Cleanroom Design,9780471942047

Cleanroom Design

by
Edition: 2nd
ISBN13: 9780471942047
ISBN10: 0471942049
Format: Hardcover
Pub. Date: 1999-05-04
Publisher(s): WILEY
List Price: $271.60

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Summary

This book has been written by an international body of authors working in a variety of industries including electronics, biotechnology and pharmaceuticals, who discuss the considerations to be taken into account when designing cleanrooms. Three chapters describe how cleanrooms are designed for the principal manufacturing areas of microelectronics, pharmaceutical manufacturing and biotechnology. Other subjects covered are international design standards, the economics of cleanroom design, high efficiency air filtration, materials used in cleanroom construction, and the provision of clean gases and water. A unique feature of this new edition includes the application of cleanroom design technology to a mini environment such as a bench-top.

Author Biography

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.

Table of Contents

Contributors xiii(2)
Preface xv
1 An Introduction to the Design of Clean and Containment Areas
1(20)
W. Whyte
Introduction
1(1)
The History of Cleanrooms
1(5)
Cleanrooms
6(12)
What is a Cleanroom?
6(1)
Classification of Cleanrooms
7(1)
Class of Rooms Required by Different Industries
8(1)
Types of Clean Areas
9(9)
Containment of Contamination
18(1)
Containment Rooms and Cabinets
18(1)
Supply of Liquid and Gases to Cleanrooms
19(1)
Acknowledgements
20(1)
Bibliography of the History of Cleanrooms
20(1)
2 International Standards for the Design of Cleanrooms
21(30)
A. L. Moller
Introduction
21(1)
The Cleanroom Standards
21(3)
The Naming of Standards, Practices and Technical Orders
21(1)
Who Produces Cleanroom Standards?
22(1)
International Development of Cleanroom Standards
22(2)
Cleanroom Standards--Influencing Standards
24(3)
Contaminants and Other Factors to be Considered
24(1)
Cleanlines--Particulate Contaminants
24(1)
Relationship Between Class and Design Materials
25(1)
Cleanrooms and Classified Rooms
25(1)
Class Conditions to be Considered When Designing to a Certain Class
26(1)
Cleanroom Classes
27(9)
The Present Engineering Classes
27(6)
The New ISO Classification Standard
33(3)
The Biocontamination and Pharmaceutical Classes
36(4)
Production of Sterile Pharmaceuticals
36(3)
Other Biocontamination Class Standards
39(1)
The Containment Classes
40(1)
Other Standards for the Cleanroom
41(4)
Cleanroom Design Standards
41(2)
Isolator and Minienvironment Design
43(1)
Recommended Practices (RPs) of the Institute of Environmental Sciences and Technology (IEST), USA
44(1)
Standards for Surface Cleanliness
44(1)
Cleanroom Standards for Design Purposes, to Select Technical Concepts and Solutions, Materials, Equipment, etc.
45(1)
Cleanroom Standards
45(2)
Abbreviations/Source Code
47(2)
Acknowledgement
49(2)
3 The Design of Cleanrooms for the Microelectronics Industry
51(28)
J. G. King
Introduction
51(1)
Manufacturing Semiconductor Circuits
52(4)
Materials
52(1)
Wafer Fabrication
53(2)
Assembly and Test
55(1)
Design Guidelines
56(2)
Design Features
58(20)
Layout
58(8)
Air Flow--Direction
66(1)
Air Flow--Quantity
67(1)
Airborne Molecular Contamination
67(1)
Filter Suspension System
68(1)
Recirculation Air Moving System
68(2)
Fresh Air System
70(1)
Air Return
70(2)
Fire Protection
72(1)
Walls
72(1)
Lighting
73(1)
Electrical System
74(1)
Monitoring Control and Alarm System
74(2)
Remainder of System
76(2)
Concluding Remarks
78(1)
Acknowledgement
78(1)
Reference
78(1)
4 The Design of Cleanrooms for the Pharmaceutical Industry
