Medical Device Package Validation Testing

Medical Device Package Validation Testing

Quest is an ISO 17025 accredited laboratory that is dedicated to providing quality turn-key solutions to your testing needs.

The integrity of terminally sterilized medical device packaging is crucial to maintaining sterility of the devices.  For example, a bubble emission test or dye penetration test, among a variety of other tests, can be used to test the integrity of the package seals of medical packaging.  Quest’s quality process includes validating these test methods per ISO 11607 prior to testing your products.  These requirements are put in place to ensure that medical device packaging systems remain sterile and provide physical protection to the medical device until the point of use.

Quest Engineering Solutions performs validation testing and is experienced in implementing validated test methods to be used to perform the testing in accordance with ISO 11607.  Quest can customize these test methods to include your preferred inspection method.  These can include variations for different materials and test methods unique to your packaging and your specific requirements.

These tests can be performed following ASTM D4169 shipping simulation tests, ASTM F1980 simulated aging tests, or as separate stand-alone activities.  Please contact Quest for shipping simulation testing, packaging inspection testing, or any other package testing you may need.

The most commonly requested ISO 11607 test standards for validation are:

  • ASTM F88        Seal Strength
  • ASTM F1140      Burst Test (Unrestrained)
  • ASTM F1886      Determining Integrity of Seals by Visual Inspection
  • ASTM F1929      Dye Penetration
  • ASTM F2054      Burst Test (Restrained)
  • ASTM F2096      Gross Leak detection (Bubble test)