Enhanced descriptions from Syndetics:

A cleanroom is a contamination-controlled environment and is essential in the industrial manufacture of many electronic, semiconductor, optical, pharmaceutical and medical products.
The use of cleanrooms for the manufacture of a large range of products such as microprocessors, CD players, lasers, pharmaceuticals and medical devices continues to grow and many companies are using cleanrooms for the first time. At the same time, new technology products that can only be produced in cleanrooms are being developed. This comprehensive overview of the fundamentals, design, testing and operation of cleanroom systems provides novices with a introduction to this state-of-the-art technology and professionals with an accessible reference to the current standards. Readers will benifit from the author's 35 years of experience in cleanroom technology R&D, consultancy and teaching. The text is complementary to the structure and content of Whyte's own and many in-house cleanroom courses in the electronics and pharmaceutical industries.
* Complementary to the highly successful Cleanroom Design, Second Edition and the forthcoming Cleanroom Testing and Running by the same author
* Presents the fundamentals and latest standards for the design, validation, testing and running of cleanroom systems
Pitched at introductory level and tailored to fulfil the training requirements of scientists and engineers new to cleanroom technology

Table of contents provided by Syndetics

• Preface (p. xiii)
• Acknowledgements (p. xiv)
• 1 Introduction (p. 1)
• 1.1 What is a Cleanroom? (p. 1)
• 1.2 The Need for Cleanrooms (p. 2)
• 1.3 Types of Cleanrooms (p. 5)
• 1.5 What is Cleanroom Technology? (p. 7)
• 2 The History of Cleanrooms (p. 9)
• 2.1 The Early Years (p. 9)
• 2.2 Ventilated Operating Rooms (p. 12)
• 2.3 Early Industrial Cleanrooms (p. 15)
• 2.4 Unidirectional Flow Cleanrooms (p. 17)
• 3 Cleanroom Classification Standards (p. 21)
• 3.1 The History (p. 21)
• 3.2 The Basis of Cleanroom Standards (p. 22)
• 3.3 Federal Standard 209 (p. 24)
• 3.3.1 The earlier Federal Standards 209 (A to D) (p. 24)
• 3.3.2 Federal Standard 209 E (p. 24)
• 3.4 ISO Standard 14644-1 (p. 26)
• 3.5 Pharmaceutical Cleanroom Classification (p. 30)
• 3.5.1 European Union Guide to Good Manufacturing Practice (p. 30)
• 3.5.2 Guideline on Sterile Drug Products Produced by Aseptic Processing (p. 33)
• 4 Information Sources (p. 37)
• 4.1 The International Confederation of Contamination Control Societies (ICCCS) (p. 37)
• 4.2 International Cleanroom Standards (p. 38)
• 4.2.1 ISO standards (p. 38)
• 4.2.2 Federal Standard 209E (p. 41)
• 4.2.3 Pharmaceutical standards (p. 41)
• 4.3 Cleanroom Books (p. 43)
• 4.4 Recommended Practices and Guides of the Institute of Environmental Sciences and Technology (IEST) (p. 43)
• 4.4.1 IEST Recommended Practices (RPs) (p. 44)
• 4.4.2 IEST Guides (p. 47)
• 4.5 Cleanroom Journals and Magazines (p. 47)
• 4.5.1 Free distribution (p. 47)
• 4.5.2 Journals and magazines available on subscription (p. 49)
