Switching Master Product in EO (Ethylene Oxide)

[dojla]

Hello everyone,

Ok, so I have got little problem that I can't seem to find the solution for.

We have a validated sterilization process where the master product does no longer exist (out of production since a long time..) and we would like to identify a new such master product. We have a good candidate product that we can use.

The current validated uses a PCD which is shown to be more challenging than the old master product, and all current products are adopted into this process.

We use an extreme over-kill cycle for EO but during audits we sometimes get questions about the master product that we do no longer have.

So the question is, can we, without full re-validation, switch the master product to our new candidate. If yes, what steps should we do?

We have the data for the selection of the PCD, if we can show that the new master product is equivalent or easier than the old master product to sterilize, would this fact suffice to make the switch?

Any help here would be highly appreciated!

 

[MIREGMGR]

(out of production since a long time..)

I'm surprised that your Notified Body didn't red-flag this no later than when your first periodic re-validation after discontinuance of that product was due.

My take would be that your periodic re-validations since then would be at least questionable, and therefore you might reasonably be expected to do a new full validation.

 

[planB]

Dojla,

refer to ISO 11135:2014, section D.7.1.6

"A means of demonstrating equivalence to a previously qualified product or internal PCD is the comparison of the relative rates of inactivation of BIs placed in a challenge location within the new or modified product and previously qualified product/master product(see D.8.6 and D.12.5.2) when both are exposed to a fractional cycle. Equivalence studies should compare the new or modified product to the internal PCD used to validate the process. If a PCD is used for this comparison, this resistance of the PCD should be assessed as part of the annual review."

So you are on the right track with
> We have the data for the selection of the PCD, if we can show that the new master product is equivalent or easier than the old master product to sterilize, would this fact suffice to make the switch?

This can be done experimentally via fractional-cycle studies or you may also be able to demonstrate equivalency/no-greater challenge by following ISO 11135:2014, section D.7.1 and /or by making use of the framework provided by AAMI TIR 28:2009, Product adoption and process equivalence for ethylene oxide sterilization.

Also note that you do not have to define an actual product being your master product, but you can also define a simulated product or even your PCD being the master.

HTH,

Gerhard

 

[dojla]

Gerhard,

Thanks for you comments! I will proceed with this strategy.

 

[big boss]

ear all
i have a question, as per the iso 11135:2014 in OQ part
1- do we need to run humidity mapping ?? as in this phrase in standard it refer to table C1 which releate to number of data logger for temp only , also is it make sense as humidity injected to be 60 % as an example so in empty chamber this not supposed to be decreased or increased !!! so can any one help to clarify this point
2- also i need to understand (( In empty chamber OQ exercises, the recorded temperature range, within the usable chamber volume during EO or inert gas exposure, of ± 3 °C of the average recorded chamber temperature at each time point should be obtained after an equilibration period)) as this not clear for me

 

[planB]

Please refrain from cross-posting. Response provided here.