Cleanroom technology : fundamentals of design, testing and operation / W. Whyte.

Includes index.

Cover; Title page; Copyright page; Dedication; 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 Classification3.6 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 Cleanrooms5.1 Non-unidirectional Airflow Cleanrooms; 5.2 Ancillary Cleanrooms; Acknowledgement; 6 Unidirectional Airflow Cleanrooms; 6.1 Types of 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 Properties8.3 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 Compliance10.5 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.

PHR