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.