Learnaboutgmp Community

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

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

Great article

Thank you

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

Dear Mr.Shakil,

Its a great article and thanks for the information.

What could be the worst case during environmental monitoring?

Thanking You,

kvkiran

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

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