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Purpose <p>This work presents a feasibility study for the transition of a batch mixing process into a continuous mixing process. The study focuses on the material characterization, continuous mixing system characterization, and the development of a real-time monitoring model using Partial Least Squares with a microNIR spectrometer.</p> Method <p>Experimental work included material characterization, the development and validation of the PLS calibration model, and characterization of the gravimetric feeders, the continuous mixer, and the stream sampler.</p> Results <p>Material characterization showed a free-flowing behavior, with low compressibility, and a not significant flow resistance, indicating suitable properties for continuous mixing. The feeders exhibited low variability within the ranges of mass flow rate in the calibration and test set blends. The mixer RPM was determined through an in-line spectral analysis and off-line calibration model. The optimal mixing conditions were found at 200 RPM. The stream sampler achieved optimal conditions at 8.08 RPM, reaching a throughput of 35.5 Kg/h with a reproducible powder dynamic in the sampling window. The effective sample mass yielded an average of 83&#xa0;mg.</p> Conclusion <p>The model predicted API concentrations using the test set blend, with a global RMSEP, RSEP, and bias of values 0.424, 0.521, and − 0.005% w/w respectively, and an RSD of prediction below 0.72%. The model showed good accuracy, precision, and performance, monitoring the blend uniformity of API. Variographic analysis assessed the process variations, indicating low variability in the process conditions. In general, this study demonstrated the feasibility of a commercial product transitioning into a continuous mixing process.</p>

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Effects of the Operating Parameters for a High API Concentration Continuous Mixing Process Feasibility Study

  • 期刊论文

  • 发表日期：

    2025年6月11日

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  • Juan M. Nasrala-Alvarez,
  • Dhavalkumar Patel,
  • Carlos Flores,
  • Rodolfo J. Romañach,
  • Rafael Mendez

摘要

Purpose

This work presents a feasibility study for the transition of a batch mixing process into a continuous mixing process. The study focuses on the material characterization, continuous mixing system characterization, and the development of a real-time monitoring model using Partial Least Squares with a microNIR spectrometer.

Method

Experimental work included material characterization, the development and validation of the PLS calibration model, and characterization of the gravimetric feeders, the continuous mixer, and the stream sampler.

Results

Material characterization showed a free-flowing behavior, with low compressibility, and a not significant flow resistance, indicating suitable properties for continuous mixing. The feeders exhibited low variability within the ranges of mass flow rate in the calibration and test set blends. The mixer RPM was determined through an in-line spectral analysis and off-line calibration model. The optimal mixing conditions were found at 200 RPM. The stream sampler achieved optimal conditions at 8.08 RPM, reaching a throughput of 35.5 Kg/h with a reproducible powder dynamic in the sampling window. The effective sample mass yielded an average of 83 mg.

Conclusion

The model predicted API concentrations using the test set blend, with a global RMSEP, RSEP, and bias of values 0.424, 0.521, and − 0.005% w/w respectively, and an RSD of prediction below 0.72%. The model showed good accuracy, precision, and performance, monitoring the blend uniformity of API. Variographic analysis assessed the process variations, indicating low variability in the process conditions. In general, this study demonstrated the feasibility of a commercial product transitioning into a continuous mixing process.