Cleanroom for highly sensitive herbal medicinal products

6000 vials per hour are produced by Abnoba GmbH in its compact, highly specialized cleanroom areas of GMP classes A-D.

Naturopathic medicines are widely used in cancer therapy. It is estimated that more than two-thirds of all cancer patients use them in addition to conventional treatments. Among the most commonly used herbal medicines are mistletoe preparations. A fact that might surprise some – after all, the plant is not automatically associated with cancer therapy in public perception. And this, although it has been used there for over 100 years!

Mistletoe preparations are produced in Germany by only a few specialized companies – including Abnoba GmbH in Niefern-Öschelbronn in southern Germany. The medium-sized pharmaceutical manufacturer produces around two million ampoules annually in modern, GMP-certified cleanrooms, supplying hospitals, pharmacies, and practices worldwide.

For over 20 years, CAT Clean Air Technology GmbH (CAT Group) from Stuttgart has been responsible for the requalification of the surprisingly compact cleanroom areas of classes A to D. Due to high quality requirements, the measurements cover a broad spectrum: determination of air volumes and air velocities, filter integrity and leak tests, determination of air cleanliness class, recovery time / room purge time, measurement of pressure cascade, room pressures, temperature, and humidity, as well as calibration of pressure, temperature, and humidity sensors.

The requalification includes not only the cleanroom areas but also the supply systems for compressed air and argon. For both media, the total microbial count and the air cleanliness class are determined. For compressed air, additional testing of the dew point and residual oil content is performed. The cleanroom areas of classes A and B are requalified semiannually according to GMP requirements, while areas of classes C and D are requalified annually.

By the way, not only the processing of mistletoe in the cleanroom requires a high level of expertise, but also the harvesting: it is done exclusively by hand directly on the host tree and only twice a year. To prevent microbial decomposition or the breakdown of valuable ingredients, the freshly harvested material is stored on-site in liquid nitrogen.