标 签:工业技术 化学工业 制药化学工业
Chapter 1Pharmacopeia and Regulations1
1.1Classification of Pharmaceutical Water1
1.2Composition of Water System3
1.3Pharmacopeia Standards4
1.4GMP Standards12
1.5Key Water Quality Indexes 15
Chapter 2Design Concept21
2.1Prevention of Microbial Contamination21
2.2Prevention of Particles Contamination26
2.3Quality Influencing Factors28
Chapter 3Unit Operation and Components41
3.1Pressure Vessels41
3.2Centrifuge Pumps57
3.3UV Light 82
3.4Filtration Devices93
3.5Valves116
Chapter 4Generation of Purified Water130
4.1Raw water Quality Indexes132
4.2Raw Water Tanks135
4.3Multi-media Filters135
4.4Activated Carbon Filters136
4.5Softening Unit137
4.6Dosing Unit138
4.7Ultrafilter for Pretreatment141
4.8Nanofilter142
4.9Microfilter142
4.10Degasser142
4.11UV Lamp143
4.12RO Unit 143
4.13EDI Unit 146
Chapter 5Generation of Water for Injection150
5.1Pyrogens151
5.2The Distillation Method155
5.3Purification Process164
Chapter 6Storage and Distribution Systems171
6.1Overview171
6.2Decision Flow Chart182
Chapter 7Pharmaceutical Steam Systems193
7.1Overview193
7.2Regulations and Pharmaceutical Steam196
7.3Pure Steam Systems198
Chapter 8Sanitation and Sterilization Technology204
8.1Overview204
8.2Regulatory Requirements for Sterilization205
8.3Basic Principle of Sterilization208
8.4Sanitation Technology211
8.5Sterilization Technology219
Chapter 9Rouge Formation228
9.1Regulatory Viewpoint228
9.2Rouge Classification230
9.3Metal Corrosion232
9.4Rouge Formation237
9.5The Risk of Rouge247
Chapter 10Derouging Stainless Steel Systems261
10.1Cleaning Technologies261
10.2Rouge Remediation Technologies276
10.3Rouge Remediation Quality Control 298
10.4Rouge Remediation Case Study304
10.5Rouge Prevention 312
10.6On-line Analytical Technologies328
Chapter 11Quality Management 333
11.1Quality Control333
11.2Welding Quality Control345
11.3Passivation Quality Control347
11.4Documentation System364
Chapter 12Automatic Control Technology367
12.1Introduction of Automatic Control Technology367
12.2Sensor Technology377
12.3Automatic Control of Unit Operation399
12.4Good Automated Manufacturing Practice406
Chapter 13Validation 410
13.1Basic Concepts 410
13.2Validation of a Pharmaceutical Water Systems 414
13.3Pharmaceutical Steam System Validation426
13.4Application of Quality Risk Management in Pharmaceutical WaterSystems 429
Bibliography 437
装 帧:精
页 数:437
开 本:大16K精
纸 张:铜版纸