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Cleanroom Technology: Fundamentals of Design, Testing and Operation / Edition 2
     

Cleanroom Technology: Fundamentals of Design, Testing and Operation / Edition 2

by William Whyte
 

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ISBN-10: 0470748060

ISBN-13: 9780470748060

Pub. Date: 03/15/2010

Publisher: Wiley

This comprehensively revised second edition includes extensive updates to the two chapters that contain information on cleanroom standards and guidelines. It contains a thoroughly updated chapter on risk management, including an important section on risk assessment. Other new subjects included cover clean-build, determination of air supply volumes for

Overview

This comprehensively revised second edition includes extensive updates to the two chapters that contain information on cleanroom standards and guidelines. It contains a thoroughly updated chapter on risk management, including an important section on risk assessment. Other new subjects included cover 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 guidance on 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.

Product Details

ISBN-13:
9780470748060
Publisher:
Wiley
Publication date:
03/15/2010
Pages:
384
Product dimensions:
6.20(w) x 9.30(h) x 1.00(d)

Table of Contents

About the Author xii

Preface xiii

Acknowledgements xiv

1 Introduction 1

1.1 What is a Cleanroom? 1

1.2 The Need for Cleanrooms 2

1.3 Types of Cleanrooms 6

1.4 What is Cleanroom Technology? 8

2 The History of Cleanrooms 11

2.1 The Earliest Years 11

2.2 Ventilated Operating Rooms 16

2.3 Early Industrial Cleanrooms 19

2.4 Unidirectional Airflow Cleanrooms 21

3 Cleanroom Classification Standards 25

3.1 The History of Standards 25

3.2 The Basis of Cleanroom Standards 26

3.3 Federal Standard 209 28

3.4 ISO Standard 14644-1:1999 29

3.5 Pharmaceutical Cleanroom Classification 33

3.6 Classification of Cleanrooms with Airborne Chemical Contamination 39

3.7 Classification of Cleanrooms with Surface Contamination 40

4 Information Sources 41

4.1 The International Confederation of Contamination Control Societies (ICCCS) 41

4.2 The ICEB 42

4.3 International Cleanroom Standards 43

4.4 Cleanroom Books 46

4.5 Recommended Practices and Guides of the Institute of Environmental Sciences and Technology (IEST) 48

4.6 Cleanroom Journals and Magazines 52

4.7 Sources of Pharmaceutical Cleanroom Documents 54

4.8 Training Videos/DVDs 55

5 Non-unidirectional Airflow and Ancillary Cleanrooms 57

5.1 Non-unidirectional Airflow Cleanrooms 57

5.2 Ancillary Cleanrooms 71

6 Unidirectional Airflow Cleanrooms 75

6.1 Types of Unidirectional Cleanrooms 75

6.2 Vertical Unidirectional Airflow Cleanrooms 77

6.3 Horizontal Unidirectional Airflow Rooms 78

6.4 The Application of Unidirectional Airflow 81

7 Separative Clean Air Devices and Containment Zones 87

7.1 Unidirectional Airflow Devices 87

7.2 Mini-environments, Isolators and RABS 89

7.3 Containment Zones 99

8 Construction and Clean-build 103

8.1 Constructional Materials and Methods 103

8.2 Outgassing and Electrostatic Properties 111

8.3 Clean-build 112

9 High Efficiency Air Filtration 117

9.1 Air Filters Used in Cleanrooms 117

9.2 The Construction of High Efficiency Filters 118

9.3 Particle Removal Mechanisms 120

9.4 Testing of High Efficiency Filters 123

9.5 Scan Testing of High Efficiency Filters 125

9.6 Filter Housings for High Efficiency Filters 126

9.7 Removal of Airborne Chemical Contamination 128

10 Cleanroom Testing and Monitoring 129

10.1 Principles of Cleanroom Testing 130

10.2 Cleanroom Tests 131

10.3 Testing in Relation to Room Type and Occupation State 134

10.4 Re-testing to Demonstrate Compliance 134

10.5 Monitoring of Cleanrooms 136

11 Measurement of Air Quantities and Pressure Differences 139

11.1 Air Quantities 140

11.2 Differential Pressure Tests 145

12 Air Movement Control: Containment, Visualization and Recovery 151

12.1 Cleanroom Containment Leak Testing 152

12.2 Air Movement Control within a Cleanroom 153

12.3 Recovery Test Methods 162

12.4 Recovery Rate Requirement in the EU GGMP 164

13 Filter Installation Leak Testing 167

13.1 The Use of Aerosol Test Challenges 169

13.2 Artificial Aerosol Test Challenges 170

13.3 Apparatus for Measuring Aerosol Penetration 173

13.4 Methods of Testing Filters and Filter Housings 175

13.5 Repair of Leaks 177

14 Airborne Particle Counts 179

14.1 Airborne Particle Counters 179

14.2 Continuous Monitoring Apparatus for Airborne Particles 181

14.3 Particle Counting in Different Occupancy States 184

14.4 Measurement of Particle Concentrations 185

14.5 Worked Example of ISO 14644-1 Test Method 188

15 Microbial Sampling 193

15.1 Microbial Sampling of the Air 193

15.2 Microbial Deposition onto Surfaces 197

15.3 Microbial Surface Sampling 199

15.4 Personnel Sampling 202

16 Operating a Cleanroom: Managing the Risk from Contamination 203

16.1 Step 1: Identification of Sources and Routes of Contamination 204

16.2 Step 2: Risk Assessment and the Control of Sources of Contamination 208

16.3 Step 3: Establish an Effective Monitoring Programme 225

16.4 Step 4: Verification and Reappraisal of the System 230

16.5 Step 5: Documentation 231

16.6 Step 6: Staff Training 231

17 Cleanroom Disciplines 233

17.1 People Allowed into Cleanrooms 233

17.2 Personal Items Not Allowed into the Cleanroom 236

17.3 Disciplines within the Cleanroom 237

17.4 Maintenance and Service Personnel 248

18 Entry and Exit of Personnel 251

18.1 Prior to Arriving at the Cleanroom 252

18.2 Changing into Cleanroom Garments 253

18.3 Exit Changing Procedures 262

19 Materials, Equipment and Machinery 265

19.1 Choice of Materials for use in a Cleanroom 266

19.2 Items Supplied from Outside Manufacturing Sources 270

19.3 Wrapping and Transportation of Materials 271

19.4 Transfer of Items and Small Pieces of Equipment through a Materials Transfer Airlock 273

19.5 Entry of Heavy Machinery and Bulky Items 279

19.6 Transfer of Materials through Hatches and Sterilisers 283

20 Cleanroom Clothing 287

20.1 Sources and Routes of Inert Airborne Particle Dispersion 288

20.2 Sources and Routes of Airborne Microbial Dispersion 293

20.3 Types of Cleanroom Clothing 295

20.4 Processing of Cleanroom Garments and Change Frequency 302

20.5 The Effect of Laundering and Wear 306

20.6 Testing of Cleanroom Clothing 306

20.7 Static Dissipative Properties of Clothing 310

21 Cleanroom Masks and Gloves 315

21.1 Cleanroom Masks 315

21.2 Cleanroom Gloves 321

22 Cleaning a Cleanroom 327

22.1 Why a Cleanroom must be Cleaned 327

22.2 Cleaning Methods and the Physics of Cleaning Surfaces 328

22.3 Implements Used to Clean Cleanrooms 331

22.4 Liquids Used in Cleaning Cleanrooms 339

22.5 How Should a Cleanroom be Cleaned? 343

22.6 Cleaning Programme 350

22.7 Test Methods 354

Index 357

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