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May 2006


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Benoit Prince <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Fri, 26 May 2006 11:44:52 -0400
text/plain (79 lines)
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

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?

Benoit Prince
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]


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