Isolation Technology
A Practical Guide, Second Edition
By Tim Coles
Published May 27th 2004 by CRC Press – 240 pages
Description
The most significant changes in isolation technology during the past five years have not been in the technology itself but in its increased acceptance. This acceptance is clearly demonstrated by the series of monographs, guidelines, and standards produced by regulatory bodies to describe best practice in the design and operation of isolators. Thoroughly revised and updated, Isolation Technology: A Practical Guide, Second Edition provides an in-depth overview of new standards and new technology.
Here's what's new in the Second Edition:
" Descriptions of and comments on new guidelines and standards
" Technological advances - such as the new breed of sanitizing gas generators
" Updates that reflect current thinking and new information
Drawing on his vast experience in this field, the author delineates practical ways to improve product standards, increase operator productivity, efficiency and safety, and cut costs. Carefully designed for easy understanding by readers from multiple fields, the book reviews the how-tos for setting up clean rooms and techniques for maintaining sterility, and includes case studies, resource listings, and numerous photographs. The combination of up-to-date information and the author's clear writing style make this the ideal resource for both experienced and beginning professionals.
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
Related Subjects
Name: Isolation Technology: A Practical Guide, Second Edition (Hardback) – CRC Press
Description: By Tim Coles. The most significant changes in isolation technology during the past five years have not been in the technology itself but in its increased acceptance. This acceptance is clearly demonstrated by the series of monographs, guidelines, and standards...
Categories: Analysis & Pharmaceutical Quality