• 4.6 Sources of Pharmaceutical Cleanroom Documents (p. 50)
• 4.7 International Cleanroom Forum (p. 51)
• 5 The Design of Turbulently Ventilated and Ancillary Cleanrooms (p. 53)
• 5.1 Turbulently Ventilated Cleanrooms (p. 53)
• 5.1.1 Air supply (p. 55)
• 5.1.2 High efficiency air filters (p. 57)
• 5.1.3 Air movement within a turbulently ventilated cleanroom (p. 57)
• 5.1.4 Room pressurisation and air movement control between rooms (p. 59)
• 5.1.5 Construction materials and finishes (p. 62)
• 5.2 Ancillary Cleanrooms (p. 63)
• 5.2.1 Clothing change area (p. 63)
• 5.2.2 Materials transfer area (p. 66)
• 5.3 Containment Rooms (p. 67)
• 6 Design of Unidirectional Cleanrooms and Clean Air Devices (p. 71)
• 6.1 Unidirectional Cleanrooms (p. 71)
• 6.1.1 Vertical flow unidirectional cleanrooms (p. 73)
• 6.1.2 Horizontal flow unidirectional flow rooms (p. 74)
• 6.1.3 Unidirectional flow rooms used in semiconductor manufacturing (p. 76)
• 6.2 Clean Air Devices (p. 81)
• 6.2.1 Unidirectional air devices (p. 81)
• 6.2.2 Isolators and minienvironments (p. 83)
• 7 Construction Materials and Surface Finishes (p. 91)
• 7.1 General Requirements (p. 91)
• 7.2 Conventional Building Techniques (p. 93)
• 7.3 Modular Construction (p. 95)
• 7.3.1 Studless wall systems (p. 95)
• 7.3.2 Framed wall systems (p. 96)
• 7.4 Doors and Widows (p. 98)
• 7.5 Floors (p. 98)
• 7.6 Ceilings (p. 99)
• 7.7 Outgassing and Electrostatic Properties (p. 100)
• 8 High Efficiency Air Filtration (p. 103)
• 8.1 Air Filters Used in Cleanrooms (p. 103)
• 8.2 The Construction of High Efficiency Filters (p. 104)
• 8.3 Particle Removal Mechanisms (p. 106)
• 8.4 Testing of High Efficiency Filters (p. 109)
• 8.4.1 Military Standard 282 (p. 109)
• 8.4.2 Sodium Flame Test (Eurovent 4/4) (p. 110)
• 8.4.3 Institute of Environmental Sciences (IEST) Recommended Practice 'Testing ULPA Filters' (p. 110)
• 8.4.4 European Standard (EN 1822) (p. 110)
• 8.5 Probe (Scan) Testing of High Efficiency Filters (p. 111)
• 8.6 Filter Housings for High Efficiency Filters (p. 112)
• 9 Cleanroom Testing and Monitoring (p. 115)
• 9.1 Principles of Cleanroom Testing (p. 116)
• 9.2 Cleanroom Tests (p. 116)
• 9.2.1 Air supply and extract quantities (p. 117)
• 9.2.2 Air movement control between areas (p. 117)
• 9.2.3 Filter installation leak test (p. 118)
• 9.2.4 Containment leak testing (p. 118)
• 9.2.5 Air movement control within the room (p. 118)
• 9.2.6 Airborne particles and microbial concentrations (p. 118)
• 9.2.7 Additional tests (p. 118)
• 9.3 Testing in Relation to Room Type and Occupation State (p. 119)
• 9.4 Re-testing to Demonstrate Compliance (p. 120)
• 9.5 Monitoring of Cleanrooms (p. 121)
• 10 Measurement of Air Quantities and Pressure Differences (p. 123)
• 10.1 Air Quantities (p. 123)
• 10.1.1 Measuring air quantities from within a cleanroom (p. 124)
• 10.1.2 Anemometers (p. 125)
• 10.2 Differential Pressure Tests (p. 127)
• 10.2.1 Apparatus for measuring pressure differences (p. 128)
• 10.2.2 Methods of checking pressure differences (p. 129)
