의료기기 멸균을 위한 전자빔의 멸균선량 설정
Establishing the Sterilization Dose of Electron Beam for Sterilization of Medical Devices
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Sterilized products are products in which no living microorganisms remain, and sterilization is to deactivate contaminated microorganisms and transform them into sterile products. The electron beam has the advantage of being easy to sterilize under the packaged state of the complete product, having a very short processing time, and not requiring separate treatment after sterilization or toxic substances. In the sterilization method using an electron beam accelerator, the sterilization dose determination and management are the main points of the quality management system. There are three methods for determining sterile doses: determining doses using bioburden information from Method 1, dose setting using molecular nucleus culture information from the incremental dose process to determine an extrapolation factor in Method 2, and determination of 25 kGy or 15 kGy of VDmax. In order to produce a complete sterilized product, the sterilization dose audit should be conducted at regular cycles in consideration of the degree of bioburden and packaging material of the product to be sterilized.
Abstract
Sterilized products are products in which no living microorganisms remain, and sterilization is to deactivate contaminated microorganisms and transform them into sterile products. The electron beam has the advantage of being easy to sterilize under the packaged state of the complete product, having a very short processing time, and not requiring separate treatment after sterilization or toxic substances. In the sterilization method using an electron beam accelerator, the sterilization dose determination and management are the main points of the quality management system. There are three methods for determining sterile doses: determining doses using bioburden information from Method 1, dose setting using molecular nucleus culture information from the incremental dose process to determine an extrapolation factor in Method 2, and determination of 25 kGy or 15 kGy of VDmax. In order to produce a complete sterilized product, the sterilization dose audit should be conducted at regular cycles in consideration of the degree of bioburden and packaging material of the product to be sterilized.
참고문헌 (13)
- A company sterilization validation, "이비테크(주)", ~, pp.Report No: EBT 190420-1 (2019)
- B company sterilization validation, "이비테크(주)", ~, pp.Report No: EBT 190930-1 (2019)
- The Study on the development of Sterilization Validation Guideline for Sterilized Medical Device Prior to Use, "한국산업기술시험원", ~, pp.Report No.12172의료기507 (2012)
- Sterilization of Health Care Products-Radiation Sterilization-Substantiation of 25 kGy as a Sterilization Dose-Method VDmax, "Association for the Advancement of Medical Instrumentation", ~, pp.TIR27 (2001)
- Booth AF, "Sterilization Validation & Routine Operation Handbook: Radiation", pp.25~58 (2018), CRC Press
- International Organization for Standardization ISO, "Sterilization of health care products-Requirements for validation and routine control-Radiation-Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices", ISO11137-1:2006(en), ~ (2006)
- International Organization for Standardization ISO, "Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the validation of a sterilization process", ISO11737-2:2009(en), ~ (2009)
- International Organization for Standardization ISO, "Sterilization of health care products-Requirements for validation and routine control-Radiation-Part 2: Establishing the sterilization dose", ISO11137-2:2013(en), ~ (2013)
- International Organization for Standardization ISO, "Medical Devices Quality Management Systems-Requirements for Regulatory Purposes", ISO13485:2016(en), ~ (2016)
- International Organization for Standardization ISO, "Sterilization of health care products-Radiation-Part 3: Guidance on dosimetric aspects of development, validation and routine control", ISO11137-3:2017(en), ~ (2017)
- International Organization for Standardization ISO, "Sterilization of health care products-Microbiological methods-Part 1: Determination of a population of microorganisms on products", ISO11737-1:2018(en), ~ (2018)
- KFDA, "Guidelines for sterilization validation of Medical devices", MDQMF-AG-2007-02, ~ (2007)
- Kowalski J, "A. Radiation sterilization-Evaluation of a new method for substantiation of 25 kGy", Radiat. Phys. Chem., 58, pp.77~86 (2000)