Multifunctional Mixing Unit for Pilot Applications in the Pharmaceutical Industry - Pharmaceutical Technology
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Multifunctional Mixing Unit for Pilot Applications in the Pharmaceutical Industry

Applications:

  • Homogenisation: achieve uniform concentration of components in liquids
  • Suspension: dissolve granular substances in liquids
  • Emulsion: mix normally immiscible or unblendable liquids

The unit has two mixing devices of the lid and one on the bottom:

  • An ULTRA TURRAX mixer with sloping installation and high rotation speed, 1000–3000rpm
  • An ANCHOR mixer with slow rotation speed, 25–75rpm
  • A MAVAG mixer with magnetic coupling

The unit is equipped with:

  • Tempering setup (TCU – Temperature Control Unit)
  • Vacuum pump
  • Compressor
  • CIP system

For the exact monitoring of the technological processes, the following sensors are installed:

  • pH
  • Conductivity
  • Oxygen concentration

The accurate portioning of the different components is achieved with measuring cells.

  • Elastomer and mechanical seals
  • The seals at rim, stumps and scrapers have FDA and GMP certificates
  • The shaft seals of the mixer devices are equipped with gas lubrication and/or a barrier fluid system

In the case of a barrier fluid solution, the PLC control system is Elastomer and monitoring the appropriate temperature, pressure and liquid levels.

The mixing process has a PLC control system that enables the regulation of:

  • the rotation speed of the mixing devices
  • the temperature of the components and the content in the unit
  • the pressure in the unit
  • the mass of the components to be added

Moreover, our units can measure

  • pH
  • oxygen concentration
  • conductivity
  • the mass to be metered

All measurement data can be saved, exported as data files and archived. The PLC and the display software are considering the requirements of 21 CFR Part 11, EU GMP Annex 11.

Lifting device

The lifting of the container and its lid is solved with closed-type double linear bushings. In case of uniformity load, the parallelism tolerance is <0.01mm and the tolerance reattaining the previous position ±0.005mm. After opening the screws fixing the lid in order to maintain and clean the unit, the lid can be removed. Moreover, the whole unit (including lid) can be lifted to ease the emptying of the mixing chamber.

We provide a complete product documentation and certificates/protocols in accordance with the pharmaceutical industry standards:

  • DQ, IQ, OQ, PQ, CC, SAT, FA etc
  • ATEX (in accordance with installation and production environment)

We perform design and construction considering the harmonised requirements of AD2000 Merkblatt and PED; all our products have CE conformity.

  • Outlet valve avoiding ‘dead space’
  • A self-developed outlet valve ensures the emptying of the substance in the mixer without residuals avoiding contamination
  • The valve is easily controlled with a Cardan shaft mechanism

Mixing devices

  • Anchor mixer: is positioned centrally on the lid with teflon scrapers
  • Magnet coupling mixer: the drive motor outside the mixing chamber transmits the torque to the rotating mixer without a shaft via a permanent magnet.
  • Mixer with slope: The mixer on the lid has a 77° angle to the horizontal and is equipped with a cooling system. It can be run with three different arms: dissolver, auger and propeller.

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