Incorporation and Characterization of a Mixing Elbow on the Pilot Plant Scale for a Mixing Sensitive Crystallization of an API

A mixing elbow was, for the first time, characterized on the pilot plant scale using the Fourth Bourne Reaction to obtain a correlation for mixing time using the approach of Johnson and Prudʹhomme and Mahajan and Kirwan. The elbow was applied for a semicontinuous mixing sensitive crystallization of an API (Active Pharmaceutical Ingredient) on the pilot plant scale to offer a means of controlling secondary nucleation and providing rapid mixing to eliminate local regions of high supersaturation. The application of the mixing elbow for the API crystallization resulted in a change in particle morphology in the form of single crystals rather than dense agglomerates that were observed in the absence of a mixing elbow.