{"id":7286,"date":"2025-07-29T12:02:12","date_gmt":"2025-07-29T04:02:12","guid":{"rendered":"https:\/\/zjbocon.com\/?p=7286"},"modified":"2025-10-01T19:30:30","modified_gmt":"2025-10-01T11:30:30","slug":"eto-sterilization-re-qualification","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/","title":{"rendered":"ETO Sterilization Re-qualification"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements\">Требования к переквалификации ETO по стерилизации<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. Частота переквалификации<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Минимальное годовое требование<\/strong><br>\u2022 At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed<br>\u2022 The scope of re-qualification must be determined and documented<br>\u2022 The review procedure shall be documented<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-2-is-re-qualification-needed-if-no-product-changes-occur\">2. Нужна ли переквалификация, если изменений в продукте не происходит?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Да, переквалификация по-прежнему требуется.<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. Предметы переквалификации<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>При определенных предварительных условиях возможны следующие варианты:<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Полная переквалификация<\/li>\n\n\n\n<li>Нет необходимости в физической или микробиологической повторной проверке.<\/li>\n\n\n\n<li>Небольшая проверка микробиологической эффективности<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Предпосылки для переквалификации<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>б) есть ли<strong>существенные изменения<\/strong>&nbsp;влияющие на стерильность продукта, произошли в:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Дизайн продукта<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD (устройство для проверки процесса)<\/li>\n\n\n\n<li>Поставщики<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>Загрузка конфигураций или производственных процессов<br>в)<strong>Анализ тенденций бионагрузки<\/strong>&nbsp;продуктов;<br>г) Ли<strong>исследования распределения температуры<\/strong>&nbsp;и работа стерилизатора демонстрируют значительные изменения со времени последней квалификации;<br>д) ли<strong>проверка распределения температуры и рециркуляции<\/strong>&nbsp;в камерах предварительного кондиционирования или зонах аэрации наблюдаются значительные изменения со времени последней квалификации;<br>е) Была ли стерилизация ETO<strong> история процесса<\/strong>&nbsp;поскольку последняя валидация демонстрирует воспроизводимость;<br>г) Ли<strong>записи контроля изменений и профилактического обслуживания<\/strong>&nbsp;подтвердить отсутствие модификаций оборудования, влияющих на процесс;<br>з) Будь<strong>никаких изменений в процессе стерилизации ETO<\/strong>&nbsp;произошло влияющее на бесплодие;<br>и) Если<strong>Изменены спецификации процесса стерилизации ETO.<\/strong>, переквалификация должна включать проверку<strong>Пределы остатков ЭО<\/strong>&nbsp;соответствие нормативным требованиям.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Нормативные стандарты<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ИСО 11135:2014<\/strong>&nbsp;<em>(Раздел 9.2: Критерии реквалификации)<\/em><\/li>\n\n\n\n<li><strong>FDA 21 CFR 211.113<\/strong>&nbsp;<em>(Контроль процесса стерилизации)<\/em><\/li>\n\n\n\n<li><strong>Приложение 1 GMP ЕС: 2022<\/strong>&nbsp;<em>(Раздел 8.5: Требования к повторной валидации)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>Требования к переквалификации ETO по стерилизации<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Переквалификация должна<strong>включать обзор производительности камеры и ежегодные технические изменения<\/strong>&nbsp;to ensure the original IQ\/OQ results remain valid. The review must cover:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Preconditioning zone temperature\/humidity profiles<\/strong>&nbsp;(если применимо);<\/li>\n\n\n\n<li><strong>Фактические профили влажности в пустой камере<\/strong>;<\/li>\n\n\n\n<li><strong>Температура зоны аэрации<\/strong>&nbsp;(если применимо);<\/li>\n\n\n\n<li><strong>Кроме того, даже если технические характеристики процесса соблюдаются<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>Неблагоприятные тенденции в работе оборудования,<\/li>\n\n\n\n<li>Нарушения стерильности;<\/li>\n\n\n\n<li>Чтобы определить, оправдана ли повторная проверка.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Специалисты по стерилизации<\/strong>&nbsp;определит объем требуемых<strong>физическая и микробиологическая повторная валидация<\/strong>&nbsp;по результатам проверки.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Критические соображения по поводу переаттестации по стерилизации<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Обработка значительных изменений<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>основные изменения<\/strong>&nbsp;are identified during re-qualification, re-execution of IQ\/OQ\/PQ may be required:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>IQ (квалификация установки)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (Оперативная квалификация)<\/strong>: Повторное тестирование затронутых функциональных параметров.