Mixing Operations For 50 L to 2000 L Single-Use Mixer: Liquid-Liquid Mixing Characterization And Slurry Suspension

Mixers are employed throughout all parts of bioprocessing. Single-use mixers (S.U.M.) are commonly used for both upstream and downstream operations. Upstream operations can include media formulation and hydration, media holding, and sterile filtration. Downstream operations can include product storage, viral inactivation, buffer preparation, and slurry preparation for column packing. Correct mixing parameters and control are key elements for successful mixing operations particularly in the transition from non single-use platform to single-use platforms. This study presents the automation of simple mixing procedures using the Thermo Scientific™ HyPerforma™ S.U.M. with Touchscreen Console. Also reported is the selection method for scalable mixing parameters allowing normalized mixing performance across all single-use mixer sizes.

The following applications are demonstrated in this study: Characterization of scalable mixing parameters by comparing power input per volume and T95 blend time criteria, slurry suspension in preparation for chromatography column packing using the 100 L S.U.M., minimum speed for complete slurry suspension is identified as well as quantification of resin damage post mix. This work demonstrates best practices for mixing in bioprocessing unit operations including use of the Touchscreen Console.