制药用水系统 英文版PDF电子书下载

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