<\/li>\n\n\n\n<li><strong>PQ (Квалификация производительности)<\/strong>: Повторно подтвердить эффективность стерилизации в новых условиях.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Дополнительные требования к параметрическому выпуску<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Для объектов, использующих<strong>параметрический выпуск<\/strong>&nbsp;(опираясь на данные процесса, а не на BI-тестирование):<br>а)<strong>Частота повторной проверки<\/strong>: Должен быть выполнен<strong>по крайней мере ежегодно<\/strong>;<br>б)<strong>Область повторной проверки<\/strong>: Должен включать<strong>микробиологические исследования<\/strong>&nbsp;чтобы подтвердить:<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Situations Requiring Full Requalification (IQ\/OQ\/PQ):<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">а)<strong>Капитальный ремонт стерилизатора.<\/strong>;<br>б)<strong>Структурные, географические или экологические изменения<\/strong>;<br>в)<strong>Необъяснимые нарушения стерильности<\/strong>;<br>г)<strong>Changes in EO supply\/delivery, diluent, or chamber load configuration<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Освобождение от физической или микробиологической переквалификации<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">При выполнении следующих условий:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Никаких изменений<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>Производительность камеры и инженерный анализ<\/strong>&nbsp;имеют квалификацию;<\/li>\n\n\n\n<li><strong>Регулярные процессы стерилизации<\/strong>&nbsp;действовали надежно в течение данного периода;<br>?<strong>Профессиональное суждение<\/strong>&nbsp;может определить, что физическая или микробиологическая переквалификация<strong>не требуется<\/strong>&nbsp;до следующего обзора.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Квалификация эффективности микробиологической деятельности ограниченного масштаба<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Может потребоваться в особых случаях<\/strong>, такой как:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Проверка постоянной пригодности БИ относительно бионагрузки продукта;<\/li>\n\n\n\n<li>Предоставление доказательств того, что нет<strong>непреднамеренные изменения<\/strong>&nbsp;произошло со времени предыдущего (пере)квалификационного исследования по истечении определенного интервала времени.<br>\u2022&nbsp;<strong>Общие требования (минимум)<\/strong>:<\/li>\n\n\n\n<li>Один<strong>работа с коротким циклом или полуциклом<\/strong>;<\/li>\n\n\n\n<li>Включая<strong>измерения температуры и влажности<\/strong>&nbsp;стерилизованных предметов.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">ЕСЛИ ВЫ ХОТИТЕ УЗНАТЬ БОЛЬШЕ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Телефон:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Электронная почта:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Локальное место: комната 1202, Цайтонг Чжунсинь, район Сяша, город Ханчжоу, провинция Чжэцзян, Китай<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Веб-сайт:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n\n\n\n<div class=\"wp-block-uagb-image uagb-block-9d7632fc 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-9-1024x1024.webp\" alt=\"\" class=\"uag-image-8487\" width=\"1024\" height=\"1024\" title=\"eto-sterilizer-9\" role=\"img\" \><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ETO Sterilization Re-qualification Requirements 1. Re-qualification Frequency \u2022&nbsp;Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, [&hellip;]<\/p>\n","protected":false},"author":234312599,"featured_media":8487,"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 center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[133125,133124],"tags":[],"class_list":["post-7286","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company-news","category-eto-sterilizer"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Переквалификация ETO по стерилизации - ETO STERILIZER<\/title>\n<meta name=\"description\" content=\"\u2022\u00a0Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation and\" \>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \>\n<link rel=\"canonical\" href=\"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/\" \>\n<meta property=\"og:locale\" content=\"ru_RU\" \>\n<meta property=\"og:type\" content=\"article\" \>\n<meta property=\"og:title\" content=\"ETO Sterilization Re-qualification\" \>\n<meta property=\"og:description\" content=\"\u2022\u00a0Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation and\" \>\n<meta property=\"og:url\" content=\"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/\" \>\n<meta property=\"og:site_name\" content=\"ETO STERILIZER\" \>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=100088482339878\" \>\n<meta property=\"article:author\" content=\"https:\/\/www.facebook.com\/profile.php?id=100088482339878\" \>\n<meta property=\"article:published_time\" content=\"2025-07-29T04:02:12+00:00\" \>\n<meta property=\"article:modified_time\" content=\"2025-10-01T11:30:30+00:00\" \>\n<meta property=\"og:image\" content=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp\" \>\n\t<meta