The process of developing and constructing a packaging system for terminally sterilized medical devices is a convoluted and pressing endeavor. The definitive nature of the medical device, the intended sterilization methods, the intended use, expiration date, transport, and storage all influence the packaging system design and choice of materials. The combination of the medical device and the packaging system should perform efficiently, safely, and adequately in the end-user’s hands.

ISO 11607-1 details the elemental attributes demanded of materials and pre-formed systems intended for use in packaging systems for terminally sterilized medical devices. It takes into consideration the vast array of potential materials, medical devices, packaging system designs, and sterilization methods.

ISO 11607-2 describes the validation requirements for forming, sealing and assembly processes. The development and validation of packaging processes are crucial to ensure that sterile barrier system integrity is maintained until opened by the users of sterile medical devices.

Goals of a terminally sterilized medical device packaging system:

  • Packaging System Performance Testing / Distribution Simulation
  • Stability Testing / Shelf Life Study
  • Packaging System Integrity Testing
    • Package Integrity (ASTM F2096: Bubble Test)
    • Seal Integrity (ASTM F1886: Visual Inspection, ASTM 1929: Dye Test)
    • Seal Strength (ASTM F88: Peel Test , ASTM F1140: Burst Test)

Testing includes, but not limited to, the following: