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Subject:
From:
Cui Qiang <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 26 May 2006 13:38:58 -0400
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text/plain
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Benoit. Prince,

I think it depends on the limit of Bioburden, which is used to measure if
 
the sterilization cycle is enough or not to achieve the set SAL. If the 

limit is very strict, the sample volume for bioburden prior to 
sterilization should be more than 1 ml, probably more than 100ml is 
suitable. Therefore, the data from bioburden test can have practical 
meaning.




On Fri, 26 May 2006 11:44:52 -0400, Benoit Prince 
<[log in to unmask]> wrote:

>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 validate
d
>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 m
l
>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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