property=\"og:image:width\" content=\"1200\" \>\n\t<meta property=\"og:image:height\" content=\"1200\" \>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \>\n<meta name=\"author\" content=\"Bocon Technical Team\" \>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \>\n<meta name=\"twitter:creator\" content=\"@BoconAnd\" \>\n<meta name=\"twitter:site\" content=\"@BoconAnd\" \>\n<meta name=\"twitter:label1\" content=\"Written by\" \>\n\t<meta name=\"twitter:data1\" content=\"Bocon Technical Team\" \>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/eto-sterilization-re-qualification\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/eto-sterilization-re-qualification\\\/\"},\"author\":{\"name\":\"Bocon Technical Team\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#\\\/schema\\\/person\\\/f12be028b8ae9843a4396dcc8012b425\"},\"headline\":\"ETO Sterilization Re-qualification\",\"datePublished\":\"2025-07-29T04:02:12+00:00\",\"dateModified\":\"2025-10-01T11:30:30+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/eto-sterilization-re-qualification\\\/\"},\"wordCount\":634,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/eto-sterilization-re-qualification\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/zjbocon.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/eto-sterilizer-9.webp\",\"articleSection\":[\"Company News\",\"ETO STERILIZER\"],\"inLanguage\":\"ru-RU\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/zjbocon.com\\\/eto-sterilization-re-qualification\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/eto-sterilization-re-qualification\\\/\",\"url\":\"https:\\\/\\\/zjbocon.com\\\/eto-sterilization-re-qualification\\\/\",\"name\":\"ETO Sterilization Re-qualification - ETO STERILIZER\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/eto-sterilization-re-qualification\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/eto-sterilization-re-qualification\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/zjbocon.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/eto-sterilizer-9.webp\",\"datePublished\":\"2025-07-29T04:02:12+00:00\",\"dateModified\":\"2025-10-01T11:30:30+00:00\",\"description\":\"\u2022\u00a0Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, and\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/eto-sterilization-re-qualification\\\/#breadcrumb\"},\"inLanguage\":\"ru-RU\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/zjbocon.com\\\/eto-sterilization-re-qualification\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"ru-RU\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/eto-sterilization-re-qualification\\\/#primaryimage\",\"url\":\"https:\\\/\\\/zjbocon.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/eto-sterilizer-9.webp\",\"contentUrl\":\"https:\\\/\\\/zjbocon.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/eto-sterilizer-9.webp\",\"width\":1200,\"height\":1200,\"caption\":\"ETO STERILIZER-HZBOCON\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/eto-sterilization-re-qualification\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/zjbocon.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"ETO Sterilization Re-qualification\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#website\",\"url\":\"https:\\\/\\\/zjbocon.com\\\/\",\"name\":\"ETO STERILIZER\",\"description\":\"One-stop Solution Supplier of Ethylene Oxide Sterilization\",\"publisher\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/zjbocon.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"ru-RU\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#organization\",\"name\":\"ETO STERILIZER\",\"url\":\"https:\\\/\\\/zjbocon.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"ru-RU\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/zjbocon.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/logo-1.webp\",\"contentUrl\":\"https:\\\/\\\/zjbocon.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/logo-1.webp\",\"width\":180,\"height\":60,\"caption\":\"ETO STERILIZER\"},\"image\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=100088482339878\",\"https:\\\/\\\/x.com\\\/BoconAnd\",\"https:\\\/\\\/www.linkedin.com\\\/in\\\/--06a221139\\\/\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#\\\/schema\\\/person\\\/f12be028b8ae9843a4396dcc8012b425\",\"name\":\"Bocon Technical Team\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"ru-RU\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/d7a825658be227f26b237e519f8541e05aabc9ff27b8eec4544a233a48c53be0?s=96&d=identicon&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/d7a825658be227f26b237e519f8541e05aabc9ff27b8eec4544a233a48c53be0?s=96&d=identicon&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/d7a825658be227f26b237e519f8541e05aabc9ff27b8eec4544a233a48c53be0?s=96&d=identicon&r=g\",\"caption\":\"Bocon Technical Team\"},\"sameAs\":[\"https:\\\/\\\/zjbocon.com\\\/\",\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=100088482339878\",\"https:\\\/\\\/www.linkedin.com\\\/in\\\/\\\/hayley--968190269\\\/\"],\"url\":\"https:\\\/\\\/zjbocon.com\\\/author\\\/15657615935a\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"ETO Sterilization Re-qualification - ETO