Radiation Sterilization of Pancreatin Preparation

The enzymatic activities (in detail, amylase-, lipase- and protease-activity) of γ-irradiated pancreatin powder preparation decrease to 50-95% at doses range of 50 kR-8 MR. The dose-inactivation relation-ships vary depending on every different manufactory lot. In the case of higher moisture content preparation as irradiation sample, amylase activities are more stable, the other side, protease activities are less stable. On the variation of these activities by γ-irradiation, there are no difference between room temperature and lower temperature (-70°C) as irradiation condition. The D10 values of contamined bacteria and fungus (contamination number: about 1×103 cells/g and 9×102 spores/g) of a pancreatin preparation are 74 C/kg (280 kR) and 60 C/kg (230 kR) . Then, these values are corresponded to 645 C/kg (2.5 MR) and 540 C/kg (2.1 MR) as perfect sterilization.