Skip to main content

Sub-Visible Particles

Meaning

Sub-Visible Particles are microscopic entities, typically aggregates of the active pharmaceutical ingredient, excipients, or process contaminants, present in parenteral drug products like injectable hormone solutions, whose size falls below the threshold of routine visual inspection (usually less than 50 micrometers). While not immediately apparent, the presence of these particulates is a significant quality concern regarding immunogenicity and vascular occlusion risk. Regulatory science demands strict control over these contaminants.