Sterile and Sustainable Mixing for the Future of Pharma Manufacturing
Why Is Sterile and Sustainable Mixing Essential in Modern Pharma Production?
Pharmaceutical production increasingly demands sterility, scalability and sustainability. Yet one critical process step, mixing, is often underestimated. DrM’s FUNDAMIX® technology, available in both stainless steel and single-use formats, delivers gentle, consistent and energy-efficient mixing for applications ranging from insulin and vaccines to plasma-derived products. It helps manufacturers achieve smarter, cleaner and more reliable operations.
Evolving Demands in Pharmaceutical Manufacturing
Pharmaceutical and biotech production are evolving rapidly. From biologics and vaccines to plasma-based therapies, manufacturing processes must now meet strict standards for sterility, consistency and environmental responsibility. Modular facilities and single-use technologies are transforming how medicines are made, while efficiency and regulatory compliance remain at the forefront.
Amid these shifts, mixing plays a vital role in determining yield, product quality and sterility. Conventional agitators with rotating impellers and dynamic seals can introduce contamination risks, excessive shear stress and complex cleaning procedures.
To address these challenges, DrM, a Swiss process equipment manufacturer with more than four decades of experience, has engineered a vibration-based alternative. Its FUNDAMIX® system provides efficient, low-shear mixing without rotating parts, supporting the shift toward cleaner, more flexible and sustainable production.
Why Does Mixing Matter in Modern Pharma Production?
Proteins and biologics are highly sensitive to mechanical stress. In insulin production, shear can damage delicate molecules and reduce potency. In vaccine manufacturing, turbulence during fermentation may harm the cells responsible for plasmid generation. Likewise, in plasma fractionation, poor homogenization can reduce the recovery of albumin and immunoglobulins.
Each of these processes also requires absolute sterility. Every moving seal represents a potential contamination risk, and cleaning or sterilization consumes significant time, water and chemicals. For manufacturers focused on productivity and sustainability, minimizing these challenges is key.
What Makes FUNDAMIX® a Reliable Solution for Pharma?
The FUNDAMIX® Vibro-Mixer uses an electromagnetic drive that oscillates a mixing plate to create axial flow. By eliminating rotating shafts and seals, the design significantly lowers contamination risk and maintenance requirements. The result is a sterile, low-shear and energy-efficient process.
Its versatility covers a wide range of applications. In insulin preparation, gentle vibration maintains uniform concentration without denaturing the protein. During vaccine fermentation, controlled movement enables continuous mixing and gas exchange while protecting fragile cells. In plasma fractionation, precise pH control ensures clean precipitation of proteins such as albumin and immunoglobulins, improving both yield and purity. The same principle applies to fill-and-finish stages, where consistent homogenization is essential before vial filling.
Designed to meet cGMP and EHEDG standards, the mixer is fully CIP and SIP compatible. It is available in capacities up to 12,000 liters, with lab-scale units for testing and process development. This flexibility allows users to validate results at small scale before confidently expanding to full production.
How Does FUNDAMIX® SU Enable Single-Use Flexibility in Biotech?
As single-use technologies continue to expand across the life sciences sector, DrM introduced FUNDAMIX® SU, the disposable version of its vibration-based system. It integrates seamlessly into modular cleanroom environments and bioreactors, providing the same uniform and gentle mixing, but entirely contained within a sterile, irradiated bag.
Designed for biologics, cell culture and gene therapy applications, FUNDAMIX® SU ensures rapid, reproducible homogenization with minimal shear. Its compact design and broad operating range make it efficient even at low volumes. By removing the need for cleaning, it conserves water and chemicals, supporting modern sustainability goals.
The single-use system is available from lab to production scale, with rental test units that allow research and development teams to evaluate performance before full-scale deployment.
How Do FUNDAMIX® and FUNDAMIX® SU Complement Each Other?
Together, FUNDAMIX® and FUNDAMIX® SU provide two complementary solutions for sterile, scalable and sustainable mixing. The stainless steel version offers long-term reliability for large-scale operations, while the single-use format adds flexibility for biotech and modular manufacturing. Both technologies lower energy consumption and contamination risk, enabling consistent performance in critical processes.
With extensive references in insulin, vaccine, plasma and vial-filling applications, FUNDAMIX® has become a trusted mixing solution in pharmaceutical facilities worldwide. As the industry moves toward digitalization, continuous manufacturing and adaptive facility design, DrM’s innovations show how even one optimized process step can advance safety, efficiency and sustainability.
What’s Next for Sterile and Sustainable Pharma Manufacturing?
Mixing remains one of the most decisive steps in pharmaceutical production. Re-evaluating how this process is performed allows manufacturers to enhance product quality and yield while reducing operational risk. With FUNDAMIX® available in both stainless steel and single-use designs, DrM delivers proven, flexible solutions for sterile and sustainable manufacturing. Whether the focus is large-scale reliability or single-use agility, FUNDAMIX® provides a strong foundation for the next generation of biomanufacturing.
