on February 9, 2015. This report reflects ideas that evolved from this meeting and current literature, including the concept of urine quality, the biological, chemical, and physical characteristics of urine, including the microbiota, cells, exosomes, pH, metabolites, proteins, and specific gravity (among others). Additionally, the manuscript presents speculative, and hopefully testable, ideas about the functional roles of urine constituents in health and disease. Moving forward, there are several questions that need further understanding and pursuit. There were suggestions to consider actively using various animal models and their biological specimens to elaborate on basic mechanistic information regarding human bladder dysfunction. Published 2018. This article is a U.S. Government work and is in the public domain in the USA.

Product quality considerations for mammalian cell culture process development and manufacturing.

Science.gov (United States)

Gramer, Michael J

2014-01-01

The manufacturing of a biologic drug from mammalian cells results in not a single substance, but an array of product isoforms, also known as variants. These isoforms arise due to intracellular or extracellular events as a result of biological or chemical modification. The most common examples related to biomanufacturing include amino acid modifications (glycosylation, isomerization, oxidation, adduct formation, pyroglutamate formation, phosphorylation, sulfation, amidation), amino acid sequence variants (genetic mutations, amino acid misincorporation, N- and C-terminal heterogeneity, clipping), and higher-order structure modifications (misfolding, aggregation, disulfide pairing). Process-related impurities (HCP, DNA, media components, viral particles) are also important quality attributes related to product safety. The observed ranges associated with each quality attribute define the product quality profile. A biologic drug must have a correct and consistent quality profile throughout clinical development and scale-up to commercial production to ensure product safety and efficacy. In general, the upstream process (cell culture) defines the quality of product-related substances, whereas the downstream process (purification) defines the residual level of process- and product-related impurities. The purpose of this chapter is to review the impact of the cell culture process on product quality. Emphasis is placed on studies with industrial significance and where the direct mechanism of product quality impact was determined. Where possible, recommendations for maintaining consistent or improved quality are provided.

Fission product source terms and engineered safety features

International Nuclear Information System (INIS)

Malinauskas, A.P.

1984-01-01

The author states that new, technically defensible, methodologies to establish realistic source term values for nuclear reactor accidents will soon be available. Although these methodologies will undoubtedly find widespread use in the development of accident response procedures, the author states that it is less clear that the industry is preparing to employ the newer results to develop a more rational approach to strategies for the mitigation of fission product releases. Questions concerning the performance of existing engineered safety systems are reviewed

The aspect of personnel metal attitude in the production safety

International Nuclear Information System (INIS)

Joyosukarto, Priyanto M.

2002-01-01

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

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

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......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...

Recent advances on biological production of difructose dianhydride III.

Science.gov (United States)

Zhu, Yingying; Yu, Shuhuai; Zhang, Wenli; Zhang, Tao; Guang, Cuie; Mu, Wanmeng

2018-04-01

Difructose dianhydride III (DFA III) is a cyclic difructose containing two reciprocal glycosidic linkages. It is easily generated with a small amount by sucrose caramelization and thus occurs in a wide range of food-stuffs during food processing. DFA III has half sweetness but only 1/15 energy of sucrose, showing potential industrial application as low-calorie sucrose substitute. In addition, it displays many benefits including prebiotic effect, low cariogenicity property, and hypocholesterolemic effect, and improves absorption of minerals, flavonoids, and immunoglobulin G. DFA III is biologically produced from inulin by inulin fructotransferase (IFTase, EC 4.2.2.18). Plenty of DFA III-producing enzymes have been identified. The crystal structure of inulin fructotransferase has been determined, and its molecular modification has been performed to improve the catalytic activity and structural stability. Large-scale production of DFA III has been studied by various IFTases, especially using an ultrafiltration membrane bioreactor. In this article, the recent findings on physiological effects of DFA III are briefly summarized; the research progresses on identification, expression, and molecular modification of IFTase and large-scale biological production of DFA III by IFTase are reviewed in detail.

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.

Food safety hazards in Georgian Tushuri Guda cheese

Directory of Open Access Journals (Sweden)

Avtandil Korakhashvili

2016-09-01

Full Text Available Scientific-research work provides a timely and valuable review of the progress being made in the greater understanding of the factors contributing to Tushuri Guda cheese making and how this experience may be applied to producing better and more consistent products with food safety HACCP system requirements. The HACCP study in this variety of cheese covers all types of food safety hazards, like biological, chemical and physical, but unfortunately it needs a more precise definition. It did not include clarification of cleaning and sanitation operations in accordance with modern standards, sanitation of grasslands and meadows. All of that are covered by the plant Good Manufacturing Practices (GMPs procedures and Good Hygiene Practices (GHPs for the obtaining of maximal food safety results.

In question: the scientific value of preclinical safety pharmacology and toxicology studies with cell-based therapies

Directory of Open Access Journals (Sweden)

Christiane Broichhausen

2014-01-01

Full Text Available A new cell-based medicinal product containing human regulatory macrophages, known as Mreg_UKR, has been developed and conforms to expectations of a therapeutic drug. Here, Mreg_UKR was subjected to pharmacokinetic, safety pharmacology, and toxicological testing, which identified no adverse reactions. These results would normally be interpreted as evidence of the probable clinical safety of Mreg_UKR; however, we contend that, owing to their uncertain biological relevance, our data do not fully support this conclusion. This leads us to question whether there is adequate scientific justification for preclinical safety testing of similar novel cell-based medicinal products using animal models. In earlier work, two patients were treated with regulatory macrophages prior to kidney transplantation. In our opinion, the absence of acute or chronic adverse effects in these cases is the most convincing available evidence of the likely safety of Mreg_UKR in future recipients. On this basis, we consider that safety information from previous clinical investigations of related cell products should carry greater weight than preclinical data when evaluating the safety profile of novel cell-based medicinal products. By extension, we argue that omitting extensive preclinical safety studies before conducting small-scale exploratory clinical investigations of novel cell-based medicinal products data may be justifiable in some instances.

Interactive influences of bioactive trace metals on biological production in oceanic waters

International Nuclear Information System (INIS)

Bruland, K.W.; Donat, J.R.; Hutchins, D.A.

1991-01-01

The authors present an overview of the oceanic chemistries of the bioactive trace metals, Mn, Fe, Co, Ni, Cu, and Zn; the authors combine field data with results from laboratory phytoplankton culture-trace metal studies and speculate on the potential influences of these trace metals on oceanic plankton production and species composition. Most field studies have focused on the effects of single metals. However, they propose that synergistic and antagonistic interactions between multiple trace metals could be very important in the oceans. Trace metal antagonisms that may prove particularly important are those between Cu and the potential biolimiting metals Fe, Mn, and Zn. These antagonistic interactions could have the greatest influence on biological productivity in areas of the open ocean isolated from terrestrial inputs, such as the remote high nutrient regions of the Pacific and Antarctic Oceans. The emerging picture of trace metal-biota interactions in these oceanic areas is one in which biology strongly influences distribution and chemical speciation of all these bioactive trace metals. It also seems likely that many of these bioactive trace metals and their speciation may influence levels of primary productivity, species composition, and trophic structure. Future investigations should give more complete consideration to the interactive effects of biologically important trace metals

Insects: an underrepresented resource for the discovery of biologically active natural products

Directory of Open Access Journals (Sweden)

Lauren Seabrooks

2017-07-01

Full Text Available Nature has been the source of life-changing and -saving medications for centuries. Aspirin, penicillin and morphine are prime examples of Nature׳s gifts to medicine. These discoveries catalyzed the field of natural product drug discovery which has mostly focused on plants. However, insects have more than twice the number of species and entomotherapy has been in practice for as long as and often in conjunction with medicinal plants and is an important alternative to modern medicine in many parts of the world. Herein, an overview of current traditional medicinal applications of insects and characterization of isolated biologically active molecules starting from approximately 2010 is presented. Insect natural products reviewed were isolated from ants, bees, wasps, beetles, cockroaches, termites, flies, true bugs, moths and more. Biological activities of these natural products from insects include antimicrobial, antifungal, antiviral, anticancer, antioxidant, anti-inflammatory and immunomodulatory effects.

Atomic risk insurance. Risk policy, safety production and expertise in Germany and the USA 1945 - 1986

International Nuclear Information System (INIS)

Wehner, Christoph

2017-01-01

The book covers the following chapters: (I) Between threat and promise: Political change and the corporate perception, the burden of the atomic bomb, promise of nuclear energy risk criticism in the pre-ecological phase, nuclear risk as investment restraint; (II) Risk policy at the insurability limit: hazard knowledge, safety production and insurance expertise in the German nuclear policy (1955-1962); (III) Risk policy beyond the catastrophe, insurability interpretation, concepts and conflicts (1957-1968); (IV) Scandalization of risk policy: safety production, confidence and expertise in the nuclear controversial debate (1969 - 1979); (V) Nuclear risk policy and the challenge of the ''risk society'' (1975-1986); (VI) From safety production to hazard probe: atomic energy And the change of insurance.

Continuous downstream processing for high value biological products: A Review.

Science.gov (United States)

Zydney, Andrew L

2016-03-01

There is growing interest in the possibility of developing truly continuous processes for the large-scale production of high value biological products. Continuous processing has the potential to provide significant reductions in cost and facility size while improving product quality and facilitating the design of flexible multi-product manufacturing facilities. This paper reviews the current state-of-the-art in separations technology suitable for continuous downstream bioprocessing, focusing on unit operations that would be most appropriate for the production of secreted proteins like monoclonal antibodies. This includes cell separation/recycle from the perfusion bioreactor, initial product recovery (capture), product purification (polishing), and formulation. Of particular importance are the available options, and alternatives, for continuous chromatographic separations. Although there are still significant challenges in developing integrated continuous bioprocesses, recent technological advances have provided process developers with a number of attractive options for development of truly continuous bioprocessing operations. © 2015 Wiley Periodicals, Inc.

Biological waste by-production costs in forest management and possibilities for their reduction

Directory of Open Access Journals (Sweden)

Jiří Kadlec

2004-01-01

Full Text Available Biological wastes in forestry were observed from view of their by-production in silvicultural and logging operations. There were identified points where biological waste was produced in this paper, waste costs ratio for silvicultural and logging operations and were made suggestions for reduction of these costs. Biological waste costs give 34.4% of total costs of silvicultural operations and 30% of total costs of logging operations. Natural regeneration and minor forest produce operations are opportunities for reduction of these costs.

75 FR 47602 - Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

Science.gov (United States)

2010-08-06

...] Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) AGENCY: Food... (OPD) grant program. The goal of FDA's OPD grant program is to support the clinical development of... product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and...

Follow-on biologics: competition in the biopharmaceutical marketplace.

Science.gov (United States)

Devine, Joshua W; Cline, Richard R; Farley, Joel F

2006-01-01

To describe the implications of a follow-on biologic approval process with focus on current stakeholders, implications of the status quo, and recommendations for future policy. A search using Medline, International Pharmaceutical Abstracts, Med Ad News, F-D-C Reports/Pink Sheets, and Google index directories was conducted with terms such as biologic, biopharmaceutical, generic, and follow-on. Articles pertaining to the follow-on biologic debate. By the authors. Over the past decade, the biopharmaceutical market has experienced substantial growth in the number of product approvals and sales. In contrast with prescription medications, biologic agents currently lack an abbreviated regulatory approval process. Evidence from the Drug Price Competition and Patent Term Restoration Act of 1984 suggests that reducing barriers to generic competition in the pharmaceutical market successfully increases generic market penetration and reduces overall prices to consumers. Although scientific and regulatory dissimilarities between biopharmaceuticals and other medications exist, a follow-on biologic approval process has the potential to play an important role in containing growth in pharmaceutical spending. In addition to biopharmaceutical and generic biopharmaceutical manufacturers, stakeholders with a vested interest in this debate include individual consumers who continue to bear the burden of spending increases in the pharmaceutical market. The debate over a follow-on process likely will be difficult as parties seek a balance between incentives for biopharmaceutical innovation, consumer safety, and affordability of existing biologic products.

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.

The Quality and Food Safety of Dry Smoke Garfish (Hemirhamphus far) Product From Maluku

Science.gov (United States)

Marthina Tapotubun, Alfonsina; Reiuwpassa, Fredrik; Apituley, Yolanda M. T. N.; Nanlohy, Hellen; Matrutty, Theodora E. A. A.

2017-10-01

Dry garfish is product of smoked process of “ikan julung” (Hemirhamphus far) and slowly the product getting dry, stiff and its colour become gold yellow-brown. The aim of this study is to find out quality and food safety of dry smoked “julung” from Maluku. The sample of this study is taken from production Keffing village, East Seram Regency, Maluku. Parameters to be analyzed are degrees of protein, fat, water, ash, TPC, Escherichia coli, Salmonella, Vibrio and total Staphylococcus aureus used standard analysis method for proximate (AOAC. 2005), sensosy parameters (BSN.2009) and food safety (BSN. 2006). Spreadsheet Ms Excel (Microsoft Inc., USA) is used for data processing; data is being analyzed descriptively to be interpreted in the research report. Dry smoked “julung” Keffing village, Maluku meet the good quality and food safety, that are ingredient degrees of water content 12.43%, protein 61.55%, fat 12.58%, ash 9.3%, TPC [6,8] × 101 CFU, total Staphylococcus sp [1,7] × 102, total E.coli 6.4 APM/g. and negatively for Salmonella and Vibrio.

