Regulatory Submittal During 3 Lot Sterilization Validation

L

lungfish

#1
Hi all,

We're currently in the midst of a change in our Eto sterilization process. Because it involves a class 3 CE marked device, we will be filing an amendment to our Design Dossier. The new process is being subjected to a 3 lot sterilization validation.

My question is in regards to the exact timing for the regulatory submittal. If each full sterilization load can be validated individually, is it possible to get approval from the notified body to ship saleable product coming out of the first load?

The alternative would be to wait until all 3 loads are completed, the report is received, and then submit to the NB. There is a 45 day review process, so by the time approval is received, there is a lag of several months from a single lot approach. Additionally, any good product sterilized as part of the 3 loads is collecting dust on the shelves while we wait for approval.

Anyone with experience in this matter, please share!
 
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Sam Lazzara

Trusted Information Resource
#2
I think the best way to answer your questions is to speak with your Notified Body project manager....now. That way, no surprises or disappointments later. Perhaps you can get him/her to agree to the submission of an initial change notice that lays out your overall plan, followed by supplements with data for each run.
 
#3
Hi,

A change of gamma sterilization protocol to accomodate 20% more devices would lead to a significant change under MDR? We are validating this change, would be require to repeat packaging integrity tests after this change in protocol?
 

chris1price

Trusted Information Resource
#4
You should start with a risk assessment. If you are increasing the number of devices, does this increase the product density? How will this effect the dose received? If the dose changes, you should consider whether repeating packaging integrity testing is required. If you don't so it, you will need a good, documented rationale. Also consider the effect of increased dose on the product itself.
 
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