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May 2018

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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 10 May 2018 12:12:28 -0400
Content-Type:
text/plain
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text/plain (149 lines)
Jovan,

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.

Tony

On Thu, May 10, 2018 at 8:39 AM, Jovan Rankov <[log in to unmask]>
wrote:

> 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
>
> Jovan
> QC Microbiologist
>
> ________________________________
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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

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The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and supported by
our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]

Sartorius https://promotions.sartorius.com/real-heroes

Steris - http://www.sterislifesciences.com/

Avista Pharma Solutions  http://www.avistapharma.com

MilliporeSigma  http://www.emdmillipore.com/

Charles River Laboratories - http://www.criver.com/

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

Nelson Labs - http://www.nelsonlabs.com

BD Diagnostic Systems - http://www.bd.com/ds/

Boston Analytical http://www.bostonanalytical.com/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PMF, or the sponsors of the list.

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