Environmental Monitoring for Biopharmaceutical Manufacturing of Bulk Drug Substances

B

Bad Habit

#1
Hello all,
I am working to qualify a new suite to ISO 14644 standards (in accordance to the white paper changes). In addition to the particulate monitoring, I am adding viable surface and air samples. My plan is to pair every ISO Site requirement in a room with both a viable surface and air site. I will qualify the area at rest (static) for three days than perform dynamic testing for five days. Following incubation and analyzing the results for of the dynamic samples, I hope to reduce the number of sites using a risk based approach. I want to know if anyone else has thought of this. The suit is large and has ISO 5, 7, and 8 locations. The ISO 5 environments will remain as they are, but the 7 and 8 I would like to reduce. Its imperative that I have the ability to reduce the number of sites following qualification, in order to create a sustainable monitoring program. Any thoughts on this are welcomed.

Kind Regards,
Bad Habit
 
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#2
Re: Environmental Monitoring for Biopharmaceutical Manufacturing of Bulk Drug Substan

A Quick Bump!

Can someone help?

Thank you very much!!
 
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