January 08 - Article of the month - Monitoring of Aseptic Environments and Processes

GOOD VALIDATION PRACTICE (cGVP) CLEANING VALIDATION
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Many thanks to Dr. M. Shakil S. Siddiqui for this informative article.

Please leave comments and thanks in this thread.

http://www.askaboutvalidation.com/featured_articles_expanded.php?uid=26

Regards

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Great article

Thank you

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Very good information. Thank you Dr Siddiqui for sharing your expertise and experience

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Dear Mr.Shakil,

Its a great article and thanks for the information.

What could be the worst case during environmental monitoring?

Thanking You,

kvkiran

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This article was really informative on monitoring aspects.
At one point ‘How the Air is sampled in a Clean Room’ you have mentioned that ‘Plates are generally exposed for 30- 60 minutes’, but according to EU guideline the exposure time is 4 hours for SPC.

I would very thankful to Dr. Siddiqui if he could furnish any information regarding how to decide alert and action levels. Is there any formula/calculation available ? You can mail me on debjitmukherjee27@gmail.com

Debjit Mukherjee

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Dear Dr.Shakeel
very good information,very useful for all level officers.