Crystal clear batch - Fiber optic probe helps control batch crystallization in pharmaceutical applications

摘要

The pharmaceutical industry uses batch crystallization routinely for separation of intermediates and purification of the active pharmaceutical ingredient (API). The process is ubiquitous within FDA approved protocols, but it is critical to maintain fine control of the crystallizer operation. Small changes in the raw materials, poorly controlled process variables, and certain impurities can affect the final crystal habit and all downstream unit processes. One solution, a fiber optic probe technology, enables nucleation and dissolution detection as well as an indirect measurement of super-saturation (the driving force for crystal growth), which are valuable capabilities in designing crystallization/purfification systems, scaling-up a defined process, and monitoring batch-to-batch variability in a large-scale, high-volume production environment. (See details on fiber optic probe in the related sidebar, "New fiber optic probe use revealed.")