Achieving ideal particle distribution with powdery active ingredients: mixers for pharmaceutical production

For Galenika, a Serbian drug manufacturer, an important processing step in the batch production of chemical and pharmaceutical active ingredients is evenly homogenizing them into powdery filler materials.

Manufacturing active ingredient compounds is a demanding process in which mixing plays an especially key role: all powdery mixtures must meet specific requirements in terms of their homogeneity, purity, particle size distribution, and stability.

amixon® vertical mixers are uniquely equipped to handle such a demanding task. They offer considerable advantages over more basic mixing machines, including ease of operation, quick and thorough cleaning, and a wide-range of processing capabilities. But above all, amixon® powder mixers guarantee excellent mixing results.

Inside amixon® pharmaceutical mixers

The helical SinConvex® blade contained in the pharmaceutical mixer creates a three-dimensional flow that encompasses the entire mixing vessel without leaving any dead-space. The rotation of the blade drives the powders upwards along the periphery before gravity pulls them back down along the center of the mixing vessel. Shovel-like mixing arms comb through the powders, creating powerful radial flows within the mixing goods. Regardless of the flowability characteristics of the initial ingredients, the mixer can create ideal homogeneity using minimal energy input. Furthermore, all surfaces that come into contact with the mixing goods, including the SinConvex® blades, are jacketed in order to homogenize the materials at the ideal temperature.

Pharmaceutical mixers: a case study

amixon® engineered a vertical mixer with a volume of three cubic meters for a pharmaceutical company who needed equipment in which to distribute microfine active ingredients into tablet masses. Additionally, the mixing process needed to include moistening and drying steps.

Here is a step-by-step breakdown of the mixing process:

  • The bulk ingredients are automatically weighed and fed into the mixer. 
  • The active ingredients are added by hand, a step that is documented via barcode registration.
  • The distributive mixing process begins, using additional multilayered cutting rotors for deagglomeration.
  • Highly viscous liquids are added, followed by the introduction of suspended, pumpable extracted compounds.
  • The intensity of the mixing action is reduced then reduced, and additional dry ingredients are added in order to gently coat the moistened particles.
  • The mixer then enters into contact drying mode, creating a highly flowable mixture that is ideal for tabletization.
  • The mixing vessel is then emptied using innovative mechanisms that achieve 99.997% discharge without segregation.

Vertikalmischer mit einem Arbeitsraum von 3 Kubikmeter

Cleaning pharmaceutical powder mixers

Efficient cleaning of mixing equipment is especially crucial in pharmaceutical production in order to prevent contamination. Not only can this impact product quality, but it is also necessary to ensure that no allergens are present. Any facility that handles bulk materials can only guarantee allergen-free processing by means of thorough wet cleaning protocols.

After discharging, the amixon® pharmaceutical mixer undergoes automated wet cleaning by means of the built-in WaterDragon® system. WaterDragon® is permanently affixed within the mixing vessel, where it emerges from behind a closure flap during cleaning, and retracts during the mixing process. The lance extends into the mixing chamber where the washing head, driven by water pressure, rotates as seven nozzles spray down the inside of the mixer.

The mixer is designed to automatically begin the cleaning process after discharge, then to empty itself of residual water, and finally to dry itself. During drying, large amounts of warm air are funneled into the mixer first through the main connection and then through the nozzle of the WaterDragon®. Once the interior of the mixing vessel is completely dry, the washing head then retracts and the closure flap seals shut, leaving the mixing vessel completely air-tight once again.



WaterDragon-Nassreinigung

The WaterDragon® system for an efficient automatic wet cleaning

This wet cleaning device is unique in that there is only one pneumatic cylinder that triggers each movement, one after another. Otherwise, the system is entirely compact and robust. After cleaning and drying, it closes automatically. The system is also gas-tight, even if there is a vacuum or pressure build-up in the mixing room. The connection can also be configured as tri-clamp or weld neck flange.

Hygiene and compliance in pharmaceutical production

Due to the seamless design of all component details, the mixer is guaranteed to comply with the highest hygiene standards, even with minimal manual cleaning. This pharmaceutical mixing machine is made of materials that do not pose undue microbiological risk and are furthermore compliant with GMP and FDA regulations regarding the production of drugs, kosher products, and bacterial cultures.

Experience the unique advantages of amixon® mixers for yourself by visiting one of our seven global testing centers, located across the globe from the USA, to Germany, to Japan.

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Left: Both loading and discharging can proceed with minimal risk of contamination with the use of standard bulk material containers.
Right: The mixer pictured here has a volume of two cubic meters and is elevated above the discharge container during the mixing process.