Automatic freeze drying endpoint determination for vials application
Automatic freeze drying endpoint determination for vials application on Lyovapor™ L-300 Pro by pressure difference test, pressure rise test and temperature difference test
Freeze-drying is a self-contained process in which samples cannot be easily analysed in real-time to detect their residual moisture content. Process optimization, in particular the required process time to obtain a dry and stable product, often relies on a trials-and-error approach. In this application note, a combination of different process analytical technologies was applied to determine the endpoint of primary and secondary drying of mannitol solutions in a laboratory freeze-dryer (Lyovapor™ L-300). A setup with serum tubing vials on temperature-controlled shelves was used. The indirect tracking of drying progress via in-situ measurements of sample parameters enables an instant adjustment of process time in a running freeze-drying cycle. It contributes to faster parameter optimization according to the required residual moisture content of the product. Furthermore, these analytical techniques provide essential tools to monitor the process reproducibility.
