Parameters Influencing Cavitation Within Vials Subjected to Drop Shock.

The pharmaceutical industry has made improvements to mitigate protein degradation during the drug manufacturing process, storage, and transportation. However, there is less quality control after the manufacturer releases the drug. Previous research has shown that drop shock due to mishandling and accidental dropping of therapeutic vials may cause cavitation, aggregation, and particle formation. In this study, the cavitation behavior of Deionized (DI) water and 10mM L-Histidine buffer solution which were subjected to drop shock by hand dropping were investigated to study the effects of vial materials, solutions, fill volumes, drop heights, and internal vial geometries. A Phantom v7 high-speed camera was used to record images at a rate of 66,700 frames per second of the vials as they underwent drop shock. These videos were then reviewed to find the angle of impact, and to determine if there was cavitation. The results indicate that decreasing fill height by using a smaller fill volume or larger diameter vials were found to mitigate cavitation across drop heights. Secondly, results indicate there is a significant difference between the cavitation behavior of glass and plastic vials, and plastic had more cavitation cases. Lastly, there was not a significant difference in the occurrence of cavitation between DI water and L-Histidine buffer solution.