Vial breakage is a serious problem in the sterile production of a lyophilized pharmaceutical. In addition to product loss, the contamination of the freeze dryer with product residues and glass fragments poses a high risk and requires considerable cleaning effort. Vial breakage is often caused by factors like thermal and mechanical stress, crystallization of formulation components, inadequate primary packaging, improperly designed process parameters, or combination of those. Understanding these factors is key to optimizing your freeze drying process and ensuring product quality and cost effectiveness.
At ProJect Pharmaceutics, we are experts in freeze drying technology and your trusted CRO partner for lyophilization cycle development and optimization. Using high-end lyophilization technologies, we swiftly identify and address the root causes of vial breakage. Through our advanced macro-video system we perform a root-cause analysis, monitoring the entire cycle to pinpoint critical parameters that lead to product defects. Based on our findings, we develop effective avoidance strategies and provide tailored solutions to optimize your product’s process and quality.
Check out our video on vial breakage on our YouTube channel https://www.youtube.com/watch?v=sP-1X2_yC7U