{"id":2128,"date":"2024-11-06T13:08:38","date_gmt":"2024-11-06T05:08:38","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2128"},"modified":"2025-12-05T10:49:36","modified_gmt":"2025-12-05T02:49:36","slug":"routine-monitoring-control-and-release-of-ethylene-oxide-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2128","title":{"rendered":"Routine Monitoring, Control, and Release of Ethylene Oxide Sterilization"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-49e85672 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\/tp2.jpg\" alt=\"Ethylene oxide sterilization chamber\" class=\"uag-image-971\" width=\"514\" height=\"358\" title=\"Ethylene role =\"img\" \><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-routine-monitoring-and-control\">日常監測與控制<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">EO（環氧乙烷）滅菌的常規監測和控制的目的是證明已對產品應用了經確認和指定的滅菌製程。應記錄並保留每個滅菌週期的數據，以證明已滿足確認的滅菌製程規格。這至少應包括以下內容：<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">a) 產品進入預處理（如果使用）時的環境溫度已達到最低確認溫度的證據。這可以透過讓負載在指定的最短時間內適應環境來實現。如果儲存溫度已知，則在進入預處理區之前無需確定產品的溫度。如果產品暴露在極端溫度下，例如在運輸過程中，產品可能需要在預處理之前儲存一段時間，以將其內部溫度和濕度穩定在可接受的範圍內。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) 監測並記錄預處理區（如使用）指定地點的溫度和濕度。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">c) 每個滅菌負荷的預處理開始時間以及負載從預處理區域移除的時間（如果使用）。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">d) 從預處理區域（如果使用）移除滅菌負荷與滅菌週期開始之間的時間間隔。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">e) 在氣體暴露階段（如果使用），室內氣體循環系統正常運作的指示器。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">f) 整個滅菌週期內腔室內的溫度和壓力。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">g) 處理階段室內的濕度，透過壓力或直接測量。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">h) 確認氣態EO已被引進滅菌室。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">i) 滅菌室內部的壓力升高以及所使用的 EO 的量或濃度。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">j) 處理時間。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">k) 曝光時間。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">l) Time, temperature, and pressure changes (if applicable) during the aeration phase and\/or venting operations (if used).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eo-sterilization-release\">環氧乙烷滅菌釋放<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-biological-indicator-method\">a) 生物指標法<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">如果使用生物指示劑（經確認的 EPCD），則應將其分佈在整個滅菌負載中，包括最難滅菌的位置或已知與這些困難點相關的位置。如果採用預處理，生物指示劑應置於預處理之前。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">滅菌週期結束後，應將生物指示劑從滅菌負荷中取出並儘快培養，以使生物指示劑復活。如果沒有及時培養，應評估延遲復甦期間暴露於殘留 EO 的影響。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">應分析生物指示劑的增長，以確定增長是否是由於未能滿足物理過程規範而導致的，這將需要重複確認過程。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) 參數釋放方法<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">參數發布依賴證明所有物理過程參數符合發布規範，而不使用生物指示劑。它僅基於物理過程參數的測量和記錄，並作為滅菌過程充分性的充分聲明。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">僅當所有製程參數均已指定、控制和直接監控時才允許參數發布。因此，採用參數發佈時，應有直接測量箱內溫度、濕度和直接分析EO濃度的設備，收集和記錄滅菌過程參數，確認滅菌過程符合規範。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">參數發布除了證明滅菌製程參數符合滅菌規範外，還需要測量並記錄以下附加數據：<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">在整個滅菌週期中，至少從兩個位置測量室內的溫度。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">在加工階段直接測量室內的濕度。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">透過在指定時間間隔直接分析滅菌室氣體來確定 EO 濃度，以充分驗證整個暴露期間是否滿足所需條件。<\/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\/\">zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>EO（環氧乙烷）滅菌的常規監測和控制的目的是證明已對產品應用了經確認和指定的滅菌製程。應記錄並保留每個滅菌週期的數據，以證明已滿足確認的滅菌製程規格。這至少應包括以下內容：<\/p>\n","protected":false},"author":234312599,"featured_media":8429,"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":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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Technical Team","author_link":"https:\/\/zjbocon.com\/?author=234312599"},"uagb_comment_info":23,"uagb_excerpt":"The purpose of routine monitoring and control of EO (Ethylene Oxide) sterilization is to demonstrate that the confirmed and specified sterilization process has been applied to the product. Data from each sterilization cycle should be recorded and retained to prove that the confirmed sterilization process specifications have been met. This should include at least the&hellip;","jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pgZDV6-yk","jetpack-related-posts":[{"id":3093,"url":"https:\/\/zjbocon.com\/?p=3093","url_meta":{"origin":2128,"position":0},"title":"Introduction to Ethylene Oxide Sterilizers","author":"Bocon Technical Team","date":"2025-02-05","format":false,"excerpt":"Discover how ethylene oxide sterilizers work, their applications, benefits, and safety considerations. Learn why they are essential for medical and industrial sterilization.","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/ethylene-oxide-sterilization-21.webp?