Thoroughly authoritative with contributions from experts in the field, this completely updated and expanded Second Edition details state-of-the-art developments in industry practices and standards relating to medical device packaging in a readily accessible format. Helps beginning and seasoned practitioners comply with recent and pending FDA Quality Systems Good Manufacturing Practices, European Medical Device Directives, ISO 14000, and other international standards and requirements! The Medical Device Packaging Handbook, Second Edition offers entirely new as well as revised chapters on packaging materials sterilization techniques, such as vapor phase processes, shelf-life testing, and expriation dating package validation methods and integrity testing bar coding technology environmentally sound packaging and disposal procedures storage autoclave case systems international standards and compliance customer needs regulatory aspects and more! Elucidating discussions with an extensive glossary and index as well as many novel references, tables, drawings and photographs, this timely Second Edition furnishes instructional, practical information for packaging, validation, process, and materials engineers; packaging designers; microbiologists, toxicologists; pharmacologists; pharmacists; drug manufacturers, distributors, and suppliers; quality assurance and food and drug regulatory personnel; and graduate-level students in these disciplines.
|Publisher:||Taylor & Francis|
|Series:||Packaging and Converting Technology Series|
|Product dimensions:||6.10(w) x 9.10(h) x 1.10(d)|
Table of Contents
Regulatory aspects; packaging specifications; packaging materials; package sterilization methods; bar-code labelling; international standards and compliance; package validation; environmental package design; storage autoclave case systems and instrument cassette designs; packaging needs for the health-care facility.
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