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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, 29 May 2006 15:25:01 -0400
Content-Type:
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Hi Dale,

	I have another question regarding volume size tested for each media. For an
article that contain less than 1 ml, the USP cited to use the entire content
of the vial. It also stated that if the required volume is not sufficient
for each medium use twice the number of articles indicated in table 3. So to
what I understand is that for a container with less than 1 ml we have to
inoculated the entire content of one vial in TSB (times the amount of sample
to be tested) and the entire content of one vial in FTM (times the amount of
sample to be tested) all in different media container since it is done by
direct inoculation.

So if the contract lab split the entire content of the vial in half and each
half was introduce in each media, the methodology is incorrect.

Example:

Volume per container: 0.7 ml (we have to test the entire content of the
vial)
Batch size: 500 articles (according to table 3 the minimum is 10 articles.
Since volume not sufficient double the quantity must test 20 articles)
Sterility test method use: Direct inoculation

Testing method should be: 0.7 ml in TSB times 10 articles, 0.7 ml in FTM
times 10 articles

Am I rigth?

Thanks

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

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]]On Behalf Of Dale Kelley
Sent: Monday, May 08, 2006 10:42 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Sterility testing


No, you should not reduce the volume below the
required amount (50% of container volume).  The first
approach would be to increase the media volume.  A
warning, once you pass 1 liter of media, you will have
more difficulty with the B&F test.  Your
interpretation of the volume is correct.  Simply put,
you must have a minimum media volume of 10 times your
sample volume.  So, if you have a 20ml sample you need
a minimum of 200ml media.
If you need to perform some evaluation studies to
determine the proper dilution factor, then you could
use lower volumes for that task.  You will still need
to perform the B&F testing at full sample size.

Dale Kelley

--- Benoit Prince <[log in to unmask]>
wrote:

> 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 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.

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