Tunable Diode Laser Absorption Spectroscopy (TDLAS) measurements combined with SMART Freeze-Dryer Technology enabled automated pharmaceutical lyophilization process development. The sensor measured water vapor temperature, density and flow velocity used to calculate water vapor mass flow rates (dm/dt). The dm/dt values were combined with a heat and mass transfer model of lyophilization to enable real-time determinations of product temperature during sublimation. The temperatures combined with a process development algorithm produced efficient freeze-drying cycles during a single lyophilization experiment. The SMART-TDLAS Freeze-Dryer Technology was used to dry placebo formulations in laboratory and pilot-scale lyophilizers, demonstrating application at multiple scales.
Copyright © 2022 Physical Sciences Inc. This paper is being presented at the IDS’2020 – 22nd International Drying Symposium in June 26 – June 29, 2022 and is made available as an electronic reprint with permission of IDS.