The advance of the sublimation front during primary drying in a freeze-drying process is one of the most critical parameters whose control is key to understand the drying kinetics for cycle development and validation as well as to ensure process robustness and repeatability during production cycles.
In addition, new GMP conditions updated in Annex 1, makes the lyophilization process more challenging.
The following article presents a new solution to overcome the current market needs with a new PAT tool capable to monitor the advance of the sublimation front temperature interface using single use wireless probes displaying process product temperature data in real time, simplifying the introduction and retrieval logistics and reducing the possible risks of cross-contamination.
