Study on electron beam radiation sterilization process for disposable medical protective clothing
The outbreak of COVID-19 has led to a sharp increase in the demand for disposable medical protective clothing in the short term. In order to shorten the marketing cycle, a large number of domestic disposable medical protective clothing products have been sterilized by electron beam irradiation, whic...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | zho |
| Published: |
Science Press
2021-02-01
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| Series: | Fushe yanjiu yu fushe gongyi xuebao |
| Subjects: | |
| Online Access: | http://www.fs.sinap.ac.cn/thesisDetails#10.11889/j.1000-3436.2021.rrj.39.010401&lang=zh |
| _version_ | 1797900520096006144 |
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| author | CUI Lei GUO Lili CAO Lian KANG Siqing YIN Yuji WANG Hongwei CHEN Tianbao WANG Guichao |
| author_facet | CUI Lei GUO Lili CAO Lian KANG Siqing YIN Yuji WANG Hongwei CHEN Tianbao WANG Guichao |
| author_sort | CUI Lei |
| collection | DOAJ |
| description | The outbreak of COVID-19 has led to a sharp increase in the demand for disposable medical protective clothing in the short term. In order to shorten the marketing cycle, a large number of domestic disposable medical protective clothing products have been sterilized by electron beam irradiation, which is more efficient than ethylene oxide sterilization. However, the performance of such clothing must adhere to strict requirements and the process parameters of this sterilization method still lack systematic data support. In order to ensure the reliability of electron beam sterilization of disposable medical protective clothing, research on a corresponding process was carried out. Typical disposable medical protective clothing available on the market made of polypropylene (PP) and coated with polyethylene (PE) was selected as the material studied. An appropriate method was selected to establish the corresponding sterilization dose with reference to the standard methods—“Disposable medical protective clothing irradiation sterilization emergency specification (temporary)” and “ISO 11137-2:2013 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose.” The change in material properties after irradiation sterilization with different absorbed doses was studied. Based on the obtained parameters, an algorithm for the average absorbed dose on irradiation by an irradiation electron linac was proposed. Results showed that absorbed doses of 20.3 kGy and 31.5 kGy allowed the products to achieve sterility assurance levels of 10-3 and 10-6, respectively. The material performance of the products after irradiation at 25.0 kGy, 30.0 kGy and 35.0 kGy were able to meet national standard requirements such as elongation at break, breaking strength, impermeability, and filtration efficiency. Thus, a satisfactory electron beam irradiation sterilization process for medical disposable protective clothing has been established. |
| first_indexed | 2024-04-10T08:47:21Z |
| format | Article |
| id | doaj.art-d5b5e1edf4a8432b9000576f905f2629 |
| institution | Directory Open Access Journal |
| issn | 1000-3436 |
| language | zho |
| last_indexed | 2024-04-10T08:47:21Z |
| publishDate | 2021-02-01 |
| publisher | Science Press |
| record_format | Article |
| series | Fushe yanjiu yu fushe gongyi xuebao |
| spelling | doaj.art-d5b5e1edf4a8432b9000576f905f26292023-02-22T07:21:49ZzhoScience PressFushe yanjiu yu fushe gongyi xuebao1000-34362021-02-01391718010.11889/j.1000-3436.2021.rrj.39.0104011000-3436（2021）01-0071-10Study on electron beam radiation sterilization process for disposable medical protective clothingCUI Lei0GUO Lili1CAO Lian2KANG Siqing3YIN Yuji4WANG Hongwei5CHEN Tianbao6WANG Guichao7China Isotope & Radiation Corporation, Beijing 100089, ChinaChina Isotope & Radiation Association, Beijing 100089, ChinaBeijing Atom Hightech Jinhui Radiation Technology Application Co., Ltd., Beijing 102412, ChinaBeijing Atom Hightech Jinhui Radiation Technology Application Co., Ltd., Beijing 102412, ChinaChina Isotope & Radiation Corporation, Beijing 100089, ChinaChina Isotope & Radiation Corporation, Beijing 100089, ChinaChina Isotope & Radiation Corporation, Beijing 100089, ChinaSuzhou CNNC Huadong Radiation Co., Ltd., Suzhou 215200, ChinaThe outbreak of COVID-19 has led to a sharp increase in the demand for disposable medical protective clothing in the short term. In order to shorten the marketing cycle, a large number of domestic disposable medical protective clothing products have been sterilized by electron beam irradiation, which is more efficient than ethylene oxide sterilization. However, the performance of such clothing must adhere to strict requirements and the process parameters of this sterilization method still lack systematic data support. In order to ensure the reliability of electron beam sterilization of disposable medical protective clothing, research on a corresponding process was carried out. Typical disposable medical protective clothing available on the market made of polypropylene (PP) and coated with polyethylene (PE) was selected as the material studied. An appropriate method was selected to establish the corresponding sterilization dose with reference to the standard methods—“Disposable medical protective clothing irradiation sterilization emergency specification (temporary)” and “ISO 11137-2:2013 Sterilization of health care products—Radiation—Part 2: Establishing the sterilization dose.” The change in material properties after irradiation sterilization with different absorbed doses was studied. Based on the obtained parameters, an algorithm for the average absorbed dose on irradiation by an irradiation electron linac was proposed. Results showed that absorbed doses of 20.3 kGy and 31.5 kGy allowed the products to achieve sterility assurance levels of 10-3 and 10-6, respectively. The material performance of the products after irradiation at 25.0 kGy, 30.0 kGy and 35.0 kGy were able to meet national standard requirements such as elongation at break, breaking strength, impermeability, and filtration efficiency. Thus, a satisfactory electron beam irradiation sterilization process for medical disposable protective clothing has been established.http://www.fs.sinap.ac.cn/thesisDetails#10.11889/j.1000-3436.2021.rrj.39.010401&lang=zhirradiation electron linacelectron beamsterilization dosedisposable medical protective clothing |
| spellingShingle | CUI Lei GUO Lili CAO Lian KANG Siqing YIN Yuji WANG Hongwei CHEN Tianbao WANG Guichao Study on electron beam radiation sterilization process for disposable medical protective clothing Fushe yanjiu yu fushe gongyi xuebao irradiation electron linac electron beam sterilization dose disposable medical protective clothing |
| title | Study on electron beam radiation sterilization process for disposable medical protective clothing |
| title_full | Study on electron beam radiation sterilization process for disposable medical protective clothing |
| title_fullStr | Study on electron beam radiation sterilization process for disposable medical protective clothing |
| title_full_unstemmed | Study on electron beam radiation sterilization process for disposable medical protective clothing |
| title_short | Study on electron beam radiation sterilization process for disposable medical protective clothing |
| title_sort | study on electron beam radiation sterilization process for disposable medical protective clothing |
| topic | irradiation electron linac electron beam sterilization dose disposable medical protective clothing |
| url | http://www.fs.sinap.ac.cn/thesisDetails#10.11889/j.1000-3436.2021.rrj.39.010401&lang=zh |
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