Products of the pharmaceutical industry
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, and 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.
From this process reality, clear technical requirements arise for mixing, drying, and reaction processes:
- high homogeneity mixing even with small active ingredient proportions
- reproducible process parameters across all batches
- gentle handling of sensitive powders and granules
- controlled liquid addition to dry systems
- integration of drying or reaction steps under vacuum or targeted pressure build-up
- closed, low-dust process management (containment)
- cleaning-friendly and validatable plant design
- comprehensive documentation according to GMP requirements.
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.
For pharmaceutical applications, this means concretely:
- uniform, reproducible mixing processes even with small dosing fractions
- controlled integration of liquid binders or active ingredient solutions
- gentle processing to ensure defined particle properties
- stable mixing processes with varying fill levels
- ergonomically designed access for cleaning and inspection
- plant layouts that support product changes, cleaning, and validation.
A central component of the project planning is the ability to realistically simulate processes in the amixon® Technical Center. There, mixing behavior, liquid addition, emptying and cleaning strategies, accompanying temperature control, and vacuum drying processes can be investigated, evaluated, and specifically designed with original materials - without speculation, with reliable results.
This results in plant concepts that can be transferred from development and pilot scale to production and operate reliably.
amixon® offers individually designed industrial mixers, dryers, and reactors for dry bulk materials for the pharmaceutical industry, integrated systems for liquid addition, combined process steps, as well as process engineering development and trials in the Technical Center.
If you want to stabilize, further develop, or redesign pharmaceutical solid processes, we support you with process technology that reflects your reality and is designed constructively for safety, reproducibility, and hygienic requirements.
Talk to us about your application and your requirements.
amixon® - Process technology for controlled solid processes.
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