{"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\/?p=7286","title":{"rendered":"ETO Sterilization Re-qualification"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements\">Requisitos de recalificación de esterilización ETO<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. Frecuencia de recalificación<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Requisito mínimo anual<\/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. ¿Es necesaria una nueva calificación si no se producen cambios en el producto?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Sí, aún se requiere recalificación<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. Artículos de recalificación<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Según determinadas condiciones previas, están disponibles las siguientes opciones<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Recalificación completa<\/li>\n\n\n\n<li>No es necesaria una revalidación física o microbiana.<\/li>\n\n\n\n<li>Validación del rendimiento microbiano a pequeña escala.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Requisitos previos para la recalificación<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>b) Si alguna<strong>cambios significativos<\/strong>&nbsp;que afectan la esterilidad del producto se han producido en:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Diseño de producto<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD (Dispositivo de desafío de proceso)<\/li>\n\n\n\n<li>Proveedores<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>Configuraciones de carga o procesos de fabricación.<br>do)<strong>Análisis de tendencias de la carga biológica<\/strong>&nbsp;de productos;<br>d) Si<strong>estudios de distribución de temperatura<\/strong>&nbsp;y el funcionamiento del esterilizador demuestran cambios significativos desde la última calificación;<br>e) Si<strong>Controles de distribución y recirculación de temperatura.<\/strong>&nbsp;en cámaras de preacondicionamiento o zonas de aireación presentan cambios significativos desde la última calificación;<br>f) Si la esterilización ETO<strong> historia del proceso<\/strong>&nbsp;desde la última validación demuestra reproducibilidad;<br>g) Si<strong>Registros de control de cambios y mantenimiento preventivo.<\/strong>&nbsp;confirmar que no existen modificaciones en el equipo que afecten el proceso;<br>h) Si<strong>sin alteraciones en el proceso de esterilización ETO<\/strong>&nbsp;que afecten la esterilidad;<br>yo) si<strong>Las especificaciones del proceso de esterilización ETO cambiaron<\/strong>, la recalificación debe incluir la verificación de<strong>Límites de residuos de EO<\/strong>&nbsp;cumplimiento de los requisitos reglamentarios.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Estándares regulatorios<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135:2014<\/strong>&nbsp;<em>(Sec. 9.2: Criterios de recalificación)<\/em><\/li>\n\n\n\n<li><strong>FDA 21 CFR 211.113<\/strong>&nbsp;<em>(Controles del proceso de esterilización)<\/em><\/li>\n\n\n\n<li><strong>Anexo 1 de GMP de la UE: 2022<\/strong>&nbsp;<em>(Sec. 8.5: Requisitos de revalidación)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>Requisitos de recalificación de esterilización ETO<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">La recalificación deberá<strong>incluir una revisión del rendimiento de la cámara y cambios de ingeniería anuales<\/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;(si corresponde);<\/li>\n\n\n\n<li><strong>Perfiles reales de humedad de la cámara vacía<\/strong>;<\/li>\n\n\n\n<li><strong>Temperaturas de la zona de aireación.<\/strong>&nbsp;(si corresponde);<\/li>\n\n\n\n<li><strong>Además, incluso si se cumplen las especificaciones del proceso<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>Tendencias adversas en el rendimiento del equipo,<\/li>\n\n\n\n<li>Fallos de esterilidad;<\/li>\n\n\n\n<li>Determinar si se justifica la revalidación.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Expertos en esterilización<\/strong>&nbsp;definirá el alcance de las<strong>revalidación física y microbiana<\/strong>&nbsp;basado en los resultados de la revisión.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Consideraciones críticas para la recalificación de esterilización<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Manejo de cambios significativos<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>cambios importantes<\/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 (Cualificación de instalación)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (calificación operativa)<\/strong>: Vuelva a probar los parámetros funcionales afectados.<\/li>\n\n\n\n<li><strong>PQ (calificación de desempeño)<\/strong>: Revalidar la eficacia de la esterilización en nuevas condiciones.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Requisitos adicionales para la liberación paramétrica<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Para instalaciones que utilizan<strong>liberación paramétrica<\/strong>&nbsp;(basándose en datos de proceso en lugar de pruebas de BI):<br>a)<strong>Frecuencia de revalidación<\/strong>: Debe realizarse<strong>al menos anualmente<\/strong>;<br>b)<strong>Alcance de la revalidación<\/strong>: Debe incluir<strong>estudios microbiológicos<\/strong>&nbsp;para confirmar:<\/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\">a)<strong>Mantenimiento mayor del esterilizador.<\/strong>;<br>b)<strong>Cambios estructurales, de ubicación o ambientales.<\/strong>;<br>do)<strong>Fallos de esterilidad inexplicables<\/strong>;<br>d)<strong>Changes in EO supply\/delivery, diluent, or chamber load configuration<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Exención de Recalificación Física o Microbiana<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Cuando se cumplan las siguientes condiciones:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Sin cambios<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>Revisión de ingeniería y desempeño de la cámara.<\/strong>&nbsp;están calificados;<\/li>\n\n\n\n<li><strong>Procesos de esterilización de rutina.<\/strong>&nbsp;haber operado de manera confiable durante el período;<br>?<strong>Juicio profesional<\/strong>&nbsp;puede determinar que la recalificación física o microbiana es<strong>no requerido<\/strong>&nbsp;hasta la próxima revisión.