Medical Product Packaging Testing

Certain properties of medical devices, medical products and packaging systems must remain constant throughout their shelf life. In order to achieve this, the packaging system must go through the relevant test and analysis processes. Test systems for the performance, microbiological structure and physical properties of packages for medical products include the following analyses:

• Paint test for sealing integrity
• Peel test, burst test and bubble test
• Air permeability test and microbiological tightness test
• Qualification of packaging materials
• Verification of packaging forming, sealing and assembly processes for terminally sterilized medical devices
• Validation of final packaging systems for sterile medical devices
• Evaluation of the shelf life of a sterile packaged medical device
• Stress medical devices, bioassessment testing strategy as well as specific performance tests

ISO 11607-1:Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems