«Association  of  Engineers  for  microcontamination  control»  (ASENMCO)
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The first edition of the book «Cleanrooms» («Чистые помещения») was published in Russian in 1998, editor A. Fedotov.

The second edition was published in 2003. It has 576 pages and color pictures and reflects major topics of Cleanroom theory and practice.

This is a truly international book.
Well-known specialists are authors of several chapters:
Dr. H. Schicht, Dr. B. White, Dr. B. Reinmueller, Prof. B. Ljungquist and other specialists.

The book can be used both by beginners and professionals on research, design, manufacturing, construction, qualification and operation of Cleanrooms.

Contents of the book


Introduction
 
1What is a cleanroom15
 1.1General15
 1.2Classification of cleanrooms17
 1.3Sources of microcontamination19
 1.4Application of cleanrooms24
 1.5Microelectronics25
 1.6Space industry26
 1.7Devices and optics28
 1.8Machinary (car industry)28
 1.9Laboratories30
 1.10Hospitals30
 1.11Food production38
 1.12GMP rules and cleanrooms47
 Requirements of GMP EC48
 – sterile products49
 – non-sterile products58
 Requirements of FDA58
 1.13Medical devices59
 1.14Plastics film61
 1.15Cells culture61
 Literature for Chapter 162
 
2Principles of contamination control65
 2.1General principles65
 2.2Cleanroom zone segregation concepts67
 2.3Airflows68
 2.4Air exchange rate80
 2.5Pressure difference81
 2.6Layout and design83
 2.7Autonomous cleanzones98
 2.8Local clean air devices100
 2.9Static electricity103
 Literature for Chapter 2104
 
3Air filtration106
 3.1Airborne particles106
 3.2Controlling airborne contamination107
 3.3Air filtration with fiber filters107
 3.4Particle segregation mechanisms110
 3.5Air filter classification according to EN 779, EN 1822 and GOST R 51251-99113
 3.6НЕРА and ULPA filter testing: the point of departure116
 3.7Assessment of the traditional НЕРА and ULPA filter test procedures116
 3.8The EN 1822 approach117
 3.9The filter combination for cleanroom systems124
 3.10On-site integrity testing of НЕРА and ULPA filters125
 Literature for Chapter 3126
 
4Air handling systems for clean rooms128
 4.1Priorities in cleanroom design128
 4.2Towards the optimum in cost-efficiency128
 4.3Room air recirculating units129
 4.4Integrated air handling systems for cleanrooms with turbulent airflow131
 4.5Integrated air handling systems for cleanrooms with unidirectional airflow133
 4.6Risk assessment for air handling systems138
 4.7Dominating the risks139
 4.8Design of environmental control systems140
 4.9Air handling units for clean room systems142
 4.10Reducing energy consumption still further145
 4.11Designing with the customer in mind146
 Literature for Chapter 4146
 
5Isolator technology for aseptic processing:
A quantum leap in sterility assurance
148
 5.1Isolators in the limelight148
 5.2Sterility assurance goals and realities148
 5.3Conceptual aspects of isolators149
 5.4Regulatory and guidance documents153
 5.5Sterilizing the isolator155
 5.6Qualification, validation and monitoring157
 5.7The economic dimension158
 5.8Application examples159
 5.9Conclusions163
 Literature for Chapter 5163
 
6Cleanroom design165
 6.1Features of clean room design165
 6.2Concept of design167
 6.3Cleanroom layout172
 6.4HVAC systems178
 6.4.1Purpose178
 6.4.2Structure180
 6.4.3Balance of air volumes184
 6.4.4Calculation of inlet air:187
 – outdoor air187
 – providing cleanliness187
 ·  using recommen dations and standards188
 ·  calculation of air exchange rate192
 ·  simplified method194
 – microbiological cleanliness195
 – withdrawal of heat and moisture196
 – compensation of exhausts196
 – compensation of leakages196
 6.4.5Premises of general application197
 6.5Thermal comfort198
 6.6Parameters of cleanroom environment202
 6.7Automatic control205
 6.8Cleanroom construction207
 Literature for Chapter 6207
 
