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May 2006

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Subject:
From:
Ravi Talluri <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 5 May 2006 08:26:52 -0500
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If you reduce number of samples tested then you are not following USP. I think you should find other ways as dilution, neutralizers etc. to test your product. Since your product is liquid you should try filtering. 


Ravi Talluri
Sr. Scientist, Microbiology
PPD Inc. 8551 Research Way
Middleton, WI 53562-3581
 
Phone: 608-203-4393
Fax: 608-827-8807
 

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List [mailto:[log in to unmask]] On Behalf Of Benoit Prince
Sent: Wednesday, May 03, 2006 2:19 PM
To: [log in to unmask]
Subject: [PMFLIST] Sterility testing

Hi All,

    We are a medical devices company. Our products are liquid medical devices that need to be sterile and are produce under aseptic process operations. According to USP the volume per container that must be tested for articles containing a volume of liquid between 1-40 ml must be half of the content but not less than 1 ml from each container tested. The product as antimicrobial properties. Is it OK to reduce the quantity of sample tested to increase the dilution ratio? Or we should increase the media volume? We did not try neutralizing agents yet since the product as natural antimicrobial properties.

Thanks
Benoit Prince
Microbiologiste
Biosyntech Canada Inc.
475 Boul. Armand-Frappier
Laval, Québec H7V 4B3
Tel: (450) 686-2437 ext: 304
Fax: (450) 686-8952
E-mail: [log in to unmask]


Web: www.biosyntech.com





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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.

Accugenix - http://www.accugenix.com

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

ATS Laboratories - http://www.ats-labs.com

Biolog - http://www.biolog.com

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

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Millipore - http://www.millipore.com

Pall - http://www.pall.com

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

Raven Biological Labs - http://www.ravenlabs.com

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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