CASE STUDY: Resolving Particulate Matter in Products and Processes

Resolving particulate contamination is critical to quality and safety of complex and high value products including pharmaceuticals, medical devices or specialty chemicals. It can also impact production efficiency, and brand integrity.

In this case study, our expert, Dr Peter Muehlschlegel describes the steps of an investigation into the occurrence of foreign particulate matter (FPM) in a lyophilised drug product. The composition of FPM was identified through the application of microscopy and spectroscopy techniques which helped to confirm the origin of the particles. The insight from this study then helped to de-risk the production process in relation to FPM.

Please complete form below to download the case study