With the most comprehensive packaging testing services in Europe for ISO 11607, we can provide all our Customer’s medical device packaging testing needs in one location.

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 services in packaging testing 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 services in ISO 11607-2 include:

  • Consultancy
    • Process development
    • IQ – OQ – PQ
  • Test plans and protocols
  • Sampling
  • Validation testing
  • Technical and regulatory files
  • Comparative performance studies
  • Packaging system analysis

Talk to Us About Our Medical Device Packaging Services:

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