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May 2011

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Subject:
From:
Gurjeet Singh Bedi <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 5 May 2011 09:37:43 +0530
Content-Type:
text/plain
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Particulate count is required if you are doing either aseptic or non sterile process activities in classified area .This is to ensure that classification of your area is intact and meeting all specific requirements of clean area. Advantage of Non viable particulate count is that the analyst get instant result of test and can take action immediately, if out of specifications observed for respective grade rooms. Viable particulate provides trend of bioburden type (microfloa) and load of classified area.
Both these tests can be used as tool during laboratory failure investigations. 


Thx.

Gurjeet Singh Bedi

Head - Microbiology Laboratory

Ranbaxy Laboratories Limited

Email: [log in to unmask]


-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Vishwas Kelkar
Sent: Sunday, 01 May, 2011 19:10
To: [log in to unmask]
Subject: Re: [PMFLIST] Particulate count

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 scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.

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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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Please take a second to visit our sponsors' web sites and say thank you for their support of this service.

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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

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