{"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
\"Ethylene<\/figure><\/div>\n\n\n\n

Routineüberwachung und -kontrolle<\/h2>\n\n\n\n

Der Zweck der routinemäßigen Überwachung und Kontrolle der EO-Sterilisation (Ethylenoxid) besteht darin, nachzuweisen, dass das bestätigte und spezifizierte Sterilisationsverfahren auf das Produkt angewendet wurde. Daten aus jedem Sterilisationszyklus sollten aufgezeichnet und aufbewahrt werden, um nachzuweisen, dass die bestätigten Spezifikationen des Sterilisationsprozesses erfüllt wurden. Dieser sollte mindestens folgende Inhalte umfassen:<\/p>\n\n\n\n

a) Nachweis, dass die Umgebungstemperatur des Produkts bei Eintritt in die Vorbehandlung (sofern verwendet) die bestätigte Mindesttemperatur erreicht hat. Dies kann dadurch erreicht werden, dass sich die Ladung für eine bestimmte Mindestzeit an die Umgebung akklimatisieren kann. Wenn die Lagertemperatur bekannt ist, ist es nicht erforderlich, die Temperatur des Produkts vor dem Eintritt in den Vorbehandlungsbereich zu bestimmen. Wenn das Produkt extremen Temperaturen ausgesetzt war, beispielsweise während des Transports, muss es vor der Vorbehandlung möglicherweise eine Zeit lang gelagert werden, um seine Innentemperatur und Luftfeuchtigkeit innerhalb eines akzeptablen Bereichs zu stabilisieren.<\/p>\n\n\n\n

b) Überwachung und Aufzeichnung der Temperatur und Luftfeuchtigkeit im Vorbehandlungsbereich (sofern vorhanden) an festgelegten Standorten.<\/p>\n\n\n\n

c) Die Startzeit der Vorbehandlung für jede Sterilisationsladung und die Zeit, zu der die Ladung aus dem Vorbehandlungsbereich entfernt wird (falls verwendet).<\/p>\n\n\n\n

d) Das Zeitintervall zwischen dem Entfernen der Sterilisationsladung aus dem Vorbehandlungsbereich (sofern verwendet) und dem Beginn des Sterilisationszyklus.<\/p>\n\n\n\n

e) Indikatoren für den ordnungsgemäßen Betrieb des Gaszirkulationssystems in der Kammer während der Gasexpositionsphase (sofern verwendet).<\/p>\n\n\n\n

f) Die Temperatur und der Druck in der Kammer während des gesamten Sterilisationszyklus.<\/p>\n\n\n\n

g) Die Luftfeuchtigkeit in der Kammer während der Verarbeitungsphase, gemessen durch Druck oder direkt.<\/p>\n\n\n\n

h) Bestätigung, dass gasförmiges EO in die Sterilisationskammer eingeleitet wurde.<\/p>\n\n\n\n

i) Der Druckanstieg in der Sterilisationskammer und die Menge oder Konzentration des verwendeten EO.<\/p>\n\n\n\n

j) Die Bearbeitungszeit.<\/p>\n\n\n\n

k) The exposure time.<\/p>\n\n\n\n

l) Time, temperature, and pressure changes (if applicable) during the aeration phase and\/or venting operations (if used).<\/p>\n\n\n\n

EO Sterilization Release<\/h2>\n\n\n\n

a) Biologische Indikatormethode<\/h3>\n\n\n\n

Wenn biologische Indikatoren (bestätigte EPCD) verwendet werden, sollten diese über die gesamte Sterilisationsladung verteilt werden, einschließlich der am schwierigsten zu sterilisierenden Stellen oder der Stellen, von denen bekannt ist, dass sie mit diesen schwierigen Stellen in Zusammenhang stehen. Wenn eine Vorbehandlung verwendet wird, sollten die biologischen Indikatoren vor der Vorbehandlung platziert werden.<\/p>\n\n\n\n

