TEMPRIS (Temperature Remote Interrogation System) is a wireless, battery-freereal-time temperature measurement system and innovative PAT tool in the field of lyophilization. TEMPRIS wireless temperature measurement addresses the various areas of lyophilization process right from cycle development in laboratory, scale-up and technology transfer, freeze dryer qualification and monitoring in production.
One of the most important critical product parameters in a freeze drying process is the product temperature (at the sublimation interface (Tp) and at the bottom of the vial (Tb), respectively). The product temperature must not exceed the critical formulation temperature given by the physicochemical properties of the formulation in order to prevent shrinkage, collapse or melt-back. The system simplifies monitoring of hard-to-reach and severe environments such as :granulation, retorts, lyophilization, tunnels, vacuum dryers, temperature chambers, sterilizers, ovens, stability chambers.
TEMPRIS features a quartz based sensor, operating on the principle of temperature dependent resonance: after excitation by a modulatedmicrowave signal (2.4 GHz) the sensor keeps on oscillating in a temperature dependent frequency. Overlaying the sensorresponse with the carrier signal leads to a frequency shift from which the product temperature Tb can be derived.
Key features and benefits of TEMPRIS include-wireless technology for easy handling and suitable for cGMP environment, no battery required and no energy input into product thus reducing freezing bias, real-time measurement for better and rapid process monitoring and control, measurement range of -60°C to +40°C, accuracy of +/- 0.5°C @ -50°C to + 40°C on the representative data, positioning device for exact center bottom position for reliable data, up to 16 sensors for extensive monitoring of batch feasible, compatible with ALUS (Automatic Loading and Unloading System) to use in production environment, data output with SCADA, CSV for exporting to common data processing software.
Tempris® Sensors is successfully used by:
Roche – Novartis – BoehringerIngelheim – Pfizer – Cilag – Bayer – Sandoz – BMS – Amgen – Fresenius – Octapharma – Famar – Oncotec – Recipharm – CSL Behring – BSP Pharmaceuticals – Genentech – Hermes – GILYOS, Dr Reddy’s, Gland Pharma , Mylan.
- Wireless, easy to handle
- Without battery
- Upto16 sensors in a freeze dryer providing for extensive monitoring
- Shorter cycle times
- Improved quality through knowledge ofTp higher utilization of freeze-dryers
- Significant cost savings
- PAT tool
- cGMP/GAMP 5 compliant.