Cleanroom Technology - Fundamentals of Design, Testing and Operation

Informationen zum Autor 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. Klappentext 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) Zusammenfassung This second edition offers a comprehensive overview of the fundamentals, design, testing and operation of cleanroom systems. It provides novices with an introduction to this state-of-the-art technology and professionals with an accessible reference to the current standards. Inhaltsverzeichnis 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 ...

Sommario

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?
 

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
* Classification of Cleanrooms with
 
Surface Contamination
 

4 Information Sources
 
4.1 The ICCCS
 
4.2 The ICEB
 
4.3 International Cleanroom Standards
 
4.4 Cleanroom Books
 
4.5 Recommended Practices and Guides of the 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 Pa

Dettagli sul prodotto

• Autori: W Whyte, William Whyte, William (University of Glasgow) Whyte
• Editore: Wiley, John and Sons Ltd
• Lingue: Inglese
• Formato: Copertina rigida
• Pubblicazione: 15.01.2010
• EAN: 9780470748060
• ISBN: 978-0-470-74806-0
• Pagine: 384
• Categorie: Scienze naturali, medicina, informatica, tecnica > Tecnica > Elettronica, elettrotecnica, telecomunicazioni; Elektrotechnik, Medizin, Regelungstechnik, Electrical & Electronics Engineering, Elektrotechnik u. Elektronik, Medical Science, Control Systems Technology, Spezialthemen Elektrotechnik, Allg. Medizin, Electrical Engineering Special Topics