{"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

Surveillance et contrôle de routine<\/h2>\n\n\n\n

Le but de la surveillance et du contrôle de routine de la stérilisation à l'oxyde d'éthylène (oxyde d'éthylène) est de démontrer que le processus de stérilisation confirmé et spécifié a été appliqué au produit. Les données de chaque cycle de stérilisation doivent être enregistrées et conservées pour prouver que les spécifications confirmées du processus de stérilisation ont été respectées. Cela devrait inclure au moins le contenu suivant :<\/p>\n\n\n\n

a) Preuve que la température ambiante du produit a atteint la température minimale confirmée lors de l'entrée dans le prétraitement (le cas échéant). Ceci peut être réalisé en permettant à la charge de s'acclimater à l'environnement pendant une durée minimale spécifiée. Si la température de stockage est connue, il n’est pas nécessaire de déterminer la température du produit avant d’entrer dans la zone de prétraitement. Si le produit a été exposé à des températures extrêmes, par exemple pendant le transport, il peut être nécessaire de le stocker pendant une certaine période avant le prétraitement afin de stabiliser sa température et son humidité internes dans une plage acceptable.<\/p>\n\n\n\n

b) Surveillance et enregistrement de la température et de l'humidité dans la zone de prétraitement (si utilisée) à des endroits spécifiés.<\/p>\n\n\n\n

c) L'heure de début du prétraitement pour chaque charge de stérilisation et l'heure à laquelle la charge est retirée de la zone de prétraitement (le cas échéant).<\/p>\n\n\n\n

d) L'intervalle de temps entre le retrait de la charge de stérilisation de la zone de prétraitement (si utilisée) et le début du cycle de stérilisation.<\/p>\n\n\n\n

e) Indicateurs du bon fonctionnement du système de circulation de gaz dans la chambre pendant la phase d'exposition au gaz (si utilisé).<\/p>\n\n\n\n

f) La température et la pression à l'intérieur de la chambre tout au long du cycle de stérilisation.<\/p>\n\n\n\n

g) L'humidité à l'intérieur de la chambre pendant la phase de traitement, mesurée par pression ou directement.<\/p>\n\n\n\n

h) Confirmation que de l'EO gazeux a été introduit dans la chambre de stérilisation.<\/p>\n\n\n\n

i) La pression augmente à l'intérieur de la chambre de stérilisation et la quantité ou la concentration d'EO utilisée.<\/p>\n\n\n\n

j) Le délai de traitement.<\/p>\n\n\n\n

k) Le temps d'exposition.<\/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

Libération de stérilisation EO<\/h2>\n\n\n\n

a) Méthode des indicateurs biologiques<\/h3>\n\n\n\n

Si des indicateurs biologiques (EPCD confirmés) sont utilisés, ils doivent être répartis tout au long de la charge de stérilisation, y compris les emplacements les plus difficiles à stériliser ou les emplacements connus pour être liés à ces endroits difficiles. Si un prétraitement est utilisé, les indicateurs biologiques doivent être placés avant le prétraitement.<\/p>\n\n\n\n

Les indicateurs biologiques doivent être retirés de la charge de stérilisation une fois le cycle de stérilisation terminé et cultivés dès que possible pour permettre aux indicateurs biologiques de se rétablir. S’ils ne sont pas cultivés en temps opportun, les effets de l’exposition à l’EO résiduel lors d’une réanimation retardée doivent être évalués.<\/p>\n\n\n\n

La croissance des indicateurs biologiques doit être analysée pour déterminer si la croissance n'est pas due à un non-respect des spécifications du processus physique, ce qui nécessiterait de répéter le processus de confirmation.<\/p>\n\n\n\n

b) Méthode de libération des paramètres<\/p>\n\n\n\n

La libération des paramètres repose sur la preuve que tous les paramètres physiques du processus répondent aux spécifications de libération sans l'utilisation d'indicateurs biologiques. Il est basé uniquement sur des mesures et des enregistrements de paramètres physiques du processus et constitue une déclaration suffisante de l’adéquation du processus de stérilisation.<\/p>\n\n\n\n

La libération des paramètres n'est autorisée que lorsque tous les paramètres du processus sont spécifiés, contrôlés et directement surveillés. Par conséquent, lorsque la libération des paramètres est utilisée, il doit y avoir un équipement pour mesurer directement la température et l'humidité à l'intérieur de la chambre et pour analyser directement la concentration d'EO, pour collecter et enregistrer les paramètres du processus de stérilisation et confirmer que le processus de stérilisation est conforme aux spécifications.<\/p>\n\n\n\n

En plus de prouver que les paramètres du processus de stérilisation répondent aux spécifications de stérilisation, la libération des paramètres nécessite également de mesurer et d'enregistrer les données supplémentaires suivantes :<\/p>\n\n\n\n

Mesurer la température à l'intérieur de la chambre à partir d'au moins deux endroits tout au long du cycle de stérilisation.<\/p>\n\n\n\n

Mesure directe de l'humidité à l'intérieur de la chambre pendant la phase de traitement.<\/p>\n\n\n\n

Détermination de la concentration d'OE par analyse directe du gaz de la chambre de stérilisation à des intervalles de temps spécifiés, pour vérifier pleinement que les conditions requises sont remplies tout au long de la période d'exposition.<\/p>\n\n\n\n

SI VOUS VOULEZ EN SAVOIR PLUS sur la stérilisation à l'oxyde d'éthylène<\/h2>\n\n\n\n

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

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

Site local : salle 1202, Caitong Zhongxin, district de Xiasha, ville de Hangzhou, province du Zhejiang, Chine<\/p>\n\n\n\n

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

Le but de la surveillance et du contrôle de routine de la stérilisation à l'oxyde d'éthylène (oxyde d'éthylène) est de démontrer que le processus de stérilisation confirmé et spécifié a été appliqué au produit. Les données de chaque cycle de stérilisation doivent être enregistrées et conservées pour prouver que les spécifications confirmées du processus de stérilisation ont été respectées. Cela devrait inclure au moins le contenu suivant :<\/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}]}}