STERILIZER","description":"\u2022\u00a0Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, and","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/","og_locale":"ru_RU","og_type":"article","og_title":"ETO Sterilization Re-qualification","og_description":"\u2022\u00a0Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, and","og_url":"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/","og_site_name":"ETO STERILIZER","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=100088482339878","article_author":"https:\/\/www.facebook.com\/profile.php?id=100088482339878","article_published_time":"2025-07-29T04:02:12+00:00","article_modified_time":"2025-10-01T11:30:30+00:00","og_image":[{"width":1200,"height":1200,"url":"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp","type":"image\/webp"}],"author":"Bocon Technical Team","twitter_card":"summary_large_image","twitter_creator":"@BoconAnd","twitter_site":"@BoconAnd","twitter_misc":{"Written by":"Bocon Technical Team","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/#article","isPartOf":{"@id":"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/"},"author":{"name":"Bocon Technical Team","@id":"https:\/\/zjbocon.com\/#\/schema\/person\/f12be028b8ae9843a4396dcc8012b425"},"headline":"ETO Sterilization Re-qualification","datePublished":"2025-07-29T04:02:12+00:00","dateModified":"2025-10-01T11:30:30+00:00","mainEntityOfPage":{"@id":"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/"},"wordCount":634,"commentCount":0,"publisher":{"@id":"https:\/\/zjbocon.com\/#organization"},"image":{"@id":"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/#primaryimage"},"thumbnailUrl":"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp","articleSection":["Company News","ETO STERILIZER"],"inLanguage":"ru-RU","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/","url":"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/","name":"ETO Sterilization Re-qualification - ETO STERILIZER","isPartOf":{"@id":"https:\/\/zjbocon.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/#primaryimage"},"image":{"@id":"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/#primaryimage"},"thumbnailUrl":"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp","datePublished":"2025-07-29T04:02:12+00:00","dateModified":"2025-10-01T11:30:30+00:00","description":"\u2022\u00a0Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, and","breadcrumb":{"@id":"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/#breadcrumb"},"inLanguage":"ru-RU","potentialAction":[{"@type":"ReadAction","target":["https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/"]}]},{"@type":"ImageObject","inLanguage":"ru-RU","@id":"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/#primaryimage","url":"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp","contentUrl":"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp","width":1200,"height":1200,"caption":"ETO STERILIZER-HZBOCON"},{"@type":"BreadcrumbList","@id":"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/zjbocon.com\/"},{"@type":"ListItem","position":2,"name":"ETO Sterilization Re-qualification"}]},{"@type":"WebSite","@id":"https:\/\/zjbocon.com\/#website","url":"https:\/\/zjbocon.com\/","name":"ETO STERILIZER","description":"One-stop Solution Supplier of Ethylene Oxide Sterilization","publisher":{"@id":"https:\/\/zjbocon.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/zjbocon.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"ru-RU"},{"@type":"Organization","@id":"https:\/\/zjbocon.com\/#organization","name":"ETO STERILIZER","url":"https:\/\/zjbocon.com\/","logo":{"@type":"ImageObject","inLanguage":"ru-RU","@id":"https:\/\/zjbocon.com\/#\/schema\/logo\/image\/","url":"https:\/\/zjbocon.com\/wp-content\/uploads\/2024\/10\/logo-1.webp","contentUrl":"https:\/\/zjbocon.com\/wp-content\/uploads\/2024\/10\/logo-1.webp","width":180,"height":60,"caption":"ETO STERILIZER"},"image":{"@id":"https:\/\/zjbocon.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=100088482339878","https:\/\/x.com\/BoconAnd","https:\/\/www.linkedin.com\/in\/--06a221139\/"]},{"@type":"Person","@id":"https:\/\/zjbocon.com\/#\/schema\/person\/f12be028b8ae9843a4396dcc8012b425","name":"Bocon Technical Team","image":{"@type":"ImageObject","inLanguage":"ru-RU","@id":"https:\/\/secure.gravatar.com\/avatar\/d7a825658be227f26b237e519f8541e05aabc9ff27b8eec4544a233a48c53be0?s=96&d=identicon&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/d7a825658be227f26b237e519f8541e05aabc9ff27b8eec4544a233a48c53be0?s=96&d=identicon&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/d7a825658be227f26b237e519f8541e05aabc9ff27b8eec4544a233a48c53be0?s=96&d=identicon&r=g","caption":"Bocon Technical