RESOURCE OVERVIEW
Vial Breakage During Lyophilization.
Lyophilization is a freeze-drying technology that is routinely used to improve stability of injectable pharmaceuticals that require cold storage in the solution form. The process involves freezing of a formulation, removal of water vapor through sublimation under reduced pressure, and removal of unfrozen water during secondary drying. Formulations are filled in glass vials of varying sizes using varying fill volumes for lyophilization. Despite the durability of glass used in lyophilization, occasionally, breakage of vials is encountered during manufacturing due to a variety of reasons.
In this whitepaper, learn more from the Simtra BioPharma Solutions (Simtra) team on the Root Causes and Mitigation Strategy for Vial Breakage during Lyophilization.