Routine ETO Sterilization

[shimonv]

Hi Everyone,
A question about About Routine ETO Sterilization: how often do you bio-burden and LAL tests? I couldn't find a clear statement in the ISO 11135 standard.

Thanks,
Shimon

 

[planB]

LAL tests are typically done per AAMI ST72:2019, "Bacterial Endotoxins - Test Methods, Routine Monitoring, And Alternatives To Batch Testing"
(essentially transferred to ISO 11737-3:2023), which stipulates batch-wise testing as a default (as already implied by its title) and options to reduce test frequency.

Bioburden: I have seen bioburden monitoring frequencies from batch-wise to quarterly.

ISO 11737-1:2018, Annex A 8.1 offers a little bit of guidance:

A rational choice for the frequency of monitoring should be made, taking into account a variety of factors [...]
Sampling can be performed at a frequency based on time (e.g. monthly, quarterly), or on production volume (e.g.
alternate batches). [...]

HTH,

 

[shimonv]

Thanks @planB ,
And just to be sure, there are no other routine test to maintain sterilization control. Right?

 

[planB]

The minimum release requirements are defined in ISO 11135, section 11.1. However, depending on your specific situation you may have established further (routine) tests, as also pointed out by the note in this section:

11.1 [..]
NOTE Formal release of the load from sterilization could require results from other tests (e.g. EO residuals,
endotoxin, physical testing, etc.) before product can enter the distribution chain.

HTH,