Validation and Verification - Catheter into a tyvek pouch



My company puts a catheter into a tyvek pouch, seals it and then sends it off for sterilization. We have run out of 9"X9" pouches and are going to use 8"x10" pouches all made from the same material by the same supplier and sterilized using the same process. Regulatory affairs says a validation and verification study must be done in order to use a different size pouch. According to the development engineer a larger pouch would actually have better sterilization performance due to the larger surface area to allow the EO gas to penetrate the pouch. We're being quoted ISO11607 as the rationale for the V&V study. Any thoughts. As a straight quality guy I fail to see the problem with this as it is the same product, same material, same specs, just a different size.

Ronen E

Problem Solver
it is the same product, same material, same specs, just a different size.

...however not validated in the context of your specific process. For instance, the bigger pouches might be manufactured (by your supplier) using different equipment and different settings. Are you going to use the very same equipment for sealing? How would you determine the settings?

Start off with a risk assessment. Perhaps you could get away with a limited scope validation.



Involved In Discussions
I know from experience that the customer requires validation for every size of the pouch, particularly because the seal is different size. We use sealing machine with different settings for each seal size. The seal is tested for breaking and for tightness.
Top Bottom