{"id":2138,"date":"2024-11-07T10:48:25","date_gmt":"2024-11-07T02:48:25","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2138"},"modified":"2025-12-05T10:47:35","modified_gmt":"2025-12-05T02:47:35","slug":"eto-sterilization-chamber-testing","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2138","title":{"rendered":"ETO Sterilization Chamber Testing"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-b98f6ad4 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\/2025\/09\/ETO-STERILIZER-FAT-225x300.webp\" alt=\"\" class=\"uag-image-8380\" width=\"225\" height=\"300\" title=\"ETO-STERILIZER-FAT\" role=\"img\" \><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-temperature-and-humidity-distribution-testing\">اختبار توزيع درجة الحرارة والرطوبة<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The temperature setting range of the ETO Sterilization Chamber should be between 30-60\u00b0C. It is recommended to perform temperature distribution testing of the sterilizer&#8217;s internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-internal-surface-temperature-test-of-eto-sterilization-chamber\">أ) اختبار درجة حرارة السطح الداخلي لغرفة التعقيم ETO:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>أثناء الاختبار، يجب أن تكون غرفة التعقيم فارغة، ولكن يمكن تركيب الأجهزة المساعدة اللازمة للتعقيم. يجب إغلاق باب غرفة التعقيم.<\/li>\n\n\n\n<li>The temperature of any preheating stage as specified by the sterilizer manufacturer should be recorded. The temperature of all internal surfaces of the sterilization chamber should not exceed the set temperature of the sterilization phase by \u00b15\u00b0C.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-b-temperature-and-humidity-test-in-the-eto-sterilization-chamber\">ب) اختبار درجة الحرارة والرطوبة في غرفة التعقيم ETO:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>أثناء الاختبار، يجب أن تكون غرفة التعقيم ETO فارغة، ولكن يمكن تركيب الأجهزة المساعدة اللازمة للتعقيم. يجب إغلاق باب غرفة التعقيم.<\/li>\n\n\n\n<li>استخدم أجهزة استشعار درجة الحرارة والرطوبة الموضوعة في مواضع محددة للمقارنة مع درجة حرارة التحكم داخل الغرفة. يجب وضع أجهزة استشعار درجة الحرارة في المواقع التي من المحتمل أن تمثل أقصى اختلافات في درجات الحرارة، مثل الأجزاء غير المدفأة من الغرفة، وبالقرب من أبواب الخزانة، وبالقرب من نقاط دخول البخار أو الغاز. وينبغي توزيع أجهزة الاستشعار الأخرى بالتساوي في جميع أنحاء الحجم القابل للاستخدام في غرفة التعقيم، بما في ذلك الوسط والأعلى والأسفل والأمام والخلف. يجب أن يفي عدد أجهزة الاستشعار بالمتطلبات الواردة في الملحق C لـ GB18279.1.<\/li>\n\n\n\n<li>ينبغي تسجيل موضع كل قياس، ويجب تسجيل درجة الحرارة والرطوبة في مناطق مختلفة من غرفة التعقيم لتحديد النقاط الساخنة والباردة المحتملة.<\/li>\n\n\n\n<li>The indoor temperature range of the sterilization chamber when empty should not exceed \u00b12\u00b0C of the set temperature or \u00b13\u00b0C of the average temperature inside the chamber.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-vacuum-pumping-rate\">معدل ضخ الفراغ<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>يجب أن يكون نظام التفريغ أثناء مرحلة ضخ التفريغ قادرًا على إخلاء غرفة التعقيم الفارغة إلى -75 كيلو باسكال أو أقل. يجب توصيل مقياس الضغط بمدخل اختبار الفراغ لمراقبة ما إذا كان يلبي المعيار المطلوب.<\/li>\n\n\n\n<li>يجب على الشركة المصنعة تأكيد الوقت اللازم للوصول إلى -50 كيلو باسكال و -75 كيلو باسكال في ظل ظروف الحمل الفارغ. يمكن استخدام جهاز توقيت لمراقبة مرحلة ضخ الفراغ، ويجب الوصول إلى المعلمات المحددة مسبقًا خلال الوقت المحدد.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-cabinet-leakage-test\"> اختبار تسرب خزانة التعقيم ETO<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">يتضمن اختبار تسرب خزانة التعقيم ETO كلاً من اختبار تسرب الفراغ (الضغط السلبي) واختبار تسرب الضغط (الضغط الإيجابي) (إن أمكن). عندما يكون ضغط تشغيل جهاز التعقيم أكبر من 5 كيلو باسكال، يجب إجراء اختبار تسرب الضغط (الضغط الإيجابي).<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The vacuum leakage test should be conducted before the sterilant injection phase and the humidification phase, with the testing method following the provisions of Appendix D.1 of YY0503. The preset pressure during the test should be less than -20 kPa and at least 20 kPa lower than the preset sterilization pressure. Once the preset pressure is reached, all valves connected to the sterilization chamber should be closed, and the vacuum pump should stop working. The pressure in the sterilization chamber should be monitored, and the pressure rise within 5 minutes should not exceed 0.3 kPa\/min. The pressure variation during the entire test should not exceed 0.1 kPa\/min.