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Screening for subvisible particles in pharmaceutical formulations – a case study
Summary
This study applied flow imaging microscopy to detect and characterize subvisible particles in pharmaceutical formulations — a quality control challenge that shares methodological overlap with microplastic detection. Improved particle characterization methods in the pharmaceutical sector can also advance techniques for identifying nanoplastics in biological and environmental samples.
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.
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