Re-Sterilizing a Device which requires Re-Opening and Repair


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Hi Fellows,

-There is this product that is packaged in a blister and sterilized in EtO.
-The current version is an adaptation of the previous version (the did not repeat the validation).
-The previous version was validated, and that included multiple cycles of sterilizations.

A functional problem was identified with the current version which requires re-opening and repair.

1. Does the standards provide guidance on such circumstances?
2. I can think of two challenges: the effect on material and residual EtO levels after a second sterilization. The material is the same a as the previous model. Would it be sufficient to write a rationale based on similarities, and if so what are the key points to address?

One last note: this product is being used in clinical trials in Europe; it is not a commercial product.

Thanks in advance,


Super Moderator

AAMI TIR28, Product adoption and process equivalency for ethylene oxide sterilization, is the standard you might be looking for. No matter whether your product is CE marked or "just" used in a clinical trial, sterilization has to be safe and effective, complying to ISO 11135:2014.

You mention a validation which covered multiple exposure to sterilization. You also mention that you did not change materials.

In case you did not significantly change any other product characteristic (including change the amount of materials, product design, manufacturing processes, packaging including product presentation to the sterilization cycle) and did not introduce significant additional bioburden and endotoxin levels or other contaminations as consequence of your repair activities, you might succeed into adopting your repaired product into the existing validation without repeating experimental studies, walking through the question list in AAMI TIR28, Annex A




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Hi Gerhard,
So, you are saying I should think of a reworked device like a newer model and follow the guideline in TIR28 Annex A for adoption?

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