ASENMCO – Books

«Association of Engineers for microcontamination control» (ASENMCO)

Select language:

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

1	What is a cleanroom		15
	1.1	General	15
	1.2	Classification of cleanrooms	17
	1.3	Sources of microcontamination	19
	1.4	Application of cleanrooms	24
	1.5	Microelectronics	25
	1.6	Space industry	26
	1.7	Devices and optics	28
	1.8	Machinary (car industry)	28
	1.9	Laboratories	30
	1.10	Hospitals	30
	1.11	Food production	38
	1.12	GMP rules and cleanrooms	47
		Requirements of GMP EC	48
		– sterile products	49
		– non-sterile products	58
		Requirements of FDA	58
	1.13	Medical devices	59
	1.14	Plastics film	61
	1.15	Cells culture	61
	Literature for Chapter 1		62

2	Principles of contamination control		65
	2.1	General principles	65
	2.2	Cleanroom zone segregation concepts	67
	2.3	Airflows	68
	2.4	Air exchange rate	80
	2.5	Pressure difference	81
	2.6	Layout and design	83
	2.7	Autonomous cleanzones	98
	2.8	Local clean air devices	100
	2.9	Static electricity	103
	Literature for Chapter 2		104

3	Air filtration		106
	3.1	Airborne particles	106
	3.2	Controlling airborne contamination	107
	3.3	Air filtration with fiber filters	107
	3.4	Particle segregation mechanisms	110
	3.5	Air filter classification according to EN 779, EN 1822 and GOST R 51251-99	113
	3.6	НЕРА and ULPA filter testing: the point of departure	116
	3.7	Assessment of the traditional НЕРА and ULPA filter test procedures	116
	3.8	The EN 1822 approach	117
	3.9	The filter combination for cleanroom systems	124
	3.10	On-site integrity testing of НЕРА and ULPA filters	125
	Literature for Chapter 3		126

4	Air handling systems for clean rooms		128
	4.1	Priorities in cleanroom design	128
	4.2	Towards the optimum in cost-efficiency	128
	4.3	Room air recirculating units	129
	4.4	Integrated air handling systems for cleanrooms with turbulent airflow	131
	4.5	Integrated air handling systems for cleanrooms with unidirectional airflow	133
	4.6	Risk assessment for air handling systems	138
	4.7	Dominating the risks	139
	4.8	Design of environmental control systems	140
	4.9	Air handling units for clean room systems	142
	4.10	Reducing energy consumption still further	145
	4.11	Designing with the customer in mind	146
	Literature for Chapter 4		146

5	Isolator technology for aseptic processing: A quantum leap in sterility assurance		148
	5.1	Isolators in the limelight	148
	5.2	Sterility assurance goals and realities	148
	5.3	Conceptual aspects of isolators	149
	5.4	Regulatory and guidance documents	153
	5.5	Sterilizing the isolator	155
	5.6	Qualification, validation and monitoring	157
	5.7	The economic dimension	158
	5.8	Application examples	159
	5.9	Conclusions	163
	Literature for Chapter 5		163

6	Cleanroom design		165
	6.1	Features of clean room design	165
	6.2	Concept of design	167
	6.3	Cleanroom layout	172
	6.4	HVAC systems	178
	6.4.1	Purpose	178
	6.4.2	Structure	180
	6.4.3	Balance of air volumes	184
	6.4.4	Calculation of inlet air:	187
		– outdoor air	187
		– providing cleanliness	187
		· using recommen dations and standards	188
		· calculation of air exchange rate	192
		· simplified method	194
		– microbiological cleanliness	195
		– withdrawal of heat and moisture	196
		– compensation of exhausts	196
		– compensation of leakages	196
	6.4.5	Premises of general application	197
	6.5	Thermal comfort	198
	6.6	Parameters of cleanroom environment	202
	6.7	Automatic control	205
	6.8	Cleanroom construction	207
	Literature for Chapter 6		207

7	Materials for cleanrooms		219
	7.1	General requirements	219
	7.2	Walls	220
	7.3	Ceilings	227
	7.4	Floors	229
	7.5	Installation of floors	235

