MOST API's REQUIRES CRYSTALLISATION
Controlling process performance
Most of the world's pharmaceutical API’s require at least one crystallisation step during their manufacturing process. Traditionally, the quality of the crystallisation process performance is determined through an off-line sample analysis of the physical and chemical quality attributes of the API crystals, after the process is complete. At this point, it is too late to resolve any quality issues. This method of testing offers no control over the manufacturing process, resulting in variable product quality, variable yields, and a proportion of batch rejects or reworks, with heavy costs associated.