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
