PBL Logo - click here to return to homepage spacer



Medical Device Package Integrity Testing

Pacific BioLabs performs the dye penetration and the microbial challenge package integrity tests. 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.

Package Integrity Tests

  • Package Integrity by Microbial Challenge (26 samples recommended)
  • Package Integrity by Dye Penetration (13 samples recommended)
  • Burst Strength Test *
  • Seal Peel *

* denotes a subcontracted test

Medical Device Package Integrity Testing Standards

Package Integrity Related Testing Services

Read More About Package Integrity Testing


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.

Request a quote Send an email