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    High-shear mixer granulator

    Pharma-Granulat

    When it comes to pharmaceutical granulation, there’s no room for compromise. That’s why Syntegon’s high-shear mixer granulator with Gentlewing impeller technology delivers robust, efficient performance even under demanding conditions. With fast, uniform mixing and a wide process window, it minimizes product loss and wall caking boosting both quality and output.

    We design our systems to simplify production and reduce operator intervention, integrating features like seamless wet milling and transfer to the fluid bed. Whether you're working with new formulations or traditional ones, Syntegon provides the flexibility and reliability you need.

    To see how our high-shear mixer granulator can support your goals, connect with an expert or take a look at our brochure.

    Connect with an expert  Download our brochure
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    Key benefits

    Achieve higher yields
    A smart design prevents wall caking and clogging and enables controlled discharging for robust and secure processes.
    High batch variability
    The position, geometry of the mixing tools and operating modes allow filling levels between 20 and 80 %.
    Go for a full service
    Whether you need formulation support, rental equipment, or a service agreement – we take your molecules to production.

    High-shear mixer technology & features

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    Gentlewing: Convincing mixing and granulation results

    The Hüttlin Gentlewing delivers superior mixing and granulation. Its contoured impeller and angled blades ensure high-shear mixing, while extended blades reduce wall caking for higher yield.

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    Gentlewing or 3-blade impeller: you have the choice!

    You have the option to choose between the innovative Gentlewing impeller and a traditional 3-blade impeller for older formulations, which are already registered with this technology.

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    Top or bottom drive: we offer total flexibility

    Our technology is available with top (HTG) or bottom drive (HBG), both offering identical geometry for consistent, high-quality results. The Gentlewing and vertical chopper enable 20–80% batch size flexibility.

    Automatic end point detection

    Besides time and current measurement, we can additionally offer torque measurement to determine the end point of granulation as a validatable end point value.

    Choose your preferred charging option

    Depending on your products’ characteristics and your plant’s layout, you can choose between different charging options: pneumatically by continuous or intermittent vacuum or alternatively by gravity filling. Especially for critical products, intermittent vacuum drastically reduces the filter load during charging.

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    Closed process for the highest safety

    In both our top and bottom drive executions, the Gentlewing and chopper shafts are equipped with a purged sealing system. The product container’s lid features an inflatable seal as well as an interlocking device to avoid cross-contamination. It further ensures product and operator safety.

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    Efficient pharma wall installation

    The wall installation enables a true separation of the GMP and technical area, reducing the required space in the pharma room. All drives and supply lines are accessible via the technical area for time-efficient and safe maintenance.

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    All benefits in a single pot

    The Hüttlin single pot combines all benefits of the leak-tight top-drive concept with a smart, efficient energy transfer via heated bowl, lid, filter housing and shaft, as well as an optimized vacuum system with optional solvent recovery. This concept meets the highest requirements regarding process times, product quality and handling.

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    Cleaning – automated and efficient

    Efficiency is one of the main benefits of our cleaning systems. Depending on your requirements, you can flexibly choose either our basic automated cleaning system or the advanced automated UltraClean technology. Thanks to its in-place cleaning, the UltraClean stainless-steel filter significantly reduces cleaning times and ensures reproducible results.

    Are you looking for a small R&D tabletop mixer?

    Mycromix granulates small amounts of products. Due to interchangeable bowls of 0.5, 1.0, 2.5, 5.0 and 10 liters, you can process a wide range of batch sizes. Mycromix features the same unique Gentlewing impeller and vertical chopper as our production-scale high-shear mixers. Mycromix is available with various options, such as preparation for organic solvents, heating/cooling jackets or a 3-blade impeller. In case you are seeking to expand your R&D capabilities, our Solidlab 1 and Solidlab 2 Plus fluid beds for drying perfectly complement the Mycromix table-top solution.

    Unlike most other solutions in the market, the Solidlab 1 comes with our PROVICON control system featuring open recipe creation and management for a time-saving product development.

    Contact us today to see how Mycromix can improve your R&D.

    Connect with an expert 
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    Use case scenarios

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    Outstanding granule quality

    Whether you compress granules into tablets or fill them into capsules or sachets, e.g. for nutraceuticals – our high-shear mixer means outstanding quality for any dosage form.

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    Tablets at their best

    Outstanding granule properties like smooth flowability and an ideal particle size distribution result in excellent compression characteristics– even at very low API concentration, e.g. for cancer therapy.

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    Easy effervescence

    Effervescent tablets support easy oral administration, but prove challenging in terms of production. Our sophisticated single pot system is perfectly suited to produce granules for highly stable effervescent tablets.

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    Yes we capsule

    Granules, pellets, and mini tablets are perfectly suited for fixed-dose or personalized combination capsules, e.g. anti-infective drugs. Our fluid bed granulators ensure optimum quality of the individual components.

    To discover detailed use case scenarios and technical insights and understand how our high-shear mixers can enhance your granulation processes, download our comprehensive guides now.

    Download our brochure

    Technical data of our high shear mixer

    starting from 
    g of product
    more than 
    kg batch size
    from 20 to 
    % usable container volume
    Technical data overview
      Mycromix Pilotmix HTG HBG GranuLean
    Product container volume (l) 0.5 – 10 25 – 150 300 – 1,800 150 – 1,200 150 – 1,200
    Batch range (kg) 0.1 – 3.5 2.5 – 60 30 – 720 15 – 480 15 – 480
    At a density of (kg/l) 0.5 0.5 0.5 0.5 0.5
    Service Agreements
    Service Agreements

    Find out more about our Service Agreements here.

