(125f) Continuous Crystallization Development for the End-to-End Manufacturing of Ciprofloxacin HCl in Refrigerator-Sized Modules
This work was part of the development of an end-to-end process for Ciprofloxacin hydrochloride in compact, reconfigurable modules. The overall process is divided in four steps, namely: synthesis, workup, isolation, and formulation. This presentation will focus on the downstream modules for workup and isolation, including continuous precipitation of Ciprofloxacin base as an intermediate and the final separation of Ciprofloxacin hydrochloride monohydrate via continuous crystallization.
The process development milestones are described first, with particular focus on how the critical crystallization conditions were selected and the role of each MSMPR step on defining the drug substanceâs critical quality attributes. Then, the workup and isolation parts of the end-to-end manufacturing campaign are described, with emphasis on how the MSMPR processes were integrated with fundamentally batch processes (e.g. filtration, drying), and how the implemented process controls ensured an extended continuous operation and a consistent drug substance quality.