Routine Bioburden Monitoring

[Balachander]

Hi,

We have both Gamma and ETO Sterilized products. Wanted to know if we need to select one product each quarter for both ETO and Gamma sterilized products or we can pick one from either Gamma or ETO product to perform quarterly monitoring.

Thanks,
Bala

 

[planB]

Bala,

in case your gamma and EO sterilized products represent each other in terms of bioburden and factors having an impact on bioburden, you could theoretically do so. You may want to keep in mind, that validation of irradiation sterilization typically follows a bioburden-based approach (e.g. VDmax25), while EO sterilization predominantly follows a BI half-cycle overkill approach. Thus, the level of required bioburden control might be different, depending on your sterilization modality.

HTH,

 

[Balachander]

Thanks for the info.

So ideally you want quarterly bioburden done for both ETO and Gamma sterilized products separately right?

 

[indubioush]

Bioburden should be done for each product. You can't extrapolate bioburden results from one product to another product.

 

[planB]

Bioburden should be done for each product. You can't extrapolate bioburden results from one product to another product.

ISO 11737-1:2018 allows definition of bioburden families - quote:

5.1.2 If product(s) are grouped in a product family for the purpose of the determination of bioburden, the rationale for inclusion of a product within a product family shall be recorded. The rationale shall include criteria to ensure that bioburden determined for a product selected from the product family is representative for the whole product family

 

[indubioush]

ISO 11737-1:2018 allows definition of bioburden families - quote:

Ah, yes. Thanks for bringing this up. I was making the assumption that the two products are completely different because they have different sterilization methods, but this may not be the case. Perhaps the OP can fill us in on whether these are products within the same family.