{"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\">Surviglianza è cuntrollu di rutina<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">U scopu di u monitoraghju di rutina è u cuntrollu di a sterilizazione EO (Ethylene Oxide) hè di dimustrà chì u prucessu di sterilizazione cunfirmatu è specificatu hè statu appiicatu à u pruduttu. I dati di ogni ciculu di sterilizazione devenu esse registrati è conservati per pruvà chì e specificazioni cunfirmate di u prucessu di sterilizazione sò state rispettate. Questu deve include almenu u cuntenutu seguente:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">a) Evidenza chì a temperatura ambientale di u pruduttu hà righjuntu a temperatura minima cunfirmata quandu entra in u pretrattamentu (se usatu). Questu pò esse ottenutu da permette à a carica di acclimate à l&#039;ambiente per un tempu minimu specificu. Se a temperatura di almacenamiento hè cunnisciuta, ùn ci hè bisognu di determinà a temperatura di u pruduttu prima di entre in a zona di pretrattamentu. Se u pruduttu hè statu espostu à temperature estreme, cum&#039;è durante u trasportu, u pruduttu pò avè bisognu à esse guardatu per un periudu prima di pretrattamentu per stabilizzà a so temperatura interna è l&#039;umidità in un intervallu accettabile.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) Monitoraghju è arregistramentu di a temperatura è l&#039;umidità in l&#039;area di pretrattamentu (se usata) in lochi specificati.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">c) U tempu di iniziu di u pretrattamentu per ogni carica di sterilizazione è u tempu chì a carica hè eliminata da l&#039;area di pretrattamentu (se usatu).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">d) L&#039;intervallu di tempu trà l&#039;eliminazione di a carica di sterilizazione da l&#039;area di pretrattamentu (se usatu) è l&#039;iniziu di u ciculu di sterilizazione.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">e) Indicatori di u funziunamentu propiu di u sistema di circulazione di gasu in a camera durante a fase di esposizione di gas (se usatu).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">f) A temperatura è a pressione in a camera in tuttu u ciclu di sterilizazione.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">g) L&#039;umidità in a camera durante a fase di trasfurmazioni, misurata da pressione o direttamente.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">h) A cunferma chì l&#039;EO gassosa hè statu introduttu in a camera di sterilizazione.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">i) L&#039;aumentu di pressione in a camera di sterilizazione è a quantità o cuncentrazione di EO utilizata.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">j) U tempu di trasfurmazioni.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">k) U tempu 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\">Liberazione di sterilizazione EO<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-biological-indicator-method\">a) Metudu di l&#039;indicatore biologicu<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Se l&#039;indicatori biologichi (EPCD cunfirmati) sò usati, anu da esse distribuiti in tutta a carica di sterilizazione, cumprese i lochi più difficiuli di sterilizà o i lochi cunnisciuti per esse ligati à sti lochi difficiuli. Se u pretrattamentu hè utilizatu, l&#039;indicatori biologichi deve esse posti prima di u pretrattamentu.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">L&#039;indicatori biologichi anu da esse eliminati da a carica di sterilizazione dopu chì u ciculu di sterilizazione finisci è cultivati ​​u più prestu pussibule per permette à l&#039;indicatori biologichi di rinviviscia. S&#039;ellu ùn sò micca cultivati ​​​​in una manera puntuale, l&#039;effetti di l&#039;esposizione à l&#039;EO residuale durante a rinascita ritardata deve esse evaluata.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A crescita di l&#039;indicatori biològichi deve esse analizatu per determinà se a crescita ùn hè micca dovuta à fallimentu di scuntrà e specificazioni di u prucessu fisicu, chì deve esse ripetutu u prucessu di cunferma.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) Metudu di Liberazione di Parametru<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A liberazione di i paràmetri si basa in a prova chì tutti i paràmetri di u prucessu fisicu risponde à e specificazioni per a liberazione senza l&#039;usu di indicatori biologichi. Hè basatu solu nantu à e misurazioni è i registri di i paràmetri di u prucessu fisicu è serve cum&#039;è una dichjarazione sufficiente di l&#039;adeguatezza di u prucessu di sterilizazione.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A liberazione di i paràmetri hè permessa solu quandu tutti i paràmetri di u prucessu sò specificati, cuntrullati è monitorati direttamente. Per quessa, quandu si usa a liberazione di i paràmetri, ci deve esse un equipamentu per a misurazione diretta di a temperatura è l&#039;umidità in a camera è per l&#039;analisi diretta di a cuncentrazione di EO, per cullà è registrà i paràmetri di u prucessu di sterilizazione è cunfirmà chì u prucessu di sterilizazione hè conforme à e specificazioni.