In-Situ Vial Strain Measurements During Freeze/Thaw Processes Using Amorphous Excipients
Ian Flynn is a graduate student at Purdue University under Dr. Alina Alexeenko researching mechanical stresses experienced by vials during lyophilization.
He received a BA in chemistry and BS in neuroscience from Indiana University in 2021 and will complete his MS in chemical engineering from Purdue in 2022. His interests include formulation and vial breakage prevention for lyophilized pharmaceutical products.
In lyophilized drug and biological products, crystallization of ice and excipients impart stresses on the walls of the vial which can be detected with a strain gauge. During the freezing process of lyophilization, there can be significant sample loss from vial breakage leading to loss of process control and additional cleaning expenses. The impacts of strain on vial integrity and the pharmaceutical ingredients are currently poorly understood. It is speculated these strains contribute to batch-to-batch variability in product stability. Possible mechanical causes of batch variability have not been an area of interest. To further fundamental understanding this research aims to evaluate the feasibility of a strain sensor to detect mechanical stresses at representative scales and correlate them to vial strength and product stability. Preliminary research with amorphous excipients has demonstrated the ability of a strain sensor to physiochemical events in freeze/thaw processes.
- Establish sensitivity of strain sensor over range of temperatures used in lyophilization
- Explore vial strain measurements for representative pharmaceutical formulations of amorphous excipients