Active pharmaceuticals (APIs)

Hosokawa Micron provides several types of vacuum dryers for APIs. Needless to say, each 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 processing

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 such as those required in the manufacture of antibiotics.

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 low 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. The end product is a fine, loose powder, directly available from the product collector.

Advantages, compared to traditional tray freeze dryers:

  • Shorter process times
  • Contained process
  • Easier handling
  • No post-milling required
  • Automatic drying possible without manual labour

Try before you buy

At the Hosokawa test 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-H flash dryer.

From pilot plant to production scale

Hosokawa Micron B.V. offers 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?

If you want to learn more about our powder process equipment, 
call us at +31 314 373 333 or fill out our inquiry form.

Related Process Equipment

Hosokawa Micron B.V. is a global industrial process machinery supplier which provides mixing, drying and agglomeration equipment and complete systems for the powder and bulk processing industry.