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FUNDAMIX® Vibro-Mixer

FUNDAMIX® Vibro-Mixer-prodcut-feature-image

Why conventional agitators struggle with sensitive pharma products

Stirred tanks are the default choice in many pharmaceutical plants, but rotating impellers bring well-known trade-offs:

  • Shear and vortex formation can denature proteins such as insulin.
  • Baffles and rotating shaft seals create surfaces that are difficult to clean.
  • The mechanical seal is a potential entry point for contamination in sterile processes.

Keeping the batch homogeneous as the tank drains is a further challenge.

How the FUNDAMIX® Vibro-Mixer works

The FUNDAMIX® mixes by oscillation instead of rotation. An electromagnetic drive moves a shaft with a perforated mixing plate up and down at high frequency. The liquid is pushed through the plate’s conical bores, generating a directed axial flow. The plate orientation sets the flow direction:

  1. Type A: upward flow for gentle blending.
  2. Type B: downward flow to keep fast-settling solids suspended or to limit foaming.
  3. Gas dispersion version: combines mixing with sparging, for aerobic and anaerobic fermentation.

Mixing intensity is adjusted through amplitude and frequency, so one design covers both very gentle agitation and more vigorous mixing.

Sterile, cleanable design for GMP production

The shaft passes through a membrane sealing unit instead of a rotating mechanical seal. The membrane is EPDM with a bonded PTFE layer on the product side, and it keeps the vessel closed under vacuum or pressure, from minus 1 to 10 bar g. There are no baffles, no lubricants inside the vessel and no vortex. The mixing plate can be positioned close to the tank bottom to keep mixing until the vessel is nearly empty.

Product-contact parts are made of 316L stainless steel with an industrial or hygienic finish, and FDA- and USP Class VI-compliant elastomers are available. Systems are designed to GMP and EHEDG guidelines, are CIP- and SIP-compatible, and are CE-marked. An ATEX version is available for Zones 1 and 2.

Control and validation of mixing parameters

For reproducible batches, the Vibro-Controller regulates amplitude in a closed loop, using a sensor on the mixing plate, and integrates with PLC or DCS systems. The handheld Vibro-Monitor measures amplitude and frequency without contact, giving quality teams a simple way to verify mixing parameters during qualification and routine operation.

Typical applications in pharmaceutical and biotech manufacturing

The FUNDAMIX® is used for:

  • insulin formulation and other protein solutions
  • vaccine production, including anaerobic fermentation
  • cultivation of mammalian cells
  • blood plasma fractionation
  • trypsinization
  • preparation of sterile media, buffers and solutions

One mixing principle from lab to production

Drive sizes from FM-1 to FM-4+ cover vessels from laboratory scale up to 12,000l, all working on the same principle. Process data from lab trials therefore transfers directly to production scale. The FUNDAMIX® can be fitted to an existing vessel or supplied as a complete packaged unit.

Test the FUNDAMIX® in your own process

Compact FUNDAMIX® test units are available for rent or purchase, and trials can also be run in DrM’s test facilities. Testing with your own product defines the plate type and mixing intensity 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.

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