Concept

Spin freezing

During freezing, vials are rapidly rotated along their longitudinal axis while the flow of an inert and cold gas cools the drug formulation leading to the solidification of the product over the entire inner vial wall. As a result, a thin product layer with an increased area for ice sublimation is obtained, speeding up the drying process and allowing the continuous processing of these vials.

Continuous drying

Efficient and uniform drying of the spin frozen vials is obtained by applying non-contact radiative energy transfer towards the complete vial surface. For each spin frozen vial there is an individual infrared heater allowing to control and optimize the entire drying trajectory.

Model based design and control

  • Process developed and designed for purpose based on first principle understanding
  • White box process
  • Allows fast model based formulation and process development (i.e., optimized product quality and process efficiency) with very limited material consumption, providing important shorter time-to-market opportunities
  • Allows design space determination with risk control
  • Essential for optimal process monitoring, process control & real-time release
  • Digital twin: support and substantiate design and engineering decisions
  • A software tool is developed and available based on first principle process models, supporting fast formulation and process development with very limited material consumption.