Cleanroom Technology E-Book

William Whyte

• Herausgeber: John Wiley & Sons
• Kategorie: Wissenschaft und neue Technologien
• Sprache: Englisch

Seitenzahl: 404

Veröffentlichungsjahr: 2011

Beschreibung

A self-contained and practical book providing step-by-step guidance to the design and construction of cleanrooms, appropriate testing methodologies, and operation for the minimization of contamination... This second edition has been comprehensively revised and includes extensive updates to the two chapters that contain information on cleanroom standards and guidelines. The chapter on risk management has been extensively revised, especially the section on risk assessment. Other new subjects that have been added to the various chapters are those on clean-build, determination of air supply volumes for non-unidirectional airflow cleanrooms, RABS (Restricted Access Barrier Systems), contamination recovery test methods, entry of large items into a cleanroom, glove allergy problems, and how to develop a cleanroom cleaning programme. Used for in-house training and a textbook in colleges, this volume is for cleanroom personnel at all levels. It provides novices with an introduction to the state-of-the-art technology and professionals with an accessible reference to the current practices. It is particularly useful in the semiconductor, pharmaceutical, biotechnology and life sciences industries. William Whyte is an international authority in cleanrooms, with over 45 years experience in research, teaching and consulting in the electronic, healthcare and pharmaceutical industries. He is a member of British and International standards committees writing the International Cleanroom standards, and has received numerous awards for his work in Cleanroom Technology. A comment on the first edition: "...extremely useful and helpful...very well-written, highly organized, easy to understand and follow..." (Environmental Geology, 2003)

