通过使用合的3D设备CFD和1D瓶尺度模拟来实现冷化初级干燥的数字双胞胎
Matej Zadravec1, Efimia Metsi-Guckel2, Blaz Kamenik3
1Research Center Pharmaceutical Engineering (RCPE) Graz Austria; University of Maribor Faculty of Mechanical Engineering Slovenia.
概括
一个新的数字双胞胎集成设备和小瓶模型,用于冷凍化扩展. 这种方法通过准确预测过程参数和处理干扰来确保强大的药物制造.
科学领域:
- 制药工程 制药工程
- 过程建模和仿真过程建模和仿真
- 化学工程是化学工程的重要组成部分.
背景情况:
- 传统的冷化模型往往是设备特定的或小瓶特定的,限制了全面的过程理解.
- 扩大冷化工艺需要准确的建模,以成功转让技术和制造高质量的药物产品.
研究的目的:
- 为冷化单元开发一个集成的数字双胞胎,以实现从实验室到商业制造的无扩展.
- 通过考虑设备和瓶子相互作用来提高冷化工艺设计的稳定性.
主要方法:
- 开发了一种双向合模型,将计算流体动力学 (CFD) 集成为设备和1D模拟用于瓶尺度.
- 执行了冰板测试的稳定状态CFD模拟,以确定设备能力曲线.
- 进行过渡,合的3D CFD和1D瓶尺度模拟,以建模初级干燥阶段.
主要成果:
- 综合模型在各种条件下准确确定了产品温度,升华率和循环时间.
- 成功模拟了初级干燥阶段,捕捉了冷机内的时间和空间动态.
- 数字双胞胎在分析流程干扰和故障场景方面表现出了能力.
结论:
- 综合数字双胞胎方法促进了可靠的扩展和冷化过程的技术转让.
- 这种建模策略增强了对过程的理解,并使更强大的冷化循环的设计成为可能.
- 开发的数字双胞胎是确保在商业规模上制造高质量的药物产品的宝贵工具.
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