Cleanroom Design

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ISBN: 9780471942047 | 0471942049
Cover: Hardcover
Copyright: 5/4/1999

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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.

Contributors

xiii

(2)

Preface

1 An Introduction to the Design of Clean and Containment Areas

(20)

W. Whyte

Introduction

(1)

The History of Cleanrooms

(5)

Cleanrooms

(12)

What is a Cleanroom?

(1)

Classification of Cleanrooms

(1)

Class of Rooms Required by Different Industries

(1)

Types of Clean Areas

(9)

Containment of Contamination

(1)

Containment Rooms and Cabinets

(1)

Supply of Liquid and Gases to Cleanrooms

(1)

Acknowledgements

(1)

Bibliography of the History of Cleanrooms

(1)

2 International Standards for the Design of Cleanrooms

(30)

A. L. Moller

Introduction

(1)

The Cleanroom Standards

(3)

The Naming of Standards, Practices and Technical Orders

(1)

Who Produces Cleanroom Standards?

(1)

International Development of Cleanroom Standards

(2)

Cleanroom Standards--Influencing Standards

(3)

Contaminants and Other Factors to be Considered

(1)

Cleanlines--Particulate Contaminants

(1)

Relationship Between Class and Design Materials

(1)

Cleanrooms and Classified Rooms

(1)

Class Conditions to be Considered When Designing to a Certain Class

(1)

Cleanroom Classes

(9)

The Present Engineering Classes

(6)

The New ISO Classification Standard

(3)

The Biocontamination and Pharmaceutical Classes

(4)

Production of Sterile Pharmaceuticals

(3)

Other Biocontamination Class Standards

(1)

The Containment Classes

(1)

Other Standards for the Cleanroom

(4)

Cleanroom Design Standards

(2)

Isolator and Minienvironment Design

(1)

Recommended Practices (RPs) of the Institute of Environmental Sciences and Technology (IEST), USA

(1)

Standards for Surface Cleanliness

(1)

Cleanroom Standards for Design Purposes, to Select Technical Concepts and Solutions, Materials, Equipment, etc.

(1)

Cleanroom Standards

(2)

Abbreviations/Source Code

(2)

Acknowledgement

(2)

3 The Design of Cleanrooms for the Microelectronics Industry

(28)

J. G. King

Introduction

(1)

Manufacturing Semiconductor Circuits

(4)

Materials

(1)

Wafer Fabrication

(2)

Assembly and Test

(1)

Design Guidelines

(2)

Design Features

(20)

Layout

(8)

Air Flow--Direction

(1)

Air Flow--Quantity

(1)

Airborne Molecular Contamination

(1)

Filter Suspension System

(1)

Recirculation Air Moving System

(2)

Fresh Air System

(1)

Air Return

(2)

Fire Protection

(1)

Walls

(1)

Lighting

(1)

Electrical System

(1)

Monitoring Control and Alarm System

(2)

Remainder of System

(2)

Concluding Remarks

(1)

Acknowledgement

(1)

Reference

(1)

4 The Design of Cleanrooms for the Pharmaceutical Industry

(36)

G. J. Farquharson

W. Whyte

Introduction

(1)

Types of Pharmaceutical Processes

(2)

Injectables

(1)

Topicals

(1)

Oral Products

(1)

Facility Design

(3)

Design Objectives

(1)

Use of Guides and Standards

(1)

Design Methodology

(1)

Cleanroom Suite Layouts

(2)

Environmental Cleanliness

(24)

Contamination Generation and Release

(1)

Ingress Through Defective HEPA Filter Systems

(1)

Contamination Removal in a Room by Displacement or Dilution Ventilation

(3)

Isolator and Barrier Devices

(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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Cleanroom Design

Summary

Author Biography

Table of Contents

Supplemental Materials