By Dr. Theodore H. Meltzer 1st Printing 1996; ISBN 0-927188-06-6, Hardcover, 865 pages
About the Book
A conjunction of interests on the parts of the United States Pharmacopeial Convention and the Food and Drug Administration, significantly augmented by the Water Quality Committee of the Pharmaceutical Research and Manufacturing Association, has served to heighten interests in the contemporary pharmaceutical water picture. Important changes impend.
This book seeks to make plain the current trends and their implications for future water system designs. It seeks particularly to set forth the rationale for the pending modifications to current approaches. The considerations of pharmaceutical water purification system design are here derived from a non-engineering point of view based on the analyses of unit process operations. The process validation requirements are approached from considerations of the purposes and performances of the several unit operations of which various purification systems are composed. Each unit process utilized in the pharmaceutical water purification system assemblages is detailed separately in its respective chapter, making plain its useful characteristics and its limitations. The regulatory requirements of pharmaceutical water systems are specified, and their attainment, by way of review of actual, existing systems, is made evident. The usefulness of the process validation concept is emphasized.
Contents:
Chapter 1 Pharmaceutical Waters
Chapter 2 Organisms and Their Control
Chapter 3 Ozone and its Applications
Chapter 4 Ultraviolet Radiation and its Application
Chapter 5 Particulate Removal by Filtration
Chapter 6 Specific Impurities: Suspended Matter, Silica, Oxygen, and Organic Substances
Chapter 7 Pretreatment of Waters
Chapter 8 Ion Exchange
Chapter 9 Reverse Osmosis, Ultrafiltration, and Electrically-Driven Demineralizations
Chapter 10 Distillation of Water
Chapter 11 Distribution and Storage, Materials of Construction, and Corrosion
Chapter 12 Pharmaceutical Water Systems
Chapter 13 Validation of the Pharmaceutical Water System
Chapter 14 Postscript
Appendix Glossary, over 600 References, Author's Index, Subject Index
About The Author
Dr. Theodore H. Meltzer is a consultant in flltration and high-purity water primarily to the pharmaceutical and semiconductor industries. His interests center on the technical requirements of marketing applications, on water system critiques and logic, and on validation concerns and practices. He has served as an expert in legal litigations in these fields. He has published some 100 papers, holds four patents, and has authored two books entitled, Filtration in the Pharmaceutical Industry and High- Purity Water Preparation for the Semiconductor, Pharmaceutical and Power Industries. He has authored or coauthored chapters on Ultraviolet and Ozone Systems, Pharmaceutical Water: Generation, Storage and Distribution, Filtrative Sterilization with Microporous Membranes, and The Sizing of Microporous Membrane Systems. Trained as a polymer chemist as well as a filtration specialist, he holds a B.S. in chemistry from the College of the City of New York, an M.A. in preparative organic and biochemistry from the University of Wisconsin, a Ph.D. in physical organic chemistry from the University of Chicago, and has performed postdoctoral work on the mechanical properties of polymers at Princeton University.
