Importance of Kv Distribution in Freeze Drying: Part II: Use in Lyo Simulation Modeling.

ABSTRACT

This article is the second of a series of two articles. In the first article of the series, a new Kv distribution model and an experimental methodology to measure the Kv distribution were introduced. In this second part, the Kv distribution is integrated into a lyo-simulation tool, to more accurately predict the variability of the product temperature, primary drying time, total sublimation mass flow and Pirani signal. The Kv distribution is also integrated into the graphical design space. The impact of incorporating the Rp distribution is briefly discussed. The comparison of the simulation tool with actual product temperature monitoring, Pirani signal or overall sublimation flow shows very good agreement in the case studies presented. Overall, the lyo-simulation incorporating the Kv distribution is a very useful tool to support industrial development, i.e. process optimization, scale assessment, technology transfer, and troubleshooting of the lyophilization process.