Cleanroom Routine Environmental Monitoring & Classification
Duration: 30 mins
Routine Environmental Monitoring in GMP cleanrooms is a manual process and is usually complex,
involving thousands of sample data points per month, manual data transcription and all too frequently
data gaps and data integrity challenges.
This webinar discusses the difference between cleanroom
classification and routine environmental monitoring, outlines the FDA 21CFR part 11 ALCOA guidance
and shows how the MET ONE 3400+ non-viable air particle counter from Beckman Coulter can automate
routine environmental monitoring programs to help manage data integrity challenges.
Tony Harrison held the Convenorship of the ISO Working Group revising ISO 14698-1 & -2 for microbial control in
cleanrooms and was the UK subject matter expert to the ISO Working Group who created the current
ISO 14644-1 & -2 documents for cleanroom classification at the heart of the aseptic manufacturing
chapters of both the European GMP and the USA cGMP documents.
Tony was also chief editor of the PHSS Best Practice Guide for Cleanroom Monitoring.
Tony is employed by Beckman Coulter Life Sciences as a Senior Manager.
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