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May 2011

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Subject:
From:
Vivek Bharambe <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Sat, 7 May 2011 09:40:33 +0530
Content-Type:
text/plain
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text/plain (174 lines)
Dear Forum,

As Knutsen commented "if you are flushing 20 liters of water before
sampling, then the production personnel should also be flushing 20 liters
before they use the water" is absolutely accepted and followed by the most
of the Pharma companies.

Measurement of the water volume, that you are flushing shall be based on
the speed of flow of water through the system i.e. in Lit/min Hence it
should be ultimately based on fixing the approximate time.

However the quantity of the water to be flushed shall be validated and
reverified periodically which is depend upon the loop length and design of
the system in your facility.

Regards,
Vivek Bharambe
CQA - Maneesh Pharmaceuticals Ltd.
Mumbai

On Fri, May 6, 2011 at 7:33 PM, Knutsen, Chris <[log in to unmask]>wrote:

> In a properly designed system, you should not have stagnant water.  The
> flush is often times performed to clear the sample port on the downstream
> side of the valve. However, if you are flushing 20 liters of water before
> sampling, then the production personnel should also be flushing 20 liters
> before they use the water. Also, I am curious, do you measure the water
> volume that you are flushing, or do you flush by a certain time.
>
> Chris Knutsen, Ph.D.
> Associate Director, Microbiology
> ABD
> Bristol-Myers Squibb Company
> 1 Squibb Drive
> New Brunswick, NJ 08902
> Tel : +1-732-227-5375
> Fax: +1-732-227-3071
> e-mail: [log in to unmask]
> 7asdf
>
> >-----Original Message-----
> >From: The Pharmaceutical Microbiology Forum Email List
> >[mailto:[log in to unmask]] On Behalf Of hemant korade
> >Sent: Thursday, May 05, 2011 12:43 PM
> >To: [log in to unmask]
> >Subject: [PMFLIST] Volume of Water sampling
>  >
> >Hi sergio
> >Acording to my knowledge it done to remove stagnant water from the
> >sampling
> >point & volume to drain is based on your drain validation.
> >
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> Please take a second to visit our sponsors' web sites and say thank you for
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> Accugenix - http://www.accugenix.com
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> American Type Culture Collection - http://www.atcc.org
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> BD Diagnostic Systems - http://www.bd.com/ds/
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> Biolog - http://www.biolog.com
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> Biomerieux - http://industry.biomerieux-usa.com
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> Biotest - http://www.BiotestUSA.com/micro<http://www.biotestusa.com/micro>
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> MicroBioLogics, Inc. - http://www.microbiologics.com
>
> MODA Technology Partners: now a LONZA company http://lonza.com/moda
>
> Pall - http://www.pall.com
>
> NovaTek International - http://www.ntint.com
>
> Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)
>
> Veltek Associates, Inc - http://www.sterile.com
>
> =================================
> 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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------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) 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.

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

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

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

Biotest - http://www.BiotestUSA.com/micro

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

MODA Technology Partners: now a LONZA company http://lonza.com/moda

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

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

=================================
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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