Future Food Production System Development Pulling From Space Biology Crop Growth Testing in Veggie

Science.gov (United States)

Massa, Gioia; Romeyn, Matt; Fritsche, Ralph

2017-01-01

Preliminary crop testing using Veggie indicates the environmental conditions provided by the ISS are generally suitable for food crop production. When plant samples were returned to Earth for analysis, their levels of nutrients were comparable to Earth-grown ground controls. Veggie-grown produce food safety microbiology analysis indicated that space-grown crops are safe to consume. Produce sanitizing wipes were used on-orbit to further reduce risk of foodborne illness. Validation growth tests indicated abiotic challenges of insufficient or excess fluid delivery, potentially reduced air flow leading to excess water, elevated CO2 leading to physiological responses, and microorganisms that became opportunistic pathogens. As NASA works to develop future space food production, several areas of research to define these systems pull from the Veggie technology validation tests. Research into effective, reusable water delivery and water recovery methods for future food production systems arises from abiotic challenges observed. Additionally, impacts of elevated CO2 and refinement of fertilizer and light recipes for crops needs to be assessed. Biotic pulls include methods or technologies to effectively sanitize produce with few consumables and low inputs; work to understand the phytomicrobiome and potentially use it to protect crops or enhance growth; selection of crops with high harvest index and desirable flavors for supplemental nutrition; crops that provide psychosocial benefits, and custom space crop development. Planning for future food production in a deep space gateway or a deep space transit vehicle requires methods of handling and storing seeds, and ensuring space seeds are free of contaminants and long-lived. Space food production systems may require mechanization and autonomous operation, with preliminary testing initiated to identify operations and capabilities that are candidates for automation. Food production design is also pulling from Veggie logistics

[Biological agents].

Science.gov (United States)

Amano, Koichi

2009-03-01

There are two types of biological agents for the treatment of rheumatoid arthritis (RA); monoclonal antibodies and recombinant proteins. Among the latter, etanercept, a recombinant fusion protein of soluble TNF receptor and IgG was approved in 2005 in Japan. The post-marketing surveillance of 13,894 RA patients revealed the efficacy and safety profiles of etanercept in the Japanese population, as well as overseas studies. Abatacept, a recombinant fusion protein of CTLA4 and IgG, is another biological agent for RA. Two clinical trials disclosed the efficacy of abatacept for difficult-to-treat patients: the AIM for MTX-resistant cases and the ATTAIN for patients who are resistant to anti-TNF. The ATTEST trial suggested abatacept might have more acceptable safety profile than infliximab. These biologics are also promising for the treatment of RA for not only relieving clinical symptoms and signs but retarding structural damage.

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.

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.

State of the art of biological hydrogen production processes

International Nuclear Information System (INIS)

Loubette, N.; Junker, M.

2006-01-01

Our report gives an overview of hydrogen production processes with bacteria or algae. 4 main processes are described: water biophotolysis, photo- fermentation biological CO conversion and dark fermentation. Chemical phenomena which lead to hydrogen generation are exp/aired. Performances, limits and outlook are given for each process. Main projects, programs and key players involved in this field of research have been listed. This paper resumes few results of this report. (authors)

State of the art of biological hydrogen production processes

International Nuclear Information System (INIS)

Nicolas Loubette; Michel Junker

2006-01-01

Our report gives an overview of hydrogen production processes with bacteria or algae. 4 main processes are described: water bio-photolysis, photo-fermentation biological CO conversion and dark fermentation. Chemical phenomena which lead to hydrogen generation are explained. Performances, limits and outlook are given for each process. Main projects, programs and key players involved in this field of research have been listed. This paper resumes few results of this report. (authors)

National experience in radiosterelization or radiodescontamination of biological products

International Nuclear Information System (INIS)

Padron, E.; Romay, Z.; Otero, I.; Chavez, A.; Prieto, E.; Sainz, D.; Rodriguez, R.; Diaz, D.

1997-01-01

The ionizing radiations are especially important when other chemical and physical methods can't be used, or they don't give the result required, for which the employment of advanced technologies for the sterilization is found in ascent at world level. To such effect, the International Atomic Energy Agency has, sponsored a coordinated program for the radiosterilization of medical and biological products in Latin America, in which Cuba participates. (author) [es

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

21 CFR 610.68 - Exceptions or alternatives to labeling requirements for biological products held by the Strategic...

Science.gov (United States)

2010-04-01

... requirements for biological products held by the Strategic National Stockpile. 610.68 Section 610.68 Food and... requirements for biological products held by the Strategic National Stockpile. (a) The appropriate FDA Center... Strategic National Stockpile. (b)(1)(i) A Strategic National Stockpile official or any entity that...

Leading safety performance indicators for resilience assessment of radiopharmaceuticals production process

International Nuclear Information System (INIS)

Grecco, Claudio H.S.; Santos, Isaac J.A.L.; Carvalho, Paulo V.R.

2011-01-01

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-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)

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)

Health and safety manual

International Nuclear Information System (INIS)

1980-02-01

The manual consists of the following chapters: general policies and administration; the Environmental Health and Safety Department; the Medical Services Department: biological hazards; chemical safety; confined space entry; cryogenic safety; electrical safety; emergency plans; engineering and construction; evacuations, trenching, and shoring; fire safety; gases, flammable and compressed; guarding, mechanical; ladders and scaffolds, work surfaces; laser safety; materials handling and storage; noise; personal protective equipment; pressure safety; radiation safety, ionizing and non-ionizing; sanitation; seismic safety; training, environmental health and safety; tools, power and hand-operated; traffic and transportation; and warning signs and devices

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

DEFF Research Database (Denmark)

Borodina, Irina; Li, Mingji

2015-01-01

Synthetic biology and metabolic engineering enable generation of novel cell factories that efficiently convert renewable feedstocks into biofuels, bulk, and fine chemicals, thus creating the basis for biosustainable economy independent on fossil resources. While over a hundred proof...... 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...

Self-sufficiency, free trade and safety.

Science.gov (United States)

Rautonen, Jukka

2010-01-01

The relationship between free trade, self-sufficiency and safety of blood and blood components has been a perennial discussion topic in the blood service community. Traditionally, national self-sufficiency has been perceived as the ultimate goal that would also maximize safety. However, very few countries are, or can be, truly self-sufficient when self-sufficiency is understood correctly to encompass the whole value chain from the blood donor to the finished product. This is most striking when plasma derived medicines are considered. Free trade of blood products, or competition, as such can have a negative or positive effect on blood safety. Further, free trade of equipment and reagents and several plasma medicines is actually necessary to meet the domestic demand for blood and blood derivatives in most countries. Opposing free trade due to dogmatic reasons is not in the best interest of any country and will be especially harmful for the developing world. Competition between blood services in the USA has been present for decades. The more than threefold differences in blood product prices between European blood services indicate that competition is long overdue in Europe, too. This competition should be welcomed but carefully and proactively regulated to avoid putting safe and secure blood supply at risk. Copyright 2009 The International Association for Biologicals. Published by Elsevier Ltd. All rights reserved.

[Knowledge and adherence to bio-safety measures and biological accidents by nursing students during their clinical practice].

Science.gov (United States)

Merino-de la Hoz, Felicitas; Durá-Ros, María Jesús; Rodríguez-Martín, Elías; González-Gómez, Silvia; Mariano López-López, Luis; Abajas-Bustillo, Rebeca; de la Horra-Gutiérrez, Inmaculada

2010-01-01

To identify the degree of knowledge and performance of bio-safety measures by nursing students and knowing the type of biological accidents suffered during their clinical practice. A cross-sectional study was conducted on the students of three Nursing courses held in May of 2008. Data was collected by an anonymous self-administered questionnaire, with a return of 54%. A total of 97% of students seemed to know the standard biosafety measures, and all of them (100%) stated that those measures must be applied to every patient. However, the reality of clinical practice shows that biosafety measures are only partially applied. An average of 60.2% implement the personal hygiene measures, 66.1% use physical barriers, and 44% use sharp materials safely. Around 32.25% of the students have suffered some biological accident, with a greater incidence in the second year: administering injections (24%), drawing blood samples with Venojet needles (18%) and recapping used needles (17%). The high level of knowledge shown by the students on standard precautions is not always shown in clinical practice. There are significant deficiencies in student safety practices: recapping of used needles continues to be one of the most common risk practices carried out. Copyright (c) 2009 Elsevier España, S.L. All rights reserved.

Pharmaceutical, biological, and clinical properties of botulinum neurotoxin type A products.

Science.gov (United States)

Frevert, Jürgen

2015-03-01

Botulinum neurotoxin injections are a valuable treatment modality for many therapeutic indications and have revolutionized the field of aesthetic medicine so that they are the leading cosmetic procedure performed worldwide. Studies show that onabotulinumtoxinA, abobotulinumtoxinA, and incobotulinumtoxinA are comparable in terms of clinical efficacy. Differences between the products relate to the botulinum neurotoxin complexes, specific biological potency, and their immunogenicity. Protein complex size and molecular weight have no effect on biological activity, stability, distribution, or side effect profile. Complexing proteins and inactive toxin (toxoid) content increase the risk of neutralizing antibody formation, which can cause secondary treatment failure, particularly in chronic disorders that require frequent injections and long-term treatment. These attributes could lead to differences in therapeutic outcomes, and, given the widespread aesthetic use of these three neurotoxin products, physicians should be aware of how they differ to ensure their safe and effective use.

Modern science for better quality control of medicinal products "Towards global harmonization of 3Rs in biologicals": The report of an EPAA workshop.

Science.gov (United States)

Schutte, Katrin; Szczepanska, Anna; Halder, Marlies; Cussler, Klaus; Sauer, Ursula G; Stirling, Catrina; Uhlrich, Sylvie; Wilk-Zasadna, Iwona; John, David; Bopst, Martin; Garbe, Joerg; Glansbeek, Harrie L; Levis, Robin; Serreyn, Pieter-Jan; Smith, Dean; Stickings, Paul

2017-07-01

This article summarizes the outcome of an international workshop organized by the European Partnership for Alternative Approaches to Animal Testing (EPAA) on Modern science for better quality control of medicinal products: Towards global harmonization of 3Rs in biologicals. As regards the safety testing of biologicals, the workshop participants agreed to actively encourage the deletion of abnormal toxicity tests and target animal batch safety tests from all relevant legal requirements and guidance documents (country-specific guidelines, pharmacopoeia monographs, WHO recommendations). To facilitate the global regulatory acceptance of non-animal methods for the potency testing of, e.g., human diphtheria and tetanus vaccines and veterinary swine erysipelas vaccines, international convergence on the scientific principles of the use of appropriately validated in vitro assays for replacing in vivo methods was identified as an overarching goal. The establishment of scientific requirements for new assays was recognized as a further means to unify regulatory approaches in different jurisdictions. It was recommended to include key regulators and manufacturers early in the corresponding discussions. Manufacturers and responsible expert groups, e.g. at the European Directorate for the Quality of Medicines and Health Care of the Council of Europe or the European Medicines Agency, were invited to consider leadership for international collaboration. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

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.

Biological Production of 3-Hydroxypropionic Acid: An Update on the Current Status

Directory of Open Access Journals (Sweden)

Leonidas Matsakas

2018-02-01

Full Text Available The production of high added-value chemicals from renewable resources is a necessity in our attempts to switch to a more sustainable society. 3-Hydroxypropionic acid (3HP is a promising molecule that can be used for the production of an important array of high added-value chemicals, such as 1,3-propanediol, acrylic acid, acrylamide, and bioplastics. Biological production of 3HP has been studied extensively, mainly from glycerol and glucose, which are both renewable resources. To enable conversion of these carbon sources to 3HP, extensive work has been performed to identify appropriate biochemical pathways and the enzymes that are involved in them. Novel enzymes have also been identified and expressed in host microorganisms to improve the production yields of 3HP. Various process configurations have also been proposed, resulting in improved conversion yields. The intense research efforts have resulted in the production of as much as 83.8 g/L 3HP from renewable carbon resources, and a system whereby 3-hydroxypropionitrile was converted to 3HP through whole-cell catalysis which resulted in 184.7 g/L 3HP. Although there are still challenges and difficulties that need to be addressed, the research results from the past four years have been an important step towards biological production of 3HP at the industrial level.

Ontology-supported research on vaccine efficacy, safety and integrative biological networks.

Science.gov (United States)

He, Yongqun

2014-07-01

While vaccine efficacy and safety research has dramatically progressed with the methods of in silico prediction and data mining, many challenges still exist. A formal ontology is a human- and computer-interpretable set of terms and relations that represent entities in a specific domain and how these terms relate to each other. Several community-based ontologies (including Vaccine Ontology, Ontology of Adverse Events and Ontology of Vaccine Adverse Events) have been developed to support vaccine and adverse event representation, classification, data integration, literature mining of host-vaccine interaction networks, and analysis of vaccine adverse events. The author further proposes minimal vaccine information standards and their ontology representations, ontology-based linked open vaccine data and meta-analysis, an integrative One Network ('OneNet') Theory of Life, and ontology-based approaches to study and apply the OneNet theory. In the Big Data era, these proposed strategies provide a novel framework for advanced data integration and analysis of fundamental biological networks including vaccine immune mechanisms.

