Flexible Packaging

A primary concern in the design of a sterile barrier system is the sterilization process.

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.

There has been much discussion and even confusion centered on meeting the worst-case requirements of ISO 11607. What makes this particularly challenging is that ISO 11607-1 addresses worst case in three areas.

Meeting the test method validation requirements of ISO 11607 has often been mistaken as simply using ASTM or other published test methods.