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Expired packaging material - Expired unused Tyvek pouches

H

Hectorbarone

Registered
#1
#1
Hello guys,

It's my first post. I looked uo this topic but couldn't find any answer.
We manufacture implantable medical devices. We have a batch of expired unused tyvek pouches. We use the expiry date indicated by the manufacturer.
My question is: can I validate an extension of the shelf life of the pouches? I thought about subjecting them to accelerated aging before sealing, and then proceed with standard sealing validation tests.

Thanks in advance.
 
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I

indubioush

Quite Involved in Discussions
#2
#2
First, contact the pouch manufacturer and ask them how they determine their expiration date. Come back with the answer, and then we will continue the discussion.
 
L

levatorsuperioris

Involved In Discussions
#3
#3
Just a thought, but is it worth the saved money to take such a regulatory risk? Say your testing gets judged insufficient during an FDA or NB audit, you could be stuck repeating many tests (microbial barrier is a particularly nasty one) to rationalize your product on the market. How much money would you save?

100k US?

You would easily spend that in testing to evaluate product/packaging on the market for safety under pressure from a Government Agency or Notified Body.

The only situation were I would think it would be worth rolling the dice is if you are stuck with the new version of Tyvek and reporting and testing problem.
 
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