Subvisible Particulate Matter Testing

ACHIEVING RELIABLE PARTICLE COUNT AND SIZE ANALYSIS OF INJECTIONS, OPHTHALMIC SOLUTIONS, AND LIPID EMULSIONS
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The United States Pharmacopeia (USP) and other agencies such as EP, JP, and ChP have established test methods to assure the minimization of particle counts in intravenous injections (parenteral drugs) and ophthalmic solutions. Particulate matter is both unwanted contamination and a potential health risk to the patient. Tests are in place for both visible and subvisible particulate matter. Subvisible particulate matter tests include USP <787>,1 <788>,2 <789>,3 and <729>,4.

• USP Test Procedure summaries
• USP <788>, Particulate Matter in Injections

The USP guidelines are in place for small volume injections (SVI, volume <100 mL) when the monographs specify the requirement and for large volume injections (LVI, volume >100 mL) for single dose infusions unless an exception is noted in the individual monograph.

This paper details the various USP subvisible particulate matter tests available to assure the minimization of particle counts in intravenous injections. And it explains how Entegris AccuSizer® and Nicomp® systems are uniquely capable solutions for performing these  tests in injections, ophthalmic solutions, and lipid emulsions.