FUNDAMIX® SU Single-Use Mixer
Why mixing is a weak point in single-use systems
Most single-use mixers still rely on a rotating impeller inside the bag. The impeller creates local shear and vortices that can damage cells and proteins, and rotating parts inside a disposable bag add risk to product integrity. Keeping the batch uniform while the bag is being drained is a further challenge.
How FUNDAMIX® SU vibratory mixing works
FUNDAMIX® SU replaces rotation with vertical oscillation. An electromagnetic drive mounted outside the bag moves a mixing plate up and down. This creates a directed axial flow through the liquid without a vortex and without baffles. Nothing rotates inside the bag, and no mechanical seal is involved. Two plate orientations let you tune the flow to the process:
- Type A, upward axial flow: gentle, consistent circulation, for example for liquid-liquid blending and formulations with light solids.
- Type B, downward axial flow: stronger agitation, for example, to keep fast-settling solids in suspension or to limit foaming.
What it means for process engineers
Mixing intensity is set through amplitude and frequency, so the same principle covers everything from very gentle suspension maintenance to more demanding mixing tasks. The mixing plate can sit just a few centimetres above the bottom of the bag. This keeps the batch homogeneous while the bag is emptied and minimises dead volume.
Heat input and energy consumption remain low. Because the bag is fully disposable, there is no cleaning, no CIP/SIP and no cross-contamination between batches, which makes changeovers fast, especially in multiproduct facilities and CMOs.
Typical applications in biopharmaceutical manufacturing
FUNDAMIX® SU is used for:
- buffer and media preparation
- insulin and other protein formulations
- suspension of cells and proteins
- intermediate mixing and hold tanks
- fill-finish and sterile vial filling
- blood plasma fractionation and parenteral nutrition solutions
- filter aid addition before cell culture clarification
Validation, bags and system configurations
Bags are available for working volumes from 1l to 500l and are delivered X-ray sterilised. They are assembled in DrM’s own ISO Class 7 cleanroom from USP Class VI compliant materials, with ADCF and endotoxin documentation to support validation. Bag integrity and weld performance are controlled through validated manufacturing processes, and options such as powder addition ports are available.
FUNDAMIX® SU can be supplied as a modular unit for integration into existing equipment, or as a fully automated skid with load cells, PLC/HMI control, recipe management, data logging and optional 21 CFR Part 11 compliance.
Test FUNDAMIX® SU in your own process
Lab-scale FUNDAMIX® SU units are available for rent or purchase and use the same mixing principle as production systems. Trials with your own product show which plate type and mixing intensity suit the process before scale-up.
To learn more, please download the brochure. To discuss your mixing step with DrM’s engineers, send an enquiry through the DrM company profile page.