Biological fermentative hydrogen production from olive pulp at 35 degrees C

Energy Technology Data Exchange (ETDEWEB)

Koutrouli, E.C.; Gavala, H.N.; Skiadas, I.V.; Lyberatos, G. [Patras Univ., Patras (Greece). Dept. of Chemical Engineering

2004-07-01

In response to energy security and environmental concerns, there is renewed interest in the use of hydrogen gas as a renewable energy source. However, many processes for generating hydrogen are extremely energy intensive and costly. This study focused on biological production of hydrogen from wastewater or other biomass. Photosynthetic and fermentation processes were outlined, but the main focus of this paper was on continuous anaerobic fermentation of low cost substrates such as olive pulp at 35 degrees C. This process is linked to the acidogenic stage of anaerobic digestion where carbohydrates are the preferred carbon source. Volatile fatty acids and alcohols are produced simultaneously with the hydrogen gas. An added advantage is that the effluent from the fermentation process can be further used by methanogenesis due to its rich organic acids content. Batch experiments with olive pulp resulted in 2.5 mmole of hydrogen per gram of total carbohydrates. It was noted that more research is required to maximize hydrogen production in a continuous process. It was suggested that hydrogen production could be optimized through hydrolysis of the non-soluble carbohydrates. This could be accomplished through physicochemical or biological pretreatments. 7 refs., 3 tabs., 1 fig.

Treating moderate to severe psoriasis - best use of biologics.

LENUS (Irish Health Repository)

Lynch, Maeve

2014-02-01

This review focuses on the efficacy, safety and best use of biologic agents in moderate-to-severe psoriasis. Recommendations from two recent guidelines are summarised. The NICE Guidelines 2012 provide recommendations on best practice for prescribing biologics. The German S3 Guidelines are based on a systematic review of published studies and report the efficacy of biologics and guidelines for treatment. Data on the safety of biologics are available for up to 5 years in psoriasis and are on the whole reassuring. Registry data is evolving and will provide data on safety to help inform long-term monitoring of patients with psoriasis on biologics agents. New anti-interleukin-17 (IL17) and anti-IL17RA biologics are in Phase 3 clinical trials and may prove to be more effective than existing biologics.

Biological agents in polyarticular juvenile idiopathic arthritis

DEFF Research Database (Denmark)

Amarilyo, Gil; Tarp, Simon; Foeldvari, Ivan

2016-01-01

BACKGROUND AND OBJECTIVE: Although various biological agents are in use for polyarticular juvenile idiopathic arthritis (pJIA), head-to-head trials comparing the efficacy and safety among them are lacking. We aimed to compare the efficacy and safety of biological agents in pJIA using all currently...

Biological activities of Agave by-products and their possible applications in food and pharmaceuticals.

Science.gov (United States)

López-Romero, Julio Cesar; Ayala-Zavala, Jesús Fernando; González-Aguilar, Gustavo Adolfo; Peña-Ramos, Etna Aida; González-Ríos, Humberto

2018-05-01

Agave leaves are considered a by-product of alcoholic beverage production (tequila, mezcal and bacanora) because they are discarded during the production process, despite accounting for approximately 50% of the total plant weight. These by-products constitute a potential source of Agave extracts rich in bioactive compounds, such as saponins, phenolic compounds and terpenes, and possess different biological effects, as demonstrated by in vitro and in vivo tests (e.g. antimicrobial, antifungal, antioxidant, anti-inflammatory, antihypertensive, immunomodulatory, antiparasitic and anticancer activity). Despite their positive results in biological assays, Agave extracts have not been widely evaluated in food systems and pharmaceutical areas, and these fields represent a potential route to improve the usage of Agave plants as food additives and agents for treating medical diseases. © 2017 Society of Chemical Industry. © 2017 Society of Chemical Industry.

Food Safety Regulation and Firm Productivity: Evidence from the French Food Industry

OpenAIRE

Requillart, Vincent; Nauges, Celine; Simioni, Michel; Bontemps, Christophe

2012-01-01

The purpose of this article is to assess whether food safety regulations imposed by the European Union in the 2000s may have induced a slow-down in the productivity of firms in the food processing sector. The impact of regulations on costs and productivity has seldom been studied. This article contributes to the literature by measuring productivity change using a panel of French food processing firms for the years 1996 to 2006. To do so, we develop an original iterative testing procedure b...

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

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...... of products commercially available on the market. Risk assessments disclose that effects harmful to the developing central nervous system (CNS) may be observed at a lower exposure than previously anticipated. We interviewed farmers in Zambia and Malawi about their cultivars, processing procedures......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...

Trustworthy Variant Derivation with Translation Validation for Safety Critical Product Lines

DEFF Research Database (Denmark)

Iosif-Lazăr, Alexandru Florin; Wasowski, Andrzej

2016-01-01

Software product line (SPL) engineering facilitates development of entire families of software products with systematic reuse. Model driven SPLs use models in the design and development process. In the safety critical domain, validation of models and testing of code increases the quality...... of the products altogether. However, to maintain this trustworthiness it is necessary to know that the SPL tools, which manipulate models and code to derive concrete product variants, do not introduce errors in the process. We propose a general technique of checking correctness of product derivation tools through...... translation validation. We demonstrate it using Featherweight VML—a core language for separate variability modeling relying on a single kind of variation point to define transformations of artifacts seen as object models. We use Featherweight VML with its semantics as a correctness specification...

Mitigating the risk of Zika virus contamination of raw materials and cell lines in the manufacture of biologicals.

Science.gov (United States)

Zmurko, Joanna; Vasey, Douglas B; Donald, Claire L; Armstrong, Alison A; McKee, Marian L; Kohl, Alain; Clayton, Reginald F

2018-02-01

Ensuring the virological safety of biologicals is challenging due to the risk of viral contamination of raw materials and cell banks, and exposure during in-process handling to known and/or emerging viral pathogens. Viruses may contaminate raw materials and biologicals intended for human or veterinary use and remain undetected until appropriate testing measures are employed. The outbreak and expansive spread of the mosquito-borne flavivirus Zika virus (ZIKV) poses challenges to screening human- and animal -derived products used in the manufacture of biologicals. Here, we report the results of an in vitro study where detector cell lines were challenged with African and Asian lineages of ZIKV. We demonstrate that this pathogen is robustly detectable by in vitro assay, thereby providing assurance of detection of ZIKV, and in turn underpinning the robustness of in vitro virology assays in safety testing of biologicals.

Is there an antagonism between nuclear safety and productivity?

International Nuclear Information System (INIS)

Dessus de Cerou, E.; Fourest, B.; Frantzen, C.; Lacoste, A.C.

1999-01-01

This article reviews the conference organized by the SFEN on November 10, 1998. The object of this meeting was to overview the recent dispositions taken by EdF about the management of its nuclear power plants. The creation of OSD (safety-availability-observatories) in each nuclear plant, whose purpose is to set a dialogue between the demands of safety and the optimization of production shows the importance given by EdF to provide a safe and competitive energy. It shows also the will of EdF to acknowledge the existence of real conflicts between radiation protection, quality assurance and competitiveness in the daily life of a nuclear facility. EdF will face a partial opening of its market by february 2000 within the limits defined by European regulations. This increase of competition could rise problems between the transparency of nuclear activities, patent rights and information reporting. (A.C.)

The Food Safety of Livestock Products (Meatball, Corned Beef, Beef Burger and Sausage Studied from Heavy Metal Residues Contamination

Directory of Open Access Journals (Sweden)

E Harlia

2010-01-01

Full Text Available The aims of animal husbandry improvements are to increase both the quality and the quantity of livestock production and to ensure the safety of the product. It is necessarry for consumers to pay attention to the food safety of livestock product because it is related to human's health. The research was conducted to determine the food safety of livestock product condition by detecting heavy metal residues on several food products from livestock like meatball, corned beef, burger’s beef, and sausages. This research was explored by using survey's method and purposive technique sampling, then the resulted data were descriptively analyzed. The observed variables were heavy metal contents such as Plumbum (Pb and Cadmium (Cd in which being measured by using AAS (Atomic Absorption Spectrophotometri . The result showed that in general, heavy metal residue of Pb from several livestock products (meatball, corned beef, beef burger, and sausages were smaller than Maximum Residue Limit (MRL, while the Cd’s residue was partly over the MRL concentration, therefore further action has to be taken as it affects the human's health. (Animal Production 12(1: 50-54 (2010 Key words : food safety, MRL, heavy metal Pb, Cd.

Enhanced biological production off Chennai triggered by October 1999 super cyclone (Orissa)

Digital Repository Service at National Institute of Oceanography (India)

Madhu, N.V.; Maheswaran, P.A.; Jyothibabu, R.; Sunil, V.; Revichandran, C.; Balasubramanian, T.; Gopalakrishnan, T.C.; Nair, K.K.C.

COMMUNICATIONS CURRENT SCIENCE, VOL. 82, NO. 12, 25 JUNE 2002 *For correspondence. (e - mail: madhu@niokochi.org) Enhanced biological production off Chennai triggered by October 1999 super cyclone (Orissa) N. V. Madhu*, P. A. Maheswaran, R... in the world?s oceans typically have duration of only a few days, but the physical and biological effects due to this perturbation can last up to several weeks 1 ? 4 . The integrated effect from these storm events has the potential to account for a...

Safety barriers to prevent release of hydrocarbons during production of oil and gas

OpenAIRE

Sklet, Snorre; Hauge, Stein

2004-01-01

This report documents a set of scenarios related to release of hydrocarbons during production on oil and gas platforms. For each release scenario, initiating events, barrier functions aimed to prevent loss of containment, and barrier systems that realize these barrier functions are identified and described. Safety barriers to prevent release of hydrocarbons during production of oil and gas

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.

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

Science.gov (United States)

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

2014-08-28

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 (A w )] 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 A w values decreased during the cheese ripening period. The competition between lactic flora and potential pathogen microorganisms and decreasing of pH and A w 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.

Analysis of accidents in uranium mines and suggestions on safety in production

International Nuclear Information System (INIS)

Xue Shiqian.

1989-01-01

The serious and fatal accidents happening in the uranium mines in China are descibed and analysed based on the classification, cause, age of the dead and economic losses brought by the accidents. The suggestions on safety in production are also presented

Safety study of the coupling of a VHTR with a hydrogen production plant

International Nuclear Information System (INIS)

Bertrand, F.; Germain, T.; Bentivoglio, F.; Bonnet, F.; Moyart, Q.; Aujollet, P.

2011-01-01

Highlights: → The paper deals with safety issues of the coupling of a VHTR with a H 2 production plant. → Internal incidents/accidents in the coupling system have been studied with the CATHARE2 code. → Transient studies have indicated a substantial grace delay when the VHTR faces the H 2 plant disturbances. → Hydrogen release and combustion leads to safety distances of about 100 m. → No showstopper has been put in evidence regarding the feasibility of the VHTR/H 2 plant coupling. - Abstract: The present paper deals with specific safety issues resulting from the coupling of a nuclear reactor (very high temperature reactor, VHTR) with a hydrogen production plant (HYPP). The first part is devoted to the safety approach consisting in taking into account the safety standards and rules dedicated to the nuclear facility as well as those dedicated to the process industry. This approach enabled two main families of events to be distinguished: the so-called internal events taking place in the coupling circuit (transients, breaks in pipes and in heat exchangers) and the external events able to threat the integrity of the various equipments (in particular the VHTR containment and emergency cooling system) that could result from accidents in the HYPP. By considering a hydrogen production by means of the iodine/sulfur (IS) process, the consequences of the both families of events aforementioned have been assessed in order to provide an order of magnitude of the effects of the incidents and accidents and also in order to propose safety provisions to mitigate these effects when it is necessary. The study of transients induced by a failure of a part of the HYPP has shown the possibility to keep the part of the HYPP unaffected by the transient under operation by means of an adapted regulation set. Moreover, the time to react in case of transfer of corrosive products in the VHTR containment has been assessed as well as the thermohydraulic loading that would experience the

Review of the ethnobotany, chemistry, biological activity and safety of the botanical dietary supplement Morinda citrifolia (noni).

Science.gov (United States)

Pawlus, Alison D; Kinghorn, Douglas A

2007-12-01

Morinda citrifolia, commonly called noni, has a long history as a medicinal plant and its use as a botanical dietary supplement has grown tremendously in recent years. This has prompted a concomitant increase in research on the phytochemical constituents and biological activity of noni. A relatively large number of scientific publications on noni have been published in recent years, including a number of review articles. The goals of this review are to provide an updated categorization of the phytochemical constituents found in noni and to provide perspective for its extensive utilization as a major botanical dietary supplement. Included herein are a comprehensive list of known ethnobotanical uses and common names of M. citrifolia, a brief summary of relevant biological studies and a discussion of the safety of noni as a supplement.

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

Regulatory Oversight of Cell and Gene Therapy Products in Canada.

Science.gov (United States)

Ridgway, Anthony; Agbanyo, Francisca; Wang, Jian; Rosu-Myles, Michael

2015-01-01

Health Canada regulates gene therapy products and many cell therapy products as biological drugs under the Canadian Food and Drugs Act and its attendant regulations. Cellular products that meet certain criteria, including minimal manipulation and homologous use, may be subjected to a standards-based approach under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations. The manufacture and clinical testing of cell and gene therapy products (CGTPs) presents many challenges beyond those for protein biologics. Cells cannot be subjected to pathogen removal or inactivation procedures and must frequently be administered shortly after final formulation. Viral vector design and manufacturing control are critically important to overall product quality and linked to safety and efficacy in patients through concerns such as replication competence, vector integration, and vector shedding. In addition, for many CGTPs, the value of nonclinical studies is largely limited to providing proof of concept, and the first meaningful data relating to appropriate dosing, safety parameters, and validity of surrogate or true determinants of efficacy must come from carefully designed clinical trials in patients. Addressing these numerous challenges requires application of various risk mitigation strategies and meeting regulatory expectations specifically adapted to the product types. Regulatory cooperation and harmonisation at an international level are essential for progress in the development and commercialisation of these products. However, particularly in the area of cell therapy, new regulatory paradigms may be needed to harness the benefits of clinical progress in situations where the resources and motivation to pursue a typical drug product approval pathway may be lacking.

