LAUSR

The presence of particulate matter (PM) in medical products and manufacturing processes is a wellestablished and accepted fact. Regulators have strict rules regarding the size distribution and number of particles that are allowed in medical products. Therefore, understanding and controlling the PM in manufacturing processes and their resultant products becomes a crucial task for the healthcare and pharmaceutical industry. In this work, we introduce a method that can provide full characterization of the PM population present in a medical product or manufacturing process, ranging from aggregate measures of the total number of particles and their size distribution to data on each individual particle, including the size, shape, and most importantly, chemical and elemental composition. Such information gives valuable, statistically unbiased insight into the full PM population, and helps to pinpoint and identify strategies to eliminate the primary sources of the PM in an accurate and proactive manner if necessary.