洁净服蓝皮书

hisun，sanofi

全面介绍洁净服的工艺，要求，标准，类型等等Contents
1.0 The Cleanroom Environment 4
1.1 A Brief History of Cleanroom Development 4
1.2 Cleanroom Design and Construction 6
1.3 Materials, Fixtures, Fittings and Construction - Points to Consider 10
1.4 Barrier Isolators, Laminar Airflow Cabinets and Biological Safety Cabinets 12
2.0 Cleanroom Classifications & Standards 14
2.1 Cleanroom Particulate Standards and Classifications 14
2.2 Cleanroom Microbiological Classifications and Standards 17
2.3 ESD Requirements and Standards 18
2.4 IEST-RP-CC003 19
2.5 ASTM F51/00 20
2.6 BS EN 14065:2002 Textiles - Laundry Processed Textiles -
Biocontamination Control System 21
3.0 Contamination Control & Staff 22
3.1 The Effect of Staff 22
3.2 Entry and Exit Procedures 25
3.3 Changing Areas 26
3.4 Gowning Techniques and Changing Procedures 28
3.5 Training Requirements 30
3.6 Garment Systems and Changing Frequency 30
4.0 Reusable Contamination Control Clothing 33
4.1 Reusable Cleanroom Clothing - the Three Principal Requirements 33
4.2 Cleanroom Fabrics 34
4.3 Cleanroom Clothing Design and Construction 38
4.4 Cleanroom Clothing Fixtures and Fittings 39
4.5 Special Cleanroom Garment and Fabric Requirements 39
4.6 Fabric Test Methods 41
4.7 Body Box Test 42
4.8 Cleanroom Undergarments 45
5.0 Disposable Contamination Control Clothing 46
5.1 Disposable Clothing 46
5.2 Bodywear 48
5.3 Headwear 51
5.4 Handwear 54
5.5 Footwear 59
6.0 Decontamination of Cleanroom Garments & Consumables 61
6.1 Purpose and Function 61
6.2 Cleanroom Garment and Consumables Decontamination Plant -
Layout and Contamination Control Requirements 63
6.3 Cleanroom Decontamination Plant Cleaning Process 69
6.4 Disinfection and Sterilisation 69
6.5 Particulate and Fibre Decontamination 73
6.6 Product Inspection and Conformance Checks 75
6.7 Labelling, Packaging and Presentation 76
6.8 Process Monitoring, Controls and Records 78
6.9 Cleanroom Decontamination Plant Audits 80
6.10 Special Customer Requirements 80


3

Section Title Page
7.0 Cleanroom Cleaning - Methods and Equipment 82
7.1 Contamination Control and the Requirement for Cleaning 82
7.2 Cleanroom Cleaning - General Considerations 83
7.3 Cleaning Plans, SOPs and Records 87
7.4 Vacuum Systems 88
7.5 Mops 89
7.6 Wipes and Swabs 91
7.7 Chemicals for Cleaning and Disinfection 96
7.8 Contamination Control Flooring and Mats 98
7.9 Confirming Effective Cleaning 99
8.0 Planning, Sourcing and Optimising Cleanroom Clothing Supply 100
8.1 Planning the Process 100
8.2 Selecting a Cleanroom Clothing Project Team 101
8.3 New Cleanroom Clothing system or Review of Existing Supply Arrangements 101
8.4 The Budget 102
8.5 Timescales 102
8.6 Fabric and Garment Style Selection Process 102
8.7 Determining the Numbers of Garments Required 104
8.8 Cleanroom Clothing Distribution Systems 107
8.9 Supply Options and Supplier Selection 109
8.10 Implementation and Maintenance of the Clothing System 111
9.0 Planning, Sourcing and Optimising Cleanroom Consumables Supply 112
10.0 Acknowledgements, References, Useful Contacts and Sources of Information 119

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