The Effects of Occupational Health and Safety Risk Factors on Job Satisfaction in Hotel Enterprises

OpenAIRE

Gonca Kilic; Murat Selim Selvi

2009-01-01

Occupational health and safety risk factors can have direct or indirect effects on levels of organizational commitment, job satisfaction, and the job productivity of workers in service companies as well as other types of industries. In this paper, the effects of physical, biological, chemical and socio-psychological risk factors, related to occupational safety and health, encountered in hotel enterprises on job satisfaction were investigated. Questionnaire survey was conducted as a data colle...

The first symposium of Research Center for Radiation Safety, NIRS. Perspective of future studies of radiation safety

International Nuclear Information System (INIS)

Shimo, Michikuni

2002-03-01

This paper summarizes presentations given in the title symposium, held at the Conference Room of National Institute of Radiological Sciences (NIRS) on November 29 and 30, 2001. Contained are Introductory remarks: Basic presentations concerning exposure dose in man; Environmental levels of radiation and radioactivity, environmental radon level and exposure dose, and radiation levels in the specific environment (like in the aircraft): Special lecture (biological effects given by space environment) concerning various needs for studies of radiation safety; Requirement for open investigations, from the view of utilization, research and development of atomic energy, from the clinical aspect, and from the epidemiological aspect: Special lecture (safety in utilization of atomic energy and radiation-Activities of Nuclear Safety Commission of Japan) concerning present state and perspective of studies of radiation safety; Safety of radiation and studies of biological effects of radiation-perspective, and radiation protection and radiation safety studies: Studies in the Research Center for Radiation Safety; Summary of studies in the center, studies of the biological effects of neutron beam, carcinogenesis by radiation and living environmental factors-complicated effects, and studies of hereditary effects: Panel discussion (future direction of studies of radiation safety for the purpose of the center's direction): and concluding remarks. (N.I.)

Safety of power transformers, power supplies, reactors and similar products - Part 1: General requirements and tests

CERN Document Server

International Electrotechnical Commission. Geneva

1998-01-01

This International Standard deals with safety aspects of power transformers, power supplies, reactors and similar products such as electrical, thermal and mechanical safety. This standard covers the following types of dry-type transformers, power supplies, including switch mode power supplies, and reactors, the windings of which may be encapsulated or non-encapsulated. It has the status of a group safety publication in accordance with IEC Guide 104.

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

Science.gov (United States)

Li, Mingji; Borodina, Irina

2015-02-01

Synthetic biology and metabolic engineering enable generation of novel cell factories that efficiently convert renewable feedstocks into biofuels, bulk, and fine chemicals, thus creating the basis for biosustainable economy independent on fossil resources. While over a hundred proof-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 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 computational tools for the prediction of biochemical pathways, molecular biology methods for assembly of DNA parts into pathways, and for introducing the pathways into the host, and finally approaches for optimizing performance of the introduced pathways. © FEMS 2015. All rights reserved. For permissions, please e-mail: journals.permission@oup.com.

Use of OECD/NEA Data Project Products in Probabilistic Safety Assessment

International Nuclear Information System (INIS)

Cherkas, G.; Raducu, Gheorghe; Riznic, J.; Yalaoui, S.; Huang, Hui-Wen; Holy, Jaroslav; Holmberg, Jan-Erik; Sandberg, Jorma; Balmain, Michel; Bonnevialle, Anne-Marie; Curnier, Florence; Georgescu, Gabriel; Lanore, Jeanne-Marie; Lindner, Arndt; Fujimoto, Haruo; Ahn, Kwang-Il; Hwang, Taesuk; Jang, Seung-Cheol; Husarcek, Jan; Kovacs, Zoltan; Vazquez, Teresa; Johanson, Gunnar; Liwaang, Bo; Nyman, Ralph; Dang, Vinh; Schoen, Gerhard; Brook, Kevin; Hamblen, David; Siu, Nathan; Sturzebecher, Karl; Tobin, Margaret; Wood, Jeff; Amri, Abdallah; Breest, Axel

2014-01-01

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

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

The Effect of Product Safety Courses on the Adoption and Outcomes of LESS Surgery.

Science.gov (United States)

Toomey, Paul G; Ross, Sharona B; Choung, Edward; Donn, Natalie; Vice, Michelle; Luberice, Kenneth; Albrink, Michael; Rosemurgy, Alexander S

2015-01-01

As technology in surgery evolves, the medical instrument industry is inevitability involved in promoting the use and appropriate (ie, effective and safe) application of its products. This study was undertaken to evaluate industry-supported product safety courses in laparoendoscopic single-site (LESS) surgery, by using the metrics of surgeons' adoption of the technique, safety of the procedure, and surgeons' perception of the surgery. LESS surgery courses that involved didactic lectures, operative videos, operation observation, collaborative learning, and simulation, were attended by 226 surgeons. With Florida Hospital Tampa Institutional Review Board approval, the surgeons were queried before and immediately after the course, to assess their attitudes toward LESS surgery. Then, well after the course, the surgeons were contacted, repeatedly if necessary, to complete questionnaires. Before the course, 82% of the surgeons undertook more than 10 laparoscopic operations per month. Immediately after the course, 86% were confident that they were prepared to perform LESS surgery. Months after the course, 77% of the respondents had adopted LESS surgery, primarily cholecystectomy; 59% had added 1 or more trocars in 0-20% of their procedures; and 73% held the opinion that operating room observation was the most helpful learning experience. Complications with LESS surgery were noted 12% of the time. Advantages of the technique were better cosmesis (58%) and patient satisfaction (38%). Disadvantages included risk of complications (37%) and higher technical demand (25%). Seventy-eight percent viewed LESS surgery as an advancement in surgical technique. In multifaceted product safety courses, operating room observation is thought to provide the most helpful instruction for those wanting to undertake LESS surgery. The procedure has been safely adopted by surgeons who frequently perform laparoscopies. The tradeoff is in performing a more difficult technique to obtain better

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

Science.gov (United States)

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

2008-01-01

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

Methodology and analysis of production safety during Pu recycling at SSC RF RIAR

International Nuclear Information System (INIS)

Kirillovich, A.P.

2000-01-01

The methodology and criteria for estimating safety in technological processes of the nuclear fuel cycle (NFC) are proposed, substantiated and verified during the large-scale Pu recycling (500 kg). The comprehensive investigation results of the radiation-ecological situation are presented during pilot production of the mixed uranium-plutonium fuel and fuel assembly at SSC RF RIAR. The methodology and experimental data bank can be used while estimating safety in the industrial recycling of Pu and minor-actinides (Np, Am, Cm) in NFC. (author)

Psoriasis : implications of biologics

NARCIS (Netherlands)

Lecluse, L.L.A.

2010-01-01

Since the end of 2004 several specific immunomodulating therapies: ‘biologic response modifiers’ or ‘biologics’ have been registered for moderate to severe psoriasis in Europe. This thesis is considering the implications of the introduction of the biologics for psoriasis patients, focusing on safety

Quality and safety of products containing Ephedra Herba on the Dutch market

OpenAIRE

Lake OA; Slijkhuis C; Maas WF; Vliet MEA van; Kaste D de; Verdonk-Kleinjan W; Keuringsdienst van Waren, regio Zuid; LGO

2001-01-01

We performed analytical studies on dietary supplements and smart products containing Ephedra herba on the Dutch market. Such products are labelled 'from natural, herbal sources' and do not fall under Dutch Medicines Act. Most of the samples tested from 1993 to 1999 contained unacceptably large amounts of ephedrine (EP) alkaloids (the active substances of Ephedra herba) in relation to the safety criteria in the literature. Some samples also contained an effect-enhancing substance (e.g. coffein...

Safety considerations for continuous hydrogen production test apparatus with capacity of 50 N-litter hydrogen per hour

International Nuclear Information System (INIS)

Onuki, Kaoru; Akino, Norio; Shimizu, Saburo; Nakajima, Hayato; Higashi, Shunichi; Kubo, Shinji

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)

High biological productivity in the central Arabian Sea during the summer monsoon driven by Ekman pumping and lateral advection

Digital Repository Service at National Institute of Oceanography (India)

PrasannaKumar, S.; Madhupratap, M.; DileepKumar, M.; Muraleedharan, P.M.; DeSouza, S.N.; Gauns, M.; Sarma, V.V.S.S.

Open oceans are generally oligotrophic and support less biological production. Results from the central Arabian Sea show that it may be an exception to this. We provide the observational evidence of fairly high biological production (up to 1700 mg C...

The assesment on safety distance determination of hydrogen production plant with RGTT200K reactor

International Nuclear Information System (INIS)

Siti Alimah; Sriyono

2013-01-01

The one of the hydrogen production process method coupled to RGTT200K is the utilization of steam reforming with (methane) natural gas as the feedstock. The integration between RGTT200K and hydrogen plant must consider many safety aspects and one of it is separation distance between these two systems. The purpose of this assessment is to study the sources of fires/explosion and to determine the safety distance between the steam reforming hydrogen production plant and RGTT200K reactor. The used methodology was literature assessment and safety distance calculation with equation R = k.W 1/3 . In this studi, safety distance determination in integration between RGTT200K and hydrogen plant was using equation based on reference of the USNRC Regulatory Guide 1.91 and mass on the equation was mass equivalent of TNT (kg). The results of the study show the hydrogen plant produces 160.000 m 3 /day, if requires storage tanks of 400.000 m 3 (based USNRC equal to 1.859 million tons of TNT equivalent) with factor k is 8, based on the equation R = k.W 1/3 , so the requirement for safety distance is 1 km. This distance may be shortened by adding a fire proof wall barrier and requires further assessment. (author)

Yeast synthetic biology for the production of recombinant therapeutic proteins.

Science.gov (United States)

Kim, Hyunah; Yoo, Su Jin; Kang, Hyun Ah

2015-02-01

The production of recombinant therapeutic proteins is one of the fast-growing areas of molecular medicine and currently plays an important role in treatment of several diseases. Yeasts are unicellular eukaryotic microbial host cells that offer unique advantages in producing biopharmaceutical proteins. Yeasts are capable of robust growth on simple media, readily accommodate genetic modifications, and incorporate typical eukaryotic post-translational modifications. Saccharomyces cerevisiae is a traditional baker's yeast that has been used as a major host for the production of biopharmaceuticals; however, several nonconventional yeast species including Hansenula polymorpha, Pichia pastoris, and Yarrowia lipolytica have gained increasing attention as alternative hosts for the industrial production of recombinant proteins. In this review, we address the established and emerging genetic tools and host strains suitable for recombinant protein production in various yeast expression systems, particularly focusing on current efforts toward synthetic biology approaches in developing yeast cell factories for the production of therapeutic recombinant proteins. © FEMS 2015. All rights reserved. For permissions, please e-mail: journals.permission@oup.com.

Biological hydrogen production from biomass by thermophilic bacteria

International Nuclear Information System (INIS)

Claassen, P.A.M.; Mars, A.E.; Budde, M.A.W.; Lai, M.; de Vrije, T.; van Niel, E.W.J.

2006-01-01

To meet the reduction of the emission of CO 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

Crop production in salt affected soils: A biological approach

Energy Technology Data Exchange (ETDEWEB)

Malik, K A [National Inst. for Biotechnology and Genetic Engineering (NIBGE), Faisalabad (Pakistan)

1995-01-01

Plant are susceptible to various stresses, affecting growth productivity. Among the abiotic stresses, soil salinity is most significant and prevalent in both developed and developing countries. As a result, good productive lands are being desertified at a very high pace. To combat this problem various approaches involving soil management and drainage are underway but with little success. It seems that a durable solution of the salinity and water-logging problems may take a long time and we may have to learn to live with salinity and to find other ways to utilize the affected lands fruitfully. A possible approach could be to tailor plants to suit the deleterious environment. The saline-sodic soils have excess of sodium, are impermeable, have little or no organic matter and are biologically almost dead. Introduction of a salt tolerant crop will provide a green cover and will improve the environment for biological activity, increase organic matter and will improve the soil fertility. The plant growth will result in higher carbon dioxide levels, and would thus create acidic conditions in the soil which would dissolve the insoluble calcium carbonate and will help exchange sodium with calcium ions on the soil complex. The biomass produced could be used directly as fodder or by the use of biotechnological and other procedures it could be converted into other value added products. However, in order to tailor plants to suit these deleterious environments, acquisition of better understanding of the biochemical and genetic aspects of salt tolerance at the cellular/molecular level is essential. For this purpose model systems have been carefully selected to carry out fundamental basic research that elucidates and identifies the major factors that confer salt tolerance in a living system. With the development of modern biotechnological methods it is now possible to introduce any foreign genetic material known to confer salt tolerance into crop plants. (Abstract Truncated)

Improvements in algal lipid production: a systems biology and gene editing approach.

