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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 Cleanroom...