{"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\/eto-sterilization-chamber-testing\/","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\">Kiểm tra phân phối nhiệt độ và độ ẩm<\/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\">a) Kiểm tra nhiệt độ bề mặt bên trong buồng khử trùng ETO:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Trong quá trình thử nghiệm, buồng khử trùng phải trống nhưng có thể lắp đặt các thiết bị phụ trợ cần thiết để khử trùng. Cửa buồng khử trùng phải được đóng lại.<\/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\">b) Kiểm tra nhiệt độ và độ ẩm trong buồng khử trùng ETO:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Trong quá trình thử nghiệm, Buồng khử trùng ETO phải trống nhưng có thể lắp đặt các thiết bị phụ trợ cần thiết để khử trùng. Cửa buồng khử trùng phải được đóng lại.<\/li>\n\n\n\n<li>Sử dụng cảm biến nhiệt độ, độ ẩm đặt ở vị trí quy định để so sánh với nhiệt độ điều khiển bên trong buồng. Cảm biến nhiệt độ phải được đặt ở những vị trí có khả năng thể hiện sự chênh lệch nhiệt độ lớn nhất, chẳng hạn như các bộ phận không được làm nóng của buồng, gần cửa tủ và gần các điểm đi vào của hơi nước hoặc khí. Các cảm biến khác phải được phân bổ đều trong toàn bộ thể tích có thể sử dụng của buồng khử trùng, bao gồm giữa, trên, dưới, trước và sau. Số lượng cảm biến phải đáp ứng yêu cầu trong Phụ lục C của GB18279.1.<\/li>\n\n\n\n<li>Vị trí của mỗi phép đo phải được ghi lại, đồng thời phải ghi lại nhiệt độ và độ ẩm ở các khu vực khác nhau của buồng khử trùng để xác định các điểm nóng và điểm lạnh tiềm ẩn.<\/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\">Tốc độ bơm chân không<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Hệ thống chân không trong giai đoạn bơm chân không phải có khả năng hút chân không khỏi buồng khử trùng trống ở mức -75 kPa hoặc thấp hơn. Đồng hồ đo áp suất phải được kết nối với đầu vào kiểm tra chân không để quan sát xem nó có đáp ứng tiêu chuẩn yêu cầu hay không.<\/li>\n\n\n\n<li>Nhà sản xuất phải xác nhận thời gian cần thiết để đạt -50 kPa và -75 kPa trong điều kiện tải rỗng. Có thể sử dụng thiết bị định giờ để theo dõi giai đoạn bơm chân không và phải đạt được các thông số đặt trước trong thời gian quy định.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-cabinet-leakage-test\"> Kiểm tra rò rỉ tủ khử trùng ETO<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Thử nghiệm rò rỉ Tủ khử trùng ETO bao gồm cả thử nghiệm rò rỉ chân không (áp suất âm) và thử nghiệm rò rỉ áp suất (áp suất dương) (nếu có). Khi áp suất làm việc của máy tiệt trùng lớn hơn 5 kPa, phải thực hiện thử nghiệm rò rỉ áp suất (áp suất dương).<\/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\"> Phần mềm tủ khử trùng ETO<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Trong quá trình tiệt trùng, phần mềm thiết bị tiệt trùng sẽ kiểm soát, giám sát quá trình tiệt trùng và đánh giá các thông số của chu trình tiệt trùng. Do đó, trong quá trình đánh giá chất lượng vận hành, phần mềm thiết bị khử trùng phải được kiểm tra trong mọi điều kiện hỏng hóc (chẳng hạn như hệ thống điều khiển và đo lường bằng máy tính). Tham khảo hướng dẫn sử dụng và thông số kỹ thuật của thiết bị tiệt trùng, đồng thời kiểm tra các chức năng của hệ thống phần mềm trong các lĩnh vực như xử lý cảnh báo, xử lý lỗi, quản lý thông tin, cài đặt thông số, giao diện ghi lại lịch sử, điều khiển và giám sát cảm biến cũng như kiểm soát và giám sát vận hành trong các điều kiện thách thức giới hạn vận hành của thiết bị.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">NẾU BẠN MUỐN BIẾT THÊM Về Khử trùng bằng Ethylene Oxide<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Điện thoại:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">E-mail:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Địa điểm địa phương: Phòng 1202, Caitong Zhongxin, Quận Xiasha, Thành phố Hàng Châu, Tỉnh Chiết Giang, Trung Quốc<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Trang web:<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\">Tài liệu tham khảo<\/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\">Hướng dẫn xác nhận công việc khử trùng thiết bị y tế tỉnh An Huy bằng ethylene oxit<\/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>Thử nghiệm buồng khử trùng ETO - ETO STERILIZER<\/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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It is recommended to perform temperature distribution testing of the sterilizer's internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.","jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pgZDV6-yu","jetpack-related-posts":[{"id":2448,"url":"https:\/\/zjbocon.com\/eto-sterilization-chamber-temperature-distribution-testing\/","url_meta":{"origin":2138,"position":0},"title":"eto sterilization Chamber Temperature Distribution Testing","author":"Bocon Technical Team","date":"2024-12-20","format":false,"excerpt":"The temperature of representative areas on the inner surfaces should be measured and recorded using temperature recording instruments that comply with the requirements of Appendix B.","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company 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Efficiency","author":"Bocon Technical Team","date":"2024-12-24","format":false,"excerpt":"3.4.1 eto sterilizer machine Temperature Setting Range The temperature setting range for the eto sterilizer is: 30 to 70\u00b0C","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/category\/company-news\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":1659,"url":"https:\/\/zjbocon.com\/sterilization-for-spice\/","url_meta":{"origin":2138,"position":2},"title":"Comparing ETO, Gamma, and Steam Sterilization for Spices","author":"Bocon Technical Team","date":"2024-10-21","format":false,"excerpt":"advantage:\u00a0This\u00a0is\u00a0a\u00a0cost-effective,\u00a0widely-used\u00a0sterilization\u00a0method\u00a0that\u00a0has\u00a0been\u00a0common\u00a0for\u00a0many\u00a0years, when you buy the machine, you can sterilize by yourself, and the cost is very cheap.large volume (1-36pallet) (around 1-35ton spice one time, depending on the density Of spice ) disadvantage:\u00a0ETO\u00a0is\u00a0a\u00a0heavily-regulated, gas.\u00a0And\u00a0will\u00a0take\u00a0more\u00a0time\u00a0than\u00a0the other\u00a0two\u00a0sterilization\u00a0way(you can install a pre-heating room and aeration room to solve this problem).","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO 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chamber to create optimal conditions for temperature, pressure, and humidity. \u00a0First, air is evacuated to enhance gas penetration, followed by a leakage test to ensure safety for personnel and the environment.\u2026","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/category\/eto-sterilizer\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/turn-key-solution.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/turn-key-solution.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/turn-key-solution.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/turn-key-solution.webp?resize=700%2C400&ssl=1 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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. Is Re-qualification Needed if No Product Changes\u2026","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/category\/company-news\/"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/posts\/2138","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/users\/234312599"}],"replies":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/comments?post=2138"}],"version-history":[{"count":6,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/posts\/2138\/revisions"}],"predecessor-version":[{"id":8878,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/posts\/2138\/revisions\/8878"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/media\/8493"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/media?parent=2138"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/categories?post=2138"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/tags?post=2138"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}