Recent drug recalls stemming from particle contamination highlight just how exacting processes are in pharma manufacturing. But thanks to increasing horsepower in both personal computers and digital cameras, pharma operators have a tool to help tame the particle beast.
PC-based image analysis can aid operators in defining process end-points and rationalizing differences between batches, says Deborah Huck of particle-analysis instrument maker Malvern, in ChemEurope.com. She describes how one manufacturer suffered repeated excipient batch failures that were discovered late in the manufacturing process because its microscopy or ensemble sizing methods were incapable of distinguishing good batches from bad.
Via automated image analysis, however, operators could evaluate the average convexity--a measure of particle surface roughness--of each excipient batch. Failed batches consistently had lower average convexity than good batches, and so could identify bad batches before they were used.
- here's the article