Telstar Develops Pioneering Single-Use Real-Time Sublimation Front-End Monitoring System for GMP Freeze Dryers

Insight

  • Post by : PA
  • Source: Telstar
  • Date: July 27, 2022

Telstar has developed a new sensor capable of monitoring in real time the progress of the sublimation front in GMP freeze-drying processes. A single-use probe, containing 5 independent temperature sensors including wireless communication which is placed inside the bottle, makes it an innovative system capable of precisely monitoring the progress of the sublimation front, key to optimizing the steps primary drying agents in freeze-drying processes.

The advance of the sublimation front during the primary drying in a lyophilization process is one of the most critical parameters whose control is essential to understand the kinetics of drying.

The new Sublime probe offers five measurement points with a minimum pitch of 2.5 mm integrated into each probe which, placed inside the bottle, allows the temperature of each level of the product to be monitored in real time.

Sublime probes are coated with FDA approved material and are available in 5 different sizes to fit any vial size from 2R to 100R. A single system can contain up to 50 probes per lyophilization batch. Without cables or batteries, the probes work with patented wireless power transmission technology and with a reading interval of 1 minute and can operate continuously between -60ºC and +60ºC. Additionally, the probes are designed as a single-use device. After using them in a freeze-drying batch, they are discarded. There is no need to retrieve them and go through a manual washing and sterilization process to be reused in the next batch, simplifying operations and eliminating any risk of cross-contamination.

Sublime probes work thanks to a proprietary gateway managing the power transmission as well as the temperature readings. This gateway can operate as a standalone station or can be integrated with the freeze dryer’s supervisory system (SCADA), including GAMP5 and 21CFR part11 compliant software. The Sublime Probe System can be integrated into any new freeze dryer or can be easily retrofitted into existing freeze dryers of any brand.

The Telstar Sublime system will be displayed at ACHEMA (Frankfurt from August 22 to 26, 2022). Stand C49 – Room 3.1

About Shirley L. Kreger

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