Sterile Barrier Integrity and Seal Strength Testing Services
Packaging integrity tests in accordance with ISO 11607
STERIS operates an ISO 17025-certified laboratory with a wide range of accredited tests. We offer complete test services for sterile barrier integrity and seal strength. Packaging integrity testing is a key validation requirement for terminally sterilized medical devices and demonstrates that the package has no breaches or defects following sterilization, distribution, and aging.
Sterile barrier integrity tests include:
- Visual inspection (ASTM F1886 / F1886M)
- Bubble leak testing (ASTM F2096)
- Dye penetration testing (ASTM F1929, ASTMF3039)
- Bubble leak under vacuum / vacuum leak testing (ASTM D4991)
Seal strength tests include:
- Peel testing / seal strength / (ASTM F88 / F88M, EN 868-5 Annex D)
- Burst testing (ASTM F1140 / F1140M, ASTM F2054 / F2054M)
- Peel characteristics and seal width measurement (EN 868-5 Annex E)
We also offer distribution simulation and accelerated and real-time aging services, providing our Customers with a comprehensive offering of validation testing.
Our technical support team also offers guidance toward:
- Packaging evaluations and concept reviews
- Risk assessment
- Identification of applicable standards
- Test planning and protocol development
- Evaluating prior validations and gap analysis
Contact our team of experts to find out more about our Global Contract Sterilization, Testing and Validation Services.