2nd Edition
Pharmaceutical Water System Design, Operation, and Validation, Second Edition
A major new work on all aspects of water, the most used raw material ingredient in the pharmaceutical and biotechnology industries—used as an excipient in pharmaceutical formulations, as a cleaning agent, and as a separately packaged product diluent.
Drawing on the author’s extensive field experience with more than 400 pharmaceutical and related water purification systems, the text’s numerous case studies illuminate the best and worst of water system design and operation.
The expanded Second Edition also includes new chapters that discuss:
- passivation and electropolishing
- rouging
- ozone systems and accessories
- USP purified water and water for injection
- individual component process and instrumentation diagram (P&IDs) with control interface
- documentation and specification requirements
- systems installation, start-up, and commissioning
Introduction
Impurities in raw water
Pretreatment techniques
Ion removal techniques—reverse osmosis
Ion removal techniques—ion exchange
Additional ion removal techniques
Distillation and Pure Steam generation
Storage systems and accessories
Ozone systems and accessories
Polishing components
Distribution systems—design, installation, and material selection
Controls and instrumentation
System design and specification guidelines
System installation, start-up, and commissioning
System validation
Biography
William V. Collentro
"This second edition has been significantly revised and updated from the first edition. The author's extensive work experience in this field is reflected throughout the book, which will serve as an excellent reference for anyone involved in manufacturing pharmaceutical waters." - Doody's Review Service
