Parenteral drugs administered by injection to patients should be essentially free of visible particles. Sub-visible particles in parenteral drugs are detected using a light obscuration particle counter, microscopic inspection on a filter, or both.
Microbiology & Quality Associates (MQA) can provide Particulate Analysis per USP <788>. There are two methods for the determination of particulate matter:
- Method 1: Light Obscuration Particle Count Test
- Method 2: Microscopic Particle Count Test