7Materials for cleanrooms219
 7.1General requirements219
 7.2Walls220
 7.3Ceilings227
 7.4Floors229
 7.5Installation of floors235
 
8Qualification of cleanrooms239
 8.1Stages of qualification239
 8.2Program of cleanroom testing247
 8.3Passport of cleanroom254
 8.4Testing of cleanroom parameters255
 8.5Qualification – from quantity to quality258
 8.6Strategy of qualification258
 Literature for Chapter 8262
 
9Testing of cleanroom264
 9.1Methods of testing of cleanrooms264
 9.2Airborne particulate count for determining cleanliness class265
 9.3Estimating of cleanliness class with method of coefficients of redundancy275
 9.4Sequential sampling procedure281
 9.5Airflow test286
 9.6Airflow volume288
 9.7Air pressure difference289
 9.8Filter leakage test290
 9.9Temperature test302
 9.10Humidity test302
 9.11Recovery time test303
 9.12Containment leak test303
 9.13Airborne particles counters304
 Literature for Chapter 9318
 
10Air dynamic systems320
 10.1Basic properties of aerosols320
 10.2Classification of aerosols and methods of generation321
 10.3tmosphere aerosols323
 10.4Form, sizes and concentration of airborne particles325
 10.5Filtration (protection methods)329
 10.6Determining of aerosol properties339
 Literature for Chapter 10342
 
11Air movements and the dispersion of contaminants343
 11.1Wakes and Vortex streets343
 11.2Factual situations in Clean Zones346
 11.3Factual situations in Cleanrooms351
 Literature for Chapter 11354
 
12Operation356
 12.1General356
 12.2Requirement for personnel357
 12.3Training364
 12.4Cleanroom garments368
 12.5Cleanroom cleaning376
 12.6Operation of equipment383
 12.7Safety384
 Literature for Chapter 12385
 
13Cleanroom disciplines and entry procedures for personnel386
 13.1Introduction386
 13.2Personnel387
 13.3Entry changing procedures388
 13.4Changing procedures390
 13.5Exit changing procedures396
 13.6Maintenance and service personnel397
 13.7Cleanroom disciplines398
 
14People as a contamination source. Modern clean room clothing systems403
 14.1Introduction403
 14.2Garments and air cleanliness404
 14.3Studies of different types of cleanroom clothing systems406
 14.4Conclusions428
 Literature for Chapter 14428
 
15Cleanrooms for microelectronics430
 15.1Development of microelectronic industry430
 15.2Chips manufacture432
 15.3Chips defects436
 15.4Cleanrooms and clean zones for microelectronics437
 15.5Cleanliness of media443
 Literature for Chapter 15447
 
16Biocontamination control448
 16.1General448
 16.2Purpose of biocontamination control in cleanrooms451
 16.3Disinfection of cleanrooms451
 16.4Air biocontamination tests458
 16.5Devices for tests of air biocontamination460
 16.6Biocontamination of surfaces467
 Literature for Chapter 16470
 
17Cleanliness in biotechnology472
 17.1Subject of biotechnology472
 17.2Stages of biotechnological manufacture475
 17.3Bioreactor487
 17.4Safety in biotechnology496
 Literature for Chapter 17512
 
18Cleanroom standards514
 18.1First cleanroom standards514
 18.2Standards of Societies of engineers516
 18.3Types of standards520
 18.4ISO cleanrooms standards523
 
19Water treatment524
 19.1Water for pharmaceutical use524
 19.2Purified water525
 19.3Water for injections539
 19.4Water for microelectronics550
 19.5Test of total organic carbon554
 Literature for Chapter 19556
 
Annex 1 Determining of ultrafine particles and macroparticles concentration557
Annex 2 Tables for PMV indexes for relative humidity 50%560
Annex 3 Compliance of metric and English units566
Annex 4 Index569
Organization which are involved in cleanroom technology572
Contents (English)573
Sponsors576
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