Re-validation of EtO sterilization after change of tape

Kees Fremerij

Starting to get Involved
Íf a change in the secondairy packaging occurs, does the EtO sterilization process need to be revalidated? The change is that paper tape for closing the outer box will be used instead of plastic tape. However more tape will be used, also on the box corners. Paper is more penetratable I would say. Not relevant minor change? Thanks in advance!


Super Moderator

sure you have to re-validate your EtO sterilization process - the question is whether you can do this exercise by performing a documented adoption analysis or whether you have to do experimental work to demonstrate continued safety and effectiveness of your sterilization process.

Essentially you would have to answer: does the replacement tape create a greater challenge to the sterilization cycle in lethality and/or residuals?

To this end, you may walk through AAMI TIR28:2009, Product adoption and process equivalence for ethylene oxide sterilization, and specifically through the questions listed in Annex A, where it says "If the answer to any of the following questions is “yes,” further evaluation to include product qualification studies of the candidate product might be required".

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