Improving Continuous Loss-in-weight Feeding Accuracy by a Novel Hopper Design

IF 2.7 4区 医学 Q2 PHARMACOLOGY & PHARMACY Journal of Pharmaceutical Innovation Pub Date : 2024-09-23 DOI:10.1007/s12247-024-09858-2
Sara Fathollahi, Valjon Demiri, Theresa R. Hörmann-Kincses, Snjezana Maljuric, Julia Massoner, Greg Mehos, Johannes G. Khinast
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Abstract

Purpose

Powder feeding is a vital unit operation in the continuous manufacturing of pharmaceutical products. Loss-in-weight twin-screw feeders are commonly used in continuous manufacturing lines. The feeding performance, i.e., the accuracy and consistency of feeding, influences the content uniformity of the final drug product. In this study, a redesigned hopper for K-Tron KT20 twin-screw feeder was designed, implemented, and investigated to improve feeding performance. The basic idea was to design the hopper in such a way that the stresses on top of the screw entrance are independent of the fill level.

Methods

Our study compared the novel system to that of the original cylindrical hopper. The effect of the redesigned hopper on the start-up, the process’ sensitivity to refill level, and the refill portion size were studied. A free-flowing, barely compressible powder and a compressible blend were used in this study to evaluate the feeding performance and the refill effects.

Results

When using compressible powders, the results showed a larger process window for refilling in the redesigned hopper and a lower refill-level sensitivity compared to the original hopper.

Conclusion

The homogenization of stresses in the redesigned hopper allowed operating at lower refill levels, and variability, especially due to refilling, was reduced. This study demonstrates novel design approaches for successfully implementing hard-to-feed materials in continuous manufacturing.

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通过新型料斗设计提高连续失重喂料精度
目的粉末喂料是连续生产医药产品的重要单元操作。失重式双螺杆喂料机通常用于连续生产线。喂料性能,即喂料的准确性和一致性,影响着最终药物产品的含量均匀性。本研究为 K-Tron KT20 双螺杆喂料机设计、实施和研究了重新设计的料斗,以提高喂料性能。我们的研究将新系统与原始圆柱形料斗进行了比较。研究了重新设计的料斗对启动的影响、工艺对加料水平的敏感性以及加料部分的大小。结果当使用可压缩粉末时,结果表明与原始料斗相比,重新设计的料斗具有更大的加料过程窗口和更低的加料水平敏感性。结论重新设计的料斗应力均匀,可以在较低的加料水平下运行,并且减少了可变性,特别是由于加料引起的可变性。这项研究展示了在连续生产中成功实施难喂材料的新型设计方法。
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来源期刊
Journal of Pharmaceutical Innovation
Journal of Pharmaceutical Innovation PHARMACOLOGY & PHARMACY-
CiteScore
3.70
自引率
3.80%
发文量
90
审稿时长
>12 weeks
期刊介绍: The Journal of Pharmaceutical Innovation (JPI), is an international, multidisciplinary peer-reviewed scientific journal dedicated to publishing high quality papers emphasizing innovative research and applied technologies within the pharmaceutical and biotechnology industries. JPI''s goal is to be the premier communication vehicle for the critical body of knowledge that is needed for scientific evolution and technical innovation, from R&D to market. Topics will fall under the following categories: Materials science, Product design, Process design, optimization, automation and control, Facilities; Information management, Regulatory policy and strategy, Supply chain developments , Education and professional development, Journal of Pharmaceutical Innovation publishes four issues a year.
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