Tyvek packaging for Medical device process validation

#1
Hi everyone,

Our company is about to commence validations including Ethylene Oxide sterilization validation (overkill method), shelf life testing (ASTM F1980) and transportation validation (ASTM D4169 DC13) for a single use medical device.

The device will be packaged in Tyvek 1073B / PE Film pouch with Chevron seal. I am having trouble getting the correct size of Tyvek pouch in time, so I’m thinking of use a bigger pouch (470mm x 220mm) for sterilization validation and shelf life validation. 470mm x 100mm will be used in production. Both sized pouches will be the exact same grade, from the same pouch vendor and will be sealed using the same validated sealing machine.

Can I justify the use of the bigger pouch for the validation? Obviously, I do not want to redo all / any of the validations because we used the incorrect size pouch. Are there any concerns relating to Bioburden / bioburden recovery / EO residuals that could be impacted by the use of the bigger pouch? Any other pitfalls I need to be aware of?

Thanks for your feedback, :)
Vish
 

Sam Lazzara

Quite Involved in Discussions
#2
Some opinions below. My bottom line opinion: "Don't do it".

Pouch heat seal validation - no impact since seal visual appearance and seal peel strength are the typical process outputs that must be validated

Package validation (including distribution simulation, aging, whole package integrity testing, etc) - impacted, since the fit of the contents into pouch will be different

Note - Using the correct size pouch also avoids the possibility that you might need to fold the pouch to make it fit into the shelf carton. Avoid folding Tyvek pouches to avoid leaks in the clear film at creases/folds; orthogonal folds are notorious for causing film leaks/pinholes; you are more likely to have to fold the larger pouch to fit it into the shelf carton, and folding is a bad idea in general. There are film materials that are more resistant to such pinholes nowadays but they cannot typically survive orthogonal folds. By "orthogonal folds" I mean folding the pouch once and then folding it again at 90 degrees from the first fold - it leads to a small stress point at the intersection of the folds.

Bioburden, including recovery - no impact

EO sterilization validation - impacted since smaller pouch is a worse case (the greater surface area of the larger pouch facilitates gas transfer to the contents)

EO residuals - impacted since smaller pouch is a worse case (same reason as EO validation)
 
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