Lyophilization is a complex process that presents many challenges. Analytical methods that enable the generation of robust process and product data can improve product quality. Headspace moisture analysis is a rapid nondestructive analytical method that addresses the limitations of traditional methods used for residual moisture determination.
This article describes how rapid non-destructive headspace moisture determination enables the generation of insightful data for product life cycle activities related to lyo cycle optimization, lyo chamber moisture mapping, freeze dryer qualification, formulation development and product stability studies.