ISPE Baseline® Guide: Volume 4 – Water and Steam Systems (Second Edition)

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Published: 15 December 2011
Pages: 264
Table of Contents ( 234 KB)

 

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The Water and Steam Systems (Second Edition) is the only comprehensive guidance of its kind and aims to assist with the design, construction, operation, and maintenance of new water and steam systems that meet current Good Manufacturing Practices (cGMPs) and comply with existing regulations and related guidance.

New chapters covering microbiological considerations, such as biofilm formation, use of sanitizers, sampling, testing, and control levels, as well as the overall impact of microbial considerations on unit operations and finished water have been added.

The Guide also has been reviewed by the US Food and Drug Administration (FDA), and their comments have been taken into consideration in the final version of the Guide.

The Guide was written by a global team of critical utilities experts with a combined experience of more than 500 years. Much of the team responsible for the original Water and Steam Systems Baseline Guide has returned to contribute to the revised Guide, providing continuity and longevity of vision to the Guide’s contents.

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