Mixing plays a central role in single-use bioprocessing, directly affecting yield, sterility, and product integrity, yet conventional single-use mixers still rely on rotating impellers inside the bag. That design introduces mechanical stress on sensitive products and adds complexity around bag geometry and drive coupling.
FUNDAMIX® SU takes a different approach. Instead of a rotating shaft, a mixing plate with conical bores oscillates vertically inside a fully enclosed, disposable bag. The motion generates controlled axial flow through the liquid, producing rapid, uniform homogenization without vortex formation. Unlike impellers, which create localized high-stress zones near the blade tips, the oscillating plate distributes mechanical stress more evenly across the working volume, which matters for cells, proteins, and other biologics that lose potency under excessive stress. The plate can also be positioned close to the bottom of the bag, reducing the mixable heel volume to around 5% and helping preserve product yield during draining.
The drive unit sits outside the bag and connects through a sealed shaft, so setup is quick and the bag itself remains a closed, pre-sterilized system, eliminating cleaning and sterilization steps between batches. Two mixing plate configurations extend this to different process needs: an upward-facing plate for fast, efficient mixing while reducing heel volume, and a downward-facing plate for processes prone to sedimentation or foaming.
This principle traces back to DrM's stainless steel FUNDAMIX® Vibro-Mixer, in use in over 580 installations worldwide across insulin production, vaccine fermentation, and plasma fractionation. FUNDAMIX® SU brings the same oscillatory mixing technology to single-use formats, scaling from 1 to 500 liters, with applications spanning buffer and media preparation, cell and protein suspension, BCG vaccine bulk concentrate mixing and fill-finish operations.
For multiproduct facilities and CMOs, removing rotating components also means faster changeover between batches and less risk of cross-contamination, without sacrificing the mixing performance that GMP processes require. For biotech and pharma manufacturers, that means one less compromise between sterility, product integrity, and operational flexibility.
Info: https://drmgroup.com
Bron: DRM group