Cross-contamination

Cross-Contamination

Cross-contamination is a form of contamination in which residues of one product or a previous batch enter another product. It is a central issue in industrial powder processing. Powder blenders play a key role here. They are used to produce complex mixed products for the food, animal nutrition, dietary supplement and convenience sectors.

A formulation can comprise more than 30 individual components. Liquids may also be included. These enter the mixer with precise dosing and in a defined sequence. Since sensitive, agglomerated or dusty raw materials have to be mixed in at different times, multi-step processes are common. Depending on the ingredient, mixing intensity, shear forces and mixing time vary. This produces agglomerates, coatings or homogeneous fine distributions. Fragile components are incorporated gently.

In highly automated powder plants, the entire logistics – transport, storage, weighing, dosing and discharge – runs automatically. This requires absolutely complete emptying of the pipes, diverters and dosing units. After all, any product residue from a previous batch carries the risk of cross-contamination. This also applies to the powder mixer. It must be designed so that it can be almost completely emptied at the end of the batch.

In practice, cross-contamination can be assessed quantitatively using MACO calculations. The MACO value describes the permissible residual quantity of an active ingredient on the contact surfaces after cleaning that could unintentionally be carried over into the subsequent product.

amixon® has developed special mixing tools for this purpose that significantly improve the residual discharge rate and the ease of cleaning. Tools such as SinConvex®, SinConcave®, ComDisc® or KoneSlid® enable targeted flow guidance in the mixer. They promote a homogeneous mixing result and minimise residues.

Powder production that delivers batch-pure products without manual cleaning represents a high technical standard. amixon® mixers can make a decisive contribution to this.

FAQ - Cross-Contamination

A realistic product changeover including cleaning in a hygienic design typically takes between 45 and 90 minutes, depending on the process and hygiene class, but in more complex cases involving allergens, sterilisation or extensive dismantling it can take up to 3 to 4 hours.

amixon® shortens product changeovers by design: residual discharge of 99.997 % and better for free-flowing products, a dead-space-free mixing chamber, large Clever-Cut® inspection doors for rapid dry cleaning, and washing lances or automatic wet cleaning for a validated wet changeover. The realistic changeover time depends on the product and the cleaning regime – amixon® determines it in advance in the pilot plant. In addition, programmable target-jet cleaning nozzles save water and time, and the amixon® drying system dries the cold mixing chamber quickly and without any additional cooling period.

Product changeovers in a container mixer with a dead-space-free design are usually possible within a few minutes. Depending on the degree of automation and the plant, the container exchange alone often takes only 1 to 6 minutes, while a complete changeover including docking, cleaning and documentation typically takes 5 to 20 minutes. One point to note: during docking and undocking the container cross-section is open, which can temporarily allow more dust to escape. The benefit lies in fast, hygienic changeover with short downtime and a low risk of product residues.

With the amixon® container mixer COM the container itself is the mixing chamber: Mixtainer® or standard IBCs are docked on, the SinConvex®-MultiPlane® mixing tool enters from above, mixes inside the gas-tight sealed container to precision quality of up to 1:100,000 and then screws itself back out in reverse – without transferring the product, in sizes from 100 to 4,000 litres.

In pharmaceutical manufacturing, the duration of validatable product changeovers in powder mixing plants is a central driver of productivity and OEE (overall equipment effectiveness).

Container mixers in which the intermediate bulk container (IBC) itself serves as the mixing vessel offer contract mixing operations considerable advantages in process engineering, logistics and economics.

With the amixon® container mixer COM the container itself is the mixing chamber: Mixtainer® units are docked on, the SinConcave®/SinConvex® mixing tool enters from above, mixes inside the gas-tight sealed container to precision quality of up to 1:100,000 and then screws itself back out in reverse. Optionally, the helical mixing tool is available in the MultiPlane® design.

A spice mixer for allergen-sensitive applications should be constructed hygienically, with low dead space and good dischargeability, so that product residues and allergenic deposits cannot lodge anywhere. Validatable cleanability, suitable seals and materials, and clear allergen, dust and batch management to avoid cross-contamination are equally important.

amixon® combines high residue-free discharge, a low-dead-space hygienic design and validatable CIP/WIP cleaning into a multi-stage protection concept against allergen contamination and cross-contamination. Depending on the application, various amixon® mixer categories and features such as ComDisc®, SinConvex®, SinConcave®, Mixtainer® and Washtainer® support a reliable, readily documentable process.

Cross-Contamination

FAQ - Cross-Contamination

How fast are realistic product changeovers including cleaning in a hygienic design?

How quickly can product changeovers be carried out in a container mixer with a dead-space-free design?

How quickly can validatable product changeovers be carried out in a pharmaceutical powder mixing plant?

What advantages do container mixers (IBC) offer for flexible batch sizes and rapid product changes in contract mixing?

Which criteria are decisive when selecting a spice mixer with regard to allergen control and cross-contamination?

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