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A quality by design (QbD) approach as part of process development in the regulated, pharmaceutical industry requires many experiments. Due to the large number, process development is time consuming and cost intensive. A key to modern process development to reduce the number of required experiments is a predictive simulation with a validated physico-chemical model. In order to expand the process expertise of steam distillation through maximum information, a model development workflow is used in this paper, which focuses on implementation, verification, parametrization and validation of a physico-chemical model. Process robustness and sensitivity of target values can be determined from the developed general model and design of experiments with statistical evaluations. The model validation is exemplified by two different types of plant systems, caraway fruits (Carum Carvi) and lavender flowers (Lavandula).

processes

Distinct and Quantitative Validation for Predictive Process Modelling in Steam Distillation of Caraway Fruits and Lavender Flower Following a Quality-By-Design (QbD) Approach