engleski

Radiation Decontamination of Pharmaceutical and Cosmetic Raw Materials and Adjuvants

The planning of the treatment by irradiation, when this treatment is used as a quality assurance (QA) measure of microbiologically contaminated materials, requires the knowledge of the initial contamination level (CL) and its radiosensitivity expressed as a decimal reduction dose D10, as well as the setting of the desired sterility assurance level (SAL). The data on microbial contamination levels typical of botanical raw materials used in the manufacture of pharmaceuticals and cosmetics, together with the corresponding radiosensitivites, are summarized in this paper. Based on a long-term experience with various botanical materials sampled from many domestic manufacturers, some regularities could be established: typical contamination levels of raw mateials decrease with the increasing level of processing, on going from crude drugs, to liquid extracts, to dry extracts. Among crude drugs, flowers and leaves are usually more contaminated than fruits and seeds. At the same time the resistivity of microflora to irradiation increases. This results in doses between 4 and 30 kGy to be required in a typical situation, or between 10 and 40 kGy under a conservative estimate. Final products, phyto-therapeutic ointments usually do not require doses higher than 10 kGy.

nije evidentirano

nije evidentirano