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Update On Undertaking Extractable And Leachable Testing
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Book Synopsis Update on Undertaking Extractable and Leachable Testing by : Andrew Feilden
Download or read book Update on Undertaking Extractable and Leachable Testing written by Andrew Feilden and published by Smithers Rapra. This book was released on 2011-03-31 with total page 180 pages. Available in PDF, EPUB and Kindle. Book excerpt: The assessment of all materials - and especially elastomeric and plastic components - for the presence of leachable and extractable components, forms an important part of the submission for approval of a new drug system or medical device. This Update gives a detailed, state-of-the-art review of the selection of techniques, available to the analyst, to perform a controlled extraction study for leachables and extractables, with an overview of the factors to consider when selecting the extraction technique. This book will be of interest to Chemists and R&D managers.
Book Synopsis Rubber Analysis by : Martin J. Forrest
Download or read book Rubber Analysis written by Martin J. Forrest and published by Walter de Gruyter GmbH & Co KG. This book was released on 2019-04-01 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rubber analysis plays a vital part in ensuring that manufactured products are fit for purpose. This comprehensive, application-based book with up-to-date referencing covers all important applications and subject area associated with the analysis of rubber compounds and rubber products. Includes characterization of rubber polymers, rubber fumes, identification of extractables and leachables, as well as reverse engineering on compounded products.
Book Synopsis Integrated Safety and Risk Assessment for Medical Devices and Combination Products by : Shayne C. Gad
Download or read book Integrated Safety and Risk Assessment for Medical Devices and Combination Products written by Shayne C. Gad and published by Springer Nature. This book was released on 2020-02-24 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: While the safety assessment (“biocompatibility”) of medical devices has been focused on issues of local tissue tolerance (irritation, sensitization, cytotoxicity) and selected quantal effects (genotoxicity and acute lethality) since first being regulated in the late 1950s, this has changed as devices assumed a much more important role in healthcare and became more complex in both composition and in their design and operation. Add to this that devices now frequently serve as delivery systems for drugs, and that drugs may be combined with devices to improve device performance, and the problems of ensuring patient safety with devices has become significantly more complex. A part of this, requirements for ensuring safety (once based on use of previously acceptable materials – largely polymers and metals) have come to requiring determining which chemical entities are potentially released from a device into patients (and how much is released). Then an appropriate and relevant (yet also conservative) risk assessment must be performed for each identified chemical structure. The challenges inherent in meeting the current requirements are multifold, and this text seeks to identify, understand, and solve all of them. • Identify and verify the most appropriate available data. • As in most cases such data is for a different route of exposure, transform it for use in assessing exposure by the route of interest. • As the duration (and rate) of exposure to moieties released from a device are most frequently different (longer) than what available data speaks to, transformation across tissue is required. • As innate and adaptive immune responses are a central part of device/patient interaction, assessing potential risks on this basis are required. • Incorporating assessments for special populations such as neonates. • Use of (Q)SAR (Quantitative Structure Activity Relationships) modeling in assessments. • Performance and presentation of integrative assessments covering all potential biologic risks. Appendices will contain summarized available biocompatibility data for commonly used device materials (polymers and metals) and safety assessments on the frequently seen moieties in extractions from devices.
