Particulate Analysis Testing
Particulate matter consists of extraneous, mobile substances unintentionally present on medical products. The test for particulate matter is suitable for revealing the presence of particles whose longest axis or effective linear dimension is 10.0um or greater. We offer Method 2: Microscopic Plate Count from the USP guidance.
Test method is performed per:
ANSI/AAMI AT6: Autologous Transfusion Devices
USP <788> Particulate Matter in Injections, Microscopic Particle Count Test (Modified)
USP <789> Particulate Matter in Ophthalmic Solutions
Upon completion of test, a final report will be issued and all records and raw data will be held for five years.
Experience you can trust
Millstone Testing Services offers comprehensive regulatory testing services backed by more than 90 years of combined experience in the medical device and pharmaceutical sectors.