Particulate Contamination Testing

Accurate, Expert, State of the Art

In Particulate Contamination Testing applications, MML customers are seeking to determine the quantity of unexpected and/or unwanted contaminant particles present in or on the surface of the sample. A combination of automated particle counting instrumentation (LO) and optical microscopy (MM) is used for these applications.

In some cases, these tests are required by various world-wide regulatory agencies (i.e. USP, U.S. FDA, EMA, JP) to be able to release and ship product; in other cases, the testing is performed as part of an on-going quality testing and product improvement program.

  • USP General Testing Chapters <729>, <787>, <788>, and <789>
  • Particle testing of clean containers and components, such as ISO <8871> for elastomeric parts for parenterals
  • Medical devices such as pacemakers/leads, catheters, and joint and limb implants
  • Automobile parts testing for relays, switches, and headlamp assemblies

When additional detailed analysis is required to solve process and production contamination problems, as a value-add service, the Particle Identification Group at MML can isolate and identify particle composition using optical microscopy, SEM/EDS, FT-IR or Raman Spectroscopy methods.

Submit a sample using our Sample Submission Form.