Book Synopsis Leachables and Extractables Handbook by : Douglas J. Ball
Download or read book Leachables and Extractables Handbook written by Douglas J. Ball and published by John Wiley & Sons. This book was released on 2012-01-24 with total page 702 pages. Available in PDF, EPUB and Kindle. Book excerpt: A practical and science-based approach for addressing toxicological concerns related to leachables and extractables associated with inhalation drug products Packaging and device components of Orally Inhaled and Nasal Drug Products (OINDP) such as metered dose inhalers, dry powder inhalers, and nasal sprays pose potential safety risks from leachables and extractables, chemicals that can be released or migrate from these components into the drug product. Addressing the concepts, background, historical use, and development of safety thresholds and their utility for qualifying leachables and extractables in OINDP, the Leachables and Extractables Handbook takes a practical approach to familiarize readers with the recent recommendations for safety and risk assessment established through a joint effort of scientists from the FDA, academia, and industry. Coverage includes best practices for the chemical evaluation and management of leachables and extractables throughout the pharmaceutical product life cycle, as well as: Guidance for pharmaceutical professionals to qualify and risk-assess container closure system leachables and extractables in drug products Principles for defining toxicological safety thresholds that are applicable to OINDP and potentially applicable to other drug products Regulatory perspectives, along with an appendix of key terms and definitions, case studies, and sample protocols Analytical chemists, packaging and device engineers, formulation development scientists, component suppliers, regulatory affairs specialists, and toxicologists will all benefit from the wealth of information offered in this important text.
Book Synopsis Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables by : Suzanne Culleton
Download or read book Disposable Technology and Single-Use Systems. Regulatory Perspective, Best Practices and Future Trends of Extractables and Leachables written by Suzanne Culleton and published by GRIN Verlag. This book was released on 2019-11-14 with total page 57 pages. Available in PDF, EPUB and Kindle. Book excerpt: Master's Thesis from the year 2015 in the subject Medicine - Biomedical Engineering, grade: 1.1, , course: MSc. Industrial Pharmaceutical Science, language: English, abstract: With the adoption of Disposable and Single-use manufacturing equipment on the rise, it is logical there is an industry push to develop a standardised set of testing requirements to thoroughly evaluate the impact of extractable and leachable (E&L) contaminants on patient safety. The main objectives of this work are to critically evaluate the preliminary research previously undertaken on the subject area of Single-Use Systems (SUS) with emphasis on the data currently generated from vendors of single-use systems, the need for harmonised supplier data, current methodologies and best practices employed for E&L testing, and also identification of key areas that warrant further study. This will be accomplished using both quantitative and qualitative research methods where primary data is sourced directly from interviews with experienced professionals in the field. The secondary information is obtained from the critical analysis of scientific publications, scholarly articles, databases, and use of statistical data generated from recent surveys on the challenges E&L present and how industry have addressed this matter thus far. From an extractables and leachables viewpoint the regulatory outlook is still quite uncertain. Some SUS suppliers deliver a very strong data package which satisfies the needs of the drug product manufacturer while others fail in this regard. So, in that sense the evaluation of extractables and leachables remains a grey area at present. The challenge for the industry now is to achieve uniformity of data across multiple single-use vendors to facilitate end user risk assessment and compliance for future regulatory submissions and better patient care.
Book Synopsis Extractables and Leachables by : Dennis Jenke
Download or read book Extractables and Leachables written by Dennis Jenke and published by John Wiley & Sons. This book was released on 2022-08-02 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt: EXTRACTABLES AND LEACHABLES Learn to address the safety aspects of packaged drug products and medical devices Pharmaceutical drug products and medical devices are expected to be effective and safe to use. This includes minimizing patient, user or product exposure to impurities leached from these items when the drug product is administered or when the medical device is used. Clearly, patient or user exposure to leachables must not adversely impact their health and safety. Furthermore, these impurities must not adversely affect key quality attributes of the drug product or medical device, including its manufacturability, stability, efficacy, appearance, shelf-life and conformance to standards. Extractables and leachables are derived from the drug product’s packaging, manufacturing systems and/or delivery systems or from the medical device’s materials of construction. It is imperative to understand and quantify the release of extractables from these items, the accumulation of leachables in drug products and the release of leachables from medical devices. Once extractables and leachables have been discovered, identified and quantified, their effect on the key product or device quality attributes, including safety, must be systematically and scientifically established according to recognized, rigorous and relevant regulatory and compendial standards and industry-driven best practices. In