During batch processing of chemical or active pharmaceutical ingredients such as Galenika, different active ingredient preparations are often used and homogeneously distributed in suitable powdery fillers. Particularly high demands are made on the mixing process when these ingredient compounds are manufactured. Specially defined requirements, for example with regard to homogeneity, purity, particle size distribution and stability apply to the powdery materials to be mixed. Amixon vertical mixers rise to this demanding task.
Author Matthias Böning Sales Manager, Amixon
Vertical mixers offer specific advantages compared to other mixer models because they are simple to operate, can be inspected and cleaned quickly and are universally suited. Above all, they ensure excellent mixing results. The equipment’s helical mixing tool creates a complete mixing flow throughout the whole area. The mixture spirals upwards on the inner wall of the vessel with no dead spaces, then flows down again in the centre of the chamber. Mixing arms, designed like scoops, interact with so-called static mixing tools to guarantee strong radial flows in the mixture. Ideal mixing qualities are achieved with minimum energy consumption regardless of the flow properties of the recipient substances (dry, damp or suspended).
Emptying rates up to 99.95 %
This statement is best illustrated by means of a practical example: for the active ingredient formulation of a pharmaceutical company, Amixon designed and delivered a vertical mixer with a working space of 3 m³, which is used for microscopic distribution of active chemicals in tablets with subsequent moistening and drying.
In the first step, the basic ingredients are automatically weighed and distributed. Next, the active ingredient preparations, which are added by hand, are integrated and registered with a bar code. The mixing process then takes place in a distributive and dispersive way with additional, multi-stage cutting rotors. This is followed by the addition of highly viscous liquids as well as suspended, pumpable extraction compounds. More dry materials are subsequently mixed in very carefully and applied to the moist particle surfaces. Finally, the mass – which is made pourable by this drying step – is tabletted.
The mixing chamber is completely emptied without segregation – in practice, emptying rates of up to 99.95 % have been achieved under ideal conditions.
Automated wet cleaning
At the end of the mixing process, automated wet cleaning can be performed using the pat-ented Waterdragon system. It is essential to clean mixing equipment efficiently. Avoiding contamination is on the one hand crucial for quality and on the other hand a “must”, for instance, to make sure dietary nutrients are free from allergens. In a bulk manufacturing plant, absolute freedom from these unwanted substances can only be ensured by efficient wet cleaning.
The Waterdragon system is permanently fixed to the mixing chamber or process apparatus. The shutter opens into the process chamber during wet cleaning to make room for the movement of a rotary washing lance. This lance moves translationally into the mixing chamber. Powered by the pressure of the washing water, the washing head rotates and seven nozzles spray the entire process apparatus. The system cleans itself, empties the remaining water and dries itself again fully automatically.
For drying, large quantities of hot air are introduced through the Waterdragon’s main pipe. This air is passed into the mixing chamber at the rotary washing head. At the end of the drying process, the washing lance moves back into the parking position and the flap closes the process chamber gas- and liquid-tight.
This patented system is particularly interesting because there is only one pneumatic cylinder which triggers all movements one after the other. It is compact and robust, and closes automatically after cleaning and drying. The system is also gas-tight, even if vacuum or overpressure is present in the mixing chamber. The connection can be configured as a tri-clamp or welding flange.
Due to the seamless design of all components, the machine guarantees a high hygienic stand-ard with only minimal operator intervention. It is considered to be microbiologically controllable and in conformity with GMP as well as being FDA-certified for the production of pharmaceutical goods, kosher products and bacterial cultures.
The advantages of these Amixon mixing systems can be verified with original products at test centres around the world: in Paderborn (Germany), Memphis (USA), Osaka (Japan), Bangkok (Thailand), Satara (India) and Tianjin (China).
Hall 1, Booth 304
cpp-net.com/0314449
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