Measurement uncertainty issues in freeze-drying processes

This paper deals with problems that have to be faced when performing mass and temperature measurements of substances subjected to freeze-drying processes. A brief description of a lyophilization process is initially presented and a deep investigation is performed in order to identify the main uncertainty contributions that affect mass and temperature measurements. A measurement system is then described that has been specifically conceived to work inside a freeze-dryer. Experimental results are reported that refer to the metrological characterization of the proposed measurement system and to its use for the monitoring of real freeze-drying processes. Experimental tests are also described that have been conceived to estimate the uncertainty contributions strictly related to this specific application.

► Freeze-drying process review to highlight the main uncertainty contributions. ► Measurement system specifically conceived to operate in a harsh environment. ► Mass and temperature uncertainty estimation in freeze-drying processes. ► Experimental results related to characterization and use of the proposed system. ► Main uncertainty contribution mainly due to the definitional uncertainty.