• 11 Air Movement Control Between and Within Cleanrooms (p. 131)
• 11.1 Cleanroom Containment Leak Testing (p. 131)
• 11.1.1 Methods of checking infiltration (p. 132)
• 11.2 Air Movement Control within a Cleanroom (p. 133)
• 11.2.1 Air movement visualisation (p. 134)
• 11.3 Recovery Test Method (p. 139)
• 12 Filter Installation Leak Testing (p. 141)
• 12.1 The Use of Aerosol Test Challenges (p. 144)
• 12.2 Artificial Smoke and Particle Test Challenges (p. 145)
• 12.2.1 Cold-generated oils (p. 145)
• 12.2.2 Hot generated smokes (p. 146)
• 12.2.3 Polystyrene latex spheres (p. 147)
• 12.3 Apparatus for Measuring Smoke Penetration (p. 147)
• 12.3.1 Photometer (p. 147)
• 12.3.2 Single particle counters (p. 148)
• 12.4 Methods of Testing Filters and Filter Housings (p. 149)
• 12.4.1 Scanning methods (p. 149)
• 12.4.2 Testing filters in unidirectional flow rooms (p. 150)
• 12.4.3 Filter testing in conventionally ventilated room (p. 151)
• 12.4.4 Repair of leaks (p. 151)
• 13 Airborne Particle Counts (p. 153)
• 13.1 Airborne Particle Counters (p. 153)
• 13.2 Continuous Monitoring Apparatus for Airborne Particles (p. 156)
• 13.3 Particle Counting in Different Occupancy States (p. 158)
• 13.4 Measurement of Particle Concentrations (ISO 14644-1) (p. 160)
• 13.4.1 Sample locations and number (p. 160)
• 13.4.2 Airborne sampling volume (p. 161)
• 13.4.3 Acceptance criteria (p. 162)
• 13.5 Worked Example of ISO 14644-1 Test Method (p. 162)
• 13.5.1 Number of locations (p. 162)
• 13.5.2 Minimum air sampling volume (p. 163)
• 13.5.3 Sampling results (p. 163)
• 14 Microbial Counts (p. 167)
• 14.1 Microbial Sampling of the Air (p. 167)
• 14.1.1 Impaction onto agar (p. 168)
• 14.2 Microbial Deposition onto Surfaces (p. 171)
• 14.2.1 Settle plate sampling (p. 171)
• 14.2.2 Calculation of the likely airborne contamination (p. 172)
• 14.3 Microbial Surface Sampling (p. 173)
• 14.3.1 Contact surface sampling (p. 173)
• 14.3.2 Swabbing (p. 174)
• 14.4 Personnel sampling (p. 175)
• 15 Operating a Cleanroom: Contamination Control (p. 177)
• 15.1 Step 1: Identification of Sources and Routes of Contamination (p. 178)
• 15.1.1 Sources of contamination (p. 178)
• 15.1.2 Airborne and contact routes of transfer (p. 179)
• 15.1.3 Construction of a risk diagram (p. 180)
• 15.2 Step 2: Assessment of the Importance of Hazards (p. 182)
• 15.3 Step 3: Identification of Methods to Control Hazards (p. 185)
• 15.4 Step 4: Sampling Methods to Monitor Hazards and Control Methods (p. 186)
• 15.5 Step 5: Establishing a Monitoring Schedule with Alert and Action Levels (p. 189)
• 15.6 Step 6: Verification and Reappraisal of the System (p. 190)
• 15.7 Step 7: Documentation (p. 190)
• 15.8 Step 8: Staff Training (p. 191)
• 16 Cleanroom Disciplines (p. 193)
• 16.1 People Allowed into Cleanrooms (p. 193)
• 16.2 Personal Items Not Allowed into the Cleanroom (p. 196)
• 16.3 Disciplines within the Cleanroom (p. 196)
• 16.3.1 Air transfer (p. 196)
• 16.3.2 Personnel behaviour (p. 198)
• 16.3.3 Handling materials (p. 206)
