- 作 者：张功臣主编
- 出 版 社：北京：化学工业出版社
- 出版年份：2017
- ISBN：9787122290946
- 标注页数：442 页
- PDF页数：461 页
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Chapter 1 Pharmacopeia and Regulations 1
1.1 Classification of Pharmaceutical Water 1
1.2 Composition of Water System 3
1.3 Pharmacopeia Standards 4
1.4 GMP Standards 12
1.5 Key Water Quality Indexes 15
Chapter 2 Design Concept 21
2.1 Prevention of Microbial Contamination 21
2.2 Prevention of Particles Contamination 26
2.3 Quality Influencing Factors 28
Chapter 3 Unit Operation and Components 41
3.1 Pressure Vessels 41
3.2 Centrifuge Pumps 57
3.3 UV Light 82
3.4 Filtration Devices 93
3.5 Valves 116
Chapter 4 Generation of Purified Water 130
4.1 Raw water Quality Indexes 132
4.2 Raw Water Tanks 135
4.3 Multi-media Filters 135
4.4 Activated Carbon Filters 136
4.5 Softening Unit 137
4.6 Dosing Unit 138
4.7 Ultrafilter for Pretreatment 141
4.8 Nanofilter 142
4.9 Microfilter 142
4.10 Degasser 142
4.11 UV Lamp 143
4.12 RO Unit 143
4.13 EDI Unit 146
Chapter 5 Generation of Water for Injection 150
5.1 Pyrogens 151
5.2 The Distillation Method 155
5.3 Purification Process 164
Chapter 6 Storage and Distribution Systems 171
6.1 Overview 171
6.2 Decision Flow Chart 182
Chapter 7 Pharmaceutical Steam Systems 193
7.1 Overview 193
7.2 Regulations and Pharmaceutical Steam 196
7.3 Pure Steam Systems 198
Chapter 8 Sanitation and Sterilization Technology 204
8.1 Overview 204
8.2 Regulatory Requirements for Sterilization 205
8.3 Basic Principle of Sterilization 208
8.4 Sanitation Technology 211
8.5 Sterilization Technology 219
Chapter 9 Rouge Formation 228
9.1 Regulatory Viewpoint 228
9.2 Rouge Classification 230
9.3 Metal Corrosion 232
9.4 Rouge Formation 237
9.5 The Risk of Rouge 247
Chapter 10 Derouging Stainless Steel Systems 261
10.1 Cleaning Technologies 261
10.2 Rouge Remediation Technologies 276
10.3 Rouge Remediation Quality Control 298
10.4 Rouge Remediation Case Study 304
10.5 Rouge Prevention 312
10.6 On-line Analytical Technologies 328
Chapter 11 Quality Management 333
11.1 Quality Control 333
11.2 Welding Quality Control 345
11.3 Passivation Quality Control 347
11.4 Documentation System 364
Chapter 12 Automatic Control Technology 367
12.1 Introduction of Automatic Control Technology 367
12.2 Sensor Technology 377
12.3 Automatic Control of Unit Operation 399
12.4 Good Automated Manufacturing Practice 406
Chapter 13 Validation 410
13.1 Basic Concepts 410
13.2 Validation of a Pharmaceutical Water Systems 414
13.3 Pharmaceutical Steam System Validation 426
13.4 Application of Quality Risk Management in Pharmaceutical Water Systems 429
Bibliography 437