The integrity of medical device packaging and pharmaceutical Container Closure Integrity (CCI) are vital to ensure patient safety. Though a range of tests in our independent laboratories, we can help clients determine the integrity and strength of their terminally sterile packaging. 

  • Integrity: evaluation to ensure continuous package sealing and identifies any failures in the continuous seal.
  • Strength: evaluation to determine the amount of force required to open the package. Failures can also occur during the three main tests for package strength: seal peel, burst, and creep.

Our pack integrity assessment comprises:

  • Packaging-system performance
  • Stability
  • Gross leak detection
  • Dye penetration
  • Seal strength
  • Determination of leaks by bubble emission
  • Visual inspection

Testing focuses 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