(345b) Multiphase Simulation Estimating Virtual Doe for Lyophilization Process.

This study introduces a computational approach to the primary drying phase of the Lyophilization process, leveraging insights from sublimation simulation and lyophilization equipment capabilities. The study focuses on enhancing the efficiency and predictability of the primary drying phase, a crucial step in the Lyophilization process widely used in pharmaceutical and biotechnological industries. The sublimation simulation model offers an in-depth understanding of the primary drying phase, enabling the optimization of process parameters such as the sublimation rates (SR). The use of estimated SR in lyophilization equipment capability estimation further enhances the process efficiency. The study explores a broad spectrum of process conditions such as shelf temperature, chamber pressure, primary drying time through a virtual design of experiments, thereby minimizing experimental costs and time. Initial results show significant contribution from the DoE analysis in process efficiency. This research significantly contributes to the development virtual twin of primary drying process in lyophilization, leading to more efficient and reliable manufacturing processes.