A new generation of PAT sensors
Telstar has developed a new sensor capable of monitoring the advance of the sublimation front in real time in GMP freeze-drying processes. A single-use probe, containing 5 independent temperature sensors including wireless communication which is placed within the vial, makes it an innovative system able to monitor the advance of the sublimation front accurately, key to optimize the primary drying steps in lyophilization processes.
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. The new Sublime probe offers five measuring points with a pitch of minimum 2,5mm integrated in each probe which, placed within the vial, allows to monitor the temperature of each level of the product in real time.
Sublime probes are coated with an FDA approved material and are available in 5 different formats to fit in any vial size from 2R to 100R. A single system can hold up to 50 probes per freeze drying batch. Without cables or batteries, the probes work with a patented wireless power transmission technology and with a reading interval of 1 minute and can work seamless between -60ºC and +60ºC. On top of this, the probes are designed as a single-use device. After using them in a freeze-drying batch they are disposed. There is no need to recover them and go through a manual process of washing and sterilizing to be reused in the next batch, which simplifies the operations and eliminates any cross-contamination risk.
Sublime probes work thanks to a proprietary gateway managing the power transmission as well as the temperature readings. This gateway can work as a standalone station or can be integrated to the supervisory system (SCADA) of the freeze dryer, including a GAMP5 and 21CFR part11 compliant software. Sublime probes system can be built in any new freeze dryer or can be easily retrofitted in existing freeze driers of any brand.