{"id":2128,"date":"2024-11-06T13:08:38","date_gmt":"2024-11-06T05:08:38","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2128"},"modified":"2025-12-05T10:49:36","modified_gmt":"2025-12-05T02:49:36","slug":"routine-monitoring-control-and-release-of-ethylene-oxide-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2128","title":{"rendered":"Routine Monitoring, Control, and Release of Ethylene Oxide Sterilization"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-49e85672 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\/2024\/10\/tp2.jpg\" alt=\"Ethylene oxide sterilization chamber\" class=\"uag-image-971\" width=\"514\" height=\"358\" title=\"Ethylene role =\"img\" \><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-routine-monitoring-and-control\">Monitoraggio e controllo di routine<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Lo scopo del monitoraggio e del controllo di routine della sterilizzazione con ossido di etilene è dimostrare che al prodotto è stato applicato il processo di sterilizzazione confermato e specificato. I dati di ciascun ciclo di sterilizzazione devono essere registrati e conservati per dimostrare che le specifiche confermate del processo di sterilizzazione sono state soddisfatte. Ciò dovrebbe includere almeno il seguente contenuto:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">a) Prova che la temperatura ambientale del prodotto ha raggiunto la temperatura minima confermata all&#039;ingresso nel pretrattamento (se utilizzato). Ciò può essere ottenuto consentendo al carico di acclimatarsi all&#039;ambiente per un tempo minimo specificato. Se si conosce la temperatura di stoccaggio, non è necessario determinare la temperatura del prodotto prima di entrare nell&#039;area di pretrattamento. Se il prodotto è stato esposto a temperature estreme, ad esempio durante il trasporto, potrebbe essere necessario conservarlo per un periodo prima del pretrattamento per stabilizzare la temperatura e l&#039;umidità interne entro un intervallo accettabile.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) Monitoraggio e registrazione della temperatura e dell&#039;umidità nell&#039;area di pretrattamento (se utilizzata) in luoghi specificati.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">c) The start time of the pretreatment for each sterilization load and the time the load is removed from the pretreatment area (if used).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">d) The time interval between removing the sterilization load from the pretreatment area (if used) and the start of the sterilization cycle.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">e) Indicators of proper operation of the gas circulation system in the chamber during the gas exposure phase (if used).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">f) The temperature and pressure inside the chamber throughout the sterilization cycle.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">g) The humidity inside the chamber during the processing phase, as measured by pressure or directly.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">h) Confirmation that gaseous EO has been introduced into the sterilization chamber.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">i) The pressure rise inside the sterilization chamber and the amount or concentration of EO used.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">j) The processing time.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">k) Il tempo di esposizione.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">l) Time, temperature, and pressure changes (if applicable) during the aeration phase and\/or venting operations (if used).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eo-sterilization-release\">Rilascio di sterilizzazione con EO<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-biological-indicator-method\">a) Metodo dell&#039;indicatore biologico<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Se vengono utilizzati indicatori biologici (EPCD confermati), questi devono essere distribuiti in tutto il carico di sterilizzazione, comprese le posizioni più difficili da sterilizzare o le posizioni note per essere correlate a questi punti difficili. Se si utilizza il pretrattamento, gli indicatori biologici devono essere posizionati prima del pretrattamento.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Gli indicatori biologici devono essere rimossi dal carico di sterilizzazione al termine del ciclo di sterilizzazione e messi in coltura il prima possibile per consentire il rilancio degli indicatori biologici. Se non vengono coltivati ​​in modo tempestivo, dovrebbero essere valutati gli effetti dell&#039;esposizione all&#039;EO residuo durante la ripresa ritardata.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">La crescita degli indicatori biologici dovrebbe essere analizzata per determinare se la crescita non è dovuta al mancato rispetto delle specifiche del processo fisico, che richiederebbe la ripetizione del processo di conferma.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) Metodo di rilascio dei parametri<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Parameter release relies on proving that all physical process parameters meet the specifications for release without the use of biological indicators. It is based solely on measurements and records of physical process parameters and serves as a sufficient declaration of the sterilization process&#8217;s adequacy.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Parameter release is only permissible when all process parameters are specified, controlled, and directly monitored. Therefore, when parameter release is used, there should be equipment for direct measurement of temperature and humidity inside the chamber and for direct analysis of EO concentration, to collect and record the sterilization process parameters and confirm that the sterilization process complies with the specifications.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Oltre a dimostrare che i parametri del processo di sterilizzazione soddisfano le specifiche di sterilizzazione, il rilascio dei parametri richiede anche la misurazione e la registrazione dei seguenti dati aggiuntivi:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Misurare la temperatura all&#039;interno della camera da almeno due punti durante il ciclo di sterilizzazione.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Misurazione diretta dell&#039;umidità all&#039;interno della camera durante la fase di lavorazione.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Determinazione della concentrazione di EO mediante analisi diretta del gas della camera di sterilizzazione a intervalli di tempo specificati, per verificare pienamente che le condizioni richieste siano soddisfatte durante tutto il periodo di esposizione.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">SE VUOI SAPERNE DI PIÙ sulla sterilizzazione con ossido di etilene<\/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","protected":false},"excerpt":{"rendered":"<p>Lo scopo del monitoraggio e del controllo di routine della sterilizzazione con ossido di etilene è dimostrare che al prodotto è stato applicato il processo di sterilizzazione confermato e specificato. I dati di ciascun ciclo di sterilizzazione devono essere registrati e conservati per dimostrare che le specifiche confermate del processo di sterilizzazione sono state soddisfatte. Ciò dovrebbe includere almeno il seguente contenuto:<\/p>\n","protected":false},"author":234312599,"featured_media":8429,"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":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center 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Ethylene oxide cylinders should be stored separately in a dry, well-ventilated room, with strict prohibition of smoking and open flames. The lighting in the sterilization chamber should be explosion-proof, and any electrical appliances that may cause electric\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\/10\/Electrical-Scale.png?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":1950,"url":"https:\/\/zjbocon.com\/?p=1950","url_meta":{"origin":2128,"position":5},"title":"eto sterilization process","author":"Bocon Technical Team","date":"2024-10-23","format":false,"excerpt":"Eto Sterilization is conducted using a eto sterilizer located in a dedicated facility.","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"eto sterilization process","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/eto-sterilization-process-e1729654271899.webp?resize=700%2C400&ssl=1 2x"},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128","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=2128"}],"version-history":[{"count":4,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128\/revisions"}],"predecessor-version":[{"id":8879,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/2128\/revisions\/8879"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8429"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=2128"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=2128"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=2128"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}