Abstract
Ampicillin is a key β-lactam antibiotic listed as a World Health Organisation (WHO) Essential Medicine . Crystallisation is a unit operation of paramount importance in pharmaceutical manufacturing, whose design and operation are essential in controlling process yield and important product quality attributes, such as mean product crystal size (MCS) and size distribution width. A published model for the solubility of ampicillin as a function of pH as well as growth and nucleation kinetics is used towards the simulation and optimisation of its batch crystallisation. This study performs multi-objective dynamic optimisation of the batch crystallisation of ampicillin to establish optimal pH trajectories for different production objectives, including maximising the mean crystal size whilst minimising the size distribution width subject to various yield constraints. Trade-offs between different product quality attributes are thus quantified, visualised and discussed.
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