Sterile and Sustainable Mixing for the Next Generation of Pharma Manufacturing

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Pharmaceutical manufacturing is evolving rapidly. From biologics and vaccines to plasma-derived therapies, processes must now combine sterility, scalability and sustainability. Single-use systems and modular biomanufacturing are reshaping facility design, while regulators and supply pressures increase demands for efficiency. 

One process step often underestimated in this transition is mixing. Whether preparing insulin, producing vaccines or fractionating plasma, homogenization directly affects yield and safety. Traditional mixers with rotating impellers sealed by dynamic gaskets can introduce contamination risks, excessive shear forces, and cleaning challenges. 

DrM, a Swiss process equipment manufacturer with more than 40 years of experience, has developed an alternative. Its FUNDAMIX^® vibration-based technology provides efficient mixing without rotating parts. Available in stainless steel and single-use versions, FUNDAMIX^® supports the industry’s transition toward smarter, cleaner and more sustainable production.

Proteins and biologics are highly sensitive. In insulin production, shear can denature proteins and reduce potency. In vaccine manufacturing, turbulence during fermentation can damage the cells used to produce plasmids. In plasma fractionation, poor mixing can lower the yield of albumin and immunoglobulins. 

Sterility is another concern, since every shaft or seal is a possible entry point for contamination, and cleaning and sterilization consume time, water and chemicals. For facilities aiming to improve efficiency and sustainability, these are growing challenges.

The FUNDAMIX^® Vibro-Mixer uses an electromagnetic drive to oscillate a mixing plate and create axial flow. By minimizing the movement of shafts and seals, contamination risks and maintenance are reduced drastically. The results are sterile, low shear and energy efficient process conditions.

Its versatility is evident when considering the plethora of applications in which the FUNDAMIX^® is used. In insulin manufacturing, gentle agitation keeps protein solutions uniform without the risk of denaturation. The same low-shear movement is critical in vaccine fermentation, where continuous mixing and oxygen sparging help remove CO₂ without damaging host cells. In plasma fractionation, rapid pH homogenization supports clean precipitation of proteins such as albumin and immunoglobulins, ensuring high yield and purity. It has also been used in fill and finish steps, when homogenization is of utmost importance before a drug substance is filled into vials.

Designed according to cGMP and EHEDG principles, the mixer is fully CIP and SIP compatible. It scales up to 12,000 liters, while lab-scale equipment is available for testing and process development. This allows manufacturers to evaluate performance in trials before moving confidently to full production scale.

With the rise of single-use technologies, DrM adapted its vibration-based design into the FUNDAMIX^® SU. This version integrates easily into modular cleanroom setups and bioreactors, offering the same uniform mixing without moving parts inside the bag.

All product contact occurs inside an irradiated single-use bag, keeping the process fully contained and sterile.

For biologics and cell and gene therapy, FUNDAMIX^® SU provides gentle, reproducible mixing, avoiding shear damage while achieving rapid homogenization. Its compact design and high turndown ratio ensures efficiency even at low liquid levels. By eliminating cleaning steps, it saves water and chemicals, directly supporting sustainability targets.

Available from lab to production scale, FUNDAMIX^® SU is also available as rental test units, allowing R&D teams to evaluate performance before scale-up.

FUNDAMIX^® and FUNDAMIX^® SU offer two complementary paths to achieve sterility, sustainability and scalability. Stainless steel units provide long-term reliability for large volume production. Single-use systems deliver flexibility and simplicity for biotech and modular manufacturing. Both technologies reduce contamination risks and energy use, while enabling consistent results in critical applications. 

With numerous references in insulin, vaccines, plasma processes, and vial filling stations, FUNDAMIX^® is a trusted solution in pharma facilities worldwide. As the industry embraces continuous processing, digital tools and flexible plants, DrM shows how innovation in a single step can support broader goals of safety, efficiency and sustainability.

Mixing is a decisive factor in pharmaceutical production. Rethinking how this step is performed enables manufacturers to improve quality and yield while lowering risk. With FUNDAMIX^® available in both stainless steel and single-use designs, DrM offers proven and flexible solutions for sterile and sustainable manufacturing. Whether the priority is large-scale reliability or single-use agility, FUNDAMIX^® provides a strong foundation for the next generation of biomanufacturing. 

For more information or to discuss your application, contact DrM and discover how FUNDAMIX^® can support your process.