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May 2006

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Subject:
From:
Benoit Prince <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 8 May 2006 08:26:01 -0400
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Hi,

	I will not reduce the number of sample but want to reduce the quantity
taken from each sample to reduce the dilution ratio. Is it OK? What is the
maximum volume of media that can be taken for direct inoculating method. The
sentence is not clear in the USP "the volume of the product is not more than
10% of the volume of the medium". For me it means that the volume of sample
must not be higher than 10% of the volume of media. So if I inoculated 1 ml
the media volume must be higher than 10ml. Am I right?

Thanks for your help.

Benoit Prince
Microbiologiste
Biosyntech Canada Inc.
475 Boul. Armand-Frappier
Laval, Québec H7V 4B3
Tel: (450) 686-2437 ext: 222
Fax: (450) 686-8952
E-mail: [log in to unmask] <mailto:[log in to unmask]>

Web: www.biosyntech.com

 <http://www.biosyntech.com/en>






-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]]On Behalf Of Ravi Talluri
Sent: Friday, May 05, 2006 9:27 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Sterility testing


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

Dupont Qualicon - http://www.qualicon.com

EMD Chemicals - http://www.emdchemicals.com

EMSL Analytical, Inc. - http://www.emsl.com

Genomic Profiling Systems, Inc. - http://www.genprosys.com

MIDI, Inc. - http://www.midi-inc.com

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

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

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

Biolog - http://www.biolog.com

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

Dupont Qualicon - http://www.qualicon.com

EMD Chemicals - http://www.emdchemicals.com

EMSL Analytical, Inc. - http://www.emsl.com

Genomic Profiling Systems, Inc. - http://www.genprosys.com

MIDI, Inc. - http://www.midi-inc.com

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

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