• 16.4 Maintenance and Service Personnel (p. 206)
• 17 Entry and Exit of Personnel (p. 209)
• 17.1 Prior to Arriving at the Cleanroom (p. 210)
• 17.2 Changing into Cleanroom Garments (p. 210)
• 17.2.1 Approaching the pre-change zone (p. 211)
• 17.2.2 Pre-change zone (p. 213)
• 17.2.3 Changing zone (p. 215)
• 17.2.4 Cleanroom entrance zone (p. 217)
• 17.3 Exit Changing Procedures (p. 220)
• 18 Materials, Equipment and Machinery (p. 223)
• 18.1 Choice of Materials (p. 223)
• 18.2 Items Supplied from Outside Manufacturing Sources (p. 225)
• 18.3 Wrapping Materials (p. 226)
• 18.4 Transfer of Materials and Small Pieces of Equipment through an Airlock (p. 228)
• 18.4.1 Transfer area with a bench (p. 229)
• 18.4.2 Transfer area without a bench (p. 232)
• 18.5 Entry of Machinery (p. 233)
• 18.6 Transfer of Materials through Hatches and Sterilisers (p. 235)
• 19 Cleanroom Clothing (p. 237)
• 19.1 Sources and Routes of Inert Particle Dispersion (p. 238)
• 19.1.1 Sources of particles and mechanisms of release (p. 239)
• 19.1.2 Routes of transfer of particles (p. 242)
• 19.2 Routes and Sources of Microbial Dispersion (p. 243)
• 19.2.1 Sources of micro-organisms (p. 241)
• 19.2.2 Routes of microbial dispersion (p. 244)
• 19.3 Types of Cleanroom Clothing (p. 245)
• 19.3.1 Clothing designs (p. 245)
• 19.3.2 Cleanroom fabrics (p. 246)
• 19.3.3 Garment construction (p. 249)
• 19.3.4 Choice of garments (p. 249)
• 19.3.5 Comfort (p. 251)
• 19.4 Processing of Cleanroom Garments and Change Frequency (p. 252)
• 19.4.1 Processing (p. 252)
• 19.4.2 Frequency of change (p. 255)
• 19.5 The Effect of Laundering and Wear (p. 256)
• 19.6 Testing of Cleanroom Clothing (p. 256)
• 19.6.1 Fabric tests (p. 25)
• 19.6.2 Dispersal of airborne bacteria and particles (p. 257)
• 19.7 Static Dissipative Properties of Clothing (p. 261)
• 20 Cleanroom Masks and Gloves (p. 263)
• 20.1 Cleanroom Masks (p. 263)
• 20.1.1 Dispersion from the mouth (p. 263)
• 20.1.2 Face masks (p. 266)
• 20.1.3 Powered exhaust headgear (p. 268)
• 20.2 Cleanroom Gloves (p. 269)
• 20.2.1 Hand contamination and gloves (p. 269)
• 20.2.2 Glove manufacturing process (p. 270)
• 20.2.3 Types of gloves (p. 270)
• 20.2.4 Testing of Gloves (p. 272)
• 21 Cleaning a Cleanroom (p. 275)
• 21.1 Why a Cleanroom Must be Cleaned (p. 275)
• 21.2 Cleaning Methods and the Physics of Cleaning Surfaces (p. 276)
• 21.2.1 Vacuuming (p. 277)
• 21.2.2 Wet wiping (p. 278)
• 21.2.3 Tacky rollers (p. 278)
• 21.3 Implements Used to Clean Cleanrooms (p. 279)
• 21.3.1 Dry and wet vacuum systems (p. 279)
• 21.3.2 Moping systems (p. 280)
• 21.3.3 Wipers (p. 283)
• 21.3.4 Tacky rollers (p. 285)
• 21.3.5 Floor scrubbing systems (p. 286)
• 21.4 Liquids Used in Cleaning Cleanrooms (p. 286)
• 21.4.1 Cleaning liquids (p. 286)
• 21.4.2 Disinfectants (p. 288)
• 21.5 How Should a Cleanroom be Cleaned? (p. 290)
• 21.5.1 General points (p. 290)
• 21.5.2 Cleaning methods with respect to area type (p. 291)
• 21.5.3 Cleaning methods (p. 293)
• 21.6 Test Methods (p. 295)
• Index (p. 297)