The impact of a Lyometrics PAT tool to monitor the temperature of product during primary drying to assist the final user in the design and scaling up of freeze-drying recipes.

A new non-invasive monitoring technique enables measurement of product interface temperature during primary drying under developmental or full production conditions, collecting more accurate, complete and reliable information, rather than physical probes. The new development utilizes a soft sensor technology that provides on-line monitoring of the global batch temperature which serves as a useful tool to design a freeze drying recipe and to perform the scaling up. This case study shows the results after implementing a continuous monitoring of product interface temperature during the lyophilization process of a high valued formulation product.