Pharmaceutical Water Systems offers comprehensive and in-depth coverage on the topic, presenting successful system operation examples selected from thousands of real-life systems. The title offers those working in pharma a deeper and more visual understanding of pharmaceutical water systems, promoting the popularization of design, manufacturing and validation through pharmaceutical water systems. The 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, and rouge remediation and prevention, among others.
Thirteen chapters cover pharmacopeia and regulations, design concepts, unit operation and components, generation of purified water, generation of water for injection, storage and distribution systems, pharmaceutical steam systems, sanitation and sterilization technology, rouge formation, derouging stainless steel systems, quality management, automatic control technology, and validation.
- Presents successful system examples that were selected from real-life systems
- Introduces novel technological innovations
- Details how pharmaceutical companies can gain competitive advantages through pharmaceutical water systems
- Offers access to many years of practical experience and real-world examples that are applied to pharmaceutical water systems
- Promotes the popularization of design, manufacturing and validation through pharmaceutical water systems
2. Design Concept
3. Unit Operation and Components
4. Generation of Purified Water
5. Generation of Water for Injection
6. Storage and Distribution System
7. Pharmaceutical Steam System
8. Sanitation and Sterilization Technology
9. Rouge Formation
10. Derouging Stainless Steel Systems
11. Quality Management
12. Automatic Control Technology
Gongchen (Philip) Zhang is a Senior GMP (Good Manufacturing Practice) compliance and engineering design expert, with over 18 years' experience in the pharmaceutical industry. He is Vice General Manager in Liquid and Biopharma Process Systems at AUSTAR Group, and an International Society for Pharmaceutical Engineering (ISPE) Training Lecturer. He is lecturer for 'Water and Steam Systems' offered by the ISPE, as well as an author on the GB50913-2013 Design Specification of Pharmaceutical Process Water Systems. He works largely on design and R&D relating to pharmaceutical clean liquid process systems. He has been involved in numerous key projects and innovations in the industry, including the concept of Water Loop SKID, biopharmaceutical USP/DSP/Preparation processes with batch control systems, intelligent LVP preparation systems, intelligent fat emulsion injection (LVP/SVP) process preparation systems, and intelligent suppository and ointment process preparation systems. He has also contributed to the development of many innovative design concepts, such as WFI systems with superheated water sterilization. Gongchen Zhang graduated from Wuhan Engineering University, and Huazhong University of Science and Technology, China, in pharmaceutical engineering, and chemical and biological engineering.