DESIGN OF A PILOT PLANT TYPE PHARMACEUTICAL REACTOR TO ADDRESS THE PROBLEM OF INTERCHANGEABILITY OF GENERIC SEMI-SOLID FORMULATIONS

Abstract

The research focuses on the design and development of a pilot plant-type pharmaceutical reactor, emphasizing its volumetric capacity and the way of transferring heat to the interior of the reactor, so that it is capable of reproducing design strategies on a laboratory / pilot scale, control to analyze and make generic semisolid formulations implementing the principles of quality by design (QbD).
From computational fluid dynamics modeling and heat transfer using the finite volume method, its performance and particle trajectory were determined when subjected to the mixing and agitation process with the aim of establishing the optimal parameters and variables for its operation.
In addition, the morphology of the reactor was studied to provide volumetric versatility in its processing, making a rapid prototype on a 1:2.5 scale and subjecting it to mixing, homogenization and color test using different volumes.
As a consequence of this, a useful reactor was obtained to process pharmaceutical semi-solids between laboratory and pilot scale volumes thanks to its volumetric versatility in the same container and also to the way of transferring heat inside it.