Screening for subvisible particles in pharmaceutical formulations – a case study

Particulate contamination arising from subvisible particles in pharmaceutical manufacturing is a major challenge affecting both product safety and manufacturer reputation. Hence, detection and quantification of subvisible particles play pivotal role in pharma industries and regulatory monitoring process. Flow imaging microscopy has been widely used to characterize and count particulate matter having profound application in imaging analytics. The current study reports our preliminary findings on sub visible particles in pharmaceutical formulations. The particle size distribution and concentration are assessed using pre-defined image libraries and statistical pattern-recognition. A total of 32 samples were screened and found to contain a size range between 70 and 12239 particles belonging to glass, fiber, plastic, and unknown product category. In conclusion, flow imaging is a simple and rapid complementary method for the detection and quantification of subvisible particulate matter screening.