ISO 11135 - Change of supplier of ethylene oxide

Hi all,
we have our own little EO sterilizer. We are planning to change the supplier of ethyleenoxide.
Do you see any problem with this change regarding validations?

In ISO 11135 is written that revalidation should be done when there is a modification to the sterilization agent and/or its presentation. This is not our case, we will change only the supplier of EO, concentration of EO will remain the same (10% EO /90%CO2).

Thank you Leona

The new sterilization supplier should already have their intact validations and a periodic forward-looking validations cycle. I am not aware of being exempt from the requirement to validate if you change physical sterilization suppliers. To my understanding you would need to re-validate since you are physically changing the location of the sterilization validation along with the physical space / equipment being used to perform the EO sterilization from now on.

Leona,

In case you are switching to a gas mixture of same or better purity, delivered in gas cylinders of same or better quality with a similar shelf life, this change of sterilant supplier might not require (partial) process re-validation.

Some suppliers offer GC analysis of the actual content of your cylinder - that could further build your case that you did actually not change your sterilant.

Since you are operating your own sterilizer, a single confirmatory sub-lethal or half cycle might also be less of hassle than the back-and-forth with whatever regulator you might have to report your supplier change to.

Hope this helps,

Leona said:

Hi all,
we have our own little EO sterilizer. We are planning to change the supplier of ethyleenoxide.
Do you see any problem with this change regarding validations?

In ISO 11135 is written that revalidation should be done when there is a modification to the sterilization agent and/or its presentation. This is not our case, we will change only the supplier of EO, concentration of EO will remain the same (10% EO /90%CO2).

Thank you Leona

Click to expand...

Thank you very much, you have confirmed my idea