edited by Brian Midcalf et al

Pharmaceutical Isolators is a new indispensable guide to the design, construction, commissioning, maintenance, use and monitoring of pharmaceutical isolators. 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, this 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.

Contents

1. Isolator Applications
2. Design
3. Transfer Devices
4. Access Devices
5. Siting of Isolators and Clothing Regimes
6. Cleaning, Decontamination and Disinfection
7. Physical Monitoring
8. Leak Testing
9. Microbiological Monitoring
10. Validation
11. Standards and Guidelines
12. Definiton of Terms

Appendices
HSE/MCA Guidance
Training
Stainless Steel for Isolators
HEPA Filtration Mechanisms, MPPS and Typical Particle Sizes
Calculations to Estimate the Size of a Leak That Can Be Detected Using DOP
Activated Carbon Filters

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