Extractables And Leachables Usa 2012 Conference Proceedings
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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.
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.
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.
Extractables And Leachables
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Author : Dennis Jenke
language : en
Publisher: John Wiley & Sons
Release Date : 2022-07-14
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 2022-07-14 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.
Leachables And Extractables 2008
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Author : Rapra Technology Limited
language : en
Publisher:
Release Date : 2008-05-01
Leachables And Extractables 2008 written by Rapra Technology Limited and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-05-01 with Extraction (Chemistry) categories.
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.
Parenteral Medications Fourth Edition
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Author : Sandeep Nema
language : en
Publisher: CRC Press
Release Date : 2019-07-19
Parenteral Medications Fourth Edition written by Sandeep Nema and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-07-19 with Business & Economics categories.
Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the science and considerable advances in the technology associated with these products and routes of administration. Key Features: Provides a comprehensive reference work on the formulation and manufacturing of parenteral dosage forms Addresses changes in the science and advances in the technology associated with parenteral medications and routes of administration Includes 13 new chapters and updated chapters throughout Contains the contributors of leading researchers in the field of parenteral medications Uses full color detailed illustrations, enhancing the learning process The fourth edition not only reflects enhanced content in all the chapters but also highlights the rapidly advancing formulation, processing, manufacturing parenteral technology including advanced delivery and cell therapies. The book is divided into seven sectionss: Section 1 - Parenteral Drug Administration and Delivery Devices; Section 2 - Formulation Design and Development; Section 3 - Specialized Drug Delivery Systems; Section 4 - Primary Packaging and Container Closure Integrity; Section 5 - Facility Design and Environmental Control; Section 6 - Sterilization and Pharmaceutical Processing; Section 7 - Quality Testing and Regulatory Requirements
Bioprocessing Piping And Equipment Design
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Author : William M. (Bill) Huitt
language : en
Publisher: John Wiley & Sons
Release Date : 2016-10-24
Bioprocessing Piping And Equipment Design written by William M. (Bill) Huitt 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 2016-10-24 with Technology & Engineering categories.
The only comprehensive and authoritative reference guide to the ASME Bioprocessing Piping and Equipment (BPE) standard This is a companion guide to the ASME Bioprocessing Piping and Equipment (BPE) Standard and explains what lies behind many of the requirements and recommendations within that industry standard. Following an introductory narrative to the Standard's early history, industry related codes and standards are explained; the design and engineering aspects cover construction materials, both metallic and nonmetallic; then components, fabrication, assembly and installation of piping systems are explored. Examination, Inspection and Testing then precede the ASME BPE certification process, concluding with a discussion on system design. The author draws on many years' experience and insights from first-hand involvement in the field of industrial piping design, engineering, construction, and management, which includes the bioprocessing industry. The reader will learn why dimensions and tolerances, process instrumentation, and material selection play such an integral part in the manufacture of components and instrumentation. This easy to understand and navigate guide will assist engineers (design, piping, chemical, etc.) who need to understand the basis for much of the Standard’s content, as do the contractors and inspectors who have to meet and validate compliance with the BPE Standard.
Biomaterials For Spinal Surgery
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Author : Luigi Ambrosio
language : en
Publisher: Elsevier
Release Date : 2012-03-12
Biomaterials For Spinal Surgery written by Luigi Ambrosio and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-03-12 with Medical categories.
There have been important developments in materials and therapies for the treatment of spinal conditions. Biomaterials for spinal surgery summarises this research and how it is being applied for the benefit of patients. After an introduction to the subject, part one reviews fundamental issues such as spinal conditions and their pathologies, spinal loads, modelling and osteobiologic agents in spinal surgery. Part two discusses the use of bone substitutes and artificial intervertebral discs whilst part three covers topics such as the use of injectable biomaterials like calcium phosphate for vertebroplasty and kyphoplasty as well as scoliosis implants. The final part of the book summarises developments in regenerative therapies such as the use of stem cells for intervertebral disc regeneration. With its distinguished editors and international team of contributors, Biomaterials for spinal surgery is a standard reference for both those developing new biomaterials and therapies for spinal surgery and those using them in clinical practice. Summarises recent developments in materials and therapies for the treatment of spinal conditions and examines how it is being applied for the benefit of patients Reviews fundamental issues such as spinal conditions and their pathologies, spinal loads, modelling and osteobiologic agents in spinal surgery Discusses the use of bone substitutes and artificial intervertebral discs and covers topics such as the use of injectable biomaterials like calcium phosphate for vertebroplasty and kyphoplasty
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.