• 한국환경보건학회지
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• 제8권1호
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• pp.81-97
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• 1982

Ethylene oxide gas has been used as a cold sterilant for heat-sensitive medical equipments and as a fumigant for food for more than 30 years, and it is used more widely than radiation although radiation sterilization has made significant inroads in recent years. But according to recent studies of toxicities such as mutagenicity, haemolytic effect and possible carcinogenicity of Ethylene oxide (ETO) and its two main reaction products, Ethylene chlorohydrin (ETCH) and Ethylene glycol (ETG), Environmental Protection Agency in U.S.A. has suggested some regulations on residual gas in drug products and medical devices for human use. The mutagenic activity of ETO compared with that of X-ray has an equivalency of 1 ppm/hr for ETO as compared to 20 mrad for X-ray, and one could suggest the present maximum allowable concentration for ETO (50 ppm) should be 400 times lower than the radiation standard (2.5 mrad/hr). Although radiation sterilization has advantages of simplicity of operation and complete reliability, changes of physico-chemical properties with possible formation of toxic substances may occur. It is therefore necessary to make some regulations of our own for residual toxicities orginated from each sterilization method.

• Maxillofacial Plastic and Reconstructive Surgery
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• 제19권3호
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• pp.287-299
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• 1997

Procurement, cutting, cleansing, freezing, freeze-drying, and demineralization of the allogeneic bone must be made under the germ-free stable condition without bacterial and/or viral contamination. Even thought the bone is procured under the germ free condition, we must have confidence on disinfection of all the solutions that come in contact with tissue during the whole procedure. Lots of antibacterial agents have been introduced for chemical sterilization. Recently ethylene oxide gas sterilization or radiation sterilization is frequently selected as a secendary sterilization procedure. The biological and biochemical response of the graft material differs with the type and concentration of the sterilizing agents, and various toxic reactions have been reported due to the graft material itself and the substance released by the chemicals. The authors conducted the Millipore filter test to observe the toxic effect on L929 fibroblasts according to the effect on activity of succinate dehydrogenase, during the secondary sterilization of the demineralized allogeneic bone powder with irradiation or ethylene oxide gas. The result were as follows : 1. Around the copper disk, positive control group, 10mm diameter discoloration was observed. 2. As same as the negative control group, the disk showed no discoloration. 3. The demineralized allogeneic bone which was sterilized with ethylene oxide gas or irradiation showed no cytotoxicity. 4. From this results, it is suggested that treatment with ethylene oxide gas or irradiation should be effective to sterilize the deminineralized allogeneic bone.

• 센서학회지
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• 제29권3호
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• pp.211-214
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• 2020

Chlorine dioxide is very effective gas for sterilization or disinfection (in manufacturing), and does not produce harmful by-products after use. However, if its concentration exceeds 10 %, it become explosive and cannot be compressed or stored. Therefore, it is necessary to measure its concentration. In this study, the concentration of chlorine dioxide with a high oxidizing strength was measured using a metal oxide sensor. The sensor was a commercially available TGS series from Figaro. The sensitivity of the sensor was inversely proportional to a low concentration of chlorine dioxide gas below 6 ppm and returned to the initial resistance at about 6 ppm. When the gas concentration reached multiples of 10 ppm, resistance of the sensor increased to several megaohms.

• 기본간호학회지
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• 제21권2호
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• pp.141-150
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• 2014

Purpose: This was a study on the expiration date of Ethylene Oxide (EO) gas sterilization and effects of the environmental factors of temperature, humidity and type of cabinet in sterile goods storage area on the expiration date. Methods: Sterile goods storage areas from 13 departments in one hospital were selected and 455 EO gas sterilization samples were prepared and kept in those areas over the 14 months of the study. Each sample was tested with a microbiological culture in the laboratory every week. If the result was positive, the sample was regarded as contaminated. The researcher visited once a month to check the temperature, humidity and type of cabinet. Results: With the exception of 1 sample which was positive at 56th week. 454 samples were confirmed as negative. The environment of the samples storage area was measured monthly. The annual average temperature was $24.2{\pm}1.6^{\circ}C$, and the mean relative humidity $34.7{\pm}15.2%$. The types of cabinet were 7 open and 6 closed. Conclusion: The results of the microbiological culture at 13 months showed that none of the samples were contaminated. Therefore the hospital's existing Expiration Date can be extended from 6 months to 13~14 months.

