Pharmaceutical Isolators: A Guide to Their Application, Design and Control - Softcover

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Considerable development has taken place over the last five years in the design and construction of pharmaceutical isolators. This new book is an indispensable guide not only to the design and construction of these isolators, but also to the commissioning, maintenance, use and monitoring of them. Chapters include: isolator applications; design; transfer devices; access devices; siting of isolators and clothing standards; cleaning, decontamination and disinfection; physical monitoring; leak testing; and microbiological monitoring. The current validation protocols are explained and the book includes some useful technical appendices.Written through the combined technical expertise of the Isolator Working Party, Pharmaceutical Isolators will assist both experienced and new users to understand and manage this technology. The book will also be a useful reference source for auditors, inspectors and all those involved in standard setting and monitoring.Brian Midcalf is Assistant PTQA Course Director at the School of Continuing Education, University of Leeds, and Working Party Chairman, UK; W Mitchell Phillips is West Midlands Quality Assurance Pharmacist, based in Birmingham, UK; John S Neiger is Chairman, Envair Limited, Haslingden, UK; Tim J Coles is Isolator Specialist, GRC Consultants, Alton, UK.