Qualification of an Environmental Monitoring Program

Industrial Management Consulting
Industrial Management Consulting


“fvlicrobiology Topics” discusses various topics in microbiology of practical use in validation and compliance.
We intend this column to be a useful resource for dai Iy work applications.
Reader comments, questions, and suggestions a.reneeded to help us fulfi!1 our objective far this column.
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

Download PDF here

Continue at: http://www.microbiol.org/wp-content/uploads/2010/07/sutton.j.val_.tech.16.2.pdf

The text above is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

Also see:


Web Data Extraction
Web Data Extraction

Leave a Reply

Your email address will not be published. Required fields are marked *