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连续操作胶囊灌装机的停留时间分布:测量技术的开发及三种缩径插件的比较。

Residence time distribution of a continuously-operated capsule filling machine: Development of a measurement technique and comparison of three volume-reducing inserts.

机构信息

Research Center Pharmaceutical Engineering GmbH, Graz, Austria.

Research Center Pharmaceutical Engineering GmbH, Graz, Austria; Institute for Process and Particle Engineering, Graz University of Technology, Graz, Austria.

出版信息

Int J Pharm. 2018 Oct 25;550(1-2):180-189. doi: 10.1016/j.ijpharm.2018.08.017. Epub 2018 Aug 12.

Abstract

This paper presents the measurement and analysis of the residence time distribution (RTD) of a tamping-pin capsule filling machine. The tamping speed and the amount of material inside the powder bowl proved to have a significant effect on the RTD. Various inserts into the powder bowl that reduce the volume and alter mixing and transport in the bowl were experimentally investigated. To obtain the RTD, a tracer-based measurement method was applied and a sophisticated data processing strategy was developed. The tracer-based method also allowed investigations of stagnant zones in the powder bowl, another important aspect in continuous manufacturing (CM). The suitability of tracer material was assessed based on a detailed characterization of bulk and tracer material. Characteristic parameters of the RTD were extracted and compared, proposing a systematic strategy for selection of a suitable insert.

摘要

本文介绍了一种用于测量和分析捣固销钉式胶囊灌装机停留时间分布(RTD)的方法。捣固速度和粉末碗内物料的量对 RTD 有显著影响。实验研究了各种插入粉末碗中的插入物,这些插入物可以减小体积并改变碗内的混合和输送。为了获得 RTD,应用了基于示踪剂的测量方法,并开发了一种复杂的数据处理策略。基于示踪剂的方法还允许研究粉末碗中的停滞区,这是连续制造(CM)中的另一个重要方面。基于对散装和示踪材料的详细特性描述,评估了示踪剂材料的适用性。提取并比较了 RTD 的特征参数,提出了一种选择合适插入物的系统策略。

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