制药用水系统 英文版
作者：张功臣 主编
出版时间： 2017年版
内容简介
《制药用水系统（英文版）》结合多年工程实践经验，对制药用水系统进行了全面、深入的总结。《制药用水系统（英文版）》大量采用实际工程案例和图片，结合ISPE及ASME BPE的理论经验，力求真实、形象、准确地介绍制药用水系统的基本概念和设计思路。本书基于“质量源于设计、预防微生物污染与预防颗粒物污染”的理念，重点介绍了制药用水系统的设计、安装、调试以及验证的基本原理与具体实践。本书还提供了制药用水系统组成材料的质量控制标准，以保证制药用水系统能稳定地为制药生产提供所需的制药用水和纯蒸汽。《制药用水系统（英文版）》适用于制药行业从事研究、设计、生产制药用水系统的技术人员，也可供制药工程相关专业高校师生阅读参考。
目录
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
