Sublimation Model – Calculation Tool

Optimal Primary Drying Settings

RheaVita has developed first principle models for the optimization of the entire continuous freeze-drying process. With only a limited amount of material, the most critical product and process parameters are characterized. These parameters are fed into the model, allowing for the calculation of the optimal process settings to obtain the dried product as efficiently as possible while meeting all Critical Quality Attributes.

The results below are generated using a tutorial version of the RheaVita sublimation tool, based upon the continuous primary drying model. Primary drying is often considered to be the most time-consuming step of the lyophilization process. This sublimation tool calculates the primary drying time using the RheaVita continuous freeze-drying technology, and allows for the estimation of increased efficiency as compared to standard batch freeze-drying. By providing the filling volume, the chamber pressure, and the critical product temperature, this model computes the most efficient dynamic primary drying conditions, i.e., the IR heater power as a function of the primary drying time. This allows for the fastest possible ice sublimation without exceeding the critical product temperature.

For more information about the RheaVita continuous freeze-drying technology and the RheaVita process development and optimization services, please get in contact with our enthusiastic team of lyo process specialists via info@rheavita.com.

In this tutorial, the use of a 10R vial is assumed and the given parameter ranges are adapted to this specific vial type. In the extended version of the RheaVita sublimation tool, the following parameters can be given as model input to compute the optimal primary drying settings, without limitations:

  • Filling volume
  • Chamber pressure
  • Critical Product Temperature
  • Vial type/Vial dimensions
  • Dried product mass transfer resistance parameters