• 방사선산업학회지
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• 제8권2호
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• pp.133-140
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• 2014

The sterilization of health care products is widely used to choose conventional Ethylene Oxide gas sterilization in South Korea. But the method has brought serious issues because of the toxic residual gas and global warming of $CO_2$ evacuation after the sterilization process. This study is carried out to confirm the application possibility of gamma sterilization instead 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 the achievement of the sterility assurance level (SAL) $10^{-6}$ through BI test. The cytotoxicity of accelerated samples of 6 months elapse evaluated by means of colony forming rate at various concentration of the extracts. pH and UV measurements at extract concentrations were tested according to the MFDS (Ministry of food & drug safety) guideline to verify a stability & safety of product sterilized. The results revealed that the extracts did not show any significant changes in cytoxicity assay as well as pH and UV values by gamma sterilization. All extract concentration was observed high cell viability, pH and UV values were calculated within the acceptable range prescribed by the guideline. It indicates that gamma sterilization could effectively substitute for conventional sterilization such as Ethylene Oxide sterilization in the sanitary aid products.

• 공기청정기술
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• 제23권3호
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• pp.34-43
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• 2010

In most productive facility of pharmaceutical companies, the fumigation using formaldehyde gas has been put into operation. Because formaldehyde gas is so bactericidal as to sterilize bacterial spore which can not be sterilized with usual disinfectants, it has been used for fumigation in many facilities such as facility of experimental animals, research institute and productive facility of pharmaceutical companies which are required to be high level of biological clean. However, the use of formaldehyde is recently under the strict management because of its causing of sick house and carcinogenesis. We introduce the conditions of sterilization using formaldehyde gas, the examples of sterilization using formaldehyde gas in a pharmaceutical manufacture and the problems of use of formaldehyde against environments and health. Further, we describe the characteristics and future subjects of the sterilization method using gasified oxidants such as hydrogen peroxide, peracetic acid and chlorine oxide.

• International Journal of Industrial Entomology and Biomaterials
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• 제42권2호
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• pp.46-50
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• 2021

When 4-hexylresorcinol (4HR) incorporated silk mat is used for clinical application, sterilization process is essential. In this study, 4HR incorporated silk mat was sterilized with ethylene oxide (EO) gas or autoclave, and then antibacterial property was evaluated. For the examination of micro-structure after the sterilization, scanning electron microscopic (SEM) exam and Fourier Transform Infrared (FT-IR) spectroscopy were also done. There was no gross difference after sterilization in SEM exam and FT-IR spectra. Antibacterial property of 4HR was also maintained after the sterilization. In conclusion, EO gas or autoclave did not damage the antibacterial property of 4HR in the silk mat.

• 한국산업보건학회지
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• 제5권1호
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• pp.68-86
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• 1995

This study was conducted at five Ethylene Oxide(EO) sterilizing processes in hospitals located in Seoul from August 8 to August 30, 1994. The main purposes of this study were to assess the TWA(Time Weighted Average) and short term exposures to EO and to evaluate factors affecting EO concentrations in sterilizing room. Results are summarized as follows. 1. The TWA concentrations of the sterilizing operators ranged from <0.005ppm to 3.04ppm and those of two sterilizing rooms out of five exceeded 1ppm, the Korean and ACGIH standards. 2. When the door of the sterilizer is opened at the end of the sterilization cycle, the short term concentrations of operators ranged from <0.005ppm to 11.4ppm, and those of three sterilizing room out of five exceeded 5ppm, the ACGIH short term exposure limit(STEL). The short term concentrations of area samples ranged from 0.24ppm to 49.2ppm and those of four sterilizing room out of five exceeded 5ppm. 3. Factors affecting EO exposure level were aeration type, the location of storage site for sterilized item, amount of gas, use period of sterilizer(p<0.005). 4. Following recommendations are suggested to minimize exposure to EO. The use of EO gas should be reduced by using another available sterilization methods, and the sterilizers and gas tank storage site should be isolated from, other work areas. Combination of local and general ventilation system should be installed. Metal carts or baskets for sterilization load should be used, and work environment and medical monitoring should be performed regularly.