Leseprobe

Contents

About the Author

Preface

Acknowledgements

1 Introduction

1.1 What is a Cleanroom?

1.2 The Need for Cleanrooms

1.3 Types of Cleanrooms

1.4 What is Cleanroom Technology?

Acknowledgements

2 The History of Cleanrooms

2.1 The Earliest Years

2.2 Ventilated Operating Rooms

2.3 Early Industrial Cleanrooms

2.4 Unidirectional Airflow Cleanrooms

Acknowledgements

3 Cleanroom Classification Standards

3.1 The History of Standards

3.2 The Basis of Cleanroom Standards

3.3 Federal Standard 209

3.4 ISO Standard 14644-1:1999

3.5 Pharmaceutical Cleanroom Classification

3.6 Classification of Cleanrooms with Airborne Chemical Contamination

3.7 Classification of Cleanrooms with Surface Contamination

Acknowledgement

4 Information Sources

4.1 The International Confederation of Contamination Control Societies (ICCCS)

4.2 The ICEB

4.3 International Cleanroom Standards

4.4 Cleanroom Books

4.5 Recommended Practices and Guides of the Institute of Environmental Sciences and Technology (IEST)

4.6 Cleanroom Journals and Magazines

4.7 Sources of Pharmaceutical Cleanroom Documents

4.8 Training Videos/DVDs

5 Non-unidirectional Airflow and Ancillary Cleanrooms

5.1 Non-unidirectional Airflow Cleanrooms

5.2 Ancillary Cleanrooms

Acknowledgement

6 Unidirectional Airflow Cleanrooms

6.1 Types of Unidirectional Airflow Cleanrooms

6.2 Vertical Unidirectional Airflow Cleanrooms

6.3 Horizontal Unidirectional Airflow Rooms

6.4 The Application of Unidirectional Airflow

Acknowledgements

7 Separative Clean Air Devices and Containment Zones

7.1 Unidirectional Airflow Devices

7.2 Mini-environments, Isolators and RABS

7.3 Containment Zones

Acknowledgements

8 Construction and Clean-build

8.1 Constructional Materials and Methods

8.2 Outgassing and Electrostatic Properties

8.3 Clean-build

Acknowledgements

9 High Efficiency Air Filtration

9.1 Air Filters used in Cleanrooms

9.2 The Construction of High Efficiency Filters

9.3 Particle Removal Mechanisms

9.4 Testing of High Efficiency Filters

9.5 Scan Testing of High Efficiency Filters

9.6 Filter Housings for High Efficiency Filters

9.7 Removal of Airborne Chemical Contamination

Acknowledgements

10 Cleanroom Testing and Monitoring

10.1 Principles of Cleanroom Testing

10.2 Cleanroom Tests

10.3 Testing in Relation to Room Type and Occupation State

10.4 Re-testing to Demonstrate Compliance

10.5 Monitoring of Cleanrooms

Acknowledgement

11 Measurement of Air Quantities and Pressure Differences

11.1 Air Quantities

11.2 Differential Pressure Tests

Acknowledgement

12 Air Movement Control: Containment, Visualisation and Recovery

12.1 Cleanroom Containment Leak Testing

12.2 Air Movement Control within a Cleanroom

12.3 Recovery Test Methods

12.4 Recovery Rate Requirement in the EU GGMP

Acknowledgement

13 Filter Installation Leak Testing

13.1 The Use of Aerosol Test Challenges

13.2 Artificial Aerosol Test Challenges

13.3 Apparatus for Measuring Aerosol Penetration

13.4 Methods of Testing Filters and Filter Housings

13.5 Repair of Leaks

Acknowledgements

14 Airborne Particle Counts

14.1 Airborne Particle Counters

14.2 Continuous Monitoring Apparatus for Airborne Particles

14.3 Particle Counting in Different Occupancy States

14.4 Measurement of Particle Concentrations

14.5 Worked Example of ISO 14644–1 Test Method

Acknowledgements

15 Microbial Sampling

15.1 Microbial Sampling of the Air

15.2 Microbial Deposition onto Surfaces

15.3 Microbial Surface Sampling

15.4 Personnel Sampling

Acknowledgements

16 Operating a Cleanroom: Managing the Risk from Contamination

16.1 Step 1: Identification of Sources and Routes of Contamination

16.2 Step 2: Risk Assessment and the Control of the Sources of Contamination

Notes

16.3 Step 3: Establish an Effective Monitoring Programme

16.4 Step 4: Verification and Reappraisal of the System

16.5 Step 5: Documentation

16.6 Step 6: Staff Training

17 Cleanroom Disciplines

17.1 People Allowed into Cleanrooms

17.2 Personal Items Not Allowed into the Cleanroom

17.3 Disciplines within the Cleanroom

17.4 Maintenance and Service Personnel

Acknowledgement

18 Entry and Exit of Personnel

18.1 Prior to Arriving at the Cleanroom

18.2 Changing into Cleanroom Garments

18.3 Exit Changing Procedures

Acknowledgements

19 Materials, Equipment and Machinery

19.1 Choice of Materials for use in a Cleanroom

19.2 Items Supplied from Outside Manufacturing

19.3 Wrapping and Transportation of Materials

19.4 Transfer of Items and Small Pieces of Equipment through a Materials Transfer Airlock

19.5 Entry of Heavy Machinery and Bulky Items

19.6 Transfer of Materials through Hatches and Sterilisers

Acknowledgement

20 Cleanroom Clothing

20.1 Sources and Routes of Inert Airborne Particle Dispersion

20.2 Sources and Routes of Airborne Microbial Dispersion

20.3 Types of Cleanroom Clothing

20.4 Processing of Cleanroom Garments and Change Frequency

20.5 The Effect of Laundering and Wear

20.6 Testing of Cleanroom Clothing

20.7 Static-Dissipative Properties of Clothing

Acknowledgements

21 Cleanroom Masks and Gloves

21.1 Cleanroom Masks

21.2 Cleanroom Gloves

Acknowledgements

22 Cleaning a Cleanroom

22.1 Why a Cleanroom must be Cleaned

22.2 Cleaning Methods and the Physics of Cleaning Surfaces

22.3 Implements Used to Clean Cleanrooms

22.4 Liquids Used in Cleaning Cleanrooms

22.5 How should a Cleanroom be Cleaned?

22.6 Cleaning Programme

22.7 Test Methods

Acknowledgements

Index

This edition first published 2010 © 2010 W. Whyte

First edition 2001 © W. Whyte

Published by: John Wiley & Sons, Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, United Kingdom

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This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. It is sold on the understanding that the publisher is not engaged in rendering professional services. If professional advice or other expert assistance is required, the services of a competent professional should be sought.

Library of Congress Cataloging-in-Publication Data

Whyte, W.

Cleanroom technology: fundamentals of design, testing and operation/W. Whyte. -- 2nd ed.

p. cm.

Includes index.

ISBN 978-0-470-74806-0 (cloth)

1. Clean rooms. I. Title. TH7694.W48 2010

620.8'6--dc22

2009031436

I dedicate this book to my sons Griogair and Murray who are both engineers and cleanrooms users.

About the Author

William (Bill) Whyte is an Honorary Research Fellow at Glasgow University. He has been involved with cleanrooms for over 45 years and has the useful dual qualifications of a BSc in microbiology and a DSc in mechanical engineering.

He has published over 130 reports and papers on contamination control and cleanroom design. He wrote the first edition of this book in 2001 and has also edited the book Cleanroom Design (second edition, 1999). He is a member of British and international standards committees writing the international cleanroom standards. He has extensive experience as an industrial consultant.

