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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
  • 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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Blog

Complex plant technology in the preparation of methyl cellulose, carboxymethyl cellulose, hydroxyethyl cellulose, etc.
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Hygienic design and HACCP for mixing powdery or moist food and pharmaceutical products
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If a production plant can empty itself, cleaning is easier. amixon ® mixers have a very good self-cleaning effect. All but a few grams of dust are discharged from the mixer. This makes dry and wet cleaning easier.

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FAQ

Surface roughness is decisive for GMP-compliant powder mixers because it directly influences cleanability, the risk of cross-contamination and hygienic safety. For product-contact surfaces, Ra ≤ 0.8 µm is usually regarded as the standard, while considerably smoother and in part electropolished surfaces are common for critical applications.

amixon® manufactures all product-contact surfaces welded and ground free of joints – on request up to highly polished, GMP-compliant surface finishes. The range of materials extends from austenitic stainless steels (1.4301 to 1.4539) through duplex steels to Alloy 59, Hastelloy-C22 and nickel for corrosive products.

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

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.

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A dead-space-free design eliminates all areas in mixers and process vessels in which product residues, cleaning media or process liquids could stagnate.

amixon® implements hygienic design by construction: the mixing chamber and mixing tool are welded and ground free of joints, and the mixing tool is supported at the top only – with no lower shaft passage. Clever-Cut® inspection doors with OmgaSeal® sealing, dead-space-free discharge fittings and washing lances make CIP/WIP cleaning validatable in accordance with EHEDG, FDA and 3-A.

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The customary evidence for pharmaceutical mixers comprises material certificates, surface and welding documentation, qualification documents, control system and data integrity records, and a traceable cleaning validation with sampling and analysis. Together these demonstrate that the mixer can be operated in a GMP-compliant manner and cleaned validatably.

amixon® makes cleaning validatable: a dead-space-free, fully accessible design with Clever-Cut® doors for swab and rinse sampling, CIP/WIP via washing lance, and residual discharge of up to 99.997 %. amixon® assists on request with DQ, IQ and OQ, with documentation in accordance with EU GMP and FDA 21 CFR Part 11 – from the URS through to commissioning.

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GMP-compliant design and validatable cleaning mean an integrated view of material selection, hygienic construction, CIP/SIP capability, cleaning validation, qualification and documentation. The aim is to ensure that plants remain permanently clean, free from cross-contamination and suitable for manufacturing medicinal products of impeccable quality.

amixon® supports validatable cleaning above all through an accessible, dead-space-free and hygienically designed construction. Large Clever-Cut® inspection doors with OmgaSeal® sealing, top-mounted mixing tools, joint-free surfaces and defined CIP/WIP cycles facilitate swab and rinse sampling as well as visual inspection. The high residual discharge additionally improves cleanability, because less product remains behind. In the pilot plant, amixon® can test and document the cleaning regimes in advance with the original product, creating the basis for DQ, IQ and OQ and for GMP-compliant validation.

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Mixing active ingredients, excipients and liquids is a critical step in pharmaceutical production. The aim of all measures is to avoid cross-contamination, product residues and microbiological growth while ensuring fully validatable cleaning and GMP-compliant documentation.

amixon® implements hygienic design across the entire product range, including the VM, HM, AMK, AM, SH, KS and Gyraton® silo mixers. Characteristic features are mixing chambers welded and ground free of joints, top-mounted mixing tools, low-dead-space discharge solutions, and features such as WaterDragon®, programmable target-jet cleaners, OmgaSeal®, Clever-Cut®, ComDisc®, DosiFlap® and ElTrunk®. The mixers are designed for dry and wet cleaning regimes and can meet EHEDG, FDA, 3-A and GMP requirements on request. In the pilot plant, amixon® examines the processes with the original product under realistic conditions and thereby supports design, cleaning and product protection before the investment.

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Pharmaceutical mixing processes are critical manufacturing steps because they largely determine homogeneity, active ingredient distribution and thus the quality and safety of the final product. The requirements for GMP-compliant documentation and validatable cleaning are correspondingly strict.

amixon® makes cleaning validatable: a dead-space-free, fully accessible design with Clever-Cut® doors for swab and rinse sampling, CIP/WIP via washing lance, and residual discharge of up to 99.997 %. amixon® assists on request with DQ, IQ and OQ, with documentation in accordance with EU GMP and FDA 21 CFR Part 11 – from the URS through to commissioning.

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For GMP inspections in pharmaceutical, biotechnological and medical device environments, a complete, risk-based and lifecycle-oriented validation and documentation package is expected, demonstrating conformity with the relevant regulations.

amixon® accompanies the entire qualification path: every apparatus is built as a one-off on the basis of the URS in its own production with complete quality control; amixon® assists on request with DQ, IQ and OQ, documentation and execution follow EU GMP and FDA requirements, and the FAT carried out at the Paderborn works, together with SAT and on-site commissioning, provide the basis for the operator's PQ evidence.

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