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From:
Victor Mencarelli <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 26 May 2006 12:39:41 -0400
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Benoit,

Basic statistics says that no less than a 1% volume (10 ml in this case) 
should be tested if you plan to claim representative.  If I were to look 
at it, I would probably recommend between 30-35 ml be tested as this would 
represent approximately the square root of the volume to be put through 
the process.  However, I can see a reasonable argument for 1% (or the 10 
ml originally stated here).

Vic Mencarelli
Regulatory Affairs Specialist
Engelhard Corp.
50 Health Sciences Dr.
Stony Brook, NY 11790
P: 631-380-2482
F: 631-689-6880
E-mail: [log in to unmask]

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Benoit Prince <[log in to unmask]> 
Sent by: The Pharmaceutical Microbiology Forum Email List 
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05/26/2006 11:44 AM
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Subject
[PMFLIST] Bioburden Testing for solution prior to sterilization






Hi all Forum Members,

    I am developping a validation protocol to validated the microbial
recovery of solutions tested for Bioburden prior to sterilization. The
product has big antimicrobal properties and that why we need to validated
the method of bioburden to demonstrate that when we test the product, 
these
properties are neutralized.The product is place in bulk in the autoclave 
(a
1 liter volume). This quantity must be tested prior to sterilization to
determine the Bioburden. This will serve us to confirm if the 
sterilization
process is long enough to kill all bacteria that are present in the 
product.
My question is for a 1 liter voume what should be the tested volume of 
that
solution.

The contract lab that wanted to develop the method for us was taking 1 ml
from the sample. This represent 0.1% of the total volume of the bulk
package. I think this is not very representative of the quantity 
sterilized.
Is there documentation that I can present to my collegues to show them 
that
1 ml is not enough ( at my eyes) or is there documentation that can 
confirm
that this is enough?

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]

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.

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