Validation Guide: Flexsafe^® Bag For LevMixer^® And Flexsafe^® Bag For Magnetic Mixer

Single-use mixing systems are increasingly used in the manufacture of biopharmaceutical products as they allow biopharmaceutical companies to realize the benefits of single-use technology throughout the process. Single-use mixing systems have been widely adopted for buffer and media preparations and are also finding applications in more critical and higher value unit operations in the downstream purification process steps.

Flexsafe^® for Magnetic Mixer1 offers powerful mixing performances for media and buffer formulation. The strong vertical vortex combined with the baffle effect of the cubical design allows instant downward movement and efficient dissolution of floating powders such as media powders or diatomaceous earth powder used in dynamic body feed filtration applications. In addition, the impeller high torque offers efficient mixing of high concentration or viscous powders such as buffer powders.

Flexsafe^® for LevMixer^®2 offers low shear mixing performances for homogenization, viral inactivation and formulation of sensitive drug substances and drug products. The levitated impeller eliminates shear effects that can affect product quality and yield premature fouling of sterilizing grade filters by degrading sensitive proteins and generating particles and aggregates.