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":8958,"url":"https:\/\/zjbocon.com\/?p=8958","url_meta":{"origin":2128,"position":1},"title":"Understanding What is ETO Sterilizers: A Comprehensive Guide","author":"Bocon Technical Team","date":"2025-12-16","format":false,"excerpt":"Discover the essentials of ETO sterilizers and ethylene oxide sterilization, ensuring the highest hygiene standards in healthcare and beyond.","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":3100,"url":"https:\/\/zjbocon.com\/?p=3100","url_meta":{"origin":2128,"position":2},"title":"How Does Ethylene Oxide Gas Sterilization Kill Microorganisms?","author":"Bocon Technical Team","date":"2025-02-05","format":false,"excerpt":"How Does Ethylene Oxide Gas Sterilization Work? The effectiveness of ethylene oxide gas sterilization lies in its ability to disrupt the cellular structure of microorganisms. Here\u2019s a step-by-step breakdown of how it works: 1.\u00a0Penetration of EO Gas Ethylene oxide gas is highly penetrative, meaning it can easily reach microorganisms even\u2026","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/tp2.jpg?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]},{"id":2004,"url":"https:\/\/zjbocon.com\/?p=2004","url_meta":{"origin":2128,"position":3},"title":"The Guide to ethylene oxide in sterilization","author":"Bocon Technical Team","date":"2024-10-28","format":false,"excerpt":"ethylene oxide in sterilization Introduction ETO is a colorless gas that is flammable and explosive. The four essential parameters (operational ranges) of ethylene oxide in sterilization are: gas concentration (450 to 1200 mg\/l); temperature (37 to 63\u00b0C); relative humidity (40 to 80%)(water molecules carry ETO to reactive sites); and exposure\u2026","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"Industry_ETO_Sterilizer","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Industry_ETO_Sterilizer.webp?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Industry_ETO_Sterilizer.webp?resize=350%2C200 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Industry_ETO_Sterilizer.webp?resize=525%2C300 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Industry_ETO_Sterilizer.webp?resize=700%2C400 2x"},"classes":[]},{"id":2471,"url":"https:\/\/zjbocon.com\/?p=2471","url_meta":{"origin":2128,"position":4},"title":"Safety Requirements for Using Ethylene Oxide in sterilization","author":"Bocon Technical Team","date":"2024-12-23","format":false,"excerpt":"when Ethylene Oxide in sterilization chamber should be equipped with fire prevention facilities. Ethylene oxide cylinders should be stored separately in a dry, well-ventilated room, with strict prohibition of smoking and open flames. The lighting in the sterilization chamber should be explosion-proof, and any electrical appliances that may cause electric\u2026","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Electrical-Scale.png?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":1950,"url":"https:\/\/zjbocon.com\/?p=1950","url_meta":{"origin":2128,"position":5},"title":"eto sterilization process","author":"Bocon Technical Team","date":"2024-10-23","format":false,"excerpt":"Eto Sterilization is conducted using a eto sterilizer located in a dedicated facility.","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"eto sterilization process","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=700%2C400&ssl=1 2x"},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/users\/234312599"}],"replies":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=2128"}],"version-history":[{"count":4,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128\/revisions"}],"predecessor-version":[{"id":8879,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128\/revisions\/8879"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8429"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2128"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2128"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2128"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}