Which design is appropriate for container mixers to ensure a dead-space-free construction and GMP compliance?
For container mixers, a hygienically compliant, crevice-free and readily cleanable design is decisive. This includes smooth internal surfaces, generous radii, conical geometries for complete discharge, flush seals as well as a validatable WIP/CIP concept with good accessibility for cleaning and inspection.
Also important are suitable materials such as 316L, low surface roughness, cleanly executed welds and dead-space-free docking systems. Product deposits, cross-contamination and areas that are difficult to clean can thereby be avoided and GMP compliance ensured.
The amixon® container mixer COM: mixing directly in the vessel, without transfer
The amixon® container mixer COM mixes directly in the bulk material container. The container itself is the mixing chamber, the transport vessel and the feed for the next process stage. This saves transfer steps and reduces contamination risks.
The SinConvex®-MultiPlane® ribbon mixing tool works in the gas-tight sealed container. It produces a three-dimensional total flow with high mixing quality, even with widely differing bulk densities, particle sizes and very small component proportions. Even ratios of up to 1:100.000 can be homogenised in a technically ideal manner.
The COM is designed for sensitive, powdered and also moist products. Optionally, a cutting rotor can be used for de-agglomeration and for liquid addition. The mixing chamber is designed for ATEX Zone 20.
A major advantage is the decoupling of the processes. Weighing in, mixing and filling run separately. While one area is being cleaned or set up, production can already be running in another.
For automatic wet cleaning and drying, a Washtainer® can be docked on. The COM is available in sizes from 100 to 4,000 litres. On request, the design is EHEDG-, FDA- and 3-A-compliant.
Every plant is designed project-specifically in accordance with the URS. amixon® verifies the mixing and cleaning parameters in the pilot plant. This produces a qualifiable solution with high process reliability.
amixon® develops and manufactures exclusively in Paderborn with a high depth of manufacture. This secures documented quality, long-term availability and a design that integrates cleanly into regulated environments.