79(36)
G. J. Farquharson
W. Whyte
Introduction
79(1)
Types of Pharmaceutical Processes
80(2)
Injectables
80(1)
Topicals
81(1)
Oral Products
81(1)
Facility Design
82(3)
Design Objectives
82(1)
Use of Guides and Standards
82(1)
Design Methodology
83(1)
Cleanroom Suite Layouts
83(2)
Environmental Cleanliness
85(24)
Contamination Generation and Release
86(1)
Ingress Through Defective HEPA Filter Systems
86(1)
Contamination Removal in a Room by Displacement or Dilution Ventilation
87(3)
Isolator and Barrier Devices
90(14)
Room Pressurization and Air Movement Control
104(5)
Temperature and Humidity Control
109(1)
Lighting Levels
109(1)
Noise Levels
109(1)
Aesthetic Considerations
110(1)
Construction, Services and Equipment
110(1)
Commissioning and Performance Qualification
111(1)
Commissioning
111(1)
Operational Qualification
111(1)
Concluding Remarks
112(1)
Acknowledgements
113(2)
5 The Design of Cleanrooms for the Medical Device Industry
115(8)
H. H. Schicht
Introduction
115(1)
The Case for Contamination Control
116(1)
Quality System Philosophy
116(1)
Air Cleanliness Requirements
116(2)
Cleanroom Configurations
118(3)
Injection Cannulae
118(1)
Heart Pacemakers
118(3)
Aortic Bioprostheses
121(1)
Concluding Remarks
121(1)
References
121(2)
6 Contamination Control Facilities for the Biotechnology Industry
123(18)
P. J. Tubito
T. J. Latham
Introduction
123(1)
Biotechnology--The Industry
124(1)
Bioprocess Operations
124(6)
Media Preparation
124(1)
Fermentation
125(1)
Recovery and Purification
126(2)
Finishing
128(1)
Utility Services
129(1)
Biocontainment
130(6)
Biocontainment Legislation
130(2)
Primary Containment
132(1)
Secondary Containment
133(2)
Decontamination of Liquid Wastes
135(1)
Biopharmaceutical Manufacturing Facilities
136(3)
Integration of Biocontainment and Product Isolation
137(1)
Fire and Explosion
138(1)
Radioactivity
138(1)
Concluding Remarks
139(2)
7 Cost-Efficiency and Energy-Saving Concepts for Cleanrooms
141(16)
H. H. Schicht
Introduction
141(1)
Minimizing the Air Flow Rate for Optimum Cost-Efficiency
141(1)
Cleanroom Systems: Custom-Made Protection Schemes
142(7)
Spot Protection
143(1)
Linear Protection
144(2)
Area Protection in Extensive Cleanrooms
146(2)
Evaluation
148(1)
Optimization of Energy Consumption in Cleanroom Systems
149(1)
Example of a Fully Integrated Energy Concept
150(1)
Some Semi-Quantitative Cost Indications
151(3)
The Cost Impact of Minienvironments and Isolators
153(1)
Concluding Remarks
154(1)
Acknowledgement
154(1)
References
155(2)
8 High Efficiency Air Filtration
157(26)
S. D. Klocke
W. Whyte
Introduction
157(1)
The Construction of High Efficiency Filters
158(1)
HEPA Filters
159(2)
ULPA Filters
161(1)
Particle Removal Mechanisms
161(4)
The High Efficiency Filter as Straightener
165(1)
The Testing of High Efficiency Filters
165(11)
United States Military-Standard 282 (Mil-Std 282)
165(2)
Sodium Flame Test (Eurovent 4/4 and British Standard 3928)
167(1)
Institute of Environmental Sciences and Technology (IEST) Recommended Practice `Testing ULPA Filters'
168(1)
European Standard (EN 1822)
169(1)
Probe (Scan) Testing of High Efficiency Filters
170(4)
Institute of Environmental Sciences and Technology (IEST) Recommended Practice `HEPA and ULPA Filters'
174(1)
Two-Flow Efficiency Testing and Encapsulation
174(2)
Filter Housings for High Efficiency Filters
176(3)
Admissible Air Leakage Seal
177(1)
Fluid Seal
177(2)
In-service Tests for High Efficiency Filters
179(2)
Filter Standards
181(1)
Acknowledgements
182(1)
9 Construction Materials and Surface Finishes for Cleanrooms
183(20)
E. C. Sirch
Introduction
