감마선 멸균기술을 이용한 의약외품의무균보증수준(SAL 10-6) 확보 및 세포독성 평가
SAL 10-6 and Cytotoxicity of Sanitary Aid Products Utilizing Gamma Sterilization Technology
1
조회
0
다운로드
0
인용
0
참고문헌
키워드
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.
참고문헌 (23)
- Bedward DA, "Converting from ETO to radiation sterilization: Educating the medical supply industry", Radiat. Phys. Chem., 46(4), pp.443~448 (1995)
- Brinston RM, "Converting to gamma-radiation sterilization: an overview for medical device manufacturers", Med. Device Technol., 4(4), pp.18~22 (1993)
- EC, "Sterilization of medical devices - Requirements for medical devices to be designated “STERILE”-Part 1: Requirements for terminally sterilized medical devices", European Committee for Standardization, ~ (2004)
- Gilbert P, "Potential impact of increased use of biocides in consumer products on prevalence of antibiotic resistance", Clin. Microbiol. Rev., 16(2), pp.189~208 (2003)
- Gisela CCM, "Ethylene oxide potential toxicity", Expert. Rev. Med. Devices, 5(3), pp.159~164 (2008)
- IAEA, "Trends in radiation sterilization of health care products", International Atomic Energy Agency, 49~62 (2008)
- ISO, "Biological evaluation of medical devices. Part 7: ethylene oxide sterilization residuals", International Standard ISO 10993-7, ~ (2008)
- KFDA, "Evaluation guideline of sanitary aid products", Korean Food & Drug Administration, ~ (2009)
- LaMontagne AD, "Long-term ethylene oxide exposure trends in US hospitals: relationship with OSHA regulatory and enforcement actions", Am. J. Public Health, 94(9), pp.1614~ (2004)
- Mendes GCC, "Ethylene oxide sterilization of medical devices: A review", Am. J. Infect. Control, 35, pp.574~581 (2007)
- Rai R, "Sterilization effects on the physical properties and cytotoxicity of poly (glycerol sebacate)", Mater. Let., 105, pp.32~35 (2013)
- Reza A, "A Case Study of an Ethylene Oxide Explosion in a Sterilization Facility", Chem. Engin. Trans., 31, pp.463~468 (2013)
- Rutala WA, "New disinfection and sterilization methods", Emerg. Infect. Dis., 7(2), pp.348~ (2001)
- Shintani H, "Formation and Elution of Toxic Compounds from γ-Ray Sterilized Medical Products: Toxic Compound Formation and Ames test of Eluted Components", Pharm. Anal. Acta, 3(185), pp.2~ (2012)
- Sobaszek A, "Working conditions and health effects of ethylene oxide exposure at hospital sterilization sites", J. Occup. Environ. Med., 41(6), pp.492~499 (1999)
- Swenson D, "Steam sterilization validation for implementation of parametric release at a healthcare facility", Biomed. Instrum. Technol., 44(2), pp.166~174 (2010)
- UNEP, "Montreal Protocol on Substances That Deplete The Ozone layer; Methyl Bromide Technical Options Committee - 1998 Assessment of Alter- natives to Methyl Bromide", 185~201 (1998)
- UNEP, "Important information that may help avoid potential confusion over the issue of ethylene oxide sterilization and protection of the ozone layer. Open-ended working group of the parties to the Montreal Protocol on substances that deplete the ozone layer", Twenty-first meeting Montreal (2001)
- Velasco-Ortega E, "In vitro evaluation of cytotoxicity and genotoxicity of a commercial titanium alloy for dental implantology", Mutat. Res.-Gen. Toxicol. Environ. Muta., 702(1), pp.17~23 (2010)
- ETHYLENE OXIDE, "WHO", World Health Organization, ~, pp.Concise International Chemical Assessment Document 54 (2003)
- "Sterilizing units, ethylene oxide. Hospital medical equipment - general information 2012" (2012)[URL]
- Yakacki CM, "Cytotoxicity and thermomechanical behavior of biomedical shape-memory polymer networks post-sterilization", Biomed. Mater., 3(1), pp.015010~ (2008)
- Yaman A, "Alternative methods of terminal sterilization for biologically active macromolecules", Curr. Opin. Drug Disc. Devel., 4(6), pp.760~763 (2001)