Team"},"sameAs":["https:\/\/zjbocon.com\/","https:\/\/www.facebook.com\/profile.php?id=100088482339878","https:\/\/www.linkedin.com\/in\/\/hayley--968190269\/"],"url":"https:\/\/zjbocon.com\/author\/15657615935a\/"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp","uagb_featured_image_src":{"full":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp",1200,1200,false],"thumbnail":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9-150x150.webp",150,150,true],"medium":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9-300x300.webp",300,300,true],"medium_large":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9-768x768.webp",768,768,true],"large":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9-1024x1024.webp",1024,1024,true],"1536x1536":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp",1200,1200,false],"2048x2048":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp",1200,1200,false],"woocommerce_thumbnail":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9-600x600.webp",600,600,true],"woocommerce_single":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9-600x600.webp",600,600,true],"woocommerce_gallery_thumbnail":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9-100x100.webp",100,100,true]},"uagb_author_info":{"display_name":"Bocon Technical Team","author_link":"https:\/\/zjbocon.com\/author\/15657615935a\/"},"uagb_comment_info":25,"uagb_excerpt":"ETO Sterilization Re-qualification Requirements 1. Re-qualification Frequency \u2022&nbsp;Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, [&hellip;]","jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pgZDV6-1Tw","jetpack-related-posts":[{"id":7268,"url":"https:\/\/zjbocon.com\/performance-qualification-pq-mpq-in-eto-sterilization\/","url_meta":{"origin":7286,"position":0},"title":"Performance Qualification (PQ)- mpq in eto sterilization","author":"Bocon Technical Team","date":"2025-07-29","format":false,"excerpt":"Methods 1. Bioburden Method: Lethality Confirmation ? Direct Count\/Enumeration Method ? Fraction-Negative Method 2. Overkill Method: Demonstrating ?12-Log Reduction ? Half-Cycle Method ? Cycle Development Method Key Terms Bioburden 12-log reduction D-value Methods Overview 1. Half-Cycle Method (Basic Principle - Run Count) Theoretical initial bioburden: 10? Test Criteria: 1 run\u2026","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/category\/company-news\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":9080,"url":"https:\/\/zjbocon.com\/essential-utilities-and-service-requirements-for-eto-sterilizers\/","url_meta":{"origin":7286,"position":1},"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). Below\u2026","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/category\/company-news\/"},"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":[]},{"id":2076,"url":"https:\/\/zjbocon.com\/ethylene-oxide-sterilization-chamber\/","url_meta":{"origin":7286,"position":2},"title":"PQ in Ethylene oxide sterilization chamber","author":"Bocon Technical Team","date":"2024-10-31","format":false,"excerpt":"PQ is the stage of validation that uses Ethylene oxide sterilization chamber to demonstrate that the Ethylene oxide sterilization equipment consistently operates in accordance with predetermined acceptance criteria and the process yields a product that is sterile and meets the specified requirements.","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/category\/eto-sterilizer\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":7277,"url":"https:\/\/zjbocon.com\/performance-qualificationpq-ppq-in-eo-sterilization\/","url_meta":{"origin":7286,"position":3},"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\/category\/company-news\/"},"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":2332,"url":"https:\/\/zjbocon.com\/terms-and-definitions-of-eto-gas-sterilization\/","url_meta":{"origin":7286,"position":4},"title":"Terms and definitions of eto gas sterilization","author":"Bocon Technical Team","date":"2024-11-26","format":false,"excerpt":"For the purposes of this document, the following terms and definitions apply in ethylene oxide sterilization 3.1 Aeration part of the eto gas sterilization process during which ethylene oxide and\/or its reaction products desorb from the medical device until predetermined levels are reached \u00a0 Note 1 to entry: This can\u2026","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/category\/eto-sterilizer\/"},"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":2138,"url":"https:\/\/zjbocon.com\/eto-sterilization-chamber-testing\/","url_meta":{"origin":7286,"position":5},"title":"ETO Sterilization Chamber Testing","author":"Bocon Technical Team","date":"2024-11-07","format":false,"excerpt":"The temperature setting range of the ETO Sterilization Chamber should be between 30-60\u00b0C. It is recommended to perform temperature distribution testing of the sterilizer's internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/category\/eto-sterilizer\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/cropped-cropped-hzbocon.png?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/posts\/7286","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/users\/234312599"}],"replies":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/comments?post=7286"}],"version-history":[{"count":12,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/posts\/7286\/revisions"}],"predecessor-version":[{"id":8613,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/posts\/7286\/revisions\/8613"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/media\/8487"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/media?parent=7286"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/categories?post=7286"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/tags?post=7286"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}