在流体床干燥过程中预测颗粒水分含量
Paloch Chinwattanawongwan1, Narueporn Sutanthavibul2, Oran Kittithreerapronchai3,4
1Department of Industrial Engineering, Faculty of Engineering, Chulalongkorn University, Bangkok, 10330, Thailand.
AAPS PharmSciTech
|August 14, 2025
概括
湿度-温度探针提供了一种精确的方法来确定制药湿颗粒干燥的终点. 这种基于传感器的方法可以在商业规模的液化床干燥机中提供准确的水分含量监测.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 工艺工程的过程工程.
- 分析化学 分析化学
背景情况:
- 制造过程的持续时间会影响药品的质量.
- 准确的终点确定对于稳定的颗粒质量至关重要.
- 传统方法包括时间和属性定义的终点.
研究的目的:
- 为了评估湿度-温度探针和近红外 (NIR) 光谱,用于监测颗粒的水分含量.
- 为了比较这些方法在商业规模的流化床干燥器 (FBD) 中对终点确定的准确性.
- 在制药干燥过程中确定实用和精确的解决方案,以实时监测制药干燥过程中的水分.
主要方法:
- 在商业规模的液化床干燥机 (FBD) 上进行的实验处理了250公斤的湿颗粒.
- 在输入/输出空气管道上使用湿度-温度传感器探针进行连续数据收集.
- 使用近红外 (NIR) 光谱仪与光纤探针用于手动采集光谱数据.
- 使用这两种方法的数据开发了含水量 (MC) 的预测模型.
- 使用根平均平方误差 (RMSE) 评估模型准确性.
主要成果:
- 湿度-温度探针模型显示了MC的更高的预测准确性,RMSE为0.11.
- 该NIR光谱模型实现了较低的预测准确度,RMSE为0.29.
- 在整个干燥过程中,基于传感器的监控被证明是实时MC跟踪的有效方法.
结论:
- 湿度-温度探针为商业规模的FBD操作中终点确定提供了精确和实用的解决方案.
- 基于传感器的湿度含量监测为此应用提供了与NIR光谱相比更高的精度.
- 这种方法可以加强对干燥过程的控制,从而有可能提高制药品质量.
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