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Isolation Technology

A Practical Guide, Second Edition

By Tim Coles

CRC Press – 2004 – 240 pages

Purchasing Options:

  • Add to CartHardback: $304.00
    978-0-8493-1944-0
    May 27th 2004

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

  1. Cleaning & Sterilization

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: Cleaning & Sterilization