Science.gov (United States)

Banerjee, Avik; Banerjee, Chiranjib; Negi, Sangeeta; Chang, Jo-Shu; Shukla, Pratyoosh

2018-05-01

In the wake of rising energy demands, microalgae have emerged as potential sources of sustainable and renewable carbon-neutral fuels, such as bio-hydrogen and bio-oil. For rational metabolic engineering, the elucidation of metabolic pathways in fine detail and their manipulation according to requirements is the key to exploiting the use of microalgae. Emergence of site-specific nucleases have revolutionized applied research leading to biotechnological gains. Genome engineering as well as modulation of the endogenous genome with high precision using CRISPR systems is being gradually employed in microalgal research. Further, to optimize and produce better algal platforms, use of systems biology network analysis and integration of omics data is required. This review discusses two important approaches: systems biology and gene editing strategies used on microalgal systems with a focus on biofuel production and sustainable solutions. It also emphasizes that the integration of such systems would contribute and compliment applied research on microalgae. Recent advances in microalgae are discussed, including systems biology, gene editing approaches in lipid bio-synthesis, and antenna engineering. Lastly, it has been attempted here to showcase how CRISPR/Cas systems are a better editing tool than existing techniques that can be utilized for gene modulation and engineering during biofuel production.

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.

Synthetic Biology and Metabolic Engineering Approaches and Its Impact on Non-Conventional Yeast and Biofuel Production

Energy Technology Data Exchange (ETDEWEB)

Madhavan, Aravind [Biotechnology Division, National Institute for Interdisciplinary Science and Technology, Council of Scientific and Industrial Research, Trivandrum (India); Rajiv Gandhi Centre for Biotechnology, Trivandrum (India); Jose, Anju Alphonsa; Binod, Parameswaran; Sindhu, Raveendran, E-mail: sindhurgcb@gmail.com; Sukumaran, Rajeev K. [Biotechnology Division, National Institute for Interdisciplinary Science and Technology, Council of Scientific and Industrial Research, Trivandrum (India); Pandey, Ashok [Biotechnology Division, National Institute for Interdisciplinary Science and Technology, Council of Scientific and Industrial Research, Trivandrum (India); Center for Innovative and Applied Bioprocessing, Mohali, Punjab (India); Castro, Galliano Eulogio [Dpt. Ingeniería Química, Ambiental y de los Materiales Edificio, Universidad de Jaén, Jaén (Spain)

2017-04-25

The increasing fossil fuel scarcity has led to an urgent need to develop alternative fuels. Currently microorganisms have been extensively used for the production of first-generation biofuels from lignocellulosic biomass. Yeast is the efficient producer of bioethanol among all existing biofuels option. Tools of synthetic biology have revolutionized the field of microbial cell factories especially in the case of ethanol and fatty acid production. Most of the synthetic biology tools have been developed for the industrial workhorse Saccharomyces cerevisiae. The non-conventional yeast systems have several beneficial traits like ethanol tolerance, thermotolerance, inhibitor tolerance, genetic diversity, etc., and synthetic biology have the power to expand these traits. Currently, synthetic biology is slowly widening to the non-conventional yeasts like Hansenula polymorpha, Kluyveromyces lactis, Pichia pastoris, and Yarrowia lipolytica. Herein, we review the basic synthetic biology tools that can apply to non-conventional yeasts. Furthermore, we discuss the recent advances employed to develop efficient biofuel-producing non-conventional yeast strains by metabolic engineering and synthetic biology with recent examples. Looking forward, future synthetic engineering tools’ development and application should focus on unexplored non-conventional yeast species.

Synthetic Biology and Metabolic Engineering Approaches and Its Impact on Non-Conventional Yeast and Biofuel Production

Directory of Open Access Journals (Sweden)

Raveendran Sindhu

2017-04-01

Full Text Available The increasing fossil fuel scarcity has led to an urgent need to develop alternative fuels. Currently microorganisms have been extensively used for the production of first-generation biofuels from lignocellulosic biomass. Yeast is the efficient producer of bioethanol among all existing biofuels option. Tools of synthetic biology have revolutionized the field of microbial cell factories especially in the case of ethanol and fatty acid production. Most of the synthetic biology tools have been developed for the industrial workhorse Saccharomyces cerevisiae. The non-conventional yeast systems have several beneficial traits like ethanol tolerance, thermotolerance, inhibitor tolerance, genetic diversity, etc., and synthetic biology have the power to expand these traits. Currently, synthetic biology is slowly widening to the non-conventional yeasts like Hansenula polymorpha, Kluyveromyces lactis, Pichia pastoris, and Yarrowia lipolytica. Herein, we review the basic synthetic biology tools that can apply to non-conventional yeasts. Furthermore, we discuss the recent advances employed to develop efficient biofuel-producing non-conventional yeast strains by metabolic engineering and synthetic biology with recent examples. Looking forward, future synthetic engineering tools’ development and application should focus on unexplored non-conventional yeast species.

Synthetic Biology and Metabolic Engineering Approaches and Its Impact on Non-Conventional Yeast and Biofuel Production

International Nuclear Information System (INIS)

Madhavan, Aravind; Jose, Anju Alphonsa; Binod, Parameswaran; Sindhu, Raveendran; Sukumaran, Rajeev K.; Pandey, Ashok; Castro, Galliano Eulogio

2017-01-01

The increasing fossil fuel scarcity has led to an urgent need to develop alternative fuels. Currently microorganisms have been extensively used for the production of first-generation biofuels from lignocellulosic biomass. Yeast is the efficient producer of bioethanol among all existing biofuels option. Tools of synthetic biology have revolutionized the field of microbial cell factories especially in the case of ethanol and fatty acid production. Most of the synthetic biology tools have been developed for the industrial workhorse Saccharomyces cerevisiae. The non-conventional yeast systems have several beneficial traits like ethanol tolerance, thermotolerance, inhibitor tolerance, genetic diversity, etc., and synthetic biology have the power to expand these traits. Currently, synthetic biology is slowly widening to the non-conventional yeasts like Hansenula polymorpha, Kluyveromyces lactis, Pichia pastoris, and Yarrowia lipolytica. Herein, we review the basic synthetic biology tools that can apply to non-conventional yeasts. Furthermore, we discuss the recent advances employed to develop efficient biofuel-producing non-conventional yeast strains by metabolic engineering and synthetic biology with recent examples. Looking forward, future synthetic engineering tools’ development and application should focus on unexplored non-conventional yeast species.

Degeneration of penicillin production in ethanol-limited chemostat cultivations of Penicillium chrysogenum : A systems biology approach

NARCIS (Netherlands)

Douma, Rutger D.; Batista, Joana M.; Touw, Kai M.; Kiel, Jan A. K. W.; Zhao, Zheng; Veiga, Tania; Klaassen, Paul; Bovenberg, Roel A. L.; Daran, Jean-Marc; van Gulik, Walter M.; Heijnen, J.J.; Krikken, Arjen

2011-01-01

Background: In microbial production of non-catabolic products such as antibiotics a loss of production capacity upon long-term cultivation (for example chemostat), a phenomenon called strain degeneration, is often observed. In this study a systems biology approach, monitoring changes from gene to

Are safety data sheets for cleaning products used in Norway a factor contributing to the risk of workers exposure to chemicals?

Directory of Open Access Journals (Sweden)

Abdulqadir M. Suleiman

2014-10-01

Full Text Available Objectives: Cleaning products are considered less hazardous than those used in other sectors. Suppliers and distributors are less conscientious when it comes to informing users on health risks. The aim of the study was to elaborate on the usefulness and clarity of information in the safety data sheets (SDS for cleaning products, and considering if the use of these SDSs can be seen as a risk factor towards occupational exposure to hazardous chemicals in the sector. Material and Methods: Safety data sheets were selected based on the risk level of the product assigned in an industrial sector scheme. 320 SDSs for cleaning products were reviewed. Constituent components found in the products over a given threshold were listed and available information thereof used to assess the perceived non-hazard consideration of the chemicals. Results: The contents of the SDSs was generic and mostly incomplete. Safety measures and health information lacked sufficient specificity despite varying compositions and concentrations of components. There is generally incompatibility between mentioned sections on the suggested non-hazardous nature of the products and health effects. Not all substances used in these products have harmonized classifications, which makes them open to various classification of the products and the suggested safety measures. This results in different companies classifying similar products differently. Risk management measures and suggested personal protective equipment (PPEs are given haphazardly. Physical properties relevant to risk assessment are not included. Conclusions: The safety data sheets are ambiguous, and they lack relevant and important information. Inadequate information and risk assessment concerning the products can lead to workers being exposed to hazardous chemicals. Underestimation of the hazard contribution of the components of the products and the insufficient, non-objective mention of appropriate control and protective

BIOMASS PRODUCTION AND FORMULATION OF Bacillus subtilis FOR BIOLOGICAL CONTROL

Directory of Open Access Journals (Sweden)

Amran Muis

2016-10-01

Full Text Available Bacillus subtilis is a widespread bacterium found in soil, water, and air. It controls the growth of certain harmful bacteria and fungi, presumably by competing for nutrients, growth sites on plants, and by directly colonizing and attaching to fungal pathogens. When applied to seeds, it colonizes the developing root system of the plants and continues to live on the root system and provides protection throughout the growing season. The study on biomass production and formulation of B. subtilis for biological control was conducted in the laboratory of Department of Plant Pathology, College of Agriculture, University of the Philippines Los Baños (UPLB-CA, College, Laguna from May to July 2005. The objective of the study was to determine the optimum pH and a good carbon source for biomass production of B. subtilis and to develop a seed treatment formulation of B. subtilis as biological control agent. Results showed that the optimum pH for growth of B. subtilis was pH 6 (1.85 x 109 cfu/ml. In laboratory tests for biomass production using cassava flour, corn flour, rice flour, and brown sugar as carbon sources, it grew best in brown sugar plus yeast extract medium (6.8 x 108 cfu ml-1 in sterile distilled water and 7.8 x 108 cfu ml-1 in coconut water. In test for bacterial biomass carriers, talc proved to be the best in terms of number of bacteria recovered from the seeds (3.98 x 105 cfu seed-1.

[Recent advances of synthetic biology for production of functional ingredients in Chinese materia medica].

Science.gov (United States)

Su, Xin-Yao; Xue, Jian-Ping; Wang, Cai-Xia

2016-11-01

The functional ingredients in Chinese materia medica are the main active substance for traditional Chinese medicine and most of them are secondary metabolites derivatives. Until now,the main method to obtain those functional ingredients is through direct extraction from the Chinese materia medica. However, the income is very low because of the high extraction costs and the decreased medicinal plants. Synthetic biology technology, as a new and microbial approach, can be able to carry out large-scale production of functional ingredients and greatly ease the shortage of traditional Chinese medicine ingredients. This review mainly focused on the recent advances in synthetic biology for the functional ingredients production. Copyright© by the Chinese Pharmaceutical Association.

The role of production and teamwork practices in construction safety: a cognitive model and an empirical case study.

Science.gov (United States)

Mitropoulos, Panagiotis Takis; Cupido, Gerardo

2009-01-01

In construction, the challenge for researchers and practitioners is to develop work systems (production processes and teams) that can achieve high productivity and high safety at the same time. However, construction accident causation models ignore the role of work practices and teamwork. This study investigates the mechanisms by which production and teamwork practices affect the likelihood of accidents. The paper synthesizes a new model for construction safety based on the cognitive perspective (Fuller's Task-Demand-Capability Interface model, 2005) and then presents an exploratory case study. The case study investigates and compares the work practices of two residential framing crews: a 'High Reliability Crew' (HRC)--that is, a crew with exceptional productivity and safety over several years, and an average performing crew from the same company. The model explains how the production and teamwork practices generate the work situations that workers face (the task demands) and affect the workers ability to cope (capabilities). The case study indicates that the work practices of the HRC directly influence the task demands and match them with the applied capabilities. These practices were guided by the 'principle' of avoiding errors and rework and included work planning and preparation, work distribution, managing the production pressures, and quality and behavior monitoring. The Task Demand-Capability model links construction research to a cognitive model of accident causation and provides a new way to conceptualize safety as an emergent property of the production practices and teamwork processes. The empirical evidence indicates that the crews' work practices and team processes strongly affect the task demands, the applied capabilities, and the match between demands and capabilities. The proposed model and the exploratory case study will guide further discovery of work practices and teamwork processes that can increase both productivity and safety in construction

Characterization of persistent colors and decolorization of effluent from biologically treated cellulosic ethanol production wastewater.

Science.gov (United States)

Shan, Lili; Liu, Junfeng; Yu, Yanling; Ambuchi, John J; Feng, Yujie

2016-05-01

The high chroma of cellulosic ethanol production wastewater poses a serious environmental concern; however, color-causing compounds are still not fully clear. The characteristics of the color compounds and decolorization of biologically treated effluent by electro-catalytic oxidation were investigated in this study. Excitation-emission matrix (EEM), fourier transform infrared spectrometer (FTIR), UV-Vis spectra, and ultrafiltration (UF) fractionation were used to analyze color compounds. High chroma of wastewater largely comes from humic materials, which exhibited great fluorescence proportion (67.1 %) in the biologically treated effluent. Additionally, the color compounds were mainly distributed in the molecular weight fractions with 3-10 and 10-30 kDa, which contributed 53.5 and 34.6 % of the wastewater color, respectively. Further decolorization of biologically treated effluent by electro-catalytic oxidation was investigated, and 98.3 % of color removal accompanied with 97.3 % reduction of humic acid-like matter was achieved after 180 min. The results presented herein will facilitate the development of a well decolorization for cellulosic ethanol production wastewater and better understanding of the biological fermentation.

Genome Engineering and Modification Toward Synthetic Biology for the Production of Antibiotics.

