Subvisible Particulate Matter Testing

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>, <788>, <789>, and <729>.

This application note demonstrates how the Entegris AccuSizer and Nicomp systems are uniquely capable solutions to subvisible particle testing in injections, ophthalmic solutions, and lipid emulsions. Combining the highest specification technology with advanced software and automation options make these the most advanced instruments available for USP particle testing.