Digital design and operation of continuous crystallization processes via mechanistic modelling

Mechanistic models are becoming more commonly applied for Research and Development in the pharmaceutical sector to gain process understanding, enable process design and operation. Traditionally, the output from this activity is a validated mechanistic model, which is capable of quantitatively predicting the behaviour of the various Critical Quality Attributes CQA) for typical batch or continuous pharmaceutical processes for a wide range of Critical Process Parameters (CPP). However, these tools are almost exclusively employed in an offline manner currently to enable digital design efforts, primarily aimed at assessing process robustness and variability, with very little subsequent online application of the mechanistic model to enable control or soft sensing.