Friday, 12 April 2013
PDA TECHNICAL LITERATURE CLEANING VALIDATION -SCOPE
The validation programs described herein assume that an overall validation program with appropriate controls is already in place for the facility, utilities, equipment and processes.
The cleaning of theenvironment is not specifically covered, however many of the same concerns that are considered for
the cleaning of process equipment also impact the cleaning of the environment.
The monitoring ofmicrobiological and endotoxin contamination and steps for their elimination are mentioned in several sections and should be part of the cleaning validation program.
However this document is notintended to be a comprehensive treatise on microbiological control, or endotoxin limitation.
Other documents have addressed microbiological programs and methods for the environmental monitoring which can be applied to cleaning.
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