Extractables And Leachables
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Leachables And Extractables Handbook
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Author : Douglas J. Ball
language : en
Publisher: John Wiley & Sons
Release Date : 2012-01-24
Leachables And Extractables Handbook written by Douglas J. Ball and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-01-24 with Science categories.
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.
Extractables And Leachables
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Author : Dennis Jenke
language : en
Publisher: John Wiley & Sons
Release Date : 2022-08-02
Extractables And Leachables written by Dennis Jenke and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-08-02 with Medical categories.
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.
Compatibility Of Pharmaceutical Solutions And Contact Materials
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Author : Dennis Jenke
language : en
Publisher: John Wiley & Sons
Release Date : 2013-02-26
Compatibility Of Pharmaceutical Solutions And Contact Materials written by Dennis Jenke and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-02-26 with Medical categories.
Important safety aspects of compatibility for therapeutic products and their manufacturing systems, delivery devices, and containers Compatibility of Pharmaceutical Products and Contact Materials helps pharmaceutical, toxicology, analytical, and regulatory affairs professionals assess the safety of leachable and extractable chemicals associated with drug product packaging, manufacturing systems, and devices. The most comprehensive resource available, its coverage includes the strategies, tactics, and regulatory requirements for performing safety assessments, along with the means for interpreting results. Structured around a logical framework for an extractables and leachables safety assessment and closely linked to the pharmaceutical product development process, Compatibility of Pharmaceutical Products and Contact Materials directly addresses the fundamental questions of "what activities need to be performed to completely, efficiently, and effectively address the issue of product safety from an extractables and leachables perspective?" and "when do the various required activities need to be performed?" Specifically, the chapters describe: Pertinent regulations and practical ways to meet guidelines Coordinating manufacturing, storage, and delivery systems development and qualification with therapeutic product development Materials characterization and the materials screening process Component and/or system qualification (illustrated by several case studies) Performing validation/migration studies and interpreting and reporting the results Creating a product registration dossier and putting it through regulatory review Product maintenance (Change Control) from an extractables and leachables perspective Likely future developments in extractables and leachables assessment Additionally, the book's appendix provides a database, including CAS registry numbers, chemical formulas and molecular weights of extractable/leachable substances that have been reported in the chemical literature. Detailing the interconnected roles played by analytical chemistry, biological science, toxicology, and regulatory science, Compatibility of Pharmaceutical Products and Contact Materials supplies a much-needed, comprehensive resource to all those in pharmaceutical product or medical device development.
Update On Undertaking Extractable And Leachable Testing
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Author : Andrew Feilden
language : en
Publisher: Smithers Rapra
Release Date : 2011-03-31
Update On Undertaking Extractable And Leachable Testing written by Andrew Feilden and has been published by Smithers Rapra this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-03-31 with Science categories.
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.
Single Use Technology In Biopharmaceutical Manufacture
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Author : Regine Eibl
language : en
Publisher: John Wiley & Sons
Release Date : 2019-07-24
Single Use Technology In Biopharmaceutical Manufacture written by Regine Eibl and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-07-24 with Medical categories.
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.
Disposable Technology And Single Use Systems Regulatory Perspective Best Practices And Future Trends Of Extractables And Leachables
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Author : Suzanne Culleton
language : en
Publisher:
Release Date : 2019-11-05
Disposable Technology And Single Use Systems Regulatory Perspective Best Practices And Future Trends Of Extractables And Leachables written by Suzanne Culleton and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-05 with categories.
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.
Extractables Leachables For Pharmaceutical Products 2011
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Author :
language : en
Publisher:
Release Date : 2011
Extractables Leachables For Pharmaceutical Products 2011 written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with categories.
Extractables And Leachables Usa 2012 Conference Proceedings
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Author :
language : en
Publisher: Smithers Rapra Technology
Release Date : 2012-05-01
Extractables And Leachables Usa 2012 Conference Proceedings written by and has been published by Smithers Rapra Technology this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-05-01 with Science categories.
As in Europe, the examination of extractables and leachables is growing in importance in the USA, due to increased regulatory scrutiny from the Food and Drugs Administration (FDA). Regulators are concerned with the interaction of various drug delivery devices, such as metered dose and dry powder inhalers (MDI and DPI) and now parenterals and ophthalmics are of increasing interest, as well as pharmaceutical process equipment. It is therefore essential that any company involved in the supply chain - from raw material suppliers, processors, converters to the pharmaceutical supplier - is fully aware of the latest developments and best practice in generating test results and data to support successful regulatory submissions to both the FDA and EMEA.
Best Practices For Leachables And Extractables
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Author : Norwood
language : en
Publisher:
Release Date :
Best Practices For Leachables And Extractables written by Norwood and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on with categories.
Extractables Leachables 2013 Conference Proceedings
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Author :
language : en
Publisher: Smithers Rapra Technology
Release Date : 2013
Extractables Leachables 2013 Conference Proceedings written by and has been published by Smithers Rapra Technology this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013 with Science categories.
After the success of the inaugural event in Baltimore, E&L USA is coming to Providence, RI on May 7-9 2013! Set to bring together even more E&L professionals with the help of an expert industry program committee, E&L USA will feature a similar breadth of presentations to the 2012 conference, including working group updates from IPAC-RS, ELSIE and USP, plus case studies of best practices in E&L testing from EMD Millipore, Johnson&Johnson, BD Medical and more.