Three Key Restrictions Limit the Design Space of the Lyophilization Process:

1 Collapse temperature

2 Safe process temperature

3 Choked flow regime, which is limited by the performance of the freeze-dryer.

  • Previous methods provided only average values, but did not determine variance from a large number of samples of measured values. As a result, the design space typically relies on safety margins based on experience and guesswork.
  • The freeze-dryers are underutilized, and there’s a lack of quality control for these margins.
  • Determination of the process parameters by AI for optimized freeze-dryer performance
Conservative method with a big safety margin

The design space of the freeze-drying process. Simplified depiction of a design space – a multidimensional representation of equipment capability limit and product knowledge