183(1)
General Considerations
183(1)
Performance Criteria of Construction Materials and Surfaces
184(3)
Functionality
185(1)
Durability
186(1)
Cleanability
186(1)
Maintainability
186(1)
Considerations for Specific Components
187(1)
Examples of Materials and Features of Construction
187(1)
Cleanroom Components for Good Surface Cleanliness and Low Deterioration
188(12)
Floor Systems
188(1)
Wall Systems
189(7)
Door Systems
196(1)
Ceiling Systems
196(4)
Possible Cleanroom Materials and Constructions
200(1)
Measures to be Taken During the Construction and Assembly of Construction
200(2)
Bibliography
202(1)
10 Purification Techniques for Clean Water
203(28)
T. Hodgkiess
Introduction
203(2)
Removal of Dissolved Ions
205(15)
Distillation
206(3)
Reverse Osmosis
209(6)
Ion Exchange
215(5)
Electrodialysis
220(3)
The Basic Process
220(2)
The Electro-deionization or Continuous Deionization Process
222(1)
Removal of Organics
223(2)
Ion Exchange
223(1)
Reverse Osmosis and Nanofiltration
224(1)
Activated Carbon Filters
224(1)
Other Methods
224(1)
Removal of Particulate Matter
225(1)
Filtration Using Sand and Other Particulate Media
225(1)
Cartridge and Microfiltration
225(1)
Ultrafiltration
226(1)
Removal of Bacteria
226(3)
Chemical Dosing
227(1)
Ultraviolet (UV) Irradiation
227(1)
Heating
228(1)
Membranes
228(1)
Concluding Remarks
229(2)
11 The Design of an Ultra-Pure Water System for Use in the Manufacture of Integrated Circuits
231(20)
R. Galbraith
Introduction
231(1)
Impact of Contaminated Water
231(3)
Ionic
232(1)
Non-Ionic
233(1)
Organic
233(1)
Bacteria
233(1)
Dissolved Gases
234(1)
Plant Design
234(17)
Source Waters
234(1)
Pre-Treatment
235(1)
Multi-Media Filter
235(1)
Activated Carbon Filter
235(1)
Organic Trap
236(1)
Chemical Addition
237(1)
Filtration
237(1)
Reverse Osmosis
238(3)
Deaeration/Degassification
241(1)
Demineralization
241(3)
Mixed Bed Units
244(1)
Polishing Mixed Bed
245(1)
Ultraviolet (UV) Systems
246(1)
Organic Reduction Using UV Radiation
247(1)
Final Filtration
247(1)
Polishing Loop
248(2)
Instrumentation
250(1)
12 The Production and Transmission of High Purity Gases for the Semiconductor Industry
251(18)
R. Galbraith
Introduction
251(1)
Use of Bulk Gases
251(1)
Nitrogen
251(1)
Hydrogen
252(1)
Oxygen
252(1)
Argon
252(1)
Impurities in Gases
252(1)
Production and Transport of Nitrogen
253(6)
Quality Requirements
253(1)
Volume
254(1)
Continuity of Supply
254(1)
Nitrogen Generator
254(3)
Nitrogen Purifier
257(2)
Production and Transport of Oxygen
259(1)
Oxygen Purifier
259(1)
Production and Transport of Argon
260(2)
Argon Purifier
260(2)
Production and Transport of Hydrogen
262(2)
Hydrogen Purifier
262(2)
Gas Distribution Systems
264(3)
Stainless Steel
264(3)
Concluding Remarks
267(2)
13 Materials for Services Pipework
269(26)
T. Hodgkiess
Introduction
269(1)
Metallic Pipeline Materials
269(7)
Carbon Steel
269(1)
Copper and Copper Alloys
270(1)
Stainless Steels
271(5)
Other Metallic Materials
276(1)
Polymeric Pipeline Materials
276(7)
General Comments
276(2)
Some Polymeric Pipe Materials
278(5)
Some Aspects of Pipework Design Using Polymers
283(4)
Thermal Expansion Effects
284(1)
Strength/Stiffness Effects
284(1)
Fibre-Reinforced Polymers
285(1)
Some Other Design Aspects
286(1)
Joining Polymers
286(1)
Costs of Pipe Materials
287(1)
Pipework Systems
288(4)
As-Received Water
288(1)
Water Passing Through the Various Stages of Purification
289(1)
Final Product Water
290(1)
Pharmaceutical Systems
291(1)
Microelectronics Industries
291(1)
Acids
292(1)
Gases
292(1)
Concluding Remarks
292(3)
Index 295

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