Ethylene Oxide Sterile Implantable Medical Device Shelf Life Extension

D

dallltho

#1
If you have a sterile implantable medical device that is sterilized by Ethylene Oxide (EO aka ETO) and want to extend the shelf life, how many product batches or lots would need to be verified via testing in order to justify the extension? Is there a general best practice? If so, which standard or regulation or guidance would direct us to verify such a number of lots to test (for example 1 lot or 3 lots etc.)?
 
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#2
dalltho,

follow ISO 11607, section 6.4. You have to justify your sample size for your seal- and packaging-integrity tests at the extended time points by a statistical rationale. Typically, you demonstrate batch-wise reproducibility of your sealing process during the PQ of your initial sealing validation at timepoint = 0, and thus, do not have to consider batch variations as a variable during aging/stability studies.

HTH,

Gerhard
 
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