{"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\">Requisiti di Riqualificazione di Sterilizazione ETO<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. Re-qualification Frequency<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Esigenza minima annuale<\/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. Hè bisognu di riqualificazione s&#039;ellu ùn ci hè micca cambiamenti di produttu?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Iè, a riqualificazione hè sempre necessaria<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. Articuli Re-qualification<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Basatu nantu à certe precondizioni, e seguenti opzioni sò dispunibili<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Riqualificazione cumpleta<\/li>\n\n\n\n<li>Ùn ci hè bisognu di rivalidazione fisica o microbiana<\/li>\n\n\n\n<li>Validazione di e prestazioni microbiche à piccula scala<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Prerequisiti per a riqualificazione<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>b) S&#039;ellu ci hè<strong>cambiamenti significativu<\/strong>&nbsp;chì affettanu a sterilità di u produttu sò accaduti in:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Disegnu di u produttu<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD (dispositivu di sfida di prucessu)<\/li>\n\n\n\n<li>Suppliers<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>Carica cunfigurazioni o prucessi di fabricazione<br>c)&nbsp;<strong>Bioburden trend analysis<\/strong>&nbsp;of products;<br>d) Whether&nbsp;<strong>studi di distribuzione di temperatura<\/strong>&nbsp;è u funziunamentu di sterilizzatore dimustranu cambiamenti significativi da l&#039;ultima qualificazione;<br>e) Whether&nbsp;<strong>Distribuzione di temperatura è cuntrolli di recirculazione<\/strong>&nbsp;in camere di preconditioning o zone di aerazione mostranu cambiamenti significativi da l&#039;ultima qualificazione;<br>f) Sia a Sterilizazione ETO<strong> process history<\/strong>&nbsp;postu chì l&#039;ultima validazione dimustra a riproducibilità;<br>g) Whether&nbsp;<strong>cuntrollu di cambià è registri di mantenimentu preventivu<\/strong>&nbsp;cunfirmà nisuna mudificazione di l&#039;equipaggiu chì afecta u prucessu;<br>h) Whether&nbsp;<strong>senza alterazioni à u prucessu di sterilizazione ETO<\/strong>&nbsp;influenza a sterilità hè accadutu;<br>i) If&nbsp;<strong>ETO specificazioni di prucessu di sterilizazione cambiatu<\/strong>, a riqualificazione deve include a verificazione di<strong>Limiti di residuu EO<\/strong>&nbsp;rispettu di i requisiti regulatori.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Norme di regulazione<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135: 2014<\/strong>&nbsp;<em>(Sec. 9.2: Criterium Requalification)<\/em><\/li>\n\n\n\n<li><strong>FDA 21 CFR 211.113<\/strong>&nbsp;<em>(Controlli di prucessu di sterilizazione)<\/em><\/li>\n\n\n\n<li><strong>EU GMP Annex 1: 2022<\/strong>&nbsp;<em>(Sec. 8.5: Revalidation requirements)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>Requisiti di Riqualificazione di Sterilizazione ETO<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A riqualificazione deve<strong>include una revisione di u rendiment di a camera è i cambiamenti annuali di l&#039;ingegneria<\/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;(se applicabile);<\/li>\n\n\n\n<li><strong>Profili di umidità di a camera viota attuale<\/strong>;<\/li>\n\n\n\n<li><strong>Temperature di a zona d&#039;aerazione<\/strong>&nbsp;(se applicabile);<\/li>\n\n\n\n<li><strong>Inoltre, ancu s&#039;è e specificazioni di u prucessu sò rispettate<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>Tendenze avverse in u rendiment di l&#039;equipaggiu,<\/li>\n\n\n\n<li>fallimenti di sterilità;<\/li>\n\n\n\n<li>Per determinà se a rivalidazione hè garantita.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Esperti di sterilizazione<\/strong>&nbsp;definisce u scopu di a dumanda<strong>rivalidazione fisica è microbica<\/strong>&nbsp;basatu nantu à i risultati di rivista.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Considerazioni critiche per a riqualificazione di sterilizazione<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Manipulendu cambiamenti significati<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>cambiamenti maiò<\/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 (qualificazione d&#039;installazione)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (qualificazione operativa)<\/strong>: Riprova i paràmetri funzionali affettati.<\/li>\n\n\n\n<li><strong>PQ (qualificazione di prestazione)<\/strong>: Re-validate l&#039;efficacità di sterilizazione sottu novi cundizioni.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Requisiti supplementari per a liberazione parametrica<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Per l&#039;usu di facilità<strong>liberazione parametrica<\/strong>&nbsp;(basatu nantu à i dati di u prucessu piuttostu cà i testi di BI):<br>a)<strong>Frequenza di re-validazione<\/strong>: Deve esse realizatu<strong>almenu annu<\/strong>;<br>b)<strong>Scopu di rivalidazione<\/strong>: Deve include<strong>studii microbiologichi<\/strong>&nbsp;per cunfirmà:<\/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>Mantenimentu maiò di u sterilizzatore<\/strong>;<br>b)<strong>Cambiamenti strutturali, di locu o ambientali<\/strong>;<br>c)&nbsp;<strong>Falli di sterilità inspiegabili<\/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>Esenzione da riqualificazione fisica o microbica<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Quandu i seguenti cundizioni sò soddisfatti:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Nisun cambiamenti<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>Rivista di prestazioni è ingegneria di a camera<\/strong>&nbsp;sò qualificati;<\/li>\n\n\n\n<li><strong>Processi di sterilizazione di rutina<\/strong>&nbsp;anu operatu in modu affidabile durante u periodu;<br>?<strong>Giudiziu prufessiunale<\/strong>&nbsp;pò stabilisce chì a riqualificazione fisica o microbica hè<strong>micca necessariu<\/strong>&nbsp;finu à a prossima rivista.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Qualificazione di Prestazione Microbiale à Scala Limitata<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Pò esse dumandatu in casi specifichi<\/strong>, cum&#039;è:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Verificà l&#039;idoneità cuntinuata di i BI relative à a biocarga di u produttu;<\/li>\n\n\n\n<li>Dendu evidenza chì no<strong>cambiamenti imprevisti<\/strong>&nbsp;accadutu da u studiu di (ri)qualificazione precedente dopu un intervallu di tempu definitu.<br>\u2022&nbsp;<strong>Requisiti generali (minimu)<\/strong>:<\/li>\n\n\n\n<li>Unu<strong>Cortu ciclu o mezzu ciclu<\/strong>;<\/li>\n\n\n\n<li>Cumpresu<strong>misurazioni di temperatura è umidità<\/strong>&nbsp;di oggetti sterilizzati.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">SE VOGLIA SAPERNE DI PIÙ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefonu:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">E-mail:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Situ lucale: Room 1202, Caitong Zhongxin, District Xiasha, Hangzhou City, Zhejiang Province, China<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">situ 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) - 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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}]}}