Science.gov (United States)

Zou, Xuan; Wang, Lianrong; Li, Zhiqiang; Luo, Jie; Wang, Yunfu; Deng, Zixin; Du, Shiming; Chen, Shi

2018-01-01

Antibiotic production is often governed by large gene clusters composed of genes related to antibiotic scaffold synthesis, tailoring, regulation, and resistance. With the expansion of genome sequencing, a considerable number of antibiotic gene clusters has been isolated and characterized. The emerging genome engineering techniques make it possible towards more efficient engineering of antibiotics. In addition to genomic editing, multiple synthetic biology approaches have been developed for the exploration and improvement of antibiotic natural products. Here, we review the progress in the development of these genome editing techniques used to engineer new antibiotics, focusing on three aspects of genome engineering: direct cloning of large genomic fragments, genome engineering of gene clusters, and regulation of gene cluster expression. This review will not only summarize the current uses of genomic engineering techniques for cloning and assembly of antibiotic gene clusters or for altering antibiotic synthetic pathways but will also provide perspectives on the future directions of rebuilding biological systems for the design of novel antibiotics. © 2017 Wiley Periodicals, Inc.

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. Published 2015. This article is a U.S. Government work and is in the public domain in the USA.

Natural products as a resource for biologically active compounds

International Nuclear Information System (INIS)

Hanke, F.J.

1986-01-01

The goal of this study was to investigate various sources of biologically active natural products in an effort to identify the active pesticidal compounds involved. The study is divided into several parts. Chapter 1 contains a discussion of several new compounds from plant and animal sources. Chapter 2 introduces a new NMR technique. In section 2.1 a new technique for better utilizing the lanthanide relaxation agent Gd(fod) 3 is presented which allows the predictable removal of resonances without line broadening. Section 2.2 discusses a variation of this technique for use in an aqueous solvent by applying this technique towards identifying the binding sites of metals of biological interest. Section 2.3 presents an unambiguous 13 C NMR assignment of melibiose. Chapter 3 deals with work relating to the molting hormone of most arthropods, 20-hydroxyecdysone. Section 3.1 discusses the use of two-dimensional NMR (2D NMR) to assign the 1 H NMR spectrum of this biologically important compound. Section 3.2 presents a new application for Droplet countercurrent chromatography (DCCC). Chapter 4 presents a basic improvement to the commercial DCCC instrument that is currently being applied to future commercial instruments. Chapter 5 discusses a curious observation of the effects that two previously known compounds, nagilactone C and (-)-epicatechin, have on lettuce and rice and suggest a possible new role for the ubiquitous flavanol (-)-epicatechin in plants

Relating safety, productivity and company type for motor-manual logging operations in the Italian Alps.

Science.gov (United States)

Montorselli, Niccolò Brachetti; Lombardini, Carolina; Magagnotti, Natascia; Marchi, Enrico; Neri, Francesco; Picchi, Gianni; Spinelli, Raffaele

2010-11-01

The study compared the performance of four different logging crews with respect to productivity, organization and safety. To this purpose, the authors developed a data collection method capable of providing a quantitative analysis of risk-taking behavior. Four crews were tested under the same working conditions, representative of close-to-nature alpine forestry. Motor-manual working methods were applied, since these methods are still prevalent in the specific study area, despite the growing popularity of mechanical processors. Crews from public companies showed a significantly lower frequency of risk-taking behavior. The best safety performance was offered by the only (public) crew that had been administered formal safety training. The study seems to deny the common prejudice that safety practice is inversely proportional to productivity. Instead, productivity is increased by introducing more efficient working methods and equipment. The quantitative analysis of risk-taking behavior developed in this study can be applied to a number of industrial fields besides forestry. Characterizing risk-taking behavior for a given case may eventually lead to the development of custom-made training programmes, which may address problem areas while avoiding that the message is weakened by the inclusion of redundant information. In the specific case of logging crews in the central Alps, the study suggests that current training courses may be weak on ergonomics, and advocates a staged training programme, focusing first on accident reduction and then expanding to the prevention of chronic illness. 2010 Elsevier Ltd. All rights reserved.

Safety management of a high energy accelerator used in the production of tritium

International Nuclear Information System (INIS)

Stark, R.M.; Brown, N.W.; Allen C.L.

1997-01-01

Interest in a high energy accelerator for producing tritium raises considerations regarding facility Safety Management. Accelerator facility hazards require safety analysis to consider factors such as: safe management of a large flux of very high energy neutrons, sustained operation in a very high energy proton and neutron field, neutron irradiation of a variety of materials, and handling and processing of significant quantities of tritium. Safety considerations of support systems and potential effects of magnetic fields must also be included. Existing Safety Management techniques, safety standards, and criteria for operation of high energy accelerators provide considerable guidance. These must, however, be reviewed to determine their appropriate use for safe operation of a very large, tritium-producing accelerator. New or revised safety standards may be required to establish and maintain the safe operating-envelope. The goal will be to develop a set of tailored standards and criteria that provide a reasonable operational envelope and assure adequate public, worker, and environmental safety. The generation of an appropriate set of safety standards and criteria will include several activities. One activity will involve evaluation of proposed facility designs to determine possible hazards. Another activity will involve a detailed review of existing accelerator safety management systems. A third activity will involve the review of operating histories of existing facilities. Facilities approximating the characteristics of the anticipated tritium production facility will be considered. Following completion of these activities a proposed Safety Management System and criteria for application to these facilities will be drafted. The need for new analytical methods and for additional safety standards will be identified. The draft document will then be reviewed and revised to establish the standards and criteria within the appropriate Department of Energy framework

Analytical similarity assessment of rituximab biosimilar CT-P10 to reference medicinal product.

Science.gov (United States)

Lee, Kyoung Hoon; Lee, Jihun; Bae, Jin Soo; Kim, Yeon Jung; Kang, Hyun Ah; Kim, Sung Hwan; Lee, So Jung; Lim, Ki Jung; Lee, Jung Woo; Jung, Soon Kwan; Chang, Shin Jae

2018-04-01

CT-P10 (Truxima™) was recently approved as the world's first rituximab biosimilar product in the European Union (EU) and South Korea. To demonstrate biosimilarity of CT-P10 with the reference medicinal product (RMP), extensive 3-way similarity assessment has been conducted between CT-P10, EU-Rituximab and US-Rituximab, focusing on the physicochemical and biological quality attributes. A multitude of state-of-the-art analyses revealed that CT-P10 has identical primary and higher order structures compared to the original product. Purity/impurity profiles of CT-P10 measured by the levels of aggregates, fragments, non-glycosylated form and process-related impurities were also found to be comparable with those of RMPs. In terms of the post-translational modification, CT-P10 contains slightly less N-terminal pyro-glutamate variant, which has been known not to affect product efficacy or safety. Oligosaccharide profiling has revealed that, although CT-P10 contains the same conserved glycan species and relative proportion with the RMPs, the content of total afucosylated glycan in CT-P10 was slightly higher than in EU- or US-Rituximab. Nevertheless, the effect of the observed level of afucosylation in CT-P10 drug product on Fc receptor binding affinity or antibody-dependent cell-mediated cytotoxicity was found to be negligible based on the spiking study with highly afucosylated sample. Arrays of biological assays representative of known and putative mechanisms of action for rituximab have shown that biological activities of CT-P10 are within the quality range of RMPs. Recent results of clinical studies have further confirmed that the CT-P10 exhibits equivalent clinical efficacy and safety profiles compared to EU- and US-Rituximab. The current 3-way similarity assessment together with clinical study results confidently demonstrate that CT-P10 is highly similar with EU- and US-Rituximab in terms of physicochemical properties, biological activities, efficacy, and safety for

Risk assessment of the biological plant protection products Nemasys G and Nemasys H with the active organism Heterorhabditis Bacteriophora. Opinion of the Panel on Plant Protection Products of the Norwegian Scientific Committee for Food Safety

OpenAIRE

Källqvist, Torsten; Borgå, Katrine; Dirven, Hubert; Eklo, Ole Martin; Grung, Merete; Lyche, Jan Ludvig; Låg, Marit; Nilsen, Asbjørn Magne; Sverdrup, Line Emilie

2014-01-01

Nemasys G and Nemasys H with the nematode Heterorhabditis bacteriophora as the active organism is applied for as a plant protection product in Norway. Nemasys G is intended for use against the garden chafer (Phyllopertha horticola) in lawns and Nemasys H against black vine weevil (Otiorhynchus sulcatus) in strawberries and ornamentals. VKM was requested by the Norwegian Food Safety Authority to consider the possible health and environmental risk related to the properties of Nemasys G and Nema...

Botulinum toxin type A products are not interchangeable: a review of the evidence

Directory of Open Access Journals (Sweden)

Brin MF

2014-10-01

Full Text Available Mitchell F Brin,1,2 Charmaine James,3 John Maltman1 1Allergan, Inc., Irvine, CA, USA; 2Department of Neurology, University of California, Irvine, CA, USA; 3Allergan, Marlow, UKAbstract: Botulinum toxin type A (BoNTA products are injectable biologic medications derived from Clostridium botulinum bacteria. Several different BoNTA products are marketed in various countries, and they are not interchangeable. Differences between products include manufacturing processes, formulations, and the assay methods used to determine units of biological activity. These differences result in a specific set of interactions between each BoNTA product and the tissue injected. Consequently, the products show differences in their in vivo profiles, including preclinical dose response curves and clinical dosing, efficacy, duration, and safety/adverse events. Most, but not all, published studies document these differences, suggesting that individual BoNTA products act differently depending on experimental and clinical conditions, and these differences may not always be predictable. Differentiation through regulatory approvals provides a measure of confidence in safety and efficacy at the specified doses for each approved indication. Moreover, the products differ in the amount of study to which they have been subjected, as evidenced by the number of publications in the peer-reviewed literature and the quantity and quality of clinical studies. Given that BoNTAs are potent biological products that meet important clinical needs, it is critical to recognize that their dosing and product performance are not interchangeable and each product should be used according to manufacturer guidelines.Keywords: onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, glabellar lines, non-interchangeability

Biofuel production in Escherichia coli. The role of metabolic engineering and synthetic biology

Energy Technology Data Exchange (ETDEWEB)

Clomburg, James M. [Rice Univ., Houston, TX (United States). Dept. of Chemical and Biomolecular Engineering; Gonzalez, Ramon [Rice Univ., Houston, TX (United States). Dept. of Chemical and Biomolecular Engineering; Rice Univ., Houston, TX (United States). Dept. of Bioengineering

2010-03-15

The microbial production of biofuels is a promising avenue for the development of viable processes for the generation of fuels from sustainable resources. In order to become cost and energy effective, these processes must utilize organisms that can be optimized to efficiently produce candidate fuels from a variety of feedstocks. Escherichia coli has become a promising host organism for the microbial production of biofuels in part due to the ease at which this organism can be manipulated. Advancements in metabolic engineering and synthetic biology have led to the ability to efficiently engineer E. coli as a biocatalyst for the production of a wide variety of potential biofuels from several biomass constituents. This review focuses on recent efforts devoted to engineering E. coli for the production of biofuels, with emphasis on the key aspects of both the utilization of a variety of substrates as well as the synthesis of several promising biofuels. Strategies for the efficient utilization of carbohydrates, carbohydrate mixtures, and noncarbohydrate carbon sources will be discussed along with engineering efforts for the exploitation of both fermentative and nonfermentative pathways for the production of candidate biofuels such as alcohols and higher carbon biofuels derived from fatty acid and isoprenoid pathways. Continued advancements in metabolic engineering and synthetic biology will help improve not only the titers, yields, and productivities of biofuels discussed herein, but also increase the potential range of compounds that can be produced. (orig.)

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.

Biological effects of radiation human health and safety

International Nuclear Information System (INIS)

1977-05-01

The biological hazards of nuclear energy usage are a growing source of public concern. The medical profession may well be expected to contribute to public debate on the issue. This document, therefore, attempts a balanced review of the known and suspected human biological consequences of exposure to different types of ionizing radiation, emphasizing in particular the nuclear industry

Permitting product liability litigation for FDA-approved drugs and devices promotes patient safety.

Science.gov (United States)

Kesselheim, A S

2010-06-01

In 2008 and 2009, the Supreme Court reviewed the question of whether patients injured by dangerous prescription drugs or medical devices can bring tort lawsuits against pharmaceutical and device manufacturers. The Court ruled that claims against device manufacturers were preempted while claims against pharmaceutical manufacturers were not. The threat of product liability lawsuits promotes patient safety by encouraging manufacturers to take greater responsibility in providing clear warnings about known adverse effects of their products.

Biological aspects of tissue-engineered cartilage.

Science.gov (United States)

Hoshi, Kazuto; Fujihara, Yuko; Yamawaki, Takanori; Harai, Motohiro; Asawa, Yukiyo; Hikita, Atsuhiko

2018-04-01

Cartilage regenerative medicine has been progressed well, and it reaches the stage of clinical application. Among various techniques, tissue engineering, which incorporates elements of materials science, is investigated earnestly, driven by high clinical needs. The cartilage tissue engineering using a poly lactide scaffold has been exploratorily used in the treatment of cleft lip-nose patients, disclosing good clinical results during 3-year observation. However, to increase the reliability of this treatment, not only accumulation of clinical evidence on safety and usefulness of the tissue-engineered products, but also establishment of scientific background on biological mechanisms, are regarded essential. In this paper, we reviewed recent trends of cartilage tissue engineering in clinical practice, summarized experimental findings on cellular and matrix changes during the cartilage regeneration, and discussed the importance of further studies on biological aspects of tissue-engineered cartilage, especially by the histological and the morphological methods.

Evolution of activities in international biological standardization since the early days of the Health Organisation of the League of Nations.

