TEMPRIS for Lyophilisation - Freeze-dryer Monitoring

TEMPRIS Features

• wireless sensor, no battery
• passive design, no thermal dissipation
• real time monitoring, no logging device ("data logger") needed, data transmission via 2.4 GHz ISM band (worldwide approval), unlimited data volumes stored on remote PC
• high accuracy, for exact monitoring of product temperature during process (+/- 1%FS)
• sterilizable
• sensors compliant to FDA 21 CFR Part 11
• general PAT (Process Analysis Techniques) tool
• easy retrofit of existing equipment possible

TEMPRIS Product Video

Special Considerations for Lyophilisation

Independent scientific research of the Freeze-Drying Focus Group (University of Erlangen, Germany) resulted in the following facts:

• no differences in the freezing behaviour in vials equipped with TEMPRIS sensors in direct comparison with vials equipped with thermocouples
• very flexible alternative for upgrade/replacement of thermocouples in any type of LYO chamber (up to 16 additional sensors)
• very good correlation of the measured temperature profile during primary drying between TEMPRIS data and thermocouple data
• very good compliance (+/-1° K) with the calculated temperature distribution over the whole product batch according to Manometric Temperature Measurements (MTM)
• TEMPRIS shows good sensitivity for endpoint detection for primary drying because of the special geometry of the sensitive sensor apex
• even solutions with high solid content do not affect the TEMPRIS data
• TEMPRIS easily allows the transfer of different "edge" and "center" profiles from the laboratory equipment up to production equipment by means of identical sensors ("quick migration")

Example of a freeze-drying run monitored by TEMPRIS probes
TC-e = thermocouple, edge vial / T-e = TEMPRIS, edge vial
TC-c = thermocouple, center vial / T-c = TEMPRIS, center vial

TEMPRIS Lyophilisation Downloads

You can download any of the following documents to your computer by right-clicking the document link and selecting the Save Target As... function from your web browser.

• Leaflet - TEMPRIS for Lyophilisation
  [ PDF File; 820 KB ]