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Package integrity tests are used to detect packaging problems that could adversely affect the sterility of a medical device. Sterile products are subjected to an environmental stress intended to simulate extreme conditions that a product might encounter in shipping or storage. The product packaging is then subjected to microbial challenge or dye penetration testing to determine if it has retained its properties as a microbial barrier.

Containers may also need to be tested (for example, containers of pharmaceuticals in liquid form.) The materials of these containers may need USP Class Plastics certification, and may need in vitro cytotoxicity testing to ensure any leachable materials from the containers are not harmful to cells.

Package Integrity Tests

  • Package Integrity by Microbial Challenge (26 samples recommended)
  • Package Integrity by Dye Penetration (13 samples recommended)
  • Burst Strength Test *
  • Seal Peel *
  • Container Closure Integrity Test for Rigid Containers
  • Helium Leak CCIT *

Container Testing

  • Cytotoxicity (in vitro)
  • USP Class Plastics (in vivo)

* denotes a subcontracted test

Intertek Logo PBL is FDA registered and ISO 9001:2008 and ISO 13485:2003 certified by Intertek. AAALAC Logo Our animal science operations are accredited by AAALAC.

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