{"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 della sterilizzazione ETO<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. Frequenza di riqualificazione<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Requisito minimo annuo<\/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. È necessaria una riqualificazione se non si verificano modifiche al prodotto?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Sì, è ancora necessaria la riqualificazione<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. Voci di riqualificazione<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>In base a determinati presupposti, sono disponibili le seguenti opzioni<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Riqualificazione completa<\/li>\n\n\n\n<li>Non è necessaria una nuova validazione fisica o microbica<\/li>\n\n\n\n<li>Convalida delle prestazioni microbiche su piccola scala<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Prerequisiti per la Riqualificazione<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>b) Se esiste<strong>cambiamenti significativi<\/strong>&nbsp;che incidono sulla sterilità del prodotto si sono verificati in:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Progettazione del prodotto<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD (dispositivo di sfida del processo)<\/li>\n\n\n\n<li>Fornitori<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>Caricare configurazioni o processi di produzione<br>C)<strong>Analisi dell&#039;andamento della carica batterica<\/strong>&nbsp;di prodotti;<br>d) Se<strong>studi sulla distribuzione della temperatura<\/strong>&nbsp;e il funzionamento dello sterilizzatore dimostrano cambiamenti significativi rispetto all&#039;ultima qualificazione;<br>e) Se<strong>controlli della distribuzione della temperatura e del ricircolo<\/strong>&nbsp;nelle camere di precondizionamento o nelle zone di aerazione si riscontrano cambiamenti significativi rispetto all&#039;ultima qualificazione;<br>f) Se la sterilizzazione con ETO<strong> storia del processo<\/strong>&nbsp;poiché l&#039;ultima validazione dimostra la riproducibilità;<br>g) Se<strong>registrazioni del controllo delle modifiche e della manutenzione preventiva<\/strong>&nbsp;confermare che non vi siano modifiche alle apparecchiature che incidano sul processo;<br>h) Se<strong>nessuna alterazione al processo di sterilizzazione con ETO<\/strong>&nbsp;si sono verificati effetti sulla sterilità;<br>i) Se<strong>Le specifiche del processo di sterilizzazione ETO sono cambiate<\/strong>, la riqualificazione deve comprendere la verifica di<strong>Limiti dei residui di OE<\/strong>&nbsp;conformità ai requisiti normativi.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Standard normativi<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO11135:2014<\/strong>&nbsp;<em>(Sez. 9.2: Criteri di riqualificazione)<\/em><\/li>\n\n\n\n<li><strong>FDA 21 CFR 211.113<\/strong>&nbsp;<em>(Controlli del processo di sterilizzazione)<\/em><\/li>\n\n\n\n<li><strong>GMP UE Allegato 1:2022<\/strong>&nbsp;<em>(Sez. 8.5: Requisiti per la riconvalida)<\/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 della sterilizzazione ETO<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">La riqualificazione dovrà<strong>includere una revisione delle prestazioni della camera e modifiche tecniche annuali<\/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 effettivi della camera vuota<\/strong>;<\/li>\n\n\n\n<li><strong>Temperature della zona di aerazione<\/strong>&nbsp;(se applicabile);<\/li>\n\n\n\n<li><strong>Inoltre, anche se le specifiche del processo sono soddisfatte<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>Tendenze negative nelle prestazioni delle apparecchiature,<\/li>\n\n\n\n<li>Fallimenti in termini di sterilità;<\/li>\n\n\n\n<li>Per determinare se la riconvalida è giustificata.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Esperti di sterilizzazione<\/strong>&nbsp;definirà l&#039;ambito richiesto<strong>rivalidazione fisica e microbica<\/strong>&nbsp;sulla base dei risultati della revisione.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Considerazioni critiche per la riqualificazione della sterilizzazione<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Gestire modifiche significative<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>cambiamenti importanti<\/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>QI (qualifica di installazione)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (Qualificazione Operativa)<\/strong>: ripetere il test dei parametri funzionali interessati.<\/li>\n\n\n\n<li><strong>PQ (Qualificazione delle prestazioni)<\/strong>: Riconvalidare l&#039;efficacia della sterilizzazione in nuove condizioni.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Requisiti aggiuntivi per il rilascio parametrico<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Per le strutture che utilizzano<strong>rilascio parametrico<\/strong>&nbsp;(basandosi sui dati di processo piuttosto che sui test BI):<br>UN)<strong>Frequenza di riconvalida<\/strong>: deve essere eseguito<strong>almeno una volta all&#039;anno<\/strong>;<br>B)<strong>Ambito di riconvalida<\/strong>: deve includere<strong>studi microbiologici<\/strong>&nbsp;per confermare:<\/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\">UN)<strong>Manutenzione generale della sterilizzatrice<\/strong>;<br>B)<strong>Cambiamenti strutturali, di posizione o ambientali<\/strong>;<br>C)<strong>Fallimenti 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 dalla Riqualificazione Fisica o Microbica<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Quando sono soddisfatte le seguenti condizioni:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Nessun cambiamento<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>Prestazioni della camera e revisione ingegneristica<\/strong>&nbsp;sono qualificati;<\/li>\n\n\n\n<li><strong>Processi di sterilizzazione di routine<\/strong>&nbsp;hanno operato in modo affidabile durante il periodo;<br>?<strong>Giudizio professionale<\/strong>&nbsp;può determinare che si tratti di una riqualificazione fisica o microbica<strong>non richiesto<\/strong>&nbsp;fino alla prossima revisione.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Qualificazione delle prestazioni microbiche su scala limitata<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Può essere richiesto in casi specifici<\/strong>, ad esempio:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Verificare l&#039;idoneità continua degli IB rispetto alla carica batterica del prodotto;<\/li>\n\n\n\n<li>Fornire la prova che no<strong>cambiamenti non intenzionali<\/strong>&nbsp;si è verificato dal precedente studio di (ri)qualificazione dopo un intervallo di tempo definito.<br>\u2022&nbsp;<strong>Requisiti generali (minimo)<\/strong>:<\/li>\n\n\n\n<li>Uno<strong>funzionamento a ciclo breve o a metà ciclo<\/strong>;<\/li>\n\n\n\n<li>Compreso<strong>misurazioni di temperatura e umidità<\/strong>&nbsp;di articoli sterilizzati.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">Se vuoi saperne di più<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefono:<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\">Sito locale: Stanza 1202, Caitong Zhongxin, distretto di Xiasha, città di Hangzhou, provincia di Zhejiang, Cina<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sito 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;&quot;<\/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 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