{"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

المراقبة والتحكم الروتيني<\/h2>\n\n\n\n

الغرض من المراقبة الروتينية والتحكم في تعقيم EO (أكسيد الإيثيلين) هو إثبات أنه تم تطبيق عملية التعقيم المؤكدة والمحددة على المنتج. يجب تسجيل البيانات من كل دورة تعقيم والاحتفاظ بها لإثبات استيفاء مواصفات عملية التعقيم المؤكدة. ويجب أن يتضمن ذلك المحتوى التالي على الأقل:<\/p>\n\n\n\n

أ) دليل على أن درجة الحرارة البيئية للمنتج قد وصلت إلى الحد الأدنى من درجة الحرارة المؤكدة عند دخول المعالجة المسبقة (في حالة استخدامها). يمكن تحقيق ذلك من خلال السماح للحمل بالتأقلم مع البيئة لفترة زمنية محددة كحد أدنى. إذا كانت درجة حرارة التخزين معروفة، ليست هناك حاجة لتحديد درجة حرارة المنتج قبل الدخول إلى منطقة المعالجة المسبقة. إذا تعرض المنتج لدرجات حرارة شديدة، أثناء النقل مثلاً، فقد يلزم تخزين المنتج لفترة قبل المعالجة المسبقة لتثبيت درجة الحرارة والرطوبة الداخلية ضمن نطاق مقبول.<\/p>\n\n\n\n

ب) مراقبة وتسجيل درجة الحرارة والرطوبة في منطقة المعالجة (في حالة استخدامها) في مواقع محددة.<\/p>\n\n\n\n

ج) وقت بدء المعالجة المسبقة لكل حمل تعقيم ووقت إزالة الحمولة من منطقة المعالجة المسبقة (إذا تم استخدامها).<\/p>\n\n\n\n

د) الفاصل الزمني بين إزالة حمولة التعقيم من منطقة المعالجة المسبقة (في حالة استخدامها) وبدء دورة التعقيم.<\/p>\n\n\n\n

هـ) مؤشرات التشغيل السليم لنظام تداول الغاز في الغرفة أثناء مرحلة التعرض للغاز (في حالة استخدامه).<\/p>\n\n\n\n

و) درجة الحرارة والضغط داخل الغرفة طوال دورة التعقيم.<\/p>\n\n\n\n

ز) الرطوبة داخل الحجرة أثناء مرحلة المعالجة مقاسة بالضغط أو بشكل مباشر.<\/p>\n\n\n\n

ح) التأكد من إدخال غاز EO الغازي إلى غرفة التعقيم.<\/p>\n\n\n\n

ط) ارتفاع الضغط داخل غرفة التعقيم وكمية أو تركيز EO المستخدم.<\/p>\n\n\n\n

ي) وقت المعالجة.<\/p>\n\n\n\n

ك) وقت التعرض.<\/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

إصدار تعقيم EO<\/h2>\n\n\n\n

أ) طريقة المؤشر البيولوجي<\/h3>\n\n\n\n

إذا تم استخدام المؤشرات البيولوجية (EPCD المؤكدة)، فيجب توزيعها في جميع أنحاء حمل التعقيم، بما في ذلك المواقع الأكثر صعوبة في التعقيم أو المواقع المعروفة بأنها مرتبطة بهذه المواقع الصعبة. إذا تم استخدام المعالجة المسبقة، فيجب وضع المؤشرات البيولوجية قبل المعالجة المسبقة.<\/p>\n\n\n\n

يجب إزالة المؤشرات البيولوجية من حمل التعقيم بعد انتهاء دورة التعقيم وزراعتها في أسرع وقت ممكن للسماح للمؤشرات البيولوجية بالانتعاش. إذا لم يتم تربيتها في الوقت المناسب، ينبغي تقييم آثار التعرض للمخلفات المتبقية من EO أثناء الإحياء المتأخر.<\/p>\n\n\n\n

وينبغي تحليل نمو المؤشرات البيولوجية لتحديد ما إذا كان النمو لا يرجع إلى عدم استيفاء مواصفات العملية الفيزيائية، الأمر الذي يتطلب تكرار عملية التأكيد.<\/p>\n\n\n\n

ب) طريقة إصدار المعلمة<\/p>\n\n\n\n

يعتمد إطلاق المعلمة على إثبات أن جميع معلمات العملية الفيزيائية تلبي مواصفات الإصدار دون استخدام المؤشرات البيولوجية. وهو يعتمد فقط على قياسات وسجلات معلمات العملية الفيزيائية ويعمل بمثابة إعلان كاف عن مدى كفاية عملية التعقيم.<\/p>\n\n\n\n

لا يُسمح بتحرير المعلمات إلا عندما يتم تحديد جميع معلمات العملية والتحكم فيها ومراقبتها مباشرة. لذلك، عند استخدام إصدار المعلمة، يجب أن تكون هناك معدات للقياس المباشر لدرجة الحرارة والرطوبة داخل الغرفة وللتحليل المباشر لتركيز EO، لجمع وتسجيل معلمات عملية التعقيم والتأكد من أن عملية التعقيم تتوافق مع المواصفات.<\/p>\n\n\n\n

بالإضافة إلى إثبات أن معلمات عملية التعقيم تلبي مواصفات التعقيم، يتطلب إصدار المعلمة أيضًا قياس وتسجيل البيانات الإضافية التالية:<\/p>\n\n\n\n

قياس درجة الحرارة داخل الحجرة من موقعين على الأقل طوال دورة التعقيم.<\/p>\n\n\n\n

قياس الرطوبة داخل الغرفة مباشرة أثناء مرحلة المعالجة.<\/p>\n\n\n\n

تحديد تركيز EO عن طريق التحليل المباشر لغاز غرفة التعقيم على فترات زمنية محددة، للتحقق بشكل كامل من استيفاء الشروط المطلوبة طوال فترة التعرض.<\/p>\n\n\n\n

إذا كنت تريد معرفة المزيد عن التعقيم بأكسيد الإيثيلين<\/h2>\n\n\n\n

هاتف:+8619975258603<\/a><\/p>\n\n\n\n

بريد إلكتروني:هايلي@hzbocon.com<\/a><\/p>\n\n\n\n

الموقع المحلي: الغرفة 1202، Caitong Zhongxin، منطقة Xiasha، مدينة Hangzhou، مقاطعة Zhejiang، الصين<\/p>\n\n\n\n

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

الغرض من المراقبة الروتينية والتحكم في تعقيم EO (أكسيد الإيثيلين) هو إثبات أنه تم تطبيق عملية التعقيم المؤكدة والمحددة على المنتج. يجب تسجيل البيانات من كل دورة تعقيم والاحتفاظ بها لإثبات استيفاء مواصفات عملية التعقيم المؤكدة. ويجب أن يتضمن ذلك المحتوى التالي على الأقل:<\/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}]}}