LYOPHILISATION SYSTEM

for producing free-flowing, sterile bulk pharmaceuticals

Active Freeze Dryer

for pharmaceutical applications

The Active Freeze Dryer (AFD) offers profound advantages over traditional tray freeze dryers. It is designed to produce free-flowing, sterile bulk pharmaceuticals in a one-pot process, with no operator intervention and no post-processing. The result is always a fine, loose powder, directly available from the product collector. The main benefits of this technology are efficiency, minimal handling and a consistent, high product quality.

Principle of operation

In the Active Freeze Dryer, the product is frozen while being agitated in a specially designed chamber. Whether the material to be dried is initially liquid, granular solid or a paste, the forced motion within the drying chamber ensures that it solidifies in the form of free flowing solid granules.

Active Freeze Drying process

Once the product is fully frozen, a deep vacuum is applied, and the sublimation starts. Heat applied to the vessel jacket is effectively distributed throughout the product due to the dynamic environment. The initially coarse, frozen granules gradually shrink as the ice structure connecting the frozen material sublimates, yielding a loose powder consisting of fine, dry particles.

Once the vacuum has been released, the chamber is opened, and the powdered product can be discharged.

  • Key features

    Contamination-free
    The Active Freeze Dryer (AFD) enables pharmaceuticals producers to fill a vessel with a suspension or solution and then freeze and dry the material, resulting in a free-flowing material, without operator interference. The powdery end product can simply be collected from the canister at the outlet of the dryer.

    Excellent cleanability
    Active Freeze Drying systems are very well suitable for Cleaning In Place or Sterilisation In Place. Furthermore, toxic materials can be processed without risk of contamination.

    Superior quality
    The Active Freeze Dryer can handle material consistencies ranging from solutions, suspensions to pastes and even wet solids. Thanks to the alternative and much faster method of freezing the material, the structure of the end product is different and, in most cases, will result in a structure with open pores with better (re)dispersibility and free-flowing properties. In addition, the particle size of the final product is in general very fine and uniform.

    Efficiency
    The Active Freeze Drying process is less labour intensive in comparison to the traditional tray-type process. Consequently, the handling is significantly shorter and simpler (no manual handling or post-processing steps), saving you time and money!

    Tailor-made system
    To take full advantage of this technology, we will help you develop and finetune your process in our extensive test facilities. After all, the parameters of the Active Freeze Drying process are different than what is known from tray freeze dryers. You know your product; and we know our AFD technology. Together we will make it work for your application.

  • Applications

    Active Freeze Drying technology is suitable for sterile bulk pharmaceuticals, including:

    • Antibiotics
    • APIs
    • Collagens
    • Proteins
  • Models

    Active Freeze Drying systems are available in three models. Their typical characteristics are described below. Please note that these values are indicative only. Detailed information is available on request.

    Model[l]AFD-5AFD-20 *AFD-100 *
    Max. net product volume (liquid) [l] 2.5 10 50
    Jacket surface area [m²] 0.13 0.33 0.98
    Max. sublimation capacity at p = 2 mbar [kg/h] 0.3 0.8 2.2


    * Sterile execution

    An Active Freeze Drying system consists of the following components:

    • Lyophilisation chamber
    • Canister and split valves
    • Vacuum dust filter
    • Vacuum pump skid
    • Heating and cooling system
    • CIP skid
    • SIP skid
    • Ancillary skid
    • Control system

Validation simplified

Validation is a critical challenge in pharmaceutical manufacturing, and freeze-drying is no exception. Manufacturers of active pharmaceutical ingredients (APIs) must comply with stringent standards set by regulatory bodies such as the EMA, FDA, cGMP, and GAMP. They must document and demonstrate that their processes consistently yield the expected results. Hosokawa Micron's innovative Active Freeze Drying technology addresses this challenge by producing fully homogeneous batches of sterile material, making validation easier, faster, and more cost-effective.

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Batch drying systems

As a global developer, manufacturer and 'one-stop shop' supplier of powder processing systems and plants, Hosokawa Micron provides a wide range of both batch and continuous drying technologies. We carefully select, configure and integrate all components and processes in order to ensure the optimal functionality, quality and efficiency of your drying system.

Thanks to our long-standing experience, we are the ideal partner to transform your drying operation into a bespoke powder processing system, from incoming base ingredients to final products.

Energy-Saving Freeze Drying Systems

Energy-saving freeze dryer for pharmaceutical products

Drying is responsible for more than 15% of energy consumption in modern industrial processes. This makes energy efficiency an important factor when designing a freeze drying system. Hosokawa Micron is an expert in developing advanced solids processing systems and we put a lot of our own energy into developing freeze drying systems that will save you energy!

Testing & Process Development

Hosokawa Micron powder processing Test Centre in Doetinchem, Netherlands

At the Hosokawa Micron Test & Process Development Centre in the Netherlands, various unit sizes (1, 5, 60, and 800 litres) are available for customer testing to assess scalability and conduct trials. The company offers a 'try before you buy' option for all its technologies, including Active Freeze Drying, supporting customers in initial product testing, and development. This collaborative approach facilitates the collection of valuable feedback and helps optimize solutions tailored to individual requirements.

Pharmaceutical customers not only appreciate the product quality – many describe it as 'revolutionary' – but also the reduced handling and easy validation of this enclosed system. Hosokawa Micron is encouraged by the growing number of pharmaceutical manufacturers worldwide recognizing the advantages of Active Freeze Drying as a more efficient alternative to traditional tray-type freeze-drying.

Let our expert help you

Talk to our seasoned experts and let them help you craft the perfect solution for your powder and bulk solids processing needs, ensuring optimal efficiency and peak performance.

Get in touch

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Sustainable Processing Systems

Hosokawa Micron B.V. is certified according to ISO 14001. Our certification covers all environmental themes of ISO 14001: air, soil, energy, waste, water, noise and hazardous substances. In addition, Hosawa Micron was awarded an EcoVadis Silver Medal for its sustainability achievements. EcoVadis determined that the company was among the top 15% of companies rated by EcoVadis in the special machinery industry.

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