Advanced Process Analytical Technology in Combination with Process Modeling for Endpoint and Model Parameter Determination in Lyophilization Process Design and Optimization

Lyophilization is widely used in the preservation of thermolabile products. The main shortcoming long processing time. processes are mostly based on a recipe that not changed, but, with Quality by Design (QbD) approach and use Process Analytical Technology (PAT), process duration can be optimized for maximum productivity while ensuring product safety. In this work, an advanced PAT endpoint determination primary drying. Manometric temperature measurement (MTM) comparative pressure to determine batch modeling outlined able calculate every vial batch. This development, control optimization.