<\/li>\n\n\n\n<li>Positive pressure leakage testing (if applicable) should be conducted before the vacuum pumping phase. The preset pressure for the test should be within 10% of the sterilizer&#8217;s preset working pressure. The pressure drop within 5 minutes should not exceed 0.3 kPa\/min. At the same time, according to the method in Appendix D.2 of YY0503, the sterilization time should be set to at least 65 minutes, using inert gas (such as air) to replace EO gas and run a normal sterilization cycle. After the sterilization phase reaches temperature stability for 2 minutes, the pressure in the sterilization chamber should be recorded. It should be recorded again after 60 minutes \u00b1 1 minute. The pressure variation rate should not exceed 0.1 kPa\/min.Auxiliary System Verification<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\">During the operational verification, the performance of related auxiliary systems should be confirmed, including but not limited to: the quality of steam provided, the ability of the EO vaporizer to reach the minimum gas input temperature, the reliability of the sterilizer\u2019s air filtration and water supply systems, and the ability of the steam generator to maintain the required supply quality under maximum sterilization load conditions.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Examples of acceptable auxiliary system performance: a) When steam is injected during the processing phase, the humidity in the sterilization chamber should show a noticeable change, and the chamber should maintain pressure within \u00b12.5 kPa of the set pressure. b) The temperature of the injected EO gas should be higher than the minimum value set for the vaporizer (usually 10.7\u00b0C at atmospheric pressure) to ensure that the EO injected is in gaseous form, not liquid. c) The filtration effectiveness of the air filtration system should meet the requirement of a filtration rate of at least 99.5% for particles greater than 0.3 microns. d) The water supply system should use purified water meeting the requirements of the 2020 edition of the Chinese Pharmacopoeia. e) The steam vapor pressure used for humidification in the sterilizer should not exceed 50 kPa.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-cabinet-software\"> برنامج خزانة التعقيم ETO<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">أثناء عملية التعقيم، سوف يقوم برنامج معدات التعقيم بالتحكم في عملية التعقيم ومراقبتها وتقييم معلمات دورة التعقيم. لذلك، أثناء عملية التأهيل التشغيلي، يجب اختبار برنامج معدات التعقيم في ظل جميع ظروف الفشل (مثل أنظمة القياس والتحكم المحوسبة). ارجع إلى دليل مستخدم جهاز التعقيم ومواصفات المعدات، واختبر وظائف نظام البرنامج في مجالات مثل التعامل مع الإنذارات، ومعالجة الأخطاء، وإدارة المعلومات، وإعدادات المعلمات، وواجهات السجل التاريخي، والتحكم في أجهزة الاستشعار ومراقبتها، والتحكم التشغيلي والمراقبة في ظل ظروف تتحدى الحدود التشغيلية للمعدات.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">إذا كنت تريد معرفة المزيد عن التعقيم بأكسيد الإيثيلين<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">هاتف:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">بريد إلكتروني:<a href=\"mailto:hayley@hzbocon.com\">هايلي@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">الموقع المحلي: الغرفة 1202، Caitong Zhongxin، منطقة Xiasha، مدينة Hangzhou، مقاطعة Zhejiang، الصين<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">موقع إلكتروني:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n\n\n\n<h2 class=\"wp-block-heading\">مراجع<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso:11135:ed-2:v1:en\">ISO 11135:2014&nbsp;Sterilization of health-care products \u2014 Ethylene oxide \u2014 Requirements for the development, validation and routine control of a sterilization process for medical devices<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/mpa.ah.gov.cn\/group5\/M00\/06\/C0\/wKg8v2VfBqaAY-YsABTsjWADtvQ314.pdf\">دليل عمل تأكيد تعقيم أكسيد الإيثيلين للأجهزة الطبية بمقاطعة آنهوي<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The temperature setting range of the ETO Sterilization Chamber should be between 30-60\u00b0C. It is recommended to perform temperature distribution testing of the sterilizer&#8217;s internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.<\/p>\n","protected":false},"author":234312599,"featured_media":8493,"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 center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[133124],"tags":[],"class_list":["post-2138","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-eto-sterilizer"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>اختبار غرفة التعقيم ETO - معقم ETO<\/title>\n<meta name=\"description\" content=\"The temperature setting range of the ETO Sterilization Chamber should be between 30-60\u00b0C. 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Re-qualification Frequency \u2022\u00a0Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed\u2022 The scope of re-qualification must be determined and documented\u2022 The review procedure shall be documented 2. 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