emulchandani
eandi12
I am updating a gamma sterilized product (carton with sterile pouch and IFU inside) to increase the size of the IFU by 2x. The original validation did not account for IFU size increases. Per ISO 11137-2, bioburden is the driver for the sterilization dose, not density or other factors. Since the bioburden in the sterile barrier did not change, does it make sense that the validation is not impacted and only the dose map would need to be verified due to the density increase?