Microbial Count


I wish to know whether we do microbial count for clean rooms in R&D facility of Solid dosage forms.


Dear Anil,
I think, We need to see that R&D facility is classified/unclassfied. If it is in classified then yes, we have to monitor the bioburden. But, most of the time the R&D areas are nonclassified, so bioburden monitoring is not a issue.
Eager to see other’s comments too.

I agree with prashant.chawla.
One must start at the beginning…Was the R&D Facility classified or unclassfied? If unclassified, then no problem, but if classified, then you would have to check and plan what level of testing is required due to the Class/Grade of classification.

Hope that this is of some help.