Monitoring of the primary drying of a lyophilization process in vials

Abstract

An innovative and modular system ( LyoMonitor) for monitoring the primary drying of a lyophilization process in vials is illustrated: it integrates some commercial devices (pressure gauges, moisture sensor and mass spectrometer), an innovative balance and a manometric temperature measurement system based on an improved algorithm (DPE) to estimate sublimating interface temperature and position, product temperature profile, heat and mass transfer coefficients. A soft-sensor using a multipoint wireless thermometer can also estimate the previous parameters in a large number of vials. The performances of the previous devices for the determination of the end of the primary drying are compared. Finally, all these sensors can be used for control purposes and for the optimization of the process recipe; the use of DPE in a control loop will be shown as an example.