Encrustation in Continuous Pharmaceutical Crystallization Processes-A Review

被引:34
|
作者
Acevedo, David [1 ]
Yang, Xiaochuan [1 ]
Liu, Yiqing C. [1 ,2 ]
O'Connor, Thomas F. [1 ]
Koswara, Andy [2 ]
Nagy, Zoltan K. [2 ]
Madurawe, Rapti [1 ]
Cruz, Celia N. [1 ]
机构
[1] US FDA, Off Pharmaceut Qual, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA
[2] Purdue Univ, Davidson Sch Chem Engn, W Lafayette, IN 47907 USA
关键词
continuous crystallization; encrustation; risk mitigation; control strategy; continuous pharmaceutical manufacturing; DIRECT NUCLEATION CONTROL; MIXED-SUSPENSION; HEAT-EXCHANGERS; HETEROGENEOUS NUCLEATION; BATCH; SHAPE; INCRUSTATION; PREVENTION; DEPOSITION; INITIATION;
D O I
10.1021/acs.oprd.9b00072
中图分类号
O69 [应用化学];
学科分类号
081704 ;
摘要
Encrustation is a risk factor that can cause product and process failure in continuous crystallization processes. Mitigation, prevention, and control of encrustation have been extensively researched. Various risk mitigation strategies proposed in the literature, such as coating of crystallizer walls, use of additives to control encrustation kinetics, and periodic steady-state operation show promising results in delaying or preventing encrustation. Because of the increased interest in the use of continuous crystallization in industrial applications, it is important to understand this risk factor further. This review presents recent developments on dynamic models, mechanisms, and risk factors for encrustation in continuous crystallization processes. Various design and control strategies to mitigate the encrustation risk are also summarized. Appropriate control strategies should be implemented during continuous crystallization to avoid the impact of encrustation on drug substance quality.
引用
收藏
页码:1134 / 1142
页数:9
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