What requirements do food supplement manufacturers place on validatable CIP/WIP cleaning and documentation?
Manufacturers of food supplements require above all validatable, reproducible and documented CIP/WIP cleaning. Firmly defined cleaning parameters, hygienic design without dead spaces, a demonstrable cleaning effect and complete GMP documentation are decisive.
Also important are clear SOPs, batch records, calibration and maintenance evidence as well as a risk-based assessment of cross-contamination, particularly with allergens and product changes. Electronic data must be tamper-proof, traceable and auditable.
How amixon® supports validatable cleaning and its documentation
Manufacturers of food supplements require validatable CIP and WIP processes. These processes must make reproducible cleaning possible. At the same time they should ensure rapid drying. Complete documentation must also be possible.
At amixon®, these requirements do not apply to individual apparatus alone. They apply to the entire product portfolio. This includes mixers, dryers, reactors and granulators.
amixon® meets these requirements with a consistently hygienic apparatus design. The product-contact internal surfaces are smooth and readily wettable. The geometries have few dead spaces. High-grade sealing systems support hygienic operation. Readily accessible inspection doors facilitate inspection. The discharge elements too are designed for very good emptiability.
A key advantage is the high residue-free discharge. For this, amixon® uses special mixing tools. These include the SinConcave® and SinConvex® mixing helices as well as the ComDisc® system. After the product has been discharged, only minimal residues remain in the mixing chamber.
This reduces the subsequent cleaning effort. At the same time, less water and fewer cleaning media are required. The conditions for reproducible cleaning results also improve. This facilitates the planning and validation of the cleaning processes.
For wet cleaning, amixon® offers various WIP and CIP-related concepts. These include freely programmable target-jet washing lances. The movements of the washing lances can be adapted to the respective apparatus and to the cleaning task.
A particular example is WaterDragon®. The system travels into the mixing chamber automatically. There it takes over the wet cleaning. Afterwards it also supports the drying of the apparatus.
Many powders react sensitively to residual moisture. At the same time, microbiological risks must be consistently avoided. amixon® therefore offers additional drying stations. These can dry even cold water out of the mixer within a few minutes.
Rapid drying reduces downtimes. It also increases process reliability between different formulations. The next production process can be started more quickly and under defined conditions.
For manufacturers it is also important that cleaning programmes can be described clearly. The programmes must run reproducibly. All relevant process steps should also be documented cleanly.
amixon® creates the technical basis for this. Cleaning sequences can be defined for the specific application. This also applies to the movements of the nozzles and washing lances. Washing steps and drying phases can likewise be designed specifically.
In this way, a simple wet cleaning becomes a controllable process. The individual sequences are traceable and repeatable. They can thereby be integrated into GMP-oriented documentation, testing and release concepts.
These possibilities apply expressly to the entire amixon® product range. This includes vertical precision mixers, hollow-sphere mixers, KoneSlid® mixers and cone mixers. Twin-shaft mixers, vacuum mixer-dryers, reactors and granulators can also be equipped with suitable cleaning and drying concepts.
In the amixon® pilot plant in Paderborn, the cleaning and drying concepts can be demonstrated under realistic conditions. There the processes can be examined and optimised together with the user.
For these trials, a test mixer with a usable volume of 2 m³ is available, among others. Users can employ their own original products. This produces practical and robust trial results.
For manufacturers of food supplements, this creates a clear added value. Fewer product residues remain in the apparatus. Water consumption during cleaning falls. Cleaning and drying times are also shortened.