Microbiologic Monitoring of Controlled Processes

Authored by: Gregory F. Peters , Marghi R. McKeon

Encyclopedia of Pharmaceutical Science and Technology

Print publication date:  July  2013
Online publication date:  July  2013

Print ISBN: 9781841848198
eBook ISBN: 9781351124874
Adobe ISBN:

10.1081/E-EPT4-v3-44

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Abstract

Microbiologic monitoring of controlled pharmaceutical and medical device manufacturing, and pharmacy compounding processes, is mandated in numerous standards and guidelines(1–3), although procedures, limits, and frequencies are not well defined (4). Because many characteristics of microbiologic sampling limit its value as a monitoring method (5), efforts to detect contamination in controlled environments require carefully developed and executed sampling plans to produce reliable data that confirm the acceptability of operating conditions.

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