Abstract
A discrete element model (DEM) has been developed for an industrial batch bin blender in which three different types of materials are mixed. The mixing dynamics have been evaluated from a model-based study with respect to the blend critical quality attributes (CQAs) which are relative standard deviation (RSD) and segregation intensity. In the actual industrial setup, a sensor mounted on the blender lid is used to determine the blend composition in this region. A model-based analysis has been used to understand the mixing efficiency in the other zones inside the blender and to determine if the data obtained near the blender-lid region are able to provide a good representation of the overall blend quality. Sub-optimal mixing zones have been identified and other potential sampling locations have been investigated in order to obtain a good approximation of the blend variability. The model has been used to study how the mixing efficiency can be improved by varying the key processing parameters, i.e., blender RPM/speed, fill level/volume and loading order. Both segregation intensity and RSD reduce at a lower fill level and higher blender RPM and are a function of the mixing time. This work demonstrates the use of a model-based approach to improve process knowledge regarding a pharmaceutical mixing process. The model can be used to acquire qualitative information about the influence of different critical process parameters and equipment geometry on the mixing dynamics.
Highlights
Powder mixing is a widely implemented unit operation in several particulate processing industries for combining two or more raw materials in the required proportions into a final blend
It should be noted that the results reported have been obtained from a model-based analysis, which qualitatively represents the scenario detailed in Section 1.1
A mathematical model has been developed based on the discrete element model (DEM) methodology for an industrial batch bin blender, where three different types of materials (API 1, active pharmaceutical ingredients (APIs) 2 and the extra granular phase) are mixed
Summary
Powder mixing is a widely implemented unit operation in several particulate processing industries (e.g., food, pharmaceutical, chemical, etc.) for combining two or more raw materials in the required proportions into a final blend (mixture). Various industrial blenders with different mixing mechanisms are available and can be chosen based on the processing requirements. Due to the presence of multiple zones, which demonstrate different mixing behavior in a tumbling blender, understanding the process dynamics in detail would be beneficial for optimal process design. These zones have variable blend uniformity (e.g., presence of super-potent and sub-potent zones). DEM calculates the total force acting on the particles due to particle-particle contacts and particle-boundary contacts (contact forces) and other body forces, for example the force of gravity It computes the acceleration or velocity using Newton’s second law and updates the particle position based on the velocity information. A very small overlap (or deformation) may be allowed
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