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Isolation technology : a practical guide

Author: Tim P Coles
Publisher: Boca Raton : Interpharm/CRC, 2004.
Edition/Format:   Print book : English : 2nd edView all editions and formats

Offers practical ways to improve product standards, increase operator productivity, efficiency, and safety, and cut costs. Designed for easy understanding by readers from multiple fields, this book  Read more...


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Document Type: Book
All Authors / Contributors: Tim P Coles
ISBN: 0849319447 9780849319440
OCLC Number: 54356793
Description: 221 pages : illustrations ; 24 cm
Contents: INTRODUCTION The Background to Isolation Technology Isolation Technology - A Definition Isolation Technology vs. Barrier Technology Some Typical Applications of Isolation Technology What Isolation Technology is Not: A Panacea AN INTRODUCTION TO THE TECHNOLOGY The Materials Air Handling in Isolators Handling the Work in Isolators A REVIEW OF TRANSFER METHODS Simple Doors Lockchambers Product Passout Ports Waste Ports Rapid Transfer Ports Operational Considerations Services FURTHER DESIGN CONSIDERATIONS Isolator Instrumentation HEPA Filter Pressure Drop Temperature and Relative Humidity Particle Counting Air Sampling Building Interface HOW TO DRAW UP A DESIGN SPECIFICATION User Requirement Specification (URS) Design Qualification Standards and Guidelines Workspace Ergonomics and Handling Rate of Work Major Equipment Interface Positive Pressure or Negative Pressure: The Cytotoxic Dilemma Turbulent Airflow or Unidirectional Downflow Transfer The Isolator Room Environment for Sterile Operations Control and Instrumentation Sterilisation and Decontamination Standard versus Special Isolator Design SEEING THE PROJECT THROUGH Liaison with Your Designer and Supplier Further Project Development Proposals and Quotations Preengineering Studies, Models, and Mockups Terms, Payment Structures, and Guarantees The OQ in More Detail Leak Detection Methods Expression of Pressure Decay Test Results Classification by Leak Rate Further Discussion of Leak Testing: The Distributed Leak Test Testing Gloves and Sleeves Further Leakage Considerations When Should Leak Testing be Carried Out Instrument Calibration Airflow Patterns Miscellaneous Checks Manuals CLEANING UP: STERILISATION AND DECONTAMINATION Sterilisation - Manual Wet Processes Fogging Processes Gassing Systems Validating the Sterilisation Process CIP in Isolators Decontamination in Toxic and Pathogenic Applications RUNNING THE OPERATION Operator Training Physical Validation Microbiological Validation Standard Operating Procedures Planned Maintenance and Servicing Documentation Conclusion REGULATORY AFFAIRS The MHRA (formerly the MCA) The U.S. FDA View Further Regulatory Comment CASE STUDIES Aventis (previously Rhone-Poulenc Rorer), Holmes Chapel, Cheshire, U.K. Dabur Oncology, Bordon, Hampshire, U.K. References Glossary Index
Responsibility: Tim Coles.
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