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Preface 
Pharmaceutical Water Systems is a practical reference text that will facilitate a comprehensive understanding of pharmaceutical water systems; it provides clear explanations of pharmaceutical technologies, chemical principles, physical chemistry, pharmacopoeia, the Good Manufacturing Practice and relevant scientific theory and engineering technology. This book uses practical examples of unit operation, cleaning technology and microbiology to demonstrate the basic characteristics of pharmaceutical water systems in a comprehensive and vivid manner.
The Good Manufacturing Practice (2010 Revision) was formally issued and implemented in the Chinese mainland on March 1st, 2011. Many advanced design concepts and process analytical technologies are promoted in the pharmaceutical industry. The author published Pharmaceutical Water Systems (First Edition in Chinese) in 2012; it was widely accepted by the industry, and provided a comprehensive theory summary and practical experience insights for pharmaceutical enterprises and institutions of higher education.
After five years, the author edited and compiled Pharmaceutical Water Systems (First Edition in English) using a more comprehensive and in depth approach with successful system operation examples chosen from thousands of actual pharmaceutical water systems. This book introduces new and innovative technological concepts, including WFI generation with the purification method, online microorganism detecting technology, design and practice of WFI systems at normal temperature, residual chlorine removal technology with UV radiation, rouge remediation and prevention, etc. It is expected that this book will help practitioners in the pharmaceutical industry acquire a deeper and more visual understanding of pharmaceutical water systems, and promote the popularization of design, manufacturing and validation ability of pharmaceutical water systems in the industry.
The Pharmaceutical Water Systems has 13 chapters; Chapter 1 to Chapter 3 are mainly covering laws and regulations, design concepts and unit operation; Chapter 4 to Chapter 7 introduce the concept of quality by design as the starting point for a pharmaceutical water systems of high quality, including purified water generation systems, WFI generation systems, storage and distribution systems and pure steam systems; Chapter 8 takes the prevention of microbial contamination as starting port to systematically describe sanitation and sterilization technologies, and make detailed analyses and summaries of various sanitation/sterilization measures; Chapter 9 and Chapter 10 take the prevention of particles contamination as the starting point of a description of the hazards of rouge formation and derouging measures, and propose reasonable suggestions for maintenance of pharmaceutical water systems; Chapter 11 covers the principle of quality control with emphasis on the importance of welding, pickling and passivation; Chapter 12 and Chapter 13 are describing the process analytical technology, commissioning and qualification methods of pharmaceutical water systems from the perspective of automatic control technology and validation.
This book uses a large number of actual engineering cases and photos, and combines that with the theoretical experience of the International Society for Pharmaceutical Engineering (ISPE) and the American Society of Mechanical Engineers Bioprocessing Equipment (ASME BPE) to introduce the basic concepts and design approaches of pharmaceutical water systems in a vivid and accurate manner. This book is based on the concepts of the “quality by design, prevention of microbial contamination and particles contamination” to introduce the rationale of design, installation, commissioning and validation of pharmaceutical water systems. It also provides the readers with the quality control specifications for materials used in a pharmaceutical water systems to ensure it can provide the pharmaceutical water and pure steam required for pharmaceutical production stably.
