For terminally sterile medical packaging there is a need to demonstrate that the manufacturing, transit and storage environments do not compromise the sterility of the pack. For sterile barrier packaging, laboratory transit testing is followed by an integrity assessment.
Testing Capabilities for Medical Packaging
At our US facility in Lansing, Michigan, our post-test integrity services focus on the following test standards:
- Section 6.3 Packaging-system performance testing of Part 1 of ISO 11607
- Section 6.4 Stability testing of Part 1 of ISO 11607
- ASTM F2096 Gross leak detection
- ASTM F1929 Dye penetration testing
- ASTM F88 Seal strength testing
- ASTM D3078 Determination of leaks by bubble emission
- ASTM F1886 Visual inspection
At our UK facilities, Smithers Pira has extensive service offerings for medical packaging including:
Need more information? Please contact us today.