Pharmaceutical isolators : a guide to their application, design and control
著者
書誌事項
Pharmaceutical isolators : a guide to their application, design and control
Pharmaceutical Press, c2004
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注記
"A Working Party of the UK NHS Pharmaceutical Quality Assurance Committee."
Includes bibliographies and index
内容説明・目次
内容説明
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 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.
目次
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. 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:
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