Process Validation Responsibilities

The purpose of validating sterile barrier packaging systems is to ensure package and device integrity. All seals, regardless of who makes them, are equally important.

When utilizing preformed sterile barrier systems, the responsibility for validation of the sterile barrier system sealing process for pouches, header, and other bags is split between the sterilization packaging manufacturer and the device packager. The sterilization packaging manufacturer will validate the process of making the seals
present on the preformed sterile barrier system. The device packager will validate the process of making the closure seals.

In a form-fill-seal process, all the seals of sterile barrier systems are formed at the medical device packager. Therefore, the validation responsibility lies solely with the medical device manufacturer. For further guidance on validation considerations, review ISO 11607-2.