造粒
工艺工程
灵敏度(控制系统)
设计质量
医药制造业
关键质量属性
过程分析技术
过程(计算)
压实
最终产品
人口
在制品
过程建模
混合(物理)
计算机科学
工程类
粒径
电子工程
操作系统
生物信息学
运营管理
物理
人口学
岩土工程
量子力学
化学工程
社会学
经济
市场经济
生物
作者
Fani Boukouvala,Vasilios Niotis,Rohit Ramachandran,Fernando J. Muzzio,Marianthi Ierapetritou
标识
DOI:10.1016/j.compchemeng.2012.02.015
摘要
Manufacturing of powder-based products is a focus of increasing research in the recent years. The main reason is the lack of predictive process models connecting process parameters and material properties to product quality attributes. Moreover, the trend towards continuous manufacturing for the production of multiple pharmaceutical products increases the need for model-based process and product design. This work aims to identify the challenges in flowsheet model development and simulation for solid-based pharmaceutical processes and show its application and advantages for the integrated simulation and sensitivity analysis of two tablet manufacturing case studies: direct compaction and dry granulation. The developed flowsheet system involves a combination of hybrid, population balance and data-based models. Results show that feeder refill fluctuations propagate downstream and cause fluctuations in the mixing uniformity of the blend as well as the tablet composition. However, this effect can be mitigated through recycling. Dynamic sensitivity analysis performed on the developed flowsheet, classifies the most significant sources of variability, which are material properties such as mean particle size and bulk density of powders.
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