He has received the following awards for his work in Cleanroom Technology: Fellowship of the IEST, Honorary Life Member of S2C2, James R Mildon Award from the IEST, Michael S Korczyneski Grant from the PDA (twice), Parenteral Society Annual Award and the CleanRooms Hall of Fame Award.

Preface

The contamination-free conditions provided by cleanrooms are essential for much of modern manufacturing industry. Without cleanrooms, productswill become contaminated and either malfunction or infect people with bacteria. Cleanrooms are used for the manufacture of items used in computers, cars, aeroplanes, spacecraft, televisions, disc players and many other electronic and mechanical devices, as well as the manufacture of medicines, medical devices and foods.

Cleanroom technology can be divided into three parts: design, testing and operation of cleanrooms, and this book covers, in a holistic way, these three main facets. The book is intended to introduce people to these subjects or to update their knowledge. Those who teach ‘cleanroom technology’ either at college, or to their cleanroom personnel, may find this book useful, as it has been written with this in mind.

Most of the principles described in the book are those that are generally accepted within cleanroom industries. However, I have found areas where no sound advice exists and have had to develop guidance using my own knowledge and experience.

The first edition of this book has been well received and translated into several languages. However, new information on cleanrooms is now available and this edition contains a substantial amount of additional material. Each chapter has been updated. This might be by the inclusion of more information, as in the chapter on the history of cleanrooms where information has been added about the early days of infection control in hospitals. However, Chapter 4 and 5, the chapters that contain information on cleanroom standards and guidelines, required extensive updating. Other chapters, such as Chapter 16, which discusses risk management, have also been extensively revised, especially the section on risk assesment. Other subjects that have been added are those on clean-build, determination of air supply volumes for non-unidirectional cleanroom, RABS (Restricted

Access Barrier Systems), contamination recovery test methods, entry of large items into a cleanroom, glove allergy problems, and how to develop a cleanrooom cleaning programme.

Acknowledgements

In the first edition of this book I acknowledged the help of (in alphabetical order) Neil Bell, Charles Berndt, Roger Diener, Gordon Farquharson, Gordon King, Lynn Morrison, Bob Peck, Martin Reeves, Hal Smith and Neil Stephenson. I also acknowledged the support of the Scottish Society for Contamination Control. Barbara McLeod read and commented on the script and Isabelle Lawson produced most of the drawings used in both editions of the book.

In preparing the second edition, I asked a number of experts in cleanroom technology to review the chapters that I had rewritten. Don Wadkins supplied information on clean-build contained in Chapter 8. R. Vijayakumar reviewed Chapter 9 on high efficiency air filters. Tim Eaton and Koss Agricola reviewed Chapter 16 on risk management. Roger Diener helped me rewrite Chapter 19 on the materials and the entry of machinery and equipment into a cleanroom. Chapter 20 on cleanroom clothing was revised with the assistance of Charles Berndt. The information on gloves in Chapter 21 was reviewed by Elizabeth Hill. My thanks go to all of these people whose help is much appreciated.

The photographs on the cover of this book are reproduced by permission of Lothian Health Services Archive at Edinburgh University Library, Micronova Manufacturing, International pbi, and Metron Technology. The permission to use other photographs, tables and drawings within the book is acknowledged at the end of each chapter.

Finally, I am most grateful to John Neiger for checking this edition from cover to cover with commendable thoroughness. John combines a considerable knowledge of clean air and containment technology with a passion for clear and understandable writing. This edition of my book has benefited greatly from his input.

2

The History of Cleanrooms

2.1 The Earliest Years

Figure 2.1 Joseph Lister

It is clear that the first cleanrooms were found in hospitals. Joseph Lister’s contribution to history was his realisation that bacteria caused surgical wound infection. The discoverer of microbes, Louis Pasteur, wrote that ‘in the field of observations, chance favours the mind that is prepared.’ This is particularly apt when applied to Lister’s discoveries. In 1860 he was appointed Regius Professor of Surgery at Glasgow University. Lister heard of Pasteur’s experiments, which showed that boiling and exclusion of air from meat broth stopped decomposition. Lister realised that this might apply to hospital wounds. He had also read that carbolic acid (the old name for phenol) was being used to decontaminate sewage. The treatment not only suppressed the smell but when the sewage was spread on fields, cows no longer picked up enterozoal infections. In 1865 Lister tried carbolic acid on wounds with great success and in 1867 he used it with similar success in surgery. During surgery he used it on instruments, on the wound and on the surgeon’s hands, and he attempted to prevent airborne infection by spraying it into the air. He found that these steps eliminated many bacteria and reduced infection in the operating room; this was the scientific basis for the first cleanrooms.