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February 2016


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Uday Bhatambarekar <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Thu, 25 Feb 2016 07:48:03 +0530
text/plain (44 lines)
I would like to know what the general consensus is on identifyiing ithe
isolates from feed water. Our specification calls for only absence of
coliforms. Our internal SOP has an action limit of 500 cfu/ml and an
alert limit of 200 cfu/ml.  We do identification
quarterly.  I want to drop the identfication completely from this drop.
We do test other drops such as after carbon filter, water softener,
after RO membrane unit,  after 0.2 micron filter and use points.
Identification on use points are done as isolated.  On process points we
were doing monthly but we want to cut it down to only when it exceeds
alert limit. I do not see any value in identifying colonies from the
feed. We have only non sterile solid oral dosage forms.

Uday Bhatambarekar

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