Presence of particulate matter on medical devices can occur due to manufacturing environment/processes or due to a device design related issue. Sources of particles in the manufacturing environment can be glove powders, cloth fibers, paper particles, packaging materials or other materials. Particles may arise because of friction, aging, degradation, drying and can have undesirable affect to the performance of the device and can significantly affect the patients.

We offer guidance in applying analytical methods for particulate testing, identifying potential sources of particulates, and developing limits for particulates depending on its intended use.

• • Writing protocol and reports according to USP 788 and AAMI TIR 42
  • Providing support in simulated use model developing and selection of materials to be used in the model and troubleshooting issues
  • Support with the organization of test with the test labs