连续制造药品制造流程的综合数据管理和信息框架:对两个试点工厂的案例研究
Yingjie Chen1, Chaitanya Sampat2, Yan-Shu Huang3
1Department of Chemical and Biomolecular Engineering, University of Delaware, Newark, DE 19716, USA.
International journal of pharmaceutics
|May 31, 2023
概括
本研究指导了工业4.0下连续制药制造的数据集成,增强数字成熟度,并使数字双胞胎能够提高效率.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 工业4.0 工业4.0 工业4.0 工业4.0 工业4.0 是什么?
- 数据整合数据集成
背景情况:
- 制药行业正在向连续制造和数字化转型.
- 综合数据管理和信息化工具对于这种转变至关重要.
- 工业4.0技术是过程开发的关键推动者.
研究的目的:
- 引导用于连续制药制造的数据集成的发展.
- 在工业4.0框架内提高数字成熟度.
- 为了促进制药过程的数字双胞胎的创建.
主要方法:
- 在学术试点项目中展示数据整合框架.
- 展示整合结构和信息流.
- 讨论复杂数据流缓解的方法.
主要成果:
- 在试点工厂中成功使用数据整合框架.
- 关于整合结构和信息流的全面细节.
- 用于整合多样化的数据源和确保安全的缓解策略.
结论:
- 开发的数据整合框架提高了连续制药制造业的数字成熟度.
- 该框架支持数字双胞胎的发展.
- 确定了工业4.0实施的实际挑战和机会.
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