8	Qualification of cleanrooms		239
	8.1	Stages of qualification	239
	8.2	Program of cleanroom testing	247
	8.3	Passport of cleanroom	254
	8.4	Testing of cleanroom parameters	255
	8.5	Qualification – from quantity to quality	258
	8.6	Strategy of qualification	258
	Literature for Chapter 8		262

9	Testing of cleanroom		264
	9.1	Methods of testing of cleanrooms	264
	9.2	Airborne particulate count for determining cleanliness class	265
	9.3	Estimating of cleanliness class with method of coefficients of redundancy	275
	9.4	Sequential sampling procedure	281
	9.5	Airflow test	286
	9.6	Airflow volume	288
	9.7	Air pressure difference	289
	9.8	Filter leakage test	290
	9.9	Temperature test	302
	9.10	Humidity test	302
	9.11	Recovery time test	303
	9.12	Containment leak test	303
	9.13	Airborne particles counters	304
	Literature for Chapter 9		318

10	Air dynamic systems		320
	10.1	Basic properties of aerosols	320
	10.2	Classification of aerosols and methods of generation	321
	10.3	tmosphere aerosols	323
	10.4	Form, sizes and concentration of airborne particles	325
	10.5	Filtration (protection methods)	329
	10.6	Determining of aerosol properties	339
	Literature for Chapter 10		342

11	Air movements and the dispersion of contaminants		343
	11.1	Wakes and Vortex streets	343
	11.2	Factual situations in Clean Zones	346
	11.3	Factual situations in Cleanrooms	351
	Literature for Chapter 11		354

12	Operation		356
	12.1	General	356
	12.2	Requirement for personnel	357
	12.3	Training	364
	12.4	Cleanroom garments	368
	12.5	Cleanroom cleaning	376
	12.6	Operation of equipment	383
	12.7	Safety	384
	Literature for Chapter 12		385

13	Cleanroom disciplines and entry procedures for personnel		386
	13.1	Introduction	386
	13.2	Personnel	387
	13.3	Entry changing procedures	388
	13.4	Changing procedures	390
	13.5	Exit changing procedures	396
	13.6	Maintenance and service personnel	397
	13.7	Cleanroom disciplines	398

14	People as a contamination source. Modern clean room clothing systems		403
	14.1	Introduction	403
	14.2	Garments and air cleanliness	404
	14.3	Studies of different types of cleanroom clothing systems	406
	14.4	Conclusions	428
	Literature for Chapter 14		428

15	Cleanrooms for microelectronics		430
	15.1	Development of microelectronic industry	430
	15.2	Chips manufacture	432
	15.3	Chips defects	436
	15.4	Cleanrooms and clean zones for microelectronics	437
	15.5	Cleanliness of media	443
	Literature for Chapter 15		447

16	Biocontamination control		448
	16.1	General	448
	16.2	Purpose of biocontamination control in cleanrooms	451
	16.3	Disinfection of cleanrooms	451
	16.4	Air biocontamination tests	458
	16.5	Devices for tests of air biocontamination	460
	16.6	Biocontamination of surfaces	467
	Literature for Chapter 16		470

17	Cleanliness in biotechnology		472
	17.1	Subject of biotechnology	472
	17.2	Stages of biotechnological manufacture	475
	17.3	Bioreactor	487
	17.4	Safety in biotechnology	496
	Literature for Chapter 17		512

18	Cleanroom standards		514
	18.1	First cleanroom standards	514
	18.2	Standards of Societies of engineers	516
	18.3	Types of standards	520
	18.4	ISO cleanrooms standards	523

19	Water treatment		524
	19.1	Water for pharmaceutical use	524
	19.2	Purified water	525
	19.3	Water for injections	539
	19.4	Water for microelectronics	550
	19.5	Test of total organic carbon	554
	Literature for Chapter 19		556

Annex 1 Determining of ultrafine particles and macroparticles concentration			557
Annex 2 Tables for PMV indexes for relative humidity 50%			560
Annex 3 Compliance of metric and English units			566
Annex 4 Index			569
Organization which are involved in cleanroom technology			572
Contents (English)			573
Sponsors			576

127299, Russia, Moscow, K. Tsetkin str., 4, office 219, «АСИНКОМ»
Tel/fax: +7(495)787-03-12, +7(495)777-72-31
WWW (English): www.asenmco.info WWW (Russian): www.asincom-group.ru оr www.asincom.info E-mail: mail@asincom.info