Medical Package Integrity Testing

Quest is an ISO 17025:2017 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 11607-1 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.

Medical Device Package Validation Testing

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 11607-1. 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 Accelerated Aging Testing, or as separate stand-alone activities.  Please contact Quest for shipping simulation testing, packaging inspection testing, or any other package testing you may need.

Common ISO 11607-1 Tests

  • ASTM F88           Seal Strength
  • ASTM F1140      Burst Test (Unrestrained)
  • ASTM F1886      Determining Integrity of Seals by Visual Inspection
  • ASTM F1929      Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
  • ASTM F3039 Standard Test Method for Detecting Leaks in Nonporous Packaging or Flexible Barrier Materials by Dye Penetration
  • ASTM F2054      Burst Test (Restrained)
  • ASTM F2096      Gross Leak detection (Bubble test)

Insulated Package Testing

Insulated packaging is often used to preserve temperature controlled samples like the COVID-19 vaccine. Some of the most requested specifications for this kind of testing include:

  • ISTA 7D
  • ASTM D4332 Temperature/Humidity Conditioning

Note: Ship testing, accelerated aging testing, and other tests offered by Quest may also apply to these types of packages.

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