PHARMA

Process technologies for tomorrow.

DRYING & BLENDING 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 System

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 blending

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 minimize 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.

TESTING & PROCESS DEVELOPMENT

At the Hosokawa test and process development centre in Doetinchem, the Netherlands, we offer you the opportunity to test your particular process on our mixing and drying equipment.

It is possible to test the Nauta vacuum dryer with your product up to 6 m³ (product volume) to ensure the PSD of your product will not be damaged on a full size batch scale. We are also capable of drying methanol based carriers on our DMR flash mill dryer.

We offer process equipment and technologies from individual units to large scale bespoke system solutions. Our principle is to deliver high performance yet affordable solutions that meet our customers' demands and long term challenges.

HOW CAN WE HELP YOU?

To learn more about our powder process equipment and systems for APIs, contact us:

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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 7% of companies rated by EcoVadis in the special machinery industry.

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