(69g) Design and Application of a Small-Scale 3D Printed Crystallization Apparatus

Transition from batch to continuous pharmaceutical manufacturing has received a significant interest in the past decade, primarily due to the advantages that compact continuous systems offer in terms of efficiency, heat and mass transfer control, and in situ control of product attributes via Process Analytical Technologies (PATs). Pharmaceutical batch manufacturing is only feasible on a large scale and is plagued with issues such as high start up costs, poor scale up performance, and being financially prohibitive for manufacturing orphan drugs. This research is focused on developing an inexpensive 3D printed continuous stirred tank crystallizer. The aim is to apply this technology to lab-scale research as well as small scale production of fine chemicals. An MSMPR (Mixed Suspension Mixed Product Removal) type crystallizer has been designed, that has the capability to be a standalone system in a small-scale continuous production process. By reducing the volume to approx. 100 mL, the cost, complexity, and prohibitive nature of early continuous crystallization development can be greatly reduced while still being large enough to accommodate common PAT probes. This can also be an alternative to a larger scale process as a cost-effective solution for small-volume production. With this 3D printed crystallizer, laboratories testing novel compounds have the opportunity to tailor process development to the intended manufacturing scale and the availability of starting material. Instead of focusing on the production of sample material, workflow can be streamlined towards testing, sample analysis and research of other potentially viable compounds.