Use of ionizing radiations for increasing the microbial purity of solid drugs

1981 
In accordance with the recommendations of the World Health Organization [i], the total number of nonpathogenic microorganisms in noninJection medicinal preparations must not exceed i000, and the number of yeast and mold fungi i00 cells in 1 g of the preparation. The presence of pathogenic and facultative pathogenic microorganisms is completely impermissible. The introduction of these recommendations is due both to the danger of infecting a patient by the use of preparations highly contaminated with microflora and to the possibility of the decomposition of the components of noninjection preparations through the activity of microorganisms on prolonged storage [2]. Finally, in a number of clinical situations it is possible only to use sterile preparations, including noninjection preparations. All these facts make the task of seeking methods for sterilizing or reducing the contamination of noninjection drugs an urgent one. One of the most promising methods of sterilizing medical products of very different types is that of radiation sterilization [3]. The advantage of this method obove other methods of sterilization is, in particular, the possibility of sterilizing articles, including drugs, in the packaged form, which excludes the possibility of their recontamination with microbes if the packaging is of suitable quality.
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