Aseptic Processing - Maximum SAL using Aseptic Processing for Sterilization

S

Sarah_B

#1
Hi,

I wonder if anyone can help me please, is there a maximum SAL you can claim when using aseptic processing for sterilisation. We sterilise with liquid chemical, (which gives a really good SAL), then aseptically process for further manufacturing. Is there a max we can claim, or is it whatever we can validate. I had heard that we can only claim 10-3?

Thanks very much for your help
Sarah
 
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Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#3
One more quick "Bump". My thanks in advance to anyone who can help with this one.
 

Ajit Basrur

Staff member
Admin
#4
Hi,

I wonder if anyone can help me please, is there a maximum SAL you can claim when using aseptic processing for sterilisation. We sterilise with liquid chemical, (which gives a really good SAL), then aseptically process for further manufacturing. Is there a max we can claim, or is it whatever we can validate. I had heard that we can only claim 10-3?

Thanks very much for your help
Sarah
FDA's stand - Liquid Chemical Sterilization

Although the terms are similar, "liquid chemical sterilization" is different from thermal and gas/vapor/plasma low temperature "sterilization." As explained on this webpage, FDA believes that sterilization with liquid chemical sterilants does not convey the same sterility assurance as sterilization using thermal or gas/vapor/plasma low temperature sterilization methods.

Biological Indicators are not appropriate or required for monitoring liquid chemical sterilization process. They are generally used for monitoring traditional sterilization processes where a SAL 10-6 is achieved. FDA has not cleared any biological indicators for monitoring liquid chemical sterilization process.
 

v9991

Trusted Information Resource
#5
not exactly to the scope of liquid chemical sterilizqtion but general approach and expectations of FDA are more detailed/elaborated here...

A sterility assurance of 10-6 or better should be demonstrated for any terminal sterilization process....
the studies performed using biological indicators (BIs) to demonstrate that the sterilization cycle results in a SAL of 1 x 10-6. The data should be derived from at least 3 consecutive successful sterilization runs that include the use of BIs and cycle parameters that are the same as the production cycle parameters or are sub-process cycle parameters. The microbial efficacy of the sterilization cycle should be demonstrated for the production load size range.
 

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