Pharmaceutical Water: System Design, Operation, and Validation, Second Edition

ISBN-13: 9781420077827 / Angielski / Twarda / 2010 / 478 str.

William V. Collentro

Opis

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

Recenzje

"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 
 

Spis treści

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.

O autorze

William V. Collentro