Drying & Mixing Systems for APIs
Hosokawa Micron provides several types of drying and blending equipment for API processing. Needless to say, each one is fully compliant with industry standards such as cGMP, FDA and GAMP.
The cGMP production of both sterile and non-sterile active pharmaceutical ingredients (APIs), demands process equipment in a realm of its own and Hosokawa Micron's ability to comply with strict cGMP standards makes us a popular choice. Our Nauta® vacuum dryer is often chosen as an effective secondary dryer for reducing moisture content in, for example, the production of antibiotics.
Contained vacuum drying
Contamination is unacceptable and the cGMP Nauta vacuum dryer is a proven technology for excellent cleaning (CIP) and sterilising (SIP) in place. It has a closed process vessel with a cover and filter made out of one piece. This eliminates dead spots and offers validated automatic SIP/CIP.
There are no oils or lubricants inside the orbit arm, thus avoiding the risk of lubricant leakage. It has a sanitary mixing screw with open flights, bottom outlet for ensuring optimal emptying and is specially designed with a mechanical seal and sampler.
To complete its full cGMP design, the Nauta vacuum dryer and its filter are equipped with fixed-mounted spray balls and spray nozzles for CIP/SIP. The gentle mixing of the orbital arm and screw makes the Nauta vacuum dryer especially suitable for the production of delicate crystals.
Active Freeze Drying
In Hosokawa’s Active Freeze Drying System the product is dried in a contained, closed system, protecting both product and operator. The API is loaded in a conical vessel. This vessel is brought under vacuum. Heat energy is transferred to the product by a heating jacket to sublimate the water or solvent. Inside the vessel an agitator ensures an optimal heat transfer and homogeneity. The end product is a fine, loose, homogeneous powder, directly available from the product collector.
Advantages, compared to traditional tray freeze dryers:
- Shorter process times
- Contained, sterile process
- Easier handling
- No post-milling required
- Automatic drying possible without manual labour
Continuous mixing
The pharmaceutical industry is looking with increasing interest towards continuous manufacturing. For continuously blending APIs with excipients, Hosokawa Micron offers the Modulomix continuous modular blender. Since the APIs in particular normally have very bad flowing properties, an intensive mixing process is required, without causing attrition effects.
The Modulomix continuous pharma blender is a versatile unit designed for a minimum holdup of product in order to minimise the losses at start and end of the production run and for fast response to process variations. The Modulomix can be integrated in a PAT (Process Analytical Technology) environment.
The Modulomix is a very compact blender that can be incorporated into Hosokawa Micron's total continuous blending systems. This means that you can combine the Modulomix modular mixer with PTS, LIW feeders, continuous blenders, PAT technologies and even downstream processing, like (wet) granulation and/or compacting.
Test before you invest
Run trials with your own materials on lab and production-scale equipment at our Test Centre in the Netherlands. The Nauta vacuum dryer can be tested with your product at volumes of up to 6 m³, allowing you to assess whether the particle size distribution (PSD) is maintained at full batch scale. We can also test methanol-based carriers on our DMR flash drying system.
Our experienced process specialists work with you to determine the right process, equipment or system configuration for your application. Each trial is supported by a detailed technical report, helping you select the right solution with confidence.
Talk to our experts
Let our process specialists help you identify the most suitable solution for your materials, process requirements and production goals.
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Hosokawa Micron B.V. is committed to sustainable and responsible process technology. Our environmental management system is certified to ISO 14001, while our EcoVadis Silver Medal places us among the top 3% of rated companies in the special-purpose machinery industry.
