감마선 멸균기술을 이용한 의약외품의무균보증수준(SAL 10-6) 확보 및 세포독성 평가
SAL 10-6 and Cytotoxicity of Sanitary Aid Products Utilizing Gamma Sterilization Technology
김광훈(그린피아기술(주)); 엄용운(그린피아기술(주)); 이후철(그린피아기술(주)); 박성현(그린피아기술(주)); 김수진(그린피아기술㈜); 김관수(그린피아기술(주)); 박순연(그린피아기술(주)); 정일윤(한국원자력연구원)
8권 2호, 133~140쪽
초록
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.
Abstract
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.
- 발행기관:
- (사)한국방사선산업학회
- 분류:
- 응용방사선학