Pharmaceutical solid processes place high demands on accuracy and control from the beginning. Raw materials are precisely specified, active ingredients are often highly effective and present in small amounts, and each batch must be processed consistently. Even the smallest deviations can have an impact on subsequent process steps. In daily practice, it mostly involves powders, granules, and premixes, whose physical properties – such as particle size, bulk density, or flow behavior – vary greatly. This diversity must be reliably controlled in the production process so that stable active ingredient-excipient systems, functional intermediates, or premixes for solid dosage forms can be created.
Typical dry products of the pharmaceutical industry include:
- pharmaceutical active ingredients (APIs)
- excipients such as lactose, mannitol, starch or cellulose derivatives
- premixes for tablet and capsule production
- granules
- powder mixtures for oral dosage forms
- dry formulations for inhalation applications
- defined intermediates for downstream process steps
All share tight specification limits and high demands on process stability.
Requirements for mixing and processing
In pharmaceutical processes, mixing is more than a technical step - it is a focal point where quality, safety, and efficiency converge. Active ingredients often need to be evenly distributed in very small proportions. At the same time, delicate powders or granules must not be damaged, as any alteration can affect dosage accuracy, release criteria, or subsequent process steps. It is also essential to ensure that the entire process is controllable from the first to the last gram. This includes the targeted addition of liquid components - such as binding solutions or active ingredient solutions - as well as functional processing in downstream process steps. Other aspects such as closed systems to protect operators and products, reproducible cleaning processes, and clearly structured product changes shape daily production. Processes must be documentable, validatable, and transferable from development to production scale.
amixon® solutions for the pharmaceutical industry
amixon® develops mixers, dryers, and reactors for pharmaceutical applications, where process safety and reproducibility are considered from the beginning.
A central element is the conical design of some amixon® mixers (e.g. the AM, AMT series, and precision mixers KS). The cone-shaped design of the mixing chamber effectively supports material flow and ensures that the mixture is evenly moved and removed, even at very low fill levels. This stabilizes mixing processes and makes product changes comparably easier.
Depending on space requirements and the mixer’s flexibility needs, amixon® offers alternatives with a flat bottom. The VM, VMT, HM series also achieve ideal mixtures and good residual emptying rates, coupled with the advantage of lower installation height compared to conical variants.
Inside such systems, the SinConvex® mixing tool is used. This is an advancement of the classic helix mixing spiral, which generates three-dimensional mixing and efficiently processes the mixture. This spiral, tailored to the geometry of the mixing chamber, generates continuous three-dimensional reshuffling of the mixture, ensuring high mixing quality - even with demanding formulations containing very different components.
A practical advantage of this design is that mixtures can be efficiently processed at variable fill levels from about 5% to 100% of the usable volume, and drainage during emptying is very effective. The combination of a conical vessel and SinConvex® tool allows for nearly complete emptying - even for difficult, finely flowing mixtures - and significantly facilitates subsequent cleaning.
