Hi Fellows,
Background
-There is this product that is packaged in a blister and sterilized in EtO.
-The current version is an adoption of the previous version.
-The previous version was validated, and it included multiple cycles of sterilizations.
-Both versions are made of the same material.
Situation
A functional problem was identified with the current version which requires re-opening, repair, and repeat of sterilization.
Questions:
How to justify a second round of sterilization?
To my knowledge, ISO 11135 and TIR28 do not deal specifically with this situation.
One way of looking at it is to consider the repaired device as 'newer version' and write an adoption rationale based on TIR28, Annex A.
Is there a better way (more efficient) to address this issue?
Thanks in advance,
Shimon