Extractables and Leachables, the chemical compatibility (including safe use) of drugs (and their containers, delivery devices and manufacturing systems) and medical devices is examined at length, focusing particularly on how trace-level extractables and leachables affect the quality and safety of a medical product and how to assess the magnitude of the effect. This is accomplished by addressing the two critical activities required to develop, register and commercialize safe, effective and affordable clinical therapies; measuring extractables and leachables (chemical characterization) and assessing their impact (for example, toxicological safety risk assessment). Each of these activities is addressed in-depth, based on the existing and developing international regulations and guidelines, current published literature and the author’s extensive personal experience. Written by a key contributor to standards, guidelines, recommended practices and the scientific literature, the book provides “insider” insights beyond those gained by merely reading the relevant texts. Given that the rapidly evolving extractables and leachables landscape, this book provides the most current and crucial information on new and forthcoming regulations and best practices. Extractables and Leachables readers will also find: A thorough summary of regulatory and compendial guidelines and the steps required to meet them A detailed and in-depth review of essential scientific principles and recommended best practices for the design, implementation, interpretation and reporting of chemical characterization studies A practical resource for optimizing the development, registration, and commercialization of safe and effective medical products A helpful tool to maximize product development and successful regulatory outcomes Extractables and Leachables is the essential reference for pharmaceutical scientists, analytical chemists, regulatory affairs professionals, engineers, and toxicologists in areas such as product research and development, product registration and approval, regulatory affairs, analytical science, quality control, and manufacturing.
Book Synopsis Practical Toxicology by : David Woolley
Download or read book Practical Toxicology written by David Woolley and published by CRC Press. This book was released on 2017-03-16 with total page 778 pages. Available in PDF, EPUB and Kindle. Book excerpt: Practical Toxicology: Evaluation, Prediction, and Risk, Third Edition shows how to conduct a program of safety evaluation and testing and then to interpret and apply the resulting data and information in the real world, beginning with the basic concepts in toxicology and progressing to the interpretation of the resulting data. Revised and updated chapters on risk assessment guide the reader to setting the foundations necessary for submission to regulatory authorities. In addition, a new chapter in the book reviews the errors in toxicology, mistakes, misuse, mismanagement, and misunderstanding with a view to avoiding these in the future. New Chapters in the Third Edition: Toxicology in silico Errors in Toxicology Safety Assessment of Extractables and Leachables. This new edition follows a practical sequence from introducing the basics of toxicology (including the vital concept of normality in controls) to describing a test program and then interpreting the data and translating that to risk assessment that can be used in a number of real world situations where safety and secure risk assessment are essential. Although written primarily from the perspective of pharmaceutical development, the test designs and toxicological problems encountered in that field are entirely relevant to those with other classes of chemicals, the only difference being the regulatory context. Toxicology is an international discipline and the book has been written to take into account some of the differences in regulatory nuance between the main regions of the world. Completely revised and written in an easily accessible style, the text address several audiences—from students and post-graduates coming to the subject for the first time to established professionals who find themselves needing to learn about toxicology, toxicity testing, interpretation of the results, and risk assessment. It is intended primarily as a textbook, with case studies and information on where to go to ask questions, but can also be used as a practical reference book. It covers all the basics of toxicology and the main aspects of safety evaluation testing and risk assessment while reviewing critically the current state of the discipline. It also provides a foundation for those seeking registration or certification.
Book Synopsis Single-Use Technology by : Adriana G. Lopes
Download or read book Single-Use Technology written by Adriana G. Lopes and published by Walter de Gruyter GmbH & Co KG. This book was released on 2019-06-17 with total page 154 pages. Available in PDF, EPUB and Kindle. Book excerpt: Single-Use Technology (SUT) is the first comprehensive publication of practical considerations for each stage of the implementation process of SUT, and covers the selection, specification, design and qualification of systems to meet end-user requirements. Having become readily available for all processing operations within the biopharmaceutical industry, SUT has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination. However, there are no clear guidelines to aid the end-user on implementation of these technologies into a validated, good manufacturing practice (GMP) environment. This book presents approaches for the implementation within various end-user facilities and systems, SUT within regulatory frameworks (ICH Q8, Q9, Q10 and GMP), standardisation and assessment strategies, specifation of user requirements and SUT design, risk assessment and evaluation as well as qualification for different SUT types.