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    Digital Solutions
    Digital Solutions

    Find out more about Digital Solutions here.

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    Maintenance
    Maintenance

    Find out more about Maintenance here.

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    Technical Support
    Technical Support

    Find out more about Technical Support here.

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    Modernizations
    Modernizations

    Find out more about Modernizations here.

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    Training
    Training

    Find out more about our Training here.

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    Expert Services
    Expert Services

    Find out more about our Expert Services here.

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    years of expertise
     
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    installed base worldwide
     
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    OSD: Many facets – one partner

    Oral solid dose (OSD) manufacturing is a demanding endeavor. There is no better partner to tackle those tasks with than Syntegon. Our OSD services and process technology will make your production a rock-solid success. Find out more in this video.

    High-shear mixer downloads

    High-shear mixer brochure
    High-shear mixer brochure

    Download
    R&D Equipment Brochure
    R&D Equipment Brochure

    Syntegon’s R&D machine portfolio covers all process steps: mixing, granulating, drying, tablet pressing and coating, pellet manufacturing, capsule filling and banding.

    Download
    Containment Brochure
    Containment Brochure

    Industry requirements and containment solutions for OSD forms

    Download
    GranuLean
    GranuLean

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    Pharma Solid
    Pharma Solid

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    Hüttlin Services
    Hüttlin Services

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    Interested in our high-shear mixer technology?

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    Frequently asked questions

    Granulation is a core step for the production of OSD (oral solid dosage) products, mostly tablets and capsules.

    Granules can be applied directly in sachets, be compressed to tablets, or filled into capsules.

    The process step of granulation leads to:

    • Improved flowability
    • Narrow particle size distribution
    • Homogeneous distribution of API and excipients
    • Reduction of segregation
    • Increased bulk density
    • Improved compactability
    • Reduction of incoming material variation

    There are several granulation methods available, including: Dry granulation with e. g. a roller compactor, and wet granulation in e. g. a high-shear mixer or a fluid bed processor (spray granulation). Each option offers benefits and limitations that need to be considered when selecting the optimal solution.

    Dry granulation with e. g. a roller compactor does not require binding agents and drying. Powders are compressed into a ribbon and then milled into granules (de-agglomeration). However, dry granulation is not suitable for all types of recipes. Moreover, the characteristics of the starting materials must meet very narrow specifications to achieve consistent end results. This can pose additional challenges in terms of starting material sourcing during the life cycle of a drug product.

    In a wet granulation process with e. g. a high-shear mixer, different powders are mixed to achieve a homogeneous blend. In the next step, a binder liquid is sprayed into the mixture which leads to the formation of liquid bridges between the particles. The impeller mixes the wet mass and forms granules by introducing shear force into the material. Additionally, a chopper is used to reduce oversized lumps into smaller pieces. High shear forces achieve a beneficial increase in granule density. The right endpoint of this process step can be determined e. g. by torque measurement, a method that allows for highly precise and repeatable results. At the end of the wet granulation process, the product is discharged from the high-shear container, sized in a wet mill, and dried e. g. in a fluid bed.

    Spray granulation in a fluid bed processor starts by mixing the different powders until a homogeneous mixture is achieved. Spray guns then add the granulation liquid to the fluidized mixture. From a design perspective, the spray nozzles can be arranged in different ways (top, tangential, bottom). To achieve high density and a narrow particle size distribution it is beneficial to spray in the area where particles have the highest kinetic energy, i. e. directly above the air distribution plate that is positioned at the bottom of the fluid bed vessel. A controlled spray rate as well as stable droplet sizes via controlled spray parameters are essential to achieve repeatable results.

    Drying of the granules already starts during the spraying step via the conditioned process air. The end of the drying step can be determined very precisely, e. g. by humidity measurements of the exhaust air.

    Another key element of spray granulation is to keep the conditioned air in a consistent range of temperature, humidity, and mass flow to achieve repeatable results - independently from regional and seasonal fluctuations in the outside air drawn in.

    To achieve repeatable granulation results in a high-shear mixer, here are some factors that need to be considered, including:

    • Peripheral speed of the impeller
    • Duration of each process step
    • Amount of liquid

    A high-shear mixer is a machine to produce granules using a wet granulation process:

    • Step 1: Charging of the excipients and API
    • Step 2: Before adding liquids, an impeller mixes the excipients and API until a homogeneous mixture is achieved
    • Step 3: Adding of liquids to bind excipients and API. Liquids are either water-based liquids, organic solvents or a binding agent
    • Step 4: The impeller mixes the wet mass and forms granules
    • Step 5: Densifying of the agglomerates
    • Step 6: Discharge with integrated wet mill and pneumatic transfer into fluid bed processor for drying

    Depending on the position of the driving shaft, one can distinguish between bottom-drive and top-drive technology high-shear mixers. Each design offers its advantages. The bottom-drive design has a fixed bowl and lid for easy container access. Top-drive high-shear mixers, in contrast, are equipped with a movable bowl and a fixed lid, which makes them fully accessible for cleaning validation.

     

     

    Top Drive Bottom Drive High Shear Mixer