Medical device procedure tray - Adding products in Custom packs

Kees Fremerij

Starting to get Involved
Does anyone has experience in the following:
A filled injector (gel and/or water) is sterilized (gamma).
This injector needs to be packed in a procedure tray which will be sterilized by EtO. Is it the best way to add it before the EtO treatment or aseptic after the sterilization?
 

Ronen E

Problem Solver
Moderator
Hello Kees and welcome to the Cove :bigwave:

As far as my understanding goes, aseptic technique can help minimize the bioburden, but if you add anything after the EtO sterilization sterility can no longer be guaranteed. So in my opinion the sequence you described is the right one.

The injector and contents will have to be validated post Gamma + EtO, to make sure that process doesn't deteriorate it.

Cheers,
Ronen.
 

pkost

Trusted Information Resource
in order to comply with article 12 sterilization requirements you have to follow the sterilisation instructions of the manufacturer...Even thought the product is already sterile, you may still run into this problem....I suspect the manufacturer of the syringe does not provide instructions to use EtO!

Instead of sterilising with EtO and then packing in aseptic conditions, could you not just group them together in the same "non sterile" pack? I have seen this done before.
 

Kees Fremerij

Starting to get Involved
The gel will be put in an aluminium pouch instead of a syringe. Gamma irradiated and prior to EtO added to the package. I think this will be the best option.
 
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