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Calificación del desempeño microbiano a escala limitada<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Puede ser necesario en casos específicos.<\/strong>, como:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Verificar la idoneidad continua de los BI en relación con la carga biológica del producto;<\/li>\n\n\n\n<li>Proporcionar pruebas de que no<strong>cambios no deseados<\/strong>&nbsp;ocurrido desde el estudio de (re)calificación anterior después de un intervalo de tiempo definido.<br>\u2022&nbsp;<strong>Requisitos generales (como mínimo)<\/strong>:<\/li>\n\n\n\n<li>Uno<strong>ejecución de ciclo corto o medio ciclo<\/strong>;<\/li>\n\n\n\n<li>Incluido<strong>mediciones de temperatura y humedad<\/strong>&nbsp;de artículos esterilizados.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">SI QUIERES SABER MÁS<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Teléfono:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Correo electrónico:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sitio local: Sala 1202, Caitong Zhongxin, distrito de Xiasha, ciudad de Hangzhou, provincia de Zhejiang, China<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sitio web:<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>Recalificación de esterilización ETO - 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\/?p=7286\" \>\n<meta property=\"og:locale\" content=\"es_ES\" \>\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\/?p=7286\" \>\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\\\/?p=7286#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/?p=7286\"},\"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\\\/?p=7286\"},\"wordCount\":634,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/?p=7286#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/zjbocon.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/eto-sterilizer-9.webp\",\"articleSection\":[\"Company News\",\"ETO STERILIZER\"],\"inLanguage\":\"es-ES\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/zjbocon.com\\\/?p=7286#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/?p=7286\",\"url\":\"https:\\\/\\\/zjbocon.com\\\/?p=7286\",\"name\":\"ETO Sterilization Re-qualification - ETO STERILIZER\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/?p=7286#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/?p=7286#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\\\/?p=7286#breadcrumb\"},\"inLanguage\":\"es-ES\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/zjbocon.com\\\/?p=7286\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"es-ES\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/?p=7286#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\\\/?p=7286#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\":\"es-ES\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#organization\",\"name\":\"ETO STERILIZER\",\"url\":\"https:\\\/\\\/zjbocon.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"es-ES\",\"@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\":\"es-ES\",\"@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=234312599\"}]}<\/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\/?p=7286","og_locale":"es_ES","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\/?p=7286","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\/?p=7286#article","isPartOf":{"@id":"https:\/\/zjbocon.com\/?p=7286"},"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\/?p=7286"},"wordCount":634,"commentCount":0,"publisher":{"@id":"https:\/\/zjbocon.com\/#organization"},"image":{"@id":"https:\/\/zjbocon.com\/?p=7286#primaryimage"},"thumbnailUrl":"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp","articleSection":["Company News","ETO STERILIZER"],"inLanguage":"es-ES","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/zjbocon.com\/?p=7286#respond"]}]},{"@type":"WebPage","@id":"https:\/\/zjbocon.com\/?p=7286","url":"https:\/\/zjbocon.com\/?p=7286","name":"ETO Sterilization Re-qualification - ETO STERILIZER","isPartOf":{"@id":"https:\/\/zjbocon.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/zjbocon.com\/?p=7286#primaryimage"},"image":{"@id":"https:\/\/zjbocon.com\/?p=7286#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\/?p=7286#breadcrumb"},"inLanguage":"es-ES","potentialAction":[{"@type":"ReadAction","target":["https:\/\/zjbocon.com\/?p=7286"]}]},{"@type":"ImageObject","inLanguage":"es-ES","@id":"https:\/\/zjbocon.com\/?p=7286#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\/?p=7286#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":"es-ES"},{"@type":"Organization","@id":"https:\/\/zjbocon.com\/#organization","name":"ETO STERILIZER","url":"https:\/\/zjbocon.com\/","logo":{"@type":"ImageObject","inLanguage":"es-ES","@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":"es-ES","@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=234312599"}]}},"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=234312599"},"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\/?p=7268","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\/?cat=133125"},"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\/?p=9080","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\/?cat=133125"},"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\/?p=2076","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\/?cat=133124"},"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\/?p=7277","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\/?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":2332,"url":"https:\/\/zjbocon.com\/?p=2332","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\/?cat=133124"},"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\/?p=2138","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\/?cat=133124"},"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\/index.php?rest_route=\/wp\/v2\/posts\/7286","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=7286"}],"version-history":[{"count":12,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286\/revisions"}],"predecessor-version":[{"id":8613,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286\/revisions\/8613"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8487"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7286"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7286"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7286"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}