STERIS offers a comprehensive offering of packaging testing services in accordance with ISO 11607.

ISO 11607-1

ISO 11607-1 specifies the requirements for materials and test methods, pre-formed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

Our Packaging Testing Services Include:

  • Protocol and test plan generation
  • Sampling programs
  • Transportation testing
  • Shelf life
    • Stability studies
    • Aging (accelerated and real time)
  • Integrity testing:
    • Bubble leak
    • Tensile/peel
    • Dye penetration
    • Vacuum decay
    • Burst test
    • Microbial challenge
  • Final reports

ISO 11607-2

ISO 11607-2 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include the forming, sealing, and assembly of pre-formed sterile barrier systems, the sterile barrier systems themselves, and the packaging systems.

Our ISO 11607-2 Packaging Services Include:

  • Consultancy
    • Process development
    • IQ – OQ – PQ
  • Test plans and protocols
  • Sampling
  • Validation testing
  • Technical and regulatory files
  • Comparative performance studies
  • Packaging system analysis
Contact our team of experts to find out more about our Global Contract Sterilization Services