• 한국기록관리학회지
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• 제1권1호
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• pp.231-243
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• 2001

Methyl bromide(MB)와 Ethylene oxide(ETO) 혼합기체를 사용하는 훈증소독방법이 일반적으로 사용되어져 오고 있다. 본 연구에서는 기록물에서 분리해 낸 미생물을 이용하여 MB와 ETO 혼합기체의 훈증소독효과를 검증하였고, 또한 미생물들에 대한 독성도 조사하였다. 미생물과 곤충에 대한 훈증소독의 살균 및 살충 효과를 검증하기 위해 기록물에서 분리한 미생물 및 해충에 대해 MB와 ETO 혼합기체[86 : 14(Vol.%)를 농도별, 처리시간별로 조건을 설정하여 훈증을 실시하였다. 해충은 모든 조건의 실험에서 전부 살충되었다. 그러나, 미생물의 경우는 MB와 ETO 혼합가스농도 $120g/m^3$에서 24시간 이상을 처리했을 때만 살균효과가 있었다. 기록물에서 분리해 낸 미생물들에 대해 독성을 조사하기 위해 효모, 무씨, 암 세포 주를 대상으로 독성 시험을 수행하였다. 그 결과, Apergillus oryzae 한 종류만 독성 효과를 보였다. 본 연구 결과를 통해 MB와 ETO 혼합가스에 의한 훈증소독은 해충의 경우는 낮은 농도에서도 효과가 있으나, 미생물은 높은 농도로 훈증을 해야만 효과가 있다는 것을 알 수 있었다. 또한 기록물에서 분리해 낸 대부분의 미생물들은 인체에 유해한 가능성이 낮을 것이라고 예상할 수 있었다.

• Restorative Dentistry and Endodontics
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• 제30권2호
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• pp.121-127
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• 2005

근관 치료시 많이 사용되고 있는 $K-flex^{(R)}$ S-S 파일 (Maillefer, USA)과 $Profile^{(R)}$ Ni-Ti 파일 (Maillefer, USA), $K-3^{(R)}$ Ni-Ti파일 (SybronEndo, USA)의 부식 정도를 보기 위하여 총 360개의 20번 file을 1) 멸균소독 방법 (고압가열멸균소독, E-O gas 소독) ,2) 근관세척 액 ($5,25\%$ 차아염소산나트륨, 생리식염수) ,3) 멸균소독 횟수 (1, 5, 10회 ) 에 따라 36개 실험군으로 나누었다. 각각의 파일을 각 군별로 처리한 뒤, 세 명의 검사자가 광학 현미경 하에서 25배의 배율로 검사하여 0; 부식 없음, 1; 경도의 부식, 2; 중등도의 부식, 3; 심한 부식으로 점수화 하였다. 심한 부식을 보이는 파일의 표면은 SEM으로 관찰하였고 Kruskal-Wallis test (p < 0.05)를 이용하여 통계 분석 처리하여 차아염소산나트륨 접촉 여부와 멸균소독 방법의 차이에 의한 부식 정도를 평가하였다. 그 결과 고압가열멸균소독을 10회 시행한 파일은 통계적으로 유의한 차이를 보여 부식 정도가 심하였고, 1회나 5회 고압가열멸균소독을 시행한 파일과 E-O 가스로 소독한 파일들은 부식의 정도가 경미하여 통계적으로 유의하지 않았다. 차아염소산나트륨 접촉 여부와 제조사 혹은 파일 재료에 따른 유의성 있는 차이는 없었다