Cleanroom Technology Fundamentals of Design, Testing and Operation

ISBN-10: 0470748060

ISBN-13: 9780470748060

Edition: 2nd 2010

Authors: William Whyte

List price: $186.95
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Description:

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. Whole text updated, including comprehensive revisions to the Standards and chapter on Non-unidirectional and ancillary cleanrooms This second edition also incorporates a new chapter and new end-of-chapter questions and answers added to aid learning Presents the fundamentals and most up-to-date standards for the design, validation, testing and running of cleanroom systems Provides step-by-step guidance to the design and construction of cleanrooms, appropriate testing methodologies and operation for the minimization of contamination
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Book details

List price: $186.95
Edition: 2nd
Copyright year: 2010
Publisher: John Wiley & Sons, Limited
Publication date: 1/15/2010
Binding: Hardcover
Pages: 384
Size: 6.25" wide x 9.50" long x 1.25" tall
Weight: 1.430
Language: English

About the Author
Preface
Acknowledgements
Introduction
What is a Cleanroom?
The Need for Cleanrooms
Types of Cleanrooms
What is Cleanroom Technology?
The History of Cleanrooms
The Earliest Years
Ventilated Operating Rooms
Early Industrial Cleanrooms
Unidirectional Airflow Cleanrooms
Cleanroom Classification Standards
The History of Standards
The Basis of Cleanroom Standards
Federal Standard 209
ISO Standard 14644-1:1999
Pharmaceutical Cleanroom Classification
Classification of Cleanrooms with Airborne Chemical Contamination
Classification of Cleanrooms with Surface Contamination
Information Sources
The International Confederation of Contamination Control Societies (ICCCS)
The ICEB
International Cleanroom Standards
Cleanroom Books
Recommended Practices and Guides of the Institute of Environmental Sciences and Technology (IEST)
Cleanroom Journals and Magazines
Sources of Pharmaceutical Cleanroom Documents
Training Videos/DVDs
Non-unidirectional Airflow and Ancillary Cleanrooms
Non-unidirectional Airflow Cleanrooms
Ancillary Cleanrooms
Unidirectional Airflow Cleanrooms
Types of Unidirectional Cleanrooms
Vertical Unidirectional Airflow Cleanrooms
Horizontal Unidirectional Airflow Rooms
The Application of Unidirectional Airflow
Separative Clean Air Devices and Containment Zones
Unidirectional Airflow Devices
Mini-environments, Isolators and RABS
Containment Zones
Construction and Clean-build
Constructional Materials and Methods
Outgassing and Electrostatic Properties
Clean-build
High Efficiency Air Filtration
Air Filters Used in Cleanrooms
The Construction of High Efficiency Filters
Particle Removal Mechanisms
Testing of High Efficiency Filters
Scan Testing of High Efficiency Filters
Filter Housings for High Efficiency Filters
Removal of Airborne Chemical Contamination
Cleanroom Testing and Monitoring
Principles of Cleanroom Testing
Cleanroom Tests
Testing in Relation to Room Type and Occupation State
Re-testing to Demonstrate Compliance
Monitoring of Cleanrooms
Measurement of Air Quantities and Pressure Differences
Air Quantities
Differential Pressure Tests
Air Movement Control: Containment, Visualization and Recovery
Cleanroom Containment Leak Testing
Air Movement Control within a Cleanroom
Recovery Test Methods
Recovery Rate Requirement in the EU GGMP
Filter Installation Leak Testing
The Use of Aerosol Test Challenges
Artificial Aerosol Test Challenges
Apparatus for Measuring Aerosol Penetration
Methods of Testing Filters and Filter Housings
Repair of Leaks
Airborne Particle Counts
Airborne Particle Counters
Continuous Monitoring Apparatus for Airborne Particles
Particle Counting in Different Occupancy States
Measurement of Particle Concentrations
Worked Example of ISO 14644-1 Test Method
Microbial Sampling
Microbial Sampling of the Air
Microbial Deposition onto Surfaces
Microbial Surface Sampling
Personnel Sampling
Operating a Cleanroom: Managing the Risk from Contamination
Step 1: Identification of Sources and Routes of Contamination
Step 2: Risk Assessment and the Control of Sources of Contamination
Step 3: Establish an Effective Monitoring Programme
Step 4: Verification and Reappraisal of the System
Step 5: Documentation
Step 6: Staff Training
Cleanroom Disciplines
People Allowed into Cleanrooms
Personal Items Not Allowed into the Cleanroom
Disciplines within the Cleanroom
Maintenance and Service Personnel
Entry and Exit of Personnel
Prior to Arriving at the Cleanroom
Changing into Cleanroom Garments
Exit Changing Procedures
Materials, Equipment and Machinery
Choice of Materials for use in a Cleanroom
Items Supplied from Outside Manufacturing Sources
Wrapping and Transportation of Materials
Transfer of Items and Small Pieces of Equipment through a Materials Transfer Airlock
Entry of Heavy Machinery and Bulky Items
Transfer of Materials through Hatches and Sterilisers
Cleanroom Clothing
Sources and Routes of Inert Airborne Particle Dispersion
Sources and Routes of Airborne Microbial Dispersion
Types of Cleanroom Clothing
Processing of Cleanroom Garments and Change Frequency
The Effect of Laundering and Wear
Testing of Cleanroom Clothing
Static Dissipative Properties of Clothing
Cleanroom Masks and Gloves
Cleanroom Masks
Cleanroom Gloves
Cleaning a Cleanroom
Why a Cleanroom must be Cleaned
Cleaning Methods and the Physics of Cleaning Surfaces
Implements Used to Clean Cleanrooms
Liquids Used in Cleaning Cleanrooms
How Should a Cleanroom be Cleaned?
Cleaning Programme
Test Methods
Index
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