In bioprocess manufacturing, one of the most challenging mixing procedures is the incorporation of powdered media into solution. Media powders tend to float on the surface of the liquid and effective mixing requires a technique to disperse the powder off the surface and into the bulk liquid. In the development of Mobius® Power MIX single-use mixers at MilliporeSigma, it is determined that the presence of a strong vortex is essential for attaining efficient mixing of media powders.<br/>By employing novel methods to quantify mixing performance and vortex formation, it is possible to generate scalability models for floating powder mixing. Measurement of mixing time is accomplished through not only traditional methods of tracing conductivity and pH, but also through the measurement of particle count and size over time. Extensive vortex mapping is generated in mixers from 100L to 3000L, at multiple volumes and speeds within each system. The key to creating scalability models is to quantify vortex size according to visual observations of the vortex. Models are made to relate vortex size to key process variables, including power input and liquid height. Using this data to create a vortex factor, it is then possible to create a scalability relationship for floating powder mixing throughout the entire series of the Mobius® Power MIX equipment. Case studies are presented to demonstrate the usefulness of the scalability model to predict mixing performance for a variety of media powders, at various process conditions.

Scalability model for mixing cell culture media in single-use GMP bioprocessing equipment

255th National Meeting (2018)

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