Mechanical steam decontamination of medicinal drugs with varying surface characteristics [Mechanische Sattdampfentkeimung von Medizinaldrogen mit unterschiedlichen Oberfl?cheneigenschaften]

摘要

Medicinal drugs often have higher microbial contamination than regulatory stipulations allow. The germ reduction is usually achieved by heat destruction, which is implemented in various saturated steam processes. The present study was carried out according to the so-called Lemgo process, a saturated steam process in which not only a thermal germ reduction but rather a substantial detachment of the microorganisms can be realized. While in earlier studies treatments have been carried out in a 1-L-chamber, here a semiindustrial scale was examined. Five medicinal drugs (nasturtium, marjoram, flax seed, fennel and onion) were decontaminated in a 5-L-ploughshare mixer. Saturated steam at 110 and 125°C for 20 s or two times 20 s was applied. Spores on all drugs could be reduced for at least two powers of ten, mostly to less than 102 colony-forming units (CFUVg (detection limit). This applied also to drugs with problematic surfaces such as flax seed (polysaccharides on the surface) or onions (many cut cells). Molds, if any, were also reduced below the detection limit. To avoid recapture effects in large scale facilities it was necessary to use a moving bed. Necessary particle retention was ensured by an additional sieve. With the Lemgo process for mechanical saturated steam decontamination, a gentle and efficient method for the reduction of spores and vegetative microorganisms on many medicinal drugs is available.