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制药用水系统 英文版【2025|PDF下载-Epub版本|mobi电子书|kindle百度云盘下载】

制药用水系统 英文版
  • 张功臣主编 著
  • 出版社： 北京：化学工业出版社
  • ISBN：9787122290946
  • 出版时间：2017
  • 标注页数：442页
  • 文件大小：92MB
  • 文件页数：461页
  • 主题词：制药厂－工业用水－给水系统－英文

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图书目录

Chapter 1 Pharmacopeia and Regulations1

1.1 Classification of Pharmaceutical Water1

1.2 Composition of Water System3

1.3 Pharmacopeia Standards4

1.4 GMP Standards12

1.5 Key Water Quality Indexes15

Chapter 2 Design Concept21

2.1 Prevention of Microbial Contamination21

2.2 Prevention of Particles Contamination26

2.3 Quality Influencing Factors28

Chapter 3 Unit Operation and Components41

3.1 Pressure Vessels41

3.2 Centrifuge Pumps57

3.3 UV Light82

3.4 Filtration Devices93

3.5 Valves116

Chapter 4 Generation of Purified Water130

4.1 Raw water Quality Indexes132

4.2 Raw Water Tanks135

4.3 Multi-media Filters135

4.4 Activated Carbon Filters136

4.5 Softening Unit137

4.6 Dosing Unit138

4.7 Ultrafilter for Pretreatment141

4.8 Nanofilter142

4.9 Microfilter142

4.10 Degasser142

4.11 UV Lamp143

4.12 RO Unit143

4.13 EDI Unit146

Chapter 5 Generation of Water for Injection150

5.1 Pyrogens151

5.2 The Distillation Method155

5.3 Purification Process164

Chapter 6 Storage and Distribution Systems171

6.1 Overview171

6.2 Decision Flow Chart182

Chapter 7 Pharmaceutical Steam Systems193

7.1 Overview193

7.2 Regulations and Pharmaceutical Steam196

7.3 Pure Steam Systems198

Chapter 8 Sanitation and Sterilization Technology204

8.1 Overview204

8.2 Regulatory Requirements for Sterilization205

8.3 Basic Principle of Sterilization208

8.4 Sanitation Technology211

8.5 Sterilization Technology219

Chapter 9 Rouge Formation228

9.1 Regulatory Viewpoint228

9.2 Rouge Classification230

9.3 Metal Corrosion232

9.4 Rouge Formation237

9.5 The Risk of Rouge247

Chapter 10 Derouging Stainless Steel Systems261

10.1 Cleaning Technologies261

10.2 Rouge Remediation Technologies276

10.3 Rouge Remediation Quality Control298

10.4 Rouge Remediation Case Study304

10.5 Rouge Prevention312

10.6 On-line Analytical Technologies328

Chapter 11 Quality Management333

11.1 Quality Control333

11.2 Welding Quality Control345

11.3 Passivation Quality Control347

11.4 Documentation System364

Chapter 12 Automatic Control Technology367

12.1 Introduction of Automatic Control Technology367

12.2 Sensor Technology377

12.3 Automatic Control of Unit Operation399

12.4 Good Automated Manufacturing Practice406

Chapter 13 Validation410

13.1 Basic Concepts410

13.2 Validation of a Pharmaceutical Water Systems414

13.3 Pharmaceutical Steam System Validation426

13.4 Application of Quality Risk Management in Pharmaceutical Water Systems429

Bibliography437

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