{"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\">Test di distribuzione di temperatura è umidità<\/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) Test di temperatura interna di a superficia di a camera di sterilizazione ETO:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Durante a prova, a camera di sterilizazione deve esse viota, ma i dispositi ausiliari necessarii per a sterilizazione ponu esse installati. A porta di a camera di sterilizazione deve esse chjusa.<\/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) Test di temperatura è umidità in a Camera di Sterilizazione ETO:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Durante a prova, a Camera di Sterilizazione ETO deve esse viota, ma i dispositi ausiliari necessarii per a sterilizazione ponu esse installati. A porta di a camera di sterilizazione deve esse chjusa.<\/li>\n\n\n\n<li>Aduprate sensori di temperatura è umidità posti in pusizioni specificate per paragunà cù a temperatura di cuntrollu in a camera. I sensori di temperatura deve esse posti in i lochi prubabilmente rapprisentanu a diffarenza massima di temperatura, cum&#039;è e parti senza riscaldamentu di a camera, vicinu à e porte di l&#039;armadiu, è vicinu à i punti d&#039;entrata di vapore o gas. L&#039;altri sensori duveranu esse distribuiti uniformemente in tuttu u voluminu utilizable di a camera di sterilizazione, cumpresu u mediu, a cima, u fondu, a fronte è a parte posteriore. U numaru di sensori deve risponde à i requisiti in l&#039;Appendice C di GB18279.1.<\/li>\n\n\n\n<li>A pusizioni di ogni misurazione deve esse arregistrata, è a temperatura è l&#039;umidità in e diverse spazii di a camara di sterilizazione deve esse registrata per identificà i punti caldi potenziali è i punti friddi.<\/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\">Tasso di Pumping Vacuum<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>U sistema di vacuum durante a fase di vacuum pumping deve esse capace di evacuà a camera di sterilizazione vacanti à -75 kPa o più bassu. Un manometru deve esse cunnessu à l&#039;entrata di prova di vacuum per osservà s&#039;ellu risponde à u standard necessariu.<\/li>\n\n\n\n<li>U fabricatore deve cunfirmà u tempu necessariu per ghjunghje à -50 kPa è -75 kPa in cundizioni di carica vacanti. Un dispusitivu di timing pò esse usatu per monitorizà a fase di pompa di vacuum, è i paràmetri predeterminati devenu esse ghjunti in u tempu specificatu.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-cabinet-leakage-test\"> Test di fuga di l&#039;armadiu di sterilizazione ETO<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">A prova di perdite di l&#039;ETO Sterilization Cabinet include sia a prova di fuga in vacuum (pressione negativa) sia a prova di fuga di pressione (pressione positiva) (se applicabile). Quandu a pressione di travagliu di u sterilizzatore hè più grande di 5 kPa, deve esse realizatu una prova di perdita di pressione (pressione positiva).<\/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\"> Software per l&#039;armadiu di sterilizazione ETO<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Durante u prucessu di sterilizazione, u software di l&#039;equipaggiu di sterilizazione cuntrollà è monitorà u prucessu di sterilizazione è valutà i paràmetri di u ciculu di sterilizazione. Per quessa, durante u prucessu di qualificazione operativa, u software di l&#039;equipaggiu di sterilizazione deve esse pruvatu in tutte e cundizioni di fallimentu (cum&#039;è sistemi di misurazione è cuntrollu informatizati). Fate riferimentu à u manuale di l&#039;usu di u sterilizzatore è e specificazioni di l&#039;equipaggiu, è pruvate e funzioni di u sistema di software in aree cum&#039;è a gestione di l&#039;allarme, u processu di l&#039;errore, a gestione di l&#039;infurmazioni, i paràmetri di i paràmetri, l&#039;interfacce di registrazione storica, u cuntrollu è u monitoraghju di i sensori, è u cuntrollu operativu è u monitoraghju in cundizioni chì sfidanu i limiti operativi di l&#039;equipaggiu.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">SE VOGLIA SAPERNE DI PIÙ nantu à a sterilizazione di l&#039;ossidu di etilene<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefonu:<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\">Situ lucale: Room 1202, Caitong Zhongxin, District Xiasha, Hangzhou City, Zhejiang Province, China<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">situ 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\">Referenze<\/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\">Guida di travagliu di cunferma di sterilizazione di l&#039;ossidu di etilene di u dispusitivu medicale di a pruvincia di Anhui<\/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>Test di Camera di Sterilizazione 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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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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