Science.gov (United States)

Sizaret, P

1988-01-01

The main activities in international biological standardization during the 18 years that followed the first international biological standardization meeting in London in 1921 were concerned with expressing the potencies of test preparations in comparison with reference materials. After the Second World War, however, it became clear that the testing of biological substances against international reference materials was only one among several measures for obtaining safe and potent products. The activities in international biological standardization were therefore widened so that, by the strict observance of specific manufacturing and control requirements, it was possible to gain further in safety and efficacy. At the end of 1987, 42 international requirements for biological substances were available and were being used as national requirements, sometimes after minor modification, by the majority of WHO's Member States. This is of utmost importance for the worldwide use of safe and potent biological products, including vaccines.

Biological risks associated with consumption of reptile products.

Science.gov (United States)

Magnino, Simone; Colin, Pierre; Dei-Cas, Eduardo; Madsen, Mogens; McLauchlin, Jim; Nöckler, Karsten; Maradona, Miguel Prieto; Tsigarida, Eirini; Vanopdenbosch, Emmanuel; Van Peteghem, Carlos

2009-09-15

The consumption of a wide variety of species of reptiles caught from the wild has been an important source of protein for humans world-wide for millennia. Terrapins, snakes, lizards, crocodiles and iguanas are now farmed and the consumption and trade of their meat and other edible products have recently increased in some areas of the world. Biological risks associated with the consumption of products from both farmed and wild reptile meat and eggs include infections caused by bacteria (Salmonella spp., Vibrio spp.), parasites (Spirometra, Trichinella, Gnathostoma, pentastomids), as well as intoxications by biotoxins. For crocodiles, Salmonella spp. constitute a significant public health risk due to the high intestinal carrier rate which is reflected in an equally high contamination rate in their fresh and frozen meat. There is a lack of information about the presence of Salmonella spp. in meat from other edible reptilians, though captive reptiles used as pets (lizards or turtles) are frequently carriers of these bacteria in Europe. Parasitic protozoa in reptiles represent a negligible risk for public health compared to parasitic metazoans, of which trichinellosis, pentastomiasis, gnathostomiasis and sparganosis can be acquired through consumption of contaminated crocodile, monitor lizard, turtle and snake meat, respectively. Other reptiles, although found to harbour the above parasites, have not been implicated with their transmission to humans. Freezing treatment inactivates Spirometra and Trichinella in crocodile meat, while the effectiveness of freezing of other reptilian meat is unknown. Biotoxins that accumulate in the flesh of sea turtles may cause chelonitoxism, a type of food poisoning with a high mortality rate in humans. Infections by fungi, including yeasts, and viruses widely occur in reptiles but have not been linked to a human health risk through the contamination of their meat. Currently there are no indications that natural transmissible spongiform

Silica diatom shells tailored with Au nanoparticles enable sensitive analysis of molecules for biological, safety and environment applications

KAUST Repository

Onesto, V.; Villani, M.; Coluccio, M. L.; Majewska, R.; Alabastri, A.; Battista, E.; Schirato, A.; Calestani, D.; Coppedé , N.; Cesarelli, M.; Amato, F.; Di Fabrizio, Enzo M.; Gentile, F.

2018-01-01

Diatom shells are a natural, theoretically unlimited material composed of silicon dioxide, with regular patterns of pores penetrating through their surface. For their characteristics, diatom shells show promise to be used as low cost, highly efficient drug carriers, sensor devices or other micro-devices. Here, we demonstrate diatom shells functionalized with gold nanoparticles for the harvesting and detection of biological analytes (bovine serum albumin—BSA) and chemical pollutants (mineral oil) in low abundance ranges, for applications in bioengineering, medicine, safety, and pollution monitoring.

Silica diatom shells tailored with Au nanoparticles enable sensitive analysis of molecules for biological, safety and environment applications

KAUST Repository

Onesto, V.

2018-04-19

Diatom shells are a natural, theoretically unlimited material composed of silicon dioxide, with regular patterns of pores penetrating through their surface. For their characteristics, diatom shells show promise to be used as low cost, highly efficient drug carriers, sensor devices or other micro-devices. Here, we demonstrate diatom shells functionalized with gold nanoparticles for the harvesting and detection of biological analytes (bovine serum albumin—BSA) and chemical pollutants (mineral oil) in low abundance ranges, for applications in bioengineering, medicine, safety, and pollution monitoring.

Creating biological nanomaterials using synthetic biology

International Nuclear Information System (INIS)

Rice, MaryJoe K; Ruder, Warren C

2014-01-01

Synthetic biology is a new discipline that combines science and engineering approaches to precisely control biological networks. These signaling networks are especially important in fields such as biomedicine and biochemical engineering. Additionally, biological networks can also be critical to the production of naturally occurring biological nanomaterials, and as a result, synthetic biology holds tremendous potential in creating new materials. This review introduces the field of synthetic biology, discusses how biological systems naturally produce materials, and then presents examples and strategies for incorporating synthetic biology approaches in the development of new materials. In particular, strategies for using synthetic biology to produce both organic and inorganic nanomaterials are discussed. Ultimately, synthetic biology holds the potential to dramatically impact biological materials science with significant potential applications in medical systems. (review)

Creating biological nanomaterials using synthetic biology.

Science.gov (United States)

Rice, MaryJoe K; Ruder, Warren C

2014-02-01

Synthetic biology is a new discipline that combines science and engineering approaches to precisely control biological networks. These signaling networks are especially important in fields such as biomedicine and biochemical engineering. Additionally, biological networks can also be critical to the production of naturally occurring biological nanomaterials, and as a result, synthetic biology holds tremendous potential in creating new materials. This review introduces the field of synthetic biology, discusses how biological systems naturally produce materials, and then presents examples and strategies for incorporating synthetic biology approaches in the development of new materials. In particular, strategies for using synthetic biology to produce both organic and inorganic nanomaterials are discussed. Ultimately, synthetic biology holds the potential to dramatically impact biological materials science with significant potential applications in medical systems.

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...

The Effect of Product Safety Courses on the Adoption and Outcomes of LESS Surgery

Science.gov (United States)

Toomey, Paul G.; Ross, Sharona B.; Choung, Edward; Donn, Natalie; Vice, Michelle; Luberice, Kenneth; Albrink, Michael

2015-01-01

Background and Objectives: As technology in surgery evolves, the medical instrument industry is inevitability involved in promoting the use and appropriate (ie, effective and safe) application of its products. This study was undertaken to evaluate industry-supported product safety courses in laparoendoscopic single-site (LESS) surgery, by using the metrics of surgeons' adoption of the technique, safety of the procedure, and surgeons' perception of the surgery. Methods: LESS surgery courses that involved didactic lectures, operative videos, operation observation, collaborative learning, and simulation, were attended by 226 surgeons. With Florida Hospital Tampa Institutional Review Board approval, the surgeons were queried before and immediately after the course, to assess their attitudes toward LESS surgery. Then, well after the course, the surgeons were contacted, repeatedly if necessary, to complete questionnaires. Results: Before the course, 82% of the surgeons undertook more than 10 laparoscopic operations per month. Immediately after the course, 86% were confident that they were prepared to perform LESS surgery. Months after the course, 77% of the respondents had adopted LESS surgery, primarily cholecystectomy; 59% had added 1 or more trocars in 0–20% of their procedures; and 73% held the opinion that operating room observation was the most helpful learning experience. Complications with LESS surgery were noted 12% of the time. Advantages of the technique were better cosmesis (58%) and patient satisfaction (38%). Disadvantages included risk of complications (37%) and higher technical demand (25%). Seventy-eight percent viewed LESS surgery as an advancement in surgical technique. Conclusion: In multifaceted product safety courses, operating room observation is thought to provide the most helpful instruction for those wanting to undertake LESS surgery. The procedure has been safely adopted by surgeons who frequently perform laparoscopies. The tradeoff is in

Yeasts in foods and beverages: impact on product quality and safety.

Science.gov (United States)

Fleet, Graham H

2007-04-01

The role of yeasts in food and beverage production extends beyond the well-known bread, beer and wine fermentations. Molecular analytical technologies have led to a major revision of yeast taxonomy, and have facilitated the ecological study of yeasts in many other products. The mechanisms by which yeasts grow in these ecosystems and impact on product quality can now be studied at the level of gene expression. Their growth and metabolic activities are moderated by a network of strain and species interactions, including interactions with bacteria and other fungi. Some yeasts have been developed as agents for the biocontrol of food spoilage fungi, and others are being considered as novel probiotic organisms. The association of yeasts with opportunistic infections and other adverse responses in humans raises new issues in the field of food safety.

[Measures for counteracting of biological terrorism in the Russian Federation].

Science.gov (United States)

Onishchenko, G G

2005-01-01

The article deals with topicality of the problem of ensuring biological safety in Russia. The necessity of a unified state policy aimed at the realization of the concept of biological safety is grounded. In particular, the expediency of the state support of research programs is emphasized. The organizational and practical measures, carried out by the Ministry of Health and Social Development in this field, are analyzed. The list of prospective measures for the organization of effective state regulation in the field of ensuring the biological safety of the country is given.

Safety and security profiles of industry networks used in safety- critical applications

Directory of Open Access Journals (Sweden)

Mária FRANEKOVÁ

2008-01-01

Full Text Available The author describes the mechanisms of safety and security profiles of industry and communication networks used within safety – related applications in technological and information levels of process control recommended according to standards IEC 61784-3,4. Nowadays the number of vendors of the safety – related communication technologies who guarantees besides the standard communication, the communication amongst the safety – related equipment according to IEC 61508 is increasing. Also the number of safety – related products is increasing, e. g. safety Fieldbus, safety PLC, safety curtains, safety laser scanners, safety buttons, safety relays and other. According to world survey the safety Fieldbus denoted the highest growth from all manufactured safety products.The main part of this paper is the description of the safety-related Fieldbus communication system, which has to guaranty Safety Integrity Level.

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.

Information and Communication Technologies for the Safety and Security of Fish and Fishery Products

Directory of Open Access Journals (Sweden)

Liliana Mihaela MOGA

2017-06-01

Full Text Available The food industry is becoming more customer-oriented and needs faster response times to deal with food scandals and incidents. Good traceability systems help to minimize the production and distribution of unsafe or poor quality products, thereby minimizing the potential for bad publicity, liability, and recalls. The current food labelling systems cannot guarantee that the food is authentic, good quality and safe. Therefore, traceability is applied as a tool to assist in the assurance of food safety and quality as well as to achieve consumer confidence. This paper presents comprehensive information about traceability systems and the evolution concerning the actors involved and the information about safety and quality in the food supply chain administrated within the systems. Some inventive factors, which influence the traceability systems adoption, are underlined.

Product Differences in Intra-articular Hyaluronic Acids for Osteoarthritis of the Knee.

Science.gov (United States)

Altman, Roy D; Bedi, Asheesh; Karlsson, Jon; Sancheti, Parag; Schemitsch, Emil

2016-08-01

Knee osteoarthritis (OA) is a common and often disabling joint disorder among adults that may result in impaired activity and daily function. A variety of treatment options are currently available and prescribed for knee OA depending on the severity of the disorder and physician preference. Intra-articular hyaluronic acid (IA-HA) injection is a treatment for knee OA that reportedly provides numerous biochemical and biological benefits, including shock absorption, chondroprotection, and anti-inflammatory effects within the knee. Clarity is needed as to whether the available IA-HA products should be considered for therapy as a group or whether there are significant differences in the products that need to be considered in treatment of OA of the knee. To determine whether there are differences in efficacy and safety with respect to intrinsic properties of available IA-HA injections for knee OA. Meta-analysis. A comprehensive literature search of the Medline, EMBASE, and PubMed databases was conducted for all existing randomized trials of IA-HA. The primary outcome measure analyzed was the mean pain score at the reported follow-up nearest to 26 weeks after injection. Pooled efficacy and safety results were recorded for subgroupings of HA product characteristics. A total of 68 studies were included for analysis. Products with an average molecular weight ≥3000 kDa provided favorable efficacy results when compared with products of an average molecular weight injection site than did avian-derived HA products, while high-molecular-weight products demonstrated the highest rate of injection site flare-up. Despite similarities, IA-HA products should not be treated as a group, as there are differences in IA-HA products that influence both efficacy and safety. In the available literature, IA-HA products with a molecular weight ≥3000 kDa and those derived from biological fermentation relate to superior efficacy and safety-factors that may influence selection an IA-HA product

78 FR 10181 - Global Quality Systems-An Integrated Approach To Improving Medical Product Safety; Public Workshop

Science.gov (United States)

2013-02-13

...] Global Quality Systems--An Integrated Approach To Improving Medical Product Safety; Public Workshop... (AFDO), is announcing a public workshop entitled ``Global Quality Systems--An Integrated Approach to... topics concerning FDA requirements related to the production and marketing of drugs and/or devices...

On the Safety of Machine Learning: Cyber-Physical Systems, Decision Sciences, and Data Products.

Science.gov (United States)

Varshney, Kush R; Alemzadeh, Homa

2017-09-01

Machine learning algorithms increasingly influence our decisions and interact with us in all parts of our daily lives. Therefore, just as we consider the safety of power plants, highways, and a variety of other engineered socio-technical systems, we must also take into account the safety of systems involving machine learning. Heretofore, the definition of safety has not been formalized in a machine learning context. In this article, we do so by defining machine learning safety in terms of risk, epistemic uncertainty, and the harm incurred by unwanted outcomes. We then use this definition to examine safety in all sorts of applications in cyber-physical systems, decision sciences, and data products. We find that the foundational principle of modern statistical machine learning, empirical risk minimization, is not always a sufficient objective. We discuss how four different categories of strategies for achieving safety in engineering, including inherently safe design, safety reserves, safe fail, and procedural safeguards can be mapped to a machine learning context. We then discuss example techniques that can be adopted in each category, such as considering interpretability and causality of predictive models, objective functions beyond expected prediction accuracy, human involvement for labeling difficult or rare examples, and user experience design of software and open data.

