Hello Everyone!
I need some help with a justification for my regulatory department. We have a thermoformed tray that we are changing suppliers on and making some much needed design improvements on. The current tray (Tray A) is made from Silicone Free PETG Copolyster 6763 and the new one from the new supplier (Tray B) is Glidex/Co-Ex 6763 PETG W/ ID. Our Tray B supplier cannot make our trays from the Silicone Free PETG Copolyster 6763 because the trays stick together and stick to the tooling. They want us to change to Glidex/Co-Ex 6763 PETG W/ID.
The shelf life for Tray A is 4 years. We currently use Glidex for a different product that has a 2-year shelf life. I can't seem to find any 4-year aging data on Glidex. My regulatory department says that I need to prove that Tray B is going to maintain SBS integrity just as long as Tray A. If I can't, we would need to submit a new 510(k) and that would kill this project. We also don't really have time to perform accelerated aging tests to fully prove this out. I plan on running a sealing validation and perform Visual Inspection, Bubble Leak, and seal strength testing on both trays and comparing the results. My gut says that if Tray B has a higher seal strength than Tray A at T=0, it should have a higher seal strength at T=4 yrs, and thus, still remain sterile and intact. Is my assumption true?
Do any of you have 4-year aging data on Glidex that you would be willing to share with me, or know where I could go looking to find such information? Also, does anyone know where I can find a paper on how seal strength of packaging changes over time?
Thank you very much!
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Michael Johnston
Packaging Engineer
MicroAire Surgical Instruments
Charlottesville VA
(434) 975-8050
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