{"id":2453,"date":"2024-12-20T11:08:14","date_gmt":"2024-12-20T03:08:14","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2453"},"modified":"2025-10-01T19:14:06","modified_gmt":"2025-10-01T11:14:06","slug":"microbial-killing-performance-of-ethylene-oxide-sterilizers","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2453","title":{"rendered":"Microbial Killing Performance of Ethylene Oxide Sterilizers"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>註1：<\/strong> 環氧乙烷滅菌條件必須透過驗證確認來獲得，並應在每個滅菌週期期間透過監測和常規控制進行驗證。 GB 18279 概述了驗證和常規控制的要求。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>註2：<\/strong> 本測試方法也適用於裝有預設值的A級環氧乙烷滅菌器。 <a href=\"https:\/\/zjbocon.com\/product\/hospital-laboratory-eto-sterilizer\/\">環氧乙烷滅菌<\/a> 程式.<\/p>\n\n\n\n<div class=\"wp-block-uagb-image uagb-block-f1766043 wp-block-uagb-image--layout-default wp-block-uagb-image--effect-static wp-block-uagb-image--align-none\"><figure class=\"wp-block-uagb-image__figure\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp\" alt=\"Microbial Killing Performance of Ethylene Oxide Sterilizers\" class=\"uag-image-1243\" width=\"731\" height=\"359\" title=\"Microbial role =\"img\" \><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-e-1-equipment\">E.1 設備<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-e-1-1\">E.1.1<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">需要四個製程挑戰設備，如下所示：<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>此過程挑戰裝置由不銹鋼管和裝有污染載體的半封閉室組成。鋼管和腔室使用 O 型環密封件和螺紋連接連接。進入腔室的唯一路徑是穿過管子的長度。<\/li>\n\n\n\n<li>管長為 4.55 m（標稱），內徑為 3.0 mm（標稱），長徑比為 1500:1。總內部體積約為32mL，其中0.85mL是腔室的體積。<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-e-1-2\">E.1.2<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Eight paper-plastic packaging bags that comply with GB\/T19633, YY\/T0698.4, and YY\/T0698.5.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-e-1-3\">E.1.3<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">符合GB18281.1和GB18281.2的污染載體。<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-e-1-4\">E.1.4<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">適用於受污染載體的恢復培養基。<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-e-1-5\">E.1.5<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">栽培盆。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-e-2-testing-steps\">E.2 測試步驟<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-e-2-1\">E.2.1<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">選擇要測試的環氧乙烷滅菌程序。<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-e-2-2\">E.2.2<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">將一個受污染的載體放入每個製程挑戰設備的測試室中。將每個製程挑戰裝置用兩個紙塑包裝袋包裹，並用封口機密封每個袋子。<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-e-2-3\">E.2.3<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">The process challenge device does not need initialization but should be maintained at 20\u00b0C \u00b1 5\u00b0C for at least one hour before testing.<br><strong>筆記：<\/strong> 這模擬了最壞的情況。<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-e-2-4\">E.2.4<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">將環氧乙烷滅菌器升至滅菌溫度，將四個包覆好的製程挑戰裝置裝入環氧乙烷滅菌器腔室中，並在裝載後15分鐘內開始測試循環。測試週期中滅菌劑的暴露時間應為環氧乙烷滅菌週期規定時間的一半。<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-e-2-5\">E.2.5<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">測試週期完成後，從環氧乙烷滅菌器中取出製程挑戰設備。<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-e-2-6\">E.2.6<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Remove the contaminated carriers from the test chamber, culture them according to the manufacturer&#8217;s instructions, and verify compliance with the requirements of section 2.13.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-e-2-7\">E.2.7<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Culture one unexposed contaminated carrier from the same batch according to the manufacturer&#8217;s instructions; it should show the presence of viable microorganisms. If not, the test is considered invalid, and retesting should be conducted.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-e-2-8\">E.2.8<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">再重複測試兩次。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">如果您想了解更多有關氧化乙烷滅菌的信息<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">電話：<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">電子郵件：<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Local Site: Room 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">網站：<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">&nbsp;zjbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Note 1: The Ethylene Oxide sterilization conditions must be obtained through validation confirmation and should be verified with monitoring and [&hellip;]<\/p>\n","protected":false},"author":234312599,"featured_media":1243,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center 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