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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 20:09:28 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (188 lines)
Nancy I assume that by current acceptable technologies you mean
Distillation or RO. With Hot water system you would not expect a bioburden
so these systems are over monitored.

I do not understand the impulse to implement stricter standards when we are
well served by the existing standards.

On Thu, May 10, 2018, 7:15 PM Nancy Tomoney <[log in to unmask]> wrote:

> Jovan,
>
>
> There should be no Gram Negative Rods in WFI if it produced with current
> acceptable technology for WFI production and if you sampling is properly.
> Hence it is a deviation  and a non-conformance investigation.  Is someone
> using hose to colelct water?  That is come error.
>
>
>
> -----Original Message-----
> From: Jovan Rankov <[log in to unmask]>
> To: PMFLIST <[log in to unmask]>
> Sent: Thu, 10 May 2018 11:08 am
> Subject: [PMFLIST] Are Gram negatives in WFI always a deviation
>
> 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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> The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
> The Microbiology Network (http://microbiologynetwork.com) and supported by
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> 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
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>
> 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
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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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