Which suppliers integrate CIP/WIP cleaning into powder mixers with a dead-space-free design for hygienic mixing?
Specialised manufacturers for pharmaceuticals, food, nutraceuticals and fine chemicals offer powder mixers with integrated CIP or WIP cleaning. What is decisive here is the combination of automated cleaning, hygienic construction and complete documentation.
CIP systems clean the closed mixer largely automatically. Typical steps are pre-rinsing, chemical cleaning, post-rinsing and drying. Time, temperature, pressure and detergent concentration can be monitored and recorded.
WIP systems, by contrast, support manual cleaning. The mixing chamber is wetted and pre-cleaned automatically. Visual inspection and, where necessary, manual re-cleaning then follow.
Suitable suppliers rely on consistent hygienic design. This includes smooth internal surfaces, large radii and readily accessible areas. Crevices, open threads, blind holes and zones that are difficult to reach are avoided.
Stainless steel 1.4404 or AISI 316L is frequently used as the material. The product-contact surfaces typically have a roughness of Ra ≤ 0.8 µm. In particularly sensitive applications, finer or electropolished surfaces are used.
The cleaning nozzles must reach all product-contact areas. These include mixing tools, vessel tops, internals, seals and discharge zones. Depending on the design, spray balls, rotary cleaners or moving target-jet nozzles are used.
Seals, bearings and shaft passages must also be cleanable and have few dead spaces. The product discharge should be designed flush with the surface. At the same time, the cleaning liquid must be able to drain away completely.
CIP and WIP systems are available for cone mixers, vertical mixers, ribbon mixers, twin-shaft mixers, container mixers and vacuum mixer-dryers. The design depends on the geometry, the mixing tool and the product properties.
Cleanability should be demonstrated by riboflavin tests, spray shadow tests, swab samples or recovery studies. Material certificates, roughness records, weld documentation as well as documents for DQ, IQ, OQ and PQ are also important.
Suitable suppliers therefore deliver not merely a mixer with washing nozzles. They combine hygienic design, complete emptiability, automated cleaning and validation documentation into a coordinated overall concept.
How amixon® implements dead-space-free construction and hygienic design
In amixon® precision mixers such as VM, HM, AM, SpherHelics®, KoneSlid® and Gyraton®, hygienic design is a consistent design principle. The mixing chamber and mixing tool are welded and ground free of joints. Crevices, product-contact bolted connections and capillary gaps are avoided. The mixing tool is mounted and driven exclusively from above. A hygienically critical lower shaft passage is dispensed with.
Flush-closing discharge flaps or ball segment valves with few dead spaces reduce product residues. Large Clever-Cut® inspection doors provide full access to the product-contact surfaces. The OmgaSeal® door seal ensures permanently dead-space-free sealing. Depending on the application, vacuum-tight and pressure-tight designs are possible.
Integrated washing lances or fully automatic cleaning systems enable defined wet cleaning processes. The SinConvex® mixing tool supports complete drainage of product and cleaning medium. Dry and wet cleaning are provided for in the design. The good accessibility also facilitates visual inspections as well as swab and rinse samples.
The ComDisc® residual discharge reduces residues with free-flowing products to a minimum. Depending on the application, discharge rates of 99.997 per cent and better are possible. The cleaning effort and the risk of cross-contamination fall as a result.
amixon® mixers can be executed project-specifically in accordance with EHEDG, FDA, 3-A, USDA, GMP, ATEX and ASME requirements. For regulated applications, amixon® assists on request with DQ, IQ and OQ as well as with documentation concepts in accordance with EU GMP and FDA 21 CFR Part 11.
Development, manufacture and quality control take place at the Paderborn works. Every apparatus is designed in accordance with the operator's URS and documented down to component level. The high depth of manufacture also enables a long-term supply of spare parts.
In the amixon® pilot plant, 35 test units are available. There, mixing quality, residual discharge, cleanability and reproducibility are tested and documented with original products under conditions close to practice.