The sources of particulate contamination are often not easy to identify. To control manufacturing processes, the measurement of particle concentration and size is necessary and has been routinely performed for many years. Technology has been developed to increase the information available for the immediate evaluation of particles. The method analyzes airborne particles or particles isolated from liquids automatically according to their number, size, and chemical composition.1,2 The analysis of thousands of particles enables users to locate the major sources of contamination in various manufacturing processes.
The analytical tool provides rapid determination of particulate contamination, thus allowing for a quick, efficient response. Over time, the ability to compare analytical result data sets assists in detecting trends and implementing the appropriate quality management. Routine use of the technology contributes to ongoing supervision and optimization of production processes.
This study reports on the use of the technology to analyze foreign particles associated with oral, inhalable, and nasal drug products (OINDP), parenterals, and coronary stents. Applications for troubleshooting and identifying latent contamination sources are discussed through several examples.