Medical device disposables - Stored in a controlled environment for 4 months - Effects on Sterilization

B

Balachander

Starting to get Involved
Hi,

We have a med device and the handpiece is sterilized using ETO. We manufactured in Oct 2022 and since there were no sales order, it was kept in the controlled environment till now. Now we want to send it our customer with a new lot # as it has minimal shelf life of 12 months. We will be performing bioburden before the sterilization run. I have a few questions regarding this now:

1. will there be any impact on sterilization. I mean bioburden of the product after 5 months ??
2. The normal load delivered to this product through the EtO sterilization accounts for the nominal manufacturing setting (product made, packaged, labeled, sent to sterilizer and marked as “sterilized” which is when the timer starts). This means that normally there is a negligible time between when the product is made and marked with a MFG and expiration date and when it is actually sterilized. In this case there will be a 5 months delay. How do we rationalize this in our NC documents. ??

Thanks,
Bala
 
planB

planB

Super Moderator
Assuming that:
- you stored your device in a sterile barrier system (SBS) after terminal sterilisation,
- there is no indication that the SBS of your device has been compromised during storage,
- your product is not susceptible to degradation over its life time (and shelf life is only determined by the stability of its SBS),
- no critical product characteristic is adversely affected by re-sterilisation (including levels of residuals),

terminal re-sterilisation after re-packaging should be straightforward, independently of how long the product has already expired.

ad (1): bioburden could only be present in case your SBS was breached. Is your controlled storage environment equivalent to the original manufacturing environment? Your planned confirmatory bioburden testing will definitely provided additional assurance.
ad (2) Unless you have specified the time period between expiry and re-sterilisation, there would not be an NC. In case you specified such a maximum time period, what were the related considerations?
 
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