Very misguided. A gross lack of microbiological knowledge and judgement on
the part of your management.
If microorganisms are found in a pharmaceutical water system they most
likely be Gram-negative, oxidase-positive bacteria.
The industry standard of not more than 10 cfu/100 mL is extremely
conservative and would eliminate any concerns about endotoxin contamination
and the sterility assurance of sterile filtered drug products.
On Thu, May 10, 2018 at 8:39 AM, Jovan Rankov <[log in to unmask]>
> Dear Forum members,
> In company where I work we have a procedure where we have to rise
> deviation if we recover 1 or more cfu of Gram negative microorganisms in
> WFI. No matter if it is WFI for the batch preparation, equipment washing or
> just sampling point. Gram negative equals deviation.
> It is clear that Gram negatives in the WFI are of great concern because of
> the endotoxins, but is it necessary to always rise deviation if we have
> only 1 cfu of Gram negative, even on rare occasions? We have very good
> results trend.
> Can you please give me some feedback on the expectations?
> Kind regards
> QC Microbiologist
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