초록 열기/닫기 버튼
The sterilization of health care products is widely used to choose conventionalEthylene Oxide gas sterilization in South Korea. But the method has brought serious issuesbecause of the toxic residual gas and global warming of CO2 evacuation after the sterilizationprocess. This study is carried out to confirm the application possibility of gamma sterilizationinstead of Ethylene Oxide in sanitary aid products. Four kinds of products (gauze, menstrual pad,bandage, menstrual tampon) were treated with gamma irradiation of 15 kGy, then analyzed theachievement of the sterility assurance level (SAL) 10- 6 through BI test. The cytotoxicity ofaccelerated samples of 6 months elapse evaluated by means of colony forming rate at variousconcentration of the extracts. pH and UV measurements at extract concentrations were testedaccording to the MFDS (Ministry of food & drug safety) guideline to verify a stability & safety ofproduct sterilized. The results revealed that the extracts did not show any significant changes incytoxicity assay as well as pH and UV values by gamma sterilization. All extract concentrationwas observed high cell viability, pH and UV values were calculated within the acceptable rangeprescribed by the guideline. It indicates that gamma sterilization could effectively substitute forconventional sterilization such as Ethylene Oxide sterilization in the sanitary aid products.
키워드열기/닫기 버튼
Sanitary aid products, Gamma sterilization, SAL, Cytotoxicityq
