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November 2019


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ganesh chaudhari <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Fri, 8 Nov 2019 09:16:39 +0530
text/plain (44 lines)
Dear members,

I have query regarding alert and action limit of purified water.
If facility is having 3 tier limit system e.g. Alert level: 70 cfu/300 mL
and Action level:100 cfu/mL, specification limit:100 cfu/mL.
During annual trend data review if alert limit found to be 15 cfu/300 mL
and action. 33 cfu/300 mL as per 2 sigma and 3 sigma calculation, whether
we need to change the limit or we can keep the same limit by giving
rationale that purified water is having stringent limit hence existing
limit will be considered for purified water.


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