{"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\">Rutinszerű felügyelet és ellenőrzés<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Az EO (etilén-oxid) sterilizálás rutinszerű monitorozásának és ellenőrzésének célja annak bizonyítása, hogy a megerősített és meghatározott sterilizálási eljárást alkalmazták a terméken. Minden sterilizálási ciklus adatait fel kell jegyezni és meg kell őrizni annak bizonyítására, hogy a sterilizálási folyamat megerősített előírásai teljesültek. Ennek legalább a következő tartalmat kell tartalmaznia:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">a) Bizonyíték arra, hogy a termék környezeti hőmérséklete az előkezelésbe való belépéskor elérte a minimálisan megerősített hőmérsékletet (ha használt). Ez úgy érhető el, hogy a terhelést egy meghatározott minimális ideig hagyjuk akklimatizálódni a környezethez. Ha a tárolási hőmérséklet ismert, nem szükséges meghatározni a termék hőmérsékletét az előkezelési területre való belépés előtt. Ha a termék szélsőséges hőmérsékletnek volt kitéve, például szállítás közben, előfordulhat, hogy a terméket az előkezelés előtt egy ideig tárolni kell, hogy a belső hőmérséklet és páratartalom elfogadható tartományon belül stabilizálódjon.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) A hőmérséklet és páratartalom figyelése és rögzítése az előkezelési területen (ha van ilyen) meghatározott helyeken.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">c) Az előkezelés kezdő időpontja minden sterilizációs töltetnél, és az az idő, amikor a töltet eltávolításra került az előkezelési területről (ha van ilyen).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">d) A sterilizálási terhelésnek az előkezelési területről való eltávolítása (ha van ilyen) és a sterilizálási ciklus kezdete közötti időtartam.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">e) A kamrában lévő gázkeringtető rendszer megfelelő működésének jelzői a gázexpozíciós fázisban (ha van ilyen).<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">f) A kamrán belüli hőmérséklet és nyomás a sterilizálási ciklus alatt.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">g) A kamrán belüli páratartalom a feldolgozási fázisban, nyomással vagy közvetlenül mérve.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">h) Annak megerősítése, hogy gáznemű EO került a sterilizáló kamrába.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">i) A nyomásemelkedés a sterilizáló kamrában és a felhasznált EO mennyisége vagy koncentrációja.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">j) A feldolgozási idő.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">k) Az expozíciós idő.<\/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\">EO sterilizálási kiadás<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-biological-indicator-method\">a) Biológiai indikátor módszer<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Ha biológiai indikátorokat (megerősített EPCD) használnak, azokat el kell osztani a sterilizálási terhelés alatt, beleértve a legnehezebben sterilizálható helyeket, vagy olyan helyeket, amelyekről ismert, hogy ezekhez a nehéz helyekhez kapcsolódnak. Előkezelés alkalmazása esetén a biológiai indikátorokat az előkezelés előtt kell elhelyezni.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A biológiai indikátorokat a sterilizálási ciklus végén el kell távolítani a sterilizálási terhelésből, és a lehető leghamarabb tenyészteni kell, hogy a biológiai indikátorok újjáéledjenek. Ha nem tenyésztik ki időben, értékelni kell a visszamaradó EO-nak való kitettség hatásait a késleltetett újraélesztés során.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A biológiai mutatók növekedését elemezni kell annak megállapítására, hogy a növekedés nem a fizikai folyamat specifikációinak teljesítésének elmulasztásából fakad-e, ami a megerősítési folyamat megismétlését igényelné.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">b) Paraméter-felszabadítási módszer<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A paraméterek felszabadítása annak bizonyításán múlik, hogy minden fizikai folyamatparaméter megfelel a biológiai indikátorok használata nélküli kibocsátásra vonatkozó előírásoknak. Kizárólag méréseken és fizikai folyamatparaméterek nyilvántartásán alapul, és elegendő nyilatkozatot jelent a sterilizálási folyamat megfelelőségéről.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A paraméterek kiadása csak akkor megengedett, ha az összes folyamatparaméter meg van adva, vezérelve és közvetlenül felügyelve. Ezért a paraméterek felszabadítása esetén a kamrán belüli hőmérséklet és páratartalom közvetlen mérésére és az EO-koncentráció közvetlen elemzésére szolgáló berendezésnek kell lennie a sterilizálási folyamat paramétereinek összegyűjtésére és rögzítésére, valamint annak megerősítésére, hogy a sterilizálási folyamat megfelel az előírásoknak.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Amellett, hogy igazolni kell, hogy a sterilizálási folyamat paraméterei megfelelnek a sterilizálási előírásoknak, a paraméterfelszabadításhoz a következő további adatok mérése és rögzítése is szükséges:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A kamrán belüli hőmérséklet mérése legalább két helyről a sterilizálási ciklus alatt.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A kamrában lévő páratartalom közvetlen mérése a feldolgozási fázisban.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Az EO-koncentráció meghatározása a sterilizációs kamra gázának meghatározott időközönkénti közvetlen analízisével, hogy teljes mértékben ellenőrizhető legyen a szükséges feltételek teljesülése az expozíciós időszak alatt.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">HA TÖBBET SZERETNÉL TUDNI az etilén-oxidos sterilizálásról<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefon:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Helyi telephely: 1202-es szoba, Caitong Zhongxin, Xiasha kerület, Hangzhou város, Zhejiang tartomány, Kína<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Weboldal:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Az EO (etilén-oxid) sterilizálás rutinszerű monitorozásának és ellenőrzésének célja annak bizonyítása, hogy a megerősített és meghatározott sterilizálási eljárást alkalmazták a terméken. Minden sterilizálási ciklus adatait fel kell jegyezni és meg kell őrizni annak bizonyítására, hogy a sterilizálási folyamat megerősített előírásai teljesültek. Ennek legalább a következő tartalmat kell tartalmaznia:<\/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. 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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}]}}