Book Synopsis Practical Guide to Single-use Technology by : Adriana G Lopes
Download or read book Practical Guide to Single-use Technology written by Adriana G Lopes and published by Smithers Rapra. This book was released on 2016-08-31 with total page 178 pages. Available in PDF, EPUB and Kindle. Book excerpt: Single-use technology (SUT) is now available for all processing operations within the biopharmaceutical industry. It has the potential to reduce capital costs, improve plant throughput and reduce the risk of cross-contamination. However, there are no clear guidelines to aid the end-user on implementation of these technologies into a validated, good manufacturing practice (GMP) environment. This book is the first comprehensive publication of practical considerations for each stage of the implementation process of SUT, and covers the selection, specification, design and qualification of systems to meet end-user requirements.Serving as an introduction and practical reference to this growing area of application within the biopharmaceutical industry, this handbook presents:An approach for SUT implementation within an end-users facility with examples for bioreactors, tangential-flow filtration and fill-finish systems;SUT within the context of regulatory guidance, such as ICH Q8, Q9, Q10 and GMP;Strategy for standardisation of single-use bag systems and assessment of extractables and leachables;Specifications of user requirements and design of specific SUT alongside process descriptions and flow diagrams;Strategies and tools to evaluate risk with examples of risk assessments applicable to design, processing and product quality; andQualification approach for different SUT types.With the information presented in this book, engineers, researchers and professionals involved in biopharmaceuticals will be better prepared to plan and make effective decisions to design and implement SUT.
Book Synopsis Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals by : Tim Sandle
Download or read book Sterility, Sterilisation and Sterility Assurance for Pharmaceuticals written by Tim Sandle and published by Elsevier. This book was released on 2013-10-31 with total page 370 pages. Available in PDF, EPUB and Kindle. Book excerpt: Failure to adequately control any microbial challenge associated within process or product by robust sterilisation will result in a contaminated marketed product, with potential harm to the patient. Sterilisation is therefore of great importance to healthcare and the manufacturers of medical devices and pharmaceuticals. Sterility, sterilisation and sterility assurance for pharmaceuticals examines different means of rendering a product sterile by providing an overview of sterilisation methods including heat, radiation and filtration. The book outlines and discusses sterilisation technology and the biopharmaceutical manufacturing process, including aseptic filling, as well as aspects of the design of containers and packaging, as well as addressing the cleanroom environments in which products are prepared. Consisting of 18 chapters, the book comprehensively covers sterility, sterilisation and microorganisms; pyrogenicity and bacterial endotoxins; regulatory requirements and good manufacturing practices; and gamma radiation. Later chapters discuss e-beam; dry heat sterilisation; steam sterilisation; sterilisation by gas; vapour sterilisation; and sterile filtration, before final chapters analyse depyrogenation; cleanrooms; aseptic processing; media simulation; biological indicators; sterility testing; auditing; and new sterilisation techniques. Covers the main sterilisation methods of physical removal, physical alteration and inactivation Includes discussion of medical devices, aseptically filled products and terminally sterilised products Describes bacterial, pyrogenic, and endotoxin risks to devices and products
Book Synopsis Process Validation in Manufacturing of Biopharmaceuticals by : Anurag Singh Rathore
Download or read book Process Validation in Manufacturing of Biopharmaceuticals written by Anurag Singh Rathore and published by CRC Press. This book was released on 2023-12-18 with total page 413 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA. Key Features: Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals. Includes case studies from the various industry leaders that demonstrate application of these concepts. Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise. Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples. Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.
Book Synopsis Single-Use Technology in Biopharmaceutical Manufacture by : Regine Eibl
Download or read book Single-Use Technology in Biopharmaceutical Manufacture written by Regine Eibl and published by John Wiley & Sons. This book was released on 2019-07-24 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.
