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May 2011

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Subject:
From:
Vishwas Kelkar <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Sun, 1 May 2011 13:40:02 +0000
Content-Type:
text/plain
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text/plain (124 lines)
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

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

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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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