Post-Test Integrity Testing for Medical Packaging

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

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

Smithers Pira has extensive service offerings for medical packaging including:


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