{"id":7268,"date":"2025-07-29T11:23:00","date_gmt":"2025-07-29T03:23:00","guid":{"rendered":"https:\/\/zjbocon.com\/?p=7268"},"modified":"2025-11-25T18:14:06","modified_gmt":"2025-11-25T10:14:06","slug":"performance-qualification-pq-mpq-in-eto-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=7268","title":{"rendered":"Performance Qualification (PQ)- mpq in eto sterilization"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-cdd67fc0 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\/2025\/09\/eto-sterilizer-6-1024x1024.webp\" alt=\"\" class=\"uag-image-8486\" width=\"1024\" height=\"1024\" title=\"eto-sterilizer-6\" role=\"img\" \><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-methods\"><strong>方法<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-bioburden-method-lethality-confirmation\"><strong>1. 生物負載法：致死率確認<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>? Direct Count\/Enumeration Method<\/strong><\/li>\n\n\n\n<li><strong>？分數負法<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-2-overkill-method-demonstrating-12-log-reduction\"><strong>2. 過度殺傷方法：演示 12-Log Reduction<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>？半循環法<\/strong><\/li>\n\n\n\n<li><strong>？循環開發法<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-key-terms\"><strong>關鍵術語<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>生物負載<\/strong><\/li>\n\n\n\n<li><strong>減少 12 個對數<\/strong><\/li>\n\n\n\n<li><strong>D值<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>方法概述<\/strong><\/h3>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>1、半循環法（基本原理 &#8211; 運行計數）<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>理論初始生物負載：10？<\/li>\n\n\n\n<li><strong>測試標準：<\/strong>\n<ul class=\"wp-block-list\">\n<li>允許倖存者運行 1 次（&#8220;部分循環&#8221; 或者 &#8220;短週期&#8221;）<\/li>\n\n\n\n<li>需要 3 個半週期，倖存者為零<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>2. 週期計算方法<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>需要<strong>已知初始生物負載 &amp; 致死率<\/strong><\/li>\n\n\n\n<li>方法選擇依據：參見<em>分數負法<\/em><\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>3、直接計數法<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>需要<strong>已知初始生物負載<\/strong><\/li>\n\n\n\n<li><strong>測試標準：<\/strong>\n<ul class=\"wp-block-list\">\n<li>1 次無滅菌劑運行（對照）<\/li>\n\n\n\n<li>1 次運行演示了 4-log 減少<\/li>\n\n\n\n<li>3 次運行，具有中等還原水平<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>4.分數負法<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>需要<strong>已知初始生物負載<\/strong><\/li>\n\n\n\n<li><strong>統計模型：<\/strong>\n<ul class=\"wp-block-list\">\n<li><strong>A3.2 HSKP<\/strong>&nbsp;（霍爾科姆-斯皮爾曼-卡伯程序）<\/li>\n\n\n\n<li><strong>A3.3 SMCP<\/strong>&nbsp;（Stumbo-Murphy-Cochran 程序）<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>生物指示劑 (BI) 的類型<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Strip\/Disk BI<\/strong><br>Strip\/Disk BI<em>Microorganism-coated carrier (e.g., paper\/filter disk) requiring transfer to growth media for incubation.<\/em><\/li>\n\n\n\n<li><strong>基於安瓿的 BI<\/strong><br><em>含有孢子和單獨生長培養基的玻璃安瓿（需要手動粉碎才能激活）。<\/em><\/li>\n\n\n\n<li><br><strong>獨立的商業智能<\/strong><br><em>集成單元：單個小瓶中的孢子條+生長培養基（通過壓縮激活）。<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">如果您想了解更多<\/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>方法 1. 生物負荷法：致死率確認 2. 過度殺傷方法：示範 12 對數減少 關鍵術語 方法概述 1. 半循環方法（基本 [&hellip;]<\/p>\n","protected":false},"author":234312599,"featured_media":8461,"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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Half-Cycle Method (Basic [&hellip;]","jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pgZDV6-1Te","jetpack-related-posts":[{"id":2013,"url":"https:\/\/zjbocon.com\/?p=2013","url_meta":{"origin":7268,"position":0},"title":"Purpose for eto sterilization validation","author":"Bocon Technical Team","date":"2024-10-28","format":false,"excerpt":"1.Purpose\u00a0for validation eto sterilization 1.1.the obtain of eto sterilization validation evidence that the equipment used for ETO sterilization has been provided and installed in accordance with its specification and can stably operate within predetermined limits and consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification.\u2026","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"eto sterilization validation","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=350%2C200 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=525%2C300 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=700%2C400 2x"},"classes":[]},{"id":7286,"url":"https:\/\/zjbocon.com\/?p=7286","url_meta":{"origin":7268,"position":1},"title":"ETO Sterilization Re-qualification","author":"Bocon Technical Team","date":"2025-07-29","format":false,"excerpt":"ETO Sterilization Re-qualification Requirements 1. Re-qualification Frequency \u2022\u00a0Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed\u2022 The scope of re-qualification must be determined and documented\u2022 The review procedure shall be documented 2. Is Re-qualification Needed if No Product Changes\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\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":7277,"url":"https:\/\/zjbocon.com\/?p=7277","url_meta":{"origin":7268,"position":2},"title":"Performance Qualification(pq)-ppq in eo sterilization","author":"Bocon Technical Team","date":"2025-07-29","format":false,"excerpt":"Physical Performance Qualification (PPQ)\u2022 It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process.How many runs should the PPQ process perform?\u2022 To demonstrate process reproducibility, at least 3 runs are required;\u2022 If 3 half-cycles were run during the MPQ process, then at least 1 additional\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\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":9080,"url":"https:\/\/zjbocon.com\/?p=9080","url_meta":{"origin":7268,"position":3},"title":"Essential Utilities and Service Requirements for ETO Sterilizers","author":"Bocon Technical Team","date":"2026-01-20","format":false,"excerpt":"The successful operation of an Ethylene Oxide (ETO) sterilizer requires more than just the machine itself; it demands a robust infrastructure of essential utilities, safety systems, and ongoing technical support. Ensuring these requirements are met is critical for process efficiency, operator safety, and regulatory compliance (such as ISO 11135). 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Established in 2006, HZBOCON has committed itself to the design, development, and manufacturing of EO sterilization equipment, catering to a wide array of industries that require effective\u2026","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.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-4.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.png?resize=1050%2C600&ssl=1 3x"},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7268","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=7268"}],"version-history":[{"count":7,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7268\/revisions"}],"predecessor-version":[{"id":8792,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7268\/revisions\/8792"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8461"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7268"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7268"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7268"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}