Abstract

Continuous manufacturing has received increasing interest because of the advantages of intrinsic safety and enhanced mass transfer in the pharmaceutical industry. However, the difficulty for scale-up has limited the application of continuous manufacturing for a long time. Recently, the tubular flow reactor equipped with the Kenics static mixer appears to be a solution for the continuous process scale-up. Although many influence factors on the mixing performance in the Kenics static mixer have been investigated, little research has been carried out on the aspect ratio. In this study, we used the coefficient of variation as the mixing evaluation index to investigate the effect of the aspect ratio (0.2–2) on the Kenics static mixer’s mixing performance. The results indicate that a low aspect ratio helps obtain a shorter mixing time and mixer length. This study suggests that adjusting the aspect ratio of the Kenics static mixer can be a new strategy for the scale-up of a continuous process in the pharmaceutical industry.

Highlights

  • We used the coefficient of variation as the mixing evaluation index to investigate the effect of the aspect ratio (0.2–2) on the Kenics static mixer’s mixing performance

  • This study suggests that adjusting the aspect ratio of the Kenics static mixer can be a new strategy for the scale-up of a continuous process in the pharmaceutical industry

  • The lack of understanding of mixing performance in milli-scale (1–10 mm) Kenics static mixers hinders the scale-up of this kind of reactor in the pharmaceutical industry

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Summary

Introduction

There has been increasing interest in continuous process in the pharmaceutical industry [1,2,3,4,5]. Hobbs et al [11,12] investigated the effects of injection location, flow ratio, and geometry on the mixing performance of the Kenics static mixer using computational fluid dynamics. Kumar et al [14] studied the mixing behavior in the Kenics static mixer (aspect ratio = 1.5). The mixing performance of the Kenics static mixer with an aspect ratio between 0.2 and 2 is evaluated by computational fluid dynam‐. The effect of the aspect ratio on the number of elements, ments, the mixer length, the mixing time, and the pressure drop of the Kenics static mixers the analyzed mixer length, the mixing time,provide and the new pressure drop the Kenics mixers are are in detail.

Materials and Methods
Coefficient of Variation
Computational Fluid Dynamics
Results and of Discussion
Discussion low
9–11. Thewith mixing
11. Effect
Effect of Aspect Ratio on Mixer Length
Effect of Aspect Ratio on Pressure Drop
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