Book Synopsis WHO Expert Committee on Biological Standardization by : World Health Organization
Download or read book WHO Expert Committee on Biological Standardization written by World Health Organization and published by World Health Organization. This book was released on 2015-06-30 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances and the establishment of international biological reference materials. Following a brief introduction the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report of particular relevance to manufacturers and national regulatory authorities outlines the discussions held on the development and adoption of new and revised WHO Recommendations Guidelines and guidance documents. Following these discussions a WHO guidance document on the Scientific principles for regulatory risk evaluation on finding an adventitious agent in a marketed vaccine was adopted along with WHO Guidelines on procedures and data requirements for changes to approved vaccines and revised WHO Recommendations to assure the quality safety and efficacy of poliomyelitis vaccines (inactivated). Subsequent sections of the report provide information on the current status and proposed development of international reference materials in the areas of antibiotics; biotherapeutics other than blood products; blood products and related substances; in vitro diagnostic device reagents; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations Guidelines and other documents on biological substances used in medicine (Annex 1). The above three WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2–4). Finally all additions and discontinuations made during the 2014 meeting to the list of International Standards Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 5. The updated full catalogue of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.
Book Synopsis WHO Expert Committee on Biological Standardization by : World Health Organization
Download or read book WHO Expert Committee on Biological Standardization written by World Health Organization and published by World Health Organization. This book was released on 2018-07-18 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances and the establishment of international biological reference materials. Following a brief introduction the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report of particular relevance to manufacturers and national regulatory authorities outlines the discussions held on the development and adoption of new and revised WHO Recommendations Guidelines and guidance documents. Following these discussions WHO Guidelines on the quality safety and efficacy of Ebola vaccines and WHO Guidelines on procedures and data requirements for changes to approved biotherapeutic products were adopted on the recommendation of the Committee. In addition the following two WHO guidance documents on the WHO prequalification of in vitro diagnostic medical devices were also adopted: (a) Technical Specifications Series (TSS) for WHO Prequalification - Diagnostic Assessment: Human immunodeficiency virus (HIV) rapid diagnostic tests for professional use and/or self-testing; and (b) Technical Guidance Series (TGS) for WHO Prequalification - Diagnostic Assessment: Establishing stability of in vitro diagnostic medical devices. Subsequent sections of the report provide information on the current status proposed development and establishment of international reference materials in the areas of: antibiotics biotherapeutics other than blood products; blood products and related substances; in vitro diagnostics; and vaccines and related substances. A series of annexes are then presented which include an updated list of all WHO Recommendations Guidelines and other documents on biological substances used in medicine (Annex 1). The above four WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2-5). Finally all additions and discontinuations made during the 2017 meeting to the list of International Standards Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 6. The updated full catalogue of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.
Book Synopsis Motion Preservation Surgery of the Spine by : James J. Yue
Download or read book Motion Preservation Surgery of the Spine written by James J. Yue and published by Elsevier Health Sciences. This book was released on 2008 with total page 817 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accompanying DVD contains 13 separate videos of ... "surgical techniques ... narrated by the experts."--P. [4] of cover.
Book Synopsis Polymers for the Medical Industry by :
Download or read book Polymers for the Medical Industry written by and published by iSmithers Rapra Publishing. This book was released on 2001-12-31 with total page 132 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Food and Drug Administration. Office of Science. Extramural Research Staff Publisher : ISBN 13 : Total Pages :1194 pages Book Rating :4.3/5 (91 download)
Book Synopsis Extramural Research Programs Supported by the Food and Drug Administration by : United States. Food and Drug Administration. Office of Science. Extramural Research Staff
Download or read book Extramural Research Programs Supported by the Food and Drug Administration written by United States. Food and Drug Administration. Office of Science. Extramural Research Staff and published by . This book was released on 1977 with total page 1194 pages. Available in PDF, EPUB and Kindle. Book excerpt:
