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.

Technical Support

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.