Cleanroom Technology
Fundamentals of Design, Testing and Operation
2. Auflage Januar 2010
384 Seiten, Hardcover
Praktikerbuch
Kurzbeschreibung
This second edition offers a comprehensive overview of the fundamentals, design, testing and operation of cleanroom systems. It provides novices with an introduction to this state-of-the-art technology and professionals with an accessible reference to the current standards.
A self-contained and practical book providing step-by-step guidance to the design and construction of cleanrooms, appropriate testing methodologies, and operation for the minimization of contamination...
This second edition has been comprehensively revised and includes extensive updates to the two chapters that contain information on cleanroom standards and guidelines. The chapter on risk management has been extensively revised, especially the section on risk assessment. Other new subjects that have been added to the various chapters are those on clean-build, determination of air supply volumes for non-unidirectional airflow cleanrooms, RABS (Restricted Access Barrier Systems), contamination recovery test methods, entry of large items into a cleanroom, glove allergy problems, and how to develop a cleanroom cleaning programme.
Used for in-house training and a textbook in colleges, this volume is for cleanroom personnel at all levels. It provides novices with an introduction to the state-of-the-art technology and professionals with an accessible reference to the current practices. It is particularly useful in the semiconductor, pharmaceutical, biotechnology and life sciences industries.
William Whyte is an international authority in cleanrooms, with over 45 years experience in research, teaching and consulting in the electronic, healthcare and pharmaceutical industries. He is a member of British and International standards committees writing the International Cleanroom standards, and has received numerous awards for his work in Cleanroom Technology.
A comment on the first edition:
"...extremely useful and helpful...very well-written, highly organized, easy to understand and follow..." (Environmental Geology, 2003)
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?
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
3 Cleanroom Classification Standards
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
* Classification of Cleanrooms with
Surface Contamination
4 Information Sources
4.1 The ICCCS
4.2 The ICEB
4.3 International Cleanroom Standards
4.4 Cleanroom Books
4.5 Recommended Practices and Guides of the IEST
4.6 Cleanroom Journals and Magazines
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
6 Unidirectional Airflow Cleanrooms
6.1 Types of Unidirectional Cleanrooms
6.2 Vertical Unidirectional Airflow Cleanrooms
6.3 Horizontal Unidirectional Airflow Rooms
6.4 The Application of Unidirectional Airflow
7 Separative Clean Air Devices and Containment Zones
7.1 Unidirectional Airflow Devices
7.2 Mini-environments, Isolators and RABS
7.3 Containment Zones
8 Construction and Clean-build
8.1 Constructional Materials and Methods
8.2 Outgassing and Electrostatic Properties
8.3 Clean-build
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
10 Cleanroom Testing and Monitoring
10.1 Principles of Cleanroom Testing
10.2 Cleanroom Tests
10.3 Testing in Relation to Room Type and
Occupation State
10.4 Re-testing to Demonstrate Compliance
10.5 Monitoring of Cleanrooms
11 Measurement of Air Quantities and Pressure
Differences
11.1 Air Quantities
11.2 Differential Pressure Tests
12 Air Movement Control: Containment, Visualization
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
13 Filter Installation Leak Testing
13.1 The Use of Aerosol Test Challenges
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
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
15 Microbial Sampling
15.1 Microbial Sampling of the Air
15.2 Microbial Deposition onto Surfaces
15.3 Microbial Surface Sampling
15.4 Personnel sampling
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 Sources
of Contamination
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
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.
19 Materials, Equipment and Machinery
19.1 Choice of Materials for use in a Cleanroom
19.2 Items Supplied from Outside Manufacturing Sources
19.3 Wrapping and Transportation of Materials
19.4 Transfer of Items and Small Pieces of Equipment
through a Material Transfer Airlock
19.5 Entry of Heavy Machinery and Bulky Items
19.6 Transfer of Materials through Hatches and Sterilisers
20 Cleanroom Clothing
20.1 Sources and Routes of Inert Airborne Particle Dispersion
20.2 Routes and Sources of Microbial Dispersion
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
21 Cleanroom Masks and Gloves
21.1 Cleanroom Masks
21.2 Cleanroom Gloves
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?
22.6 Cleaning Programme
22.7 Test Methods
Index