The author thanks Gordon Farquharson, ISPE senior lecturer, for his support and encouragement. Mr Gordon Farquharson devotes his enthusiasm to the transfer of scientific knowledge of water and steam systems promoting the development of the pharmaceutical industry.At the same time, the compilation of this book has been assisted by Dr Anthony Bevilacqua, head of R&D at Mettler Toledo, he is serving on USP Chemical Analysis Expert Committee and the ISPE Critical Utilities COP Steering Committee, and has made great contributions to the development of pharmacopoeia water. It is expected that this book will not only help the operators involved in the use and maintenance of pharmaceutical water, but also meet the requirements of in-depth understanding of pharmaceutical water systems by technicians who work on the design, installation, commissioning, validation and management of pharmaceutical water systems.
This book is authored by Gongchen Zhang. Relevant regulatory authorities, biopharmaceutical enterprises, institutes of higher education, engineering consulting companies and brand suppliers participated in the writing and proofreading of this book. All participant units and authors have exerted great efforts to the compilation of Pharmaceutical Water Systems. The author thanks the following writers and entities who have participated in the compilation of this book.
Chapter 1 Pharmacopoeia and Regulations
Gordon Farquharson ISPE Germany
Mars Ho ISPE China
Anthony Charles Bevilacqua Mettler Toledo USA
Yu Dechao Innovent USA
Chapter 2 Design Concept
Harry Jost Neumo Germany
Long Zhaozhong Haoxin China
Li li CNBG China
Wilfried Kappel Kappel Consult Germany
Gao Qiang AustarPharma USA
Chapter 3 Unit Operation and Components
Heiko Maehnert KPA Germany
Shen Yanmin Grundfos Denmar
Mareike Monninger Gemu Germany
Chen Yankun Nerve China
Chapter 4 Generation of Purified Water
Xu Jingfeng Ionpure USA
Wang Xujian Rocksensor Switzerland
Wang Tao Hanovia UK
Chapter 5 Generation of Water for Injection
Timo Heino Finn Aqua Finland
George Gsell Meco USA
Shi Tao Pall USA
Ren Hongyu Aqua Chem USA
Chapter 6 Storage and Distribution Systems
John M. Hyde Hyde Engineering+Consulting USA
Per Ake Olsson Alfalaval Sweden
Li Xiaotian Austar China
Chapter 7 Pharmaceutical Steam System
Timo Heino Finn Aqua Finland
Matt Feldman Yula USA
Gao Xiaoliang Glparma China
Chapter 8 Sanitation and Sterilization Technology
Morven McAlister Pall USA
Huang Kaixun Huazhong University of Science and Technology China
Zhang Heng Wuhan Institute of Technology China
Chapter 9 Rouge Formation
Paul Lopolito Steris USA
Sun Yongjie Austar China
Luo Xiaoyan East China University of science and technology China
Chapter 10 Derouging Stainless Steel Systems
Nissan Cohen Rohrback Cosasco Systems USA
Liu Chao Buchang Pharma China
Wu Guangzhao Austar China
Chapter 11 Quality Management
Yin Xuelin ISPE China
Zhang Ping ISPE China
Zhang Jinwei Olive association China
Wang xuefeng Science Sun Pharma. China
Chapter 12 Automatic Control Technology
Karl Scholz Rocksensor Switzerland
Marc Klingler Burkert Germany
Chen Yuewu Austar China
Chapter 13 Validation
Christian Bachofen CB consultancy Switzerland
Ma Yiling Austar China
Jia Xiaoyan Austar China
This book is translated by professional translation team. All participant translators have exerted great efforts to the compilation of Pharmaceutical Water Systems. The author thanks the following translators who have participated in the compilation of this book.
Professional translation team
Dumitru Cristescu Bogdan Education institutions Romania
Zhang Yajie Olive association China
Zhang Jianli Austar China
Chen Lijuan Austar China
Yang Yalan Austar China
Wang Ruiqing Austar China
This book is of particular relevance to technicians who are engaged in researching, designing and manufacturing clean stainless steel fluid process systems, as well as the technical, production and engineering maintenance personnel from the pharmaceutical, chemical, daily chemicals manufacturing and semiconductor industry. At the same time, it can be used as reference material for majors related to materials chemistry, metal anticorrosion, pharmaceutical engineering, pharmaceutical preparation, bioengineering, etc. in institutes of higher education. Due to the limitation of knowledge level of the author and urgent time, the inappropriateness and error may exist in the book. The author will appreciate comments and suggestions from the readers regarding this book. 

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 Water Systems 429

Bibliography 437

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张功臣，从事GMP合规性及工程设计咨询多年，毕业于武汉工程大学制药工程专业及华中科技大学生物化学与生物专业。拥有18年的制药行业实践经验与多项制药工业领域专利。主要从事制药行业洁净流体工艺系统（制药用水系统、制药工艺配液系统、CIP/SIP系统）的设计与研发工作，国际制药工程协会（ISPE）“水与蒸汽系统”课程特约讲师；中国较早的流体工艺系统模块化设计理念推广者，中国较早研发并实践批处理控制（Batch）的生物原液工艺配料系统、智能型大输液工艺配料系统、智能型脂肪乳注射剂工艺配料系统、智能型栓剂与膏剂工艺配制系统、注射用水过热水灭菌、热储存/旁路常温循环的注射用水系统、科学除锈与钝化、纯化法制备高纯水或注射用水、水电解臭氧消毒的应用与subloop冷用点降温模块化等诸多创新设计理念。