导语

  

内容提要

  

    张功臣主编的《制药用水系统(英文版)(精)》为英文版，结合多年工程实践实验，对制药用水系统进行了深入的总结和归纳。
    本书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。
    本书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。

Chapter 1 Pharmacopeia and Regulations
  1.1  Classification of Pharmaceutical Water
  1.2  Composition of Water System
  1.3  Pharmacopeia Standards
  1.4  GMP Standards
  1.5  Key Water Quality Indexes
Chapter 2 Design Concept
  2.1  Prevention of Microbial Contamination
  2.2  Prevention of Particles Contamination
  2.3  Quality Influencing Factors
Chapter 3 Unit Operation and Components
  3.1  Pressure Vessels
  3.2  Centrifuge Pumps
  3.3  UV Light
  3.4  Filtration Devices
  3.5  Valves
Chapter 4 Generation of Purified Water
  4.1  Raw water Quality Indexes
  4.2  Raw Water Tanks
  4.3  Multi-media Filters
  4.4  Activated Carbon Filters
  4.5  Softening Unit
  4.6  Dosing Unit
  4.7  Ultrafilter for Pretreatment
  4.8  Nanofilter
  4.9  Microfilter
  4.10  Degasser
  4.11  UV Lamp
  4.12  RO Unit
  4.13  EDI Unit
Chapter 5 Generation of Water for Injection
  5.1  Pyrogens
  5.2  The Distillation Method
  5.3  Purification Process
Chapter 6 Storage and Distribution Systems
  6.1  Overview
  6.2  Decision Flow Chart
Chapter 7 Pharmaceutical Steam Systems
  7.1  Overview
  7.2  Regulations and Pharmaceutical Steam
  7.3  Pure Steam Systems
Chapter 8 Sanitation and Sterilization Technology
  8.1  Overview
  8.2  Regulatory Requirements for Sterilization
  8.3  Basic Principle of Sterilization
  8.4  Sanitation Technology
  8.5  Sterilization Technology
Chapter 9 Rouge Formation
  9.1  Regulatory Viewpoint
  9.2  Rouge Classification
  9.3  Metal Corrosion
  9.4  Rouge Formation
  9.5  The Risk of Rouge
Chapter 10 Derouging Stainless Steel Systems
  10.1  Cleaning Technologies
  10.2  Rouge Remediation Technologies
  10.3  Rouge Remediation Quality Control
  10.4  Rouge Remediation Case Study
  10.5  Rouge Prevention
  10.6  On-line Analytical Technologies
Chapter 11 Quality Management
  11.1  Quality Control
  11.2  Welding Quality Control
  11.3  Passivation Quality Control
  11.4  Documentation System
Chapter 12 Automatic Control Technology
  12.1  Introduction of Automatic Control Technology
  12.2  Sensor Technology
  12.3  Automatic Control of Unit Operation
  12.4  Good Automated Manufacturing Practice
Chapter 13 Validation
  13.1  Basic Concepts
  13.2  Validation of a Pharmaceutical Water Systems
  13.3  Pharmaceutical Steam System Validation
  13.4  Application of Quality Risk Management in Pharmaceutical Water Systems
Bibliography