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) 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. 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 Particle Concentrations 14.5 Worked Example of ISO 14644 1 Test Method 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 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 Sources of Contamination 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 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. 19 Materials, Equipment and Machinery 19.1 Choice of Materials for use in a Cleanroom 19.2 Items Supplied from Outside Manufacturing Sources 19.3 Wrapping and Transportation of Materials 19.4 Transfer of Items and Small Pieces of Equipment through a Material Transfer Airlock 19.5 Entry of Heavy Machinery and Bulky Items 19.6 Transfer of Materials through Hatches and Sterilisers 20 Cleanroom Clothing 20.1 Sources and Routes of Inert Airborne Particle Dispersion 20.2 Routes and Sources of 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 21 Cleanroom Masks and Gloves 21.1 Cleanroom Masks 21.2 Cleanroom Gloves 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 Index