Qualification of an Environmental Monitoring Program

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“fvlicrobiology Topics” discusses various topics in microbiology of practical use in validation and compliance.
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KEY POINTS
The following key points are discussed in this article:
• The number ofsites to be used in qualifying clean rooms for non-viable particulate measurements
can be found in International Organization for Standardization (ISO) 14644-1. However, there
are no recognized standards for determination of this number for viable air (passive and active) nor
for surface monitoring. A method is suggested in this article

• Recommendations for the selection ofsample sites to be used in the qualification program are provided. These recommendations are directed at providing data to allowcreation of a program useful in determination ofthe state ofcontrol ofthe facility

• The frequency ofsampling during a qualification study ofthis type should minimally be at least the
rate ofthe eventual routine monitoring program for each area

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