Cleanroom Technology

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)

Auteur
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.

Résumé
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)

Contenu
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?

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.

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.

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.

6 Unidirectional Airflow Cleanrooms.

6.1 Types of Unidirectional Cleanrooms.

6.2 Vertical Unidirectional Airflow Cleanrooms.

6.3 Horizontal Unidirectional Airflow Rooms.

6.4 The Application of Unidirectional Airflow.

7 Separative Clean Air Devices and Containment Zones.

7.1 Unidirectional Airflow Devices.

7.2 Mini-environments, Isolators and RABS.

7.3 Containment Zones.

8 Construction and Clean-build.

8.1 Constructional Materials and Methods.

8.2 Outgassing and Electrostatic Properties.

8.3 Clean-build.

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.

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.

11 Measurement of Air Quantities and Pressure Differences.

11.1 Air Quantities.

11.2 Differential Pressure Tests.

12 Air Movement Control: Containment, Visualization 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.

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.

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.

15 Microbial Sampling. 15.1 Microbial Sampling of the Air.<...