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Mixing plants for powder preparation of chemical and pharmaceutical active ingredients

Powdered active ingredients from chemical synthesis are highly pure and highly concentrated. This high concentration can also be dangerous: Paracelsus coined the important phrase on toxicity as early as the 16th century: - “All things are poison, and nothing is without poison; the dosage alone makes it so a thing is not a poison.” Before the active ingredients can be marketed, they have to be converted into a user-friendly form using filling agents.

This type of formulation is understood to include both dilution by carriers and adjustment of particle size by size reduction, build-up granulation, fluidized bed agglomeration or compaction, and binding of any dusts that may be present. In special cases, the active ingredient particles are coated with a protective film.

The final mixing process is of particular importance. It must ensure the absolutely uniform distribution of the active substance in the carrier substance. In addition, the mixer must effectively deagglomerate. In some cases, liquid additives are mixed in. The distribution of these particles must be micro-fine. In this way, unwanted dusts can be bound. The surface activity of the active ingredient particles must not be changed in the process.

The formulation process must take place in a completely closed system (containment). No dust may escape from the system and no foreign substances may enter the active ingredient mixture.

"Containment" also means protection

"Containment" in this context also means the technical protection of operating personnel and the environment from the mixtures of active substances.

The permanent tightness of a process plant is not a trivial matter. In the case of powder mixers and synthesis reactors, seals on shaft feedthroughs should be mentioned first and foremost. One part of the sealing system is stationary, the other part (the shaft surface) moves with more or less speed. The peripheral speeds can be 8 m/s and more. The bulk goods in the mixing container can be abrasive, adhesive, curing, nanoparticulate dusting and toxic.

In addition, the mixing goods in the mixing container may be under pressure. Differential pressures of minus 1, plus 3 bar, 6 bar or even 25 bar are not uncommon. Although the problem of shaft penetration and sealing is more than 100 years old, there is still no universal solution for permanent tightness. Labyrinth seals, lip seals, flow gap seals, stuffing box packings, mechanical seals; single and double acting, dry running, liquid or gas lubricated, ..... and combinations of different seal types. The topic is and remains highly topical. amixon® has gathered a great deal of experience over forty years and has developed many tried-and-tested solutions. Matched to the respective product and the preparation task in the mixer, the most economical solution is offered.

Shaft seals must have a long service life. This can be guaranteed in most applications today. Nevertheless, shaft seals are wearing parts. amixon® has a lot of know-how to minimize wear. This extends the service life. Nevertheless, seals must be replaced at some point. This is where amixon® has done pioneering work and brought hygienic, dry-running radial shaft seals (based on PTFE) in a split design to market maturity.

Whereas in the past the gearbox had to be dismantled in order to fit a new lip seal to the main mixing unit, this can now be done conveniently and safely inside the mixing chamber. This saves time and minimizes the effort.

Highest hygienic standards for powder preparation

When it comes to powder processing of chemical and pharmaceutical active ingredients, amixon® is committed to the highest standards of hygiene: Any cross-contamination must be avoided. This also means, for example, absolute freedom from allergens. For this purpose, all our mixing devices are manufactured without joints. This enables thorough damp or wet cleaning. With WaterDragon®, wet cleaning and drying can be fully automated. amixon® mixers are microbiologically controllable and meet all EHEDG, GMP and FDA requirements.

Quality assurance also includes a thorough inspection. amixon® facilitates this activity for the operator by means of large inspection doors. These are equipped with high-quality OmgaSeal® seals. This achieves a dead space-free seal particularly close to the process area.

WaterDragon® - fully automatic wet cleaning and drying

WaterDragon® is a product of amixon GmbH. A tank wash lance is operated at low pressure so that the largest possible water droplets emerge from the nozzles. The nozzles are oriented in three directions: to the front, to the side and to the rear. The nozzles rotate slowly around the axis of the lance. To reach all areas of a process apparatus / mixer, several WaterDragon® systems must be installed. After wet cleaning is completed, large quantities of warm air are blown into the mixing chamber.

Piloting in the amixon® test center

Benefit from 40 years of know-how in powder processing: In our excellently equipped test center in Paderborn, you can test all the advantages of the amixon® mixing systems.

Additional amixon® test centers are located in the USA, China, Japan, India, Thailand and South Korea. We also support your product and process development with trials and demonstrations at these locations. amixon® is the undisputed quality and innovation leader in the field of vertical mixers. With amixon® mixers you are far ahead of many competitors.

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