Pharmaceutical Water Systems

Pharmaceutical Water Systems by Meltzer, Theodore H.. hardcover edition. ISBN: 9780927188067.

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.