A New Tool for Monitoring Pharmaceutical Freeze Drying

The paper discusses how through the combination of TDLAS Near-IR spectroscopic measurements and a well-established heat and mass transfer model describing freeze drying, users can obtain information about key process parameters affecting end product quality.

The white paper provides an informative introduction to the physics behind the TDLAS principle of operation. The authors also describe the application of the technique, using the SP Scientific LyoFlux 200 LyoFlux sensor, to primary and secondary freeze drying endpoint and product temperature determinations. In addition to the determination of process endpoints and product temperatures, the LyoFlux 200 TDLAS sensor can be used to assess freeze dryer equipment capability limits, monitor process and product parameters and also for developing drying cycles based upon Quality by Design procedures.

In summary, the white paper shows how the LyoFlux 200 TDLAS sensor provides a unique measurement capability that provides autonomous and continuous water vapor mass flow determinations throughout the freeze drying process. LyoFlux is therefore applicable to laboratory, pilot and production scale freeze dryers, enabling use of this PAT tool for process scale-up and process control.

To download a copy of this white paper please visit www.spscientific.com/ArticlesAndTechnicalPapers/?q=Application+of+TDLAS**. For further information on the LyoFlux 200 please contact SP Scientific on +1-845-255-5000 or email shireen.scott@spscientific.com.

SP Scientific is a leading manufacturer of laboratory to production scale freeze dryers / lyophilizers, centrifugal evaporators and concentrators, thermal control system and glassware washers. The company sells its products under well-known brands including VirTis, Hull, FTS Systems, Genevac, and National-Hotpack. SP Scientific has ISO 9001:2008 registered production facilities in the USA and Europe.