Die biologischen Indikatoren sollten nach Ende des Sterilisationszyklus aus der Sterilisationsladung entfernt und so bald wie möglich kultiviert werden, damit die biologischen Indikatoren wieder aufleben können. Wenn sie nicht rechtzeitig kultiviert werden, sollten die Auswirkungen der Exposition gegenüber restlichem EO während der verzögerten Wiederbelebung bewertet werden.<\/p>\n\n\n\n

Das Wachstum der biologischen Indikatoren sollte analysiert werden, um festzustellen, ob das Wachstum nicht auf die Nichterfüllung der physikalischen Prozessspezifikationen zurückzuführen ist, was eine Wiederholung des Bestätigungsprozesses erfordern würde.<\/p>\n\n\n\n

b) Parameterfreigabemethode<\/p>\n\n\n\n

Die Parameterfreigabe beruht auf dem Nachweis, dass alle physikalischen Prozessparameter die Spezifikationen für die Freigabe ohne den Einsatz biologischer Indikatoren erfüllen. Es basiert ausschließlich auf Messungen und Aufzeichnungen physikalischer Prozessparameter und dient als ausreichende Erklärung der Angemessenheit des Sterilisationsprozesses.<\/p>\n\n\n\n

Parameter release is only permissible when all process parameters are specified, controlled, and directly monitored. Daher sollte bei Verwendung der Parameterfreigabe eine Ausrüstung zur direkten Messung von Temperatur und Luftfeuchtigkeit in der Kammer sowie zur direkten Analyse der EO-Konzentration vorhanden sein, um die Parameter des Sterilisationsprozesses zu erfassen und aufzuzeichnen und zu bestätigen, dass der Sterilisationsprozess den Spezifikationen entspricht.<\/p>\n\n\n\n

Neben dem Nachweis, dass die Parameter des Sterilisationsprozesses den Sterilisationsspezifikationen entsprechen, erfordert die Parameterfreigabe auch die Messung und Aufzeichnung der folgenden zusätzlichen Daten:<\/p>\n\n\n\n

Messung der Temperatur in der Kammer während des gesamten Sterilisationszyklus an mindestens zwei Stellen.<\/p>\n\n\n\n

Direkte Messung der Luftfeuchtigkeit im Inneren der Kammer während der Verarbeitungsphase.<\/p>\n\n\n\n

Bestimmung der EO-Konzentration durch direkte Analyse des Gases der Sterilisationskammer in festgelegten Zeitintervallen, um vollständig zu überprüfen, ob die erforderlichen Bedingungen während des gesamten Expositionszeitraums erfüllt sind.<\/p>\n\n\n\n

WENN SIE MEHR ÜBER DIE Ethylenoxid-Sterilisation ERFAHREN WOLLEN<\/h2>\n\n\n\n

Telefon:+8619975258603<\/a><\/p>\n\n\n\n

E-Mail:hayley@hzbocon.com<\/a><\/p>\n\n\n\n

Lokaler Standort: Raum 1202, Caitong Zhongxin, Bezirk Xiasha, Stadt Hangzhou, Provinz Zhejiang, China<\/p>\n\n\n\n

Webseite:hzbocon.com<\/a>zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Der Zweck der routinemäßigen Überwachung und Kontrolle der EO-Sterilisation (Ethylenoxid) besteht darin, nachzuweisen, dass das bestätigte und spezifizierte Sterilisationsverfahren auf das Produkt angewendet wurde. Daten aus jedem Sterilisationszyklus sollten aufgezeichnet und aufbewahrt werden, um nachzuweisen, dass die bestätigten Spezifikationen des Sterilisationsprozesses erfüllt wurden. Dieser sollte mindestens folgende Inhalte umfassen:<\/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…","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 "Company News"","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 "Company News"","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 "Company News"","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 "ETO STERILIZER"","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 "Company News"","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 "ETO STERILIZER"","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}]}}