Emerging PAT for Freeze-Drying Processes for Advanced Process Control

Abstract

Lyophilization is a widely used drying operation, but long processing times are a major drawback. Most lyophilization processes are conducted by a recipe that is not changed or optimized after implementation. With the regulatory demanded quality by design (QbD) approach, the process can be controlled inside an optimal range, ensuring safe process conditions. Process analytical technology (PAT) is crucial because it allows real-time monitoring and is part of a control strategy. In this work, emerging PAT (manometric temperature measurement (MTM), comparative pressure measurement, heat flux sensors, and ice ruler) are used for measurements during the freeze-drying process, and their potential for implementation inside a control strategy is outlined.