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Pharmaceutical Isolators
A guide to their application, design and control
Midcalf, Brian; Phillips, Mitchell; Neiger, John S; Coles, Tim J
First edition
Edited by Brian Midcalf - Assistant PTQA Course Director, School of Continuing Education, University of Leeds, Mitchell Phillips - West Midlands Quality Assurance Pharmacist, John S Neiger - Chairman, Envair Limited, Haslingden and Tim J Coles - Isolator Specialist, GRC Consultants, Alton
Written through the combined technical expertise of the Isolator Working Party, this new title 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.
1. Isolator Applications
2. Design
3. Transfer Devices
4. Access Devices
5. Siting of Isolators and Clothing Regimes
6. Cleaning, Decontamination & Disinfection
7. Physical Monitoring
8. Leak Testing
9. Microbiological Monitoring
10. Validation
11. Standards and Guidelines
12. Definiton of Terms
A1. 'Handling Cytotoxic Drugs in Isolators in NHS Pharmacies.' HSE/MCA Guidance
A2. Training
A3. Stainless Steel for Isolators
A4. HEPA Filtration Mechanisms, MPPS and Typical Particle Sizes
A5. Calculations to Estimate the Size of a Leak That Can Be Detected Using DOP
A6. Activated Carbon Filters
A7. Useful Tables
'The text is written in a clear and concise manner and desired information is readily accessible.'
Linda Felton, University of Mexico, College of Pharmacy, Mexico
Also consider
ISBN 978 0 85369 573 8
Published May 2004
Paperback
234 x 156mm (288pp)
