Cleanroom Technology Fundamentals of Design, Testing and Operation By William Whyte 2nd Edition (informative)
Free download Cleanroom Technology Fundamentals of Design, Testing and Operation By William Whyte 2nd Edition
2nd Edition
Authors of: Cleanroom Technology Fundamentals of Design, Testing and Operation By William Whyte 2nd Edition
William Whyte
Table of Contents in Cleanroom Technology Fundamentals of Design, Testing and Operation By William Whyte 2nd Edition
About the Author
Preface
Acknowledgements
1 Introduction
1.1 What is a Cleanroom?
1.2 The Need for Cleanrooms
1.3 Types of Cleanrooms
1.4 What is Cleanroom Technology?
Acknowledgements
2 The History of Cleanrooms
2.1 The Earliest Years
2.2 Ventilated Operating Rooms
2.3 Early Industrial Cleanrooms
2.4 Unidirectional Airflow Cleanrooms
Acknowledgements
3 Cleanroom Classification Standards
2
3.1 The History of Standards
3.2 The Basis of Cleanroom Standards
3.3 Federal Standard 209
3.4 ISO Standard 14644-1:1999
3.5 Pharmaceutical Cleanroom Classification
3.6 Classification of Cleanrooms with Airborne Chemical
Contamination
3.7 Classification of Cleanrooms with Surface
Contamination
Acknowledgement
4 Information Sources
4.1 The International Confederation of Contamination
Control Societies (ICCCS)
4.2 The ICEB
4.3 International Cleanroom Standards
4.4 Cleanroom Books
4.5 Recommended Practices and Guides of the Institute of
Environmental Sciences and Technology (IEST)
4.6 Cleanroom Journals and Magazines
3
4.7 Sources of Pharmaceutical Cleanroom Documents
4.8 Training Videos/DVDs
5 Non-unidirectional Airflow and Ancillary Cleanrooms
5.1 Non-unidirectional Airflow Cleanrooms
5.2 Ancillary Cleanrooms
Acknowledgement
6 Unidirectional Airflow Cleanrooms
6.1 Types of Unidirectional Airflow Cleanrooms
6.2 Vertical Unidirectional Airflow Cleanrooms
6.3 Horizontal Unidirectional Airflow Rooms
6.4 The Application of Unidirectional Airflow
Acknowledgements
7 Separative Clean Air Devices and Containment Zones
7.1 Unidirectional Airflow Devices
7.2 Mini-environments, Isolators and RABS
7.3 Containment Zones
Acknowledgements
4
8 Construction and Clean-build
8.1 Constructional Materials and Methods
8.2 Outgassing and Electrostatic Properties
8.3 Clean-build
Acknowledgements
9 High Efficiency Air Filtration
9.1 Air Filters used in Cleanrooms
9.2 The Construction of High Efficiency Filters
9.3 Particle Removal Mechanisms
9.4 Testing of High Efficiency Filters
9.5 Scan Testing of High Efficiency Filters
9.6 Filter Housings for High Efficiency Filters
9.7 Removal of Airborne Chemical Contamination
Acknowledgements
10 Cleanroom Testing and Monitoring
10.1 Principles of Cleanroom Testing
10.2 Cleanroom Tests
5
10.3 Testing in Relation to Room Type and Occupation
State
10.4 Re-testing to Demonstrate Compliance
10.5 Monitoring of Cleanrooms
Acknowledgement
11 Measurement of Air Quantities and Pressure
Differences
11.1 Air Quantities
11.2 Differential Pressure Tests
Acknowledgement
12 Air Movement Control: Containment, Visualisation and
Recovery
12.1 Cleanroom Containment Leak Testing
12.2 Air Movement Control within a Cleanroom
12.3 Recovery Test Methods
12.4 Recovery Rate Requirement in the EU GGMP
Acknowledgement
13 Filter Installation Leak Testing
13.1 The Use of Aerosol Test Challenges
6
13.2 Artificial Aerosol Test Challenges
13.3 Apparatus for Measuring Aerosol Penetration
13.4 Methods of Testing Filters and Filter Housings
13.5 Repair of Leaks
Acknowledgements
14 Airborne Particle Counts
14.1 Airborne Particle Counters
14.2 Continuous Monitoring Apparatus for Airborne
Particles
14.3 Particle Counting in Different Occupancy States
14.4 Measurement of Particle Concentrations
14.5 Worked Example of ISO 14644–1 Test
Method
Acknowledgements
15 Microbial Sampling
15.1 Microbial Sampling of the Air
15.2 Microbial Deposition onto Surfaces
15.3 Microbial Surface Sampling
7
15.4 Personnel Sampling
Acknowledgements
16 Operating a Cleanroom: Managing the Risk from
Contamination
16.1 Step 1: Identification of Sources and Routes of
Contamination
16.2 Step 2: Risk Assessment and the Control of the
Sources of Contamination
Notes
16.3 Step 3: Establish an Effective Monitoring Programme
16.4 Step 4: Verification and Reappraisal of the System
16.5 Step 5: Documentation
16.6 Step 6: Staff Training
17 Cleanroom Disciplines
17.1 People Allowed into Cleanrooms
17.2 Personal Items Not Allowed into the Cleanroom
17.3 Disciplines within the Cleanroom
17.4 Maintenance and Service Personnel
Acknowledgement
8
18 Entry and Exit of Personnel
18.1 Prior to Arriving at the Cleanroom
18.2 Changing into Cleanroom Garments
18.3 Exit Changing Procedures
Acknowledgements
19 Materials, Equipment and Machinery
19.1 Choice of Materials for use in a Cleanroom
19.2 Items Supplied from Outside Manufacturing
19.3 Wrapping and Transportation of Materials
19.4 Transfer of Items and Small Pieces of Equipment
through a Materials Transfer Airlock
19.5 Entry of Heavy Machinery and Bulky Items
19.6 Transfer of Materials through Hatches and Sterilisers
Acknowledgement
20 Cleanroom Clothing
20.1 Sources and Routes of Inert Airborne Particle
Dispersion
20.2 Sources and Routes of Airborne Microbial Dispersion
9
20.3 Types of Cleanroom Clothing
20.4 Processing of Cleanroom Garments and Change
Frequency
20.5 The Effect of Laundering and Wear
20.6 Testing of Cleanroom Clothing
20.7 Static-Dissipative Properties of Clothing
Acknowledgements
21 Cleanroom Masks and Gloves
21.1 Cleanroom Masks
21.2 Cleanroom Gloves
Acknowledgements
22 Cleaning a Cleanroom
22.1 Why a Cleanroom must be Cleaned
22.2 Cleaning Methods and the Physics of Cleaning
Surfaces
22.3 Implements Used to Clean Cleanrooms
22.4 Liquids Used in Cleaning Cleanrooms
22.5 How should a Cleanroom be Cleaned?
10
22.6 Cleaning Programme
22.7 Test Methods
Acknowledgements
Index
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Free download Cleanroom Technology Fundamentals of Design, Testing and Operation By William Whyte 2nd Edition
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