Mechanical Engineering Commons^™

Cavitation In Pharmaceutical Manufacturing And Shipping, Donn Sederstrom

Electronic Theses and Dissertations

Therapeutic proteins are used to successfully treat hemophilia, Crohn's Disease, diabetes, and cancer. Recent product recalls have occurred because of sub-visible particle formation resulting from the inherent instability of proteins. It has been suggested that particle formation is associated with late stage processing steps of filling, shipping, and delivery. Previous work at the University of Denver demonstrated that fluid cavitation can generate a large number of sub-visible protein particles in ultra clean formulations, but that mitigation can be achieved with fluid property manipulation. The goal of this research was to (1) assess the risk of cavitation under common pharmaceutical manufacturing …