Packaging Integrity Testing Services

STERIS Laboratories provides technical support to help our Customers develop a packaging integrity solution that meets the testing requirements of ISO 11607.

Our experience in building and validating custom designed tests and test equipment enables us to provide packaging integrity solutions, with flexible test systems to meet both development and longer term product testing needs. Tests are built to international standards and CE certified where required

Our Packaging Services:

  • Packaging design and optimization
  • Packaging validation testing
  • Transportation testing to ASTM, ISTA and ISO standards
  • Ageing/shelf studies – accelerated ageing and real time ageing
  • Sterility and seal integrity testing:
    • Bubble leak
    • Dye penetration
    • Peel test
    • Burst and seal strength
    • Visual intact
  • Visual adhesive transfer
  • Comparative material performance testing
  • Protocol and test plan generation
  • Dangerous goods testing
  • Cold chain testing
  • Medical device product testing
  • Customized test equipment

STERIS Laboratories provides:

  • Experienced testing in delivery systems, implantable devices and medical electronics
  • State-of-the-art test equipment and test systems
  • Services complementary to in-house or third party packaging production
  • Specialist expertise in packaging testing and reliability services

Medical device packaging should be considered at the earliest stages of product design

A project launch may require additional time and costs should a package redesign be required in the late stages of a project, including:
  • Costs associated with packaging redesign
  • Revision of packaging specifications, drawings etc.
  • Additional sterilization validation
  • Repeat and/or delay of shelf life studies
  • Repeat and/or delay of accelerated and real-time aging
  • Repeated transportation and packaging validation
  • Delayed release-to-market for the medical device
Available services vary between laboratories. Contact us to learn more about the services offered at each of our locations

Contact our team of experts to find out more about Packaging Integrity