Effects of Subzero Temperature Exposure and Supercooling on Glass Vial Breakage: Risk Management and Other Applications in Cold Chain Distribution

During the distribution of temperature-sensitive products (cold chain distribution), unintentional exposure of typical glass drug vials to subzero (below 0 °C) temperatures introduces potential risks of glass vial breakage during freeze (as well as thaw) and potential destabilizing effects of any biologic or pharmaceutical contained within. Vial breakage during freezing not only leads to product loss, but also to potential safety/sterility issues. This paper focuses on the physical aspects of tested glass vials as well as thermodynamic behaviors observed (specifically supercooling) in liquid product. In this study, filled glass vials varying from 5 to 500 mL were subjected to specific temperature levels (-15, -10, and -6 °C) in controlled chambers. Thermocouples were used to record temperatures within various probed vials and the ambient temperature of the controlled chamber. Vials were visually inspected for cracks/fractures after every cycle of conditioning. Samples of the cracked and non-cracked vials were sent to a third party glass analysis laboratory for further observations. This study provides insight into the physical impact of exposing filled glass vials to subzero temperatures for short durations commonly observed during cold chain distribution.