Manufacturing of curd products of increased biological value for the elderly from dried components.

Science.gov (United States)

Zabodalova, Ludmila A; Belozerova, Maria S; Evstigneeva, Tatiana N

2018-01-01

In recent years, the number of elderly people has increased, and the diseases that arise in old age are associated, amongst other factors, with malnutrition. In the elderly, the need for primary nutrients and energy changes, so the development of food products intended for this particular group of people is becom- ing increasingly important. The purpose of this research is to work out the composition of and technology for producing low-fat curd products from raw milk and vegetable components. The developed products can be used for their gerodietetic properties, because nutritional and energy needs in the elderly were taken into account when designing the product. The curd product was manufactured from skimmed dried milk (SDM), soy isolate protein (SIP) and spelt grain. Optimal conditions for the recombination of SIP were determined. The influence of mass fraction of SIP on the properties of the clot and the end product was studied. The degree of dispersion of the grain component was determined, from the organoleptic evaluation of samples of the mixture, and the optimum method of addition was chosen. The method of adding cooked spelt into the clot after pressing was chosen. Harrington’s generalized desirability function was used for the calculation of the optimum mass frac- tion of the grain component in the end product. The formulation and technology for a curd product based on dry ingredients were determined. The amino acid composition and content of essential components in the developed product were determined, and the biological and nutritional value were calculated. The use of dry ingredients for the production of a curd product makes it possible to manufac- ture the product in the absence of raw milk. The formulation of the product is designed taking into account the needs of the body in old age. The incorporation of spelt increases the biological value of the curd product to 81.5%.

Industrial systems biology and its impact on synthetic biology of yeast cell factories

DEFF Research Database (Denmark)

Fletcher, Eugene; Krivoruchko, Anastasia; Nielsen, Jens

2016-01-01

Engineering industrial cell factories to effectively yield a desired product while dealing with industrially relevant stresses is usually the most challenging step in the development of industrial production of chemicals using microbial fermentation processes. Using synthetic biology tools......, microbial cell factories such as Saccharomyces cerevisiae can be engineered to express synthetic pathways for the production of fuels, biopharmaceuticals, fragrances, and food flavors. However, directing fluxes through these synthetic pathways towards the desired product can be demanding due to complex...... regulation or poor gene expression. Systems biology, which applies computational tools and mathematical modeling to understand complex biological networks, can be used to guide synthetic biology design. Here, we present our perspective on how systems biology can impact synthetic biology towards the goal...

RESEARCHES CONCERNING THE EFFECT OF SOME BIOLOGICALLY-ACTIVE PRODUCTS ON FORAGE BIOMASS YIELD IN SMOOTH BROME

Directory of Open Access Journals (Sweden)

I. PET

2008-05-01

Full Text Available Vegetal biostimulants are organic products (natural or synthesized that exert upon plant growth an action similar to the phytohormones’ one, when they are applied in small amounts, in certain stages of plant development. Biostimulants change organisms or organs’ development, nutrition or resistance, under various stress conditions, by inducing changes into the vital processes leading to the improvement of crop quality and quantity, to a better and more operative mechanical harvesting and to an improvement in the agricultural products’ preservation. The application of biologically-active products in the smooth brome crop determined growth of the dry matter yield of up to 1.11 t/ha depending on the product used, and the foliar surface index increased in the variants with application of biologically-active products with up to 1.16 m2SA/m2 land, compared to the control variant.

Biological productivity and potential resources of the exclusive economic zone (EEZ) of India

Digital Repository Service at National Institute of Oceanography (India)

Goswami, S.C.

An assessment of the biological production and the potential fishery resources has been made based on the data collected over a period of 15 years (1976-1991). The entire Exclusive Economic Zone (EEZ), measuring 2.02 million km sup(2) was divided...

Field safety notices released by manufacturers in cases of failure of products for infection testing: analysis of cases reported to the BfArM between 2005 and 2007.

Science.gov (United States)

Siekmeier, R; Lisson, K; Wetzel, D

2010-11-04

The European Directive 98/79/EC for in vitro diagnostic medical devices (IVD) regulates marketing and post marketing surveillance of IVD in the European Economic Area. Manufacturers have to inform the responsible Competent Authorities (CA) about incidents and field safety corrective actions (FSCA) related to IVD. In Germany, the Federal Institute for Drugs and Medical Devices (BfArM) is the responsible CA for most IVD, only few IVD as specified in Annex II of the Directive are under the responsibility of the Paul Ehrlich Institute (PEI). In case of a FSCA manufacturers have to inform customers by means of a Field Safety Notice (FSN) which should be sent to BfArM prior to release and is published on the BfArM homepage. Between beginning of 2005 and end of 2007 the BfArM received a total of 1025 reports regarding IVD. From these, 38 related to tests, reagents, calibrators, and control materials for infection testing, 13 related to analysers and general consumables (n = 8 and n = 5, respectively) based on culture techniques, and 7 related to analysers and general consumables (n = 5 and n = 2, respectively) based on molecular biological methods. FSCA were performed in Germany in 32 (84.2%) of all notifications related to tests reagents, calibrators, and control materials as well as in 13 (100%) and 7 (100%) of notifications related to analysers and consumables based on culture techniques and molecular biological methods, respectively. A number of relevant deficiencies regarding the quality of the FSN were separately demonstrated for FSN in German and English language. In brief, manufacturers often sent their FSN to the BfArM with delay. Additionally, a subset of FSN provided insufficient information on the product related risks or the measures to be performed by the customer to mitigate product related risks. Furthermore, customer confirmation forms often were missing in the FSN sent to the BfArM. Our data suggest that for IVD for infection testing FSCA and FSN are

Proposal of safety design methodologies for an HTGR-hydrogen production system. Mainly on countermeasures against fire and explosion

International Nuclear Information System (INIS)

Nishihara, Tetsuo; Hada, Kazuhiko; Shiozawa, Syusaku

1996-03-01

Among key issues of the safety design for an HTGR-hydrogen production system is to ensure the safety of the nuclear reactor against fire and explosion accidents in the hydrogen production plant. The fire and explosion accidents in the hydrogen production plant are categorized into the following two cases; Accidents inside the reactor building (R/B) and accidents outside the R/B. Against accidents inside the R/B, the proposed safety design concept is to prevent the occurrence of the accidents based on the defence in depth concept. The piping system and/or heat transfer tubes which have the potential possibility of combustible materials ingress into the R/B due to the failure are designed at the highest aseismic level to prevent the failure against severe earthquake. Even if the failure occurs, the piping trench and related compartments are fulfilled with nitrogen so as to prevent the occurrence of accidents. The proposed safety design concept for the accidents outside the R/B is the mitigation of effects of accidents. Proposed countermeasures is to take the safe distance between the hydrogen production plant and the items important to safety in the nuclear plant. We showed that the anticipated accidents to estimate the safe distance are large scale pool burning, fireball, pressure vessel burst and vapor cloud explosion. Especially, new estimating concept to establish the safe distance is proposed for the vapor cloud explosion. To reduce the safe distance, we proposed the underground non-pressurized storage tank and ventilation system for the storage of large amount of combustible liquid. (author). 61 refs

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).

Optimizing Safety Stock Levels in Modular Production Systems Using Component Commonality and Group Technology Philosophy: A Study Based on Simulation

Directory of Open Access Journals (Sweden)

Kenneth Edgar Hernandez-Ruiz

2016-01-01

Full Text Available Modular production and component commonality are two widely used strategies in the manufacturing industry to meet customers growing needs for customized products. Using these strategies, companies can enhance their performance to achieve optimal safety stock levels. Despite the importance of safety stocks in business competition, little attention has been paid to the way to reduce them without affecting the customer service levels. This paper develops a mathematical model to reduce safety stock levels in organizations that employ modular production. To construct the model, we take advantage of the benefits of aggregate inventories, standardization of components, component commonality, and Group Technology philosophy in regard to stock levels. The model is tested through the simulation of three years of operation of two modular product systems. For each system, we calculated and compared the safety stock levels for two cases: (1 under the only presence of component commonality and (2 under the presence of both component commonality and Group Technology philosophy. The results show a reduction in safety stock levels when we linked the component commonality with the Group Technology philosophy. The paper presents a discussion of the implications of each case, features of the model, and suggestions for future research.

Microbial production of natural and non-natural flavonoids: Pathway engineering, directed evolution and systems/synthetic biology.

Science.gov (United States)

Pandey, Ramesh Prasad; Parajuli, Prakash; Koffas, Mattheos A G; Sohng, Jae Kyung

2016-01-01

In this review, we address recent advances made in pathway engineering, directed evolution, and systems/synthetic biology approaches employed in the production and modification of flavonoids from microbial cells. The review is divided into two major parts. In the first, various metabolic engineering and system/synthetic biology approaches used for production of flavonoids and derivatives are discussed broadly. All the manipulations/engineering accomplished on the microorganisms since 2000 are described in detail along with the biosynthetic pathway enzymes, their sources, structures of the compounds, and yield of each product. In the second part of the review, post-modifications of flavonoids by four major reactions, namely glycosylations, methylations, hydroxylations and prenylations using recombinant strains are described. Copyright © 2016 Elsevier Inc. All rights reserved.

FDA Regulation of Follow-On Biologics

Science.gov (United States)

2009-02-24

opening a pathway for the approval of follow-on biologics. A biologic is a preparation, such as a drug or a vaccine , that is made from living...2006 Drug Trend Report, April 2006, p. 38. C Biologic vs. Follow-on Biologic A biologic is a preparation, such as a drug or a vaccine , that is...doc9496/s1695.pdf. 19 Thijs J. Giezen, Aukje K. Mantel-Teeuwisse, and Sabine M. J. M. Straus, et al., “Safety-related regulatory actions for biologicals

Leachables and extractables handbook: safety evaluation, qualification, and best practices applied to inhalation drug products

National Research Council Canada - National Science Library

Ball, Douglas J

2012-01-01

...). It discusses best practices for evaluation and management of leachables and extractables throughout the pharma product lifecycle by providing practical knowledge about how and why safety thresholds were developed...

Safety evaluation of small samples for isotope production

International Nuclear Information System (INIS)

Sharma, Archana; Singh, Tej; Varde, P.V.

2015-09-01

Radioactive isotopes are widely used in basic and applied science and engineering, most notably as environmental and industrial tracers, and for medical imaging procedures. Production of radioisotope constitutes important activity of Indian nuclear program. Since its initial criticality DHRUVA reactor has been facilitating the regular supply of most of the radioisotopes required in the country for application in the fields of medicine, industry and agriculture. In-pile irradiation of the samples requires a prior estimation of the sample reactivity load, heating rate, activity developed and shielding thickness required for post irradiation handling. This report is an attempt to highlight the contributions of DHRUVA reactor, as well as to explain in detail the methodologies used in safety evaluation of the in pile irradiation samples. (author)

Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA)

DEFF Research Database (Denmark)

Leuschner, R. G. K.; Robinson, T. P.; Hugas, M.

2010-01-01

Qualified Presumption of Safety (QPS) is a generic risk assessment approach applied by the European Food Safety Authority (EFSA) to notified biological agents aiming at simplifying risk assessments across different scientific Panels and Units. The aim of this review is to outline the implementation...... and value of the QPS assessment for EFSA and to explain its principles such as the unambiguous identity of a taxonomic unit, the body of knowledge including potential safety concerns and how these considerations lead to a list of biological agents recommended for QPS which EFSA keeps updated through...

Biological control of Alternaria radicina in seed production of carrots with Ulocladium atrum

NARCIS (Netherlands)

Köhl, J.; Langerak, C.J.; Meekes, E.T.M.; Molhoek, W.M.L.

2004-01-01

Black rot of carrots is caused by seed-borne Alternaria radicina. Biological control of seed infestation by treatments applied to plants in flower during seed production with the fungal antagonist Ulocladium atrum was investigated in laboratory and field experiments resulting in a reduction of seed

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

Science.gov (United States)

2013-11-04

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

The yeast stands alone: the future of protein biologic production.

Science.gov (United States)

Love, Kerry R; Dalvie, Neil C; Love, J Christopher

2017-12-22

Yeasts are promising alternative hosts for the manufacturing of recombinant protein therapeutics because they simply and efficiently meet needs for both platform and small-market drugs. Fast accumulation of biomass and low-cost media reduce the cost-of-goods when using yeast, which in turn can enable agile, small-volume manufacturing facilities. Small, tractable yeast genomes are amenable to rapid process development, facilitating strain and product quality by design. Specifically, Pichia pastoris is becoming a widely accepted yeast for biopharmaceutical manufacturing in much of the world owing to a clean secreted product and the rapidly expanding understanding of its cell biology as a host organism. We advocate for a near term partnership spanning industry and academia to promote open source, timely development of yeast hosts. Copyright © 2017. Published by Elsevier Ltd.

Westinghouse independent safety review of Savannah River production reactors

International Nuclear Information System (INIS)

Leggett, W.D.; McShane, W.J.; Liparulo, N.J.; McAdoo, J.D.; Strawbridge, L.E.; Call, D.W.

1989-01-01

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 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