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
- 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