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May 2011

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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 5 May 2011 09:50:41 +0530
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The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
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From:
Vivek Bharambe <[log in to unmask]>
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Dear Hannah Chen,

Particulate testing is also performed if your area modification done OR any
civil work is carried out for some or the other purpose.
It is required for clean room, where the aseptic process is performed. and
also for non-sterile facility areas where your critical processes are
carried out without LAF.

And frequency is as said by Mr. Vishwas K. is the general practice in our
field.

Regards,
Vivek Bharambe
CQA - Maneesh Pharmaceuticals Ltd.
Mumbai
On Sun, May 1, 2011 at 7:10 PM, Vishwas Kelkar <[log in to unmask]> wrote:

> You are right,
> As per GMP requirements, particulate testing to be performed during PQ-room
> qualification and after that counts to be verified periodically to generate
> base line trend. You can decide frequency based on your critically of
> operation such as product contact or non product contact activites performed
> in clean room. Generally industry frequancy is bi-annually for Grade-D rooms
> and quaterly for Grade-C rooms.
>
> ________________________________________
> From: The Pharmaceutical Microbiology Forum Email List [
> [log in to unmask]] on behalf of Chen, Hannah [
> [log in to unmask]]
> Sent: Wednesday, April 27, 2011 1:40 PM
> To: [log in to unmask]
> Subject: [PMFLIST] Particulate count
>
> Dear Forum Members,
>
>
>
> Could any one explain when particulate count testing is required? For my
> understanding, it is only required for clean room, where the aseptic
> process is performed. Not for non-sterile facility.
>
>
>
> Any comments will be appreciated.
>
>
>
>
>
>  Hannah Chen
>
>   Microbiologist
>
>   WellSpring Pharmaceutical Canada Corp.
>
>   400 Iroquios Shore Road
>
>   Oakville, Ontario L6H 1M5
>
>   Phone: 905-337-4500 ext.4023
>
>   Fax: 905-337-3539
>
>   Email: [log in to unmask]
>
>
>
>
>
>
>
>
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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<http://www.biotestusa.com/micro>
>
> MicroBioLogics, Inc. - http://www.microbiologics.com
>
> Millipore - http://www.millipore.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.
>

------------------
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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