Analyze The Crystallization Path That Occurs During Cooling

Abstract

The pharmaceutical and fine chemical industries rely heavily on crystallisation for the separation and purification of substances. In pharmaceutical active ingredient manufacturing, crystallisation procedures have generally been recipe-based operations, with minimal room for dynamic process control or modification. Traditional crystallisation techniques for pharmaceutical active ingredients were recipe-based, leaving little room for process control and modification. As the regulatory climate shifts from quality-by-testing (QbT) to quality-by-design (QbD) and the process analytical technology (PAT) push takes hold, now is an ideal time to investigate the impact of such quality-based attention on crystallisation control.