Update On Undertaking Extractable And Leachable Testing
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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.
Rubber Analysis
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Author : Martin J. Forrest
language : en
Publisher: Walter de Gruyter GmbH & Co KG
Release Date : 2019-04-01
Rubber Analysis written by Martin J. Forrest and has been published by Walter de Gruyter GmbH & Co KG this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-04-01 with Technology & Engineering categories.
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.
Integrated Safety And Risk Assessment For Medical Devices And Combination Products
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Author : Shayne C. Gad
language : en
Publisher: Springer Nature
Release Date : 2020-02-24
Integrated Safety And Risk Assessment For Medical Devices And Combination Products written by Shayne C. Gad and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-02-24 with Medical categories.
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.
Leachables And Extractables Handbook
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Author : Douglas J. Ball
language : en
Publisher: John Wiley & Sons
Release Date : 2012-02-08
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 2012-02-08 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.
Fossil Energy Update
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Author :
language : en
Publisher:
Release Date : 1981
Fossil Energy Update written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1981 with Fossil fuels categories.
Land Drainage Principles Methods And Applications
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Author : Bhattacharya, A.K. & Michael, A.M.
language : en
Publisher: Vikas Publishing House
Release Date : 2006
Land Drainage Principles Methods And Applications written by Bhattacharya, A.K. & Michael, A.M. and has been published by Vikas Publishing House this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006 with Technology & Engineering categories.
Land Drainage – Principles, Methods and Applications presents the latest information, concepts and technology for ensuring sustainable agricultural production and environmental management by adopting land drainage measures. It focuses on a subject, central to the sustainability of irrigated agriculture. The authors’ considerable field work experience and strong grip on the subject are pivotal in conceptualizing this book. This book provides an explicit description of the subject for students as well as the practicing engineers in this area. A logical sequence is followed in the presentation of chapters, beginning with the occurrence of drainage problems, their causes, remedies, design and execution of drainage systems and the benefits of drainage. The book can claim to be the only comprehensive title on the subject in India. SALIENT FEATURES 1. Follows an application-centric approach based on mathematical and statistical concepts 2. Provides a global scenario of drainage by studying different drainage models 3. Discusses drainage in the Indian context 4. Text is supported by statistical inputs and well illustrated examples 5. Includes self-assessment questions with answers and a number of solved and unsolved problems 6. Includes case studies of Drainage and Salt Management
Practical Guide To Single Use Technology
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Author : Adriana G Lopes
language : en
Publisher: Smithers Rapra
Release Date : 2016-08-31
Practical Guide To Single Use Technology written by Adriana G Lopes and has been published by Smithers Rapra this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-08-31 with Science categories.
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.
Practical Toxicology
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Author : David Woolley
language : en
Publisher: CRC Press
Release Date : 2017-03-16
Practical Toxicology written by David Woolley and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-03-16 with Medical categories.
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.
Missouri River Basin Progress Report
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Author : Interior Missouri Basin Field Committee
language : en
Publisher:
Release Date : 1960
Missouri River Basin Progress Report written by Interior Missouri Basin Field Committee and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1960 with Missouri River Valley categories.