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">In addition to proving that the sterilization process parameters meet the sterilization specifications, parameter release also requires measuring and recording the following additional data:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Measuring the temperature inside the chamber at least from two locations throughout the sterilization cycle.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Directly measuring the humidity inside the chamber during the processing phase.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Determining the EO concentration by direct analysis of the sterilization chamber&#8217;s gas at specified time intervals, to fully verify that the required conditions are met throughout the exposure period.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">SE VOGLIA SAPERNE DI PIÙ nantu à a sterilizazione di l&#039;ossidu di etilene<\/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","protected":false},"excerpt":{"rendered":"<p>U scopu di u monitoraghju di rutina è u cuntrollu di a sterilizazione EO (Ethylene Oxide) hè di dimustrà chì u prucessu di sterilizazione cunfirmatu è specificatu hè statu appiicatu à u pruduttu. I dati di ogni ciculu di sterilizazione devenu esse registrati è conservati per pruvà chì e specificazioni cunfirmate di u prucessu di sterilizazione sò state rispettate. Questu deve include almenu u cuntenutu seguente:<\/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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Technical Team","author_link":"https:\/\/zjbocon.com\/?author=234312599"},"uagb_comment_info":23,"uagb_excerpt":"The purpose of routine monitoring and control of EO (Ethylene Oxide) sterilization is to demonstrate that the confirmed and specified sterilization process has been applied to the product. Data from each sterilization cycle should be recorded and retained to prove that the confirmed sterilization process specifications have been met. This should include at least the&hellip;","jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pgZDV6-yk","jetpack-related-posts":[{"id":3093,"url":"https:\/\/zjbocon.com\/?p=3093","url_meta":{"origin":2128,"position":0},"title":"Introduction to Ethylene Oxide Sterilizers","author":"Bocon Technical Team","date":"2025-02-05","format":false,"excerpt":"Discover how ethylene oxide sterilizers work, their applications, benefits, and safety considerations. Learn why they are essential for medical and industrial sterilization.","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\/ethylene-oxide-sterilization-21.webp?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":8958,"url":"https:\/\/zjbocon.com\/?p=8958","url_meta":{"origin":2128,"position":1},"title":"Understanding What is ETO Sterilizers: A Comprehensive Guide","author":"Bocon Technical Team","date":"2025-12-16","format":false,"excerpt":"Discover the essentials of ETO sterilizers and ethylene oxide sterilization, ensuring the highest hygiene standards in healthcare and beyond.","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-3.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-3.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-3.png?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":3100,"url":"https:\/\/zjbocon.com\/?p=3100","url_meta":{"origin":2128,"position":2},"title":"How Does Ethylene Oxide Gas Sterilization Kill Microorganisms?","author":"Bocon Technical Team","date":"2025-02-05","format":false,"excerpt":"How Does Ethylene Oxide Gas Sterilization Work? The effectiveness of ethylene oxide gas sterilization lies in its ability to disrupt the cellular structure of microorganisms. Here\u2019s a step-by-step breakdown of how it works: 1.\u00a0Penetration of EO Gas Ethylene oxide gas is highly penetrative, meaning it can easily reach microorganisms even\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\/tp2.jpg?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]},{"id":2004,"url":"https:\/\/zjbocon.com\/?p=2004","url_meta":{"origin":2128,"position":3},"title":"The Guide to ethylene oxide in sterilization","author":"Bocon Technical Team","date":"2024-10-28","format":false,"excerpt":"ethylene oxide in sterilization Introduction ETO is a colorless gas that is flammable and explosive. The four essential parameters (operational ranges) of ethylene oxide in sterilization are: gas concentration (450 to 1200 mg\/l); temperature (37 to 63\u00b0C); relative humidity (40 to 80%)(water molecules carry ETO to reactive sites); and exposure\u2026","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"Industry_ETO_Sterilizer","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Industry_ETO_Sterilizer.webp?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Industry_ETO_Sterilizer.webp?resize=350%2C200 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Industry_ETO_Sterilizer.webp?resize=525%2C300 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Industry_ETO_Sterilizer.webp?resize=700%2C400 2x"},"classes":[]},{"id":2471,"url":"https:\/\/zjbocon.com\/?p=2471","url_meta":{"origin":2128,"position":4},"title":"Safety Requirements for Using Ethylene Oxide in sterilization","author":"Bocon Technical Team","date":"2024-12-23","format":false,"excerpt":"when Ethylene Oxide in sterilization chamber should be equipped with fire prevention facilities. 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}]}}