{"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\">Ittestjar tad-Distribuzzjoni tat-Temperatura u l-Umdità<\/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 tat-Temperatura tal-wiċċ Intern tal-Kamra ta&#039; Sterilizzazzjoni ETO:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Matul it-test, il-kamra tal-isterilizzazzjoni għandha tkun vojta, iżda jistgħu jiġu installati apparati awżiljarji meħtieġa għall-isterilizzazzjoni. Il-bieb tal-kamra tal-isterilizzazzjoni għandu jingħalaq.<\/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) It-Test tat-Temperatura u l-Umdità fil-Kamra ta&#039; Sterilizzazzjoni ETO:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Matul it-test, il-Kamra ta &#039;Sterilizzazzjoni ETO għandha tkun vojta, iżda jistgħu jiġu installati apparati awżiljarji meħtieġa għall-isterilizzazzjoni. Il-bieb tal-kamra tal-isterilizzazzjoni għandu jingħalaq.<\/li>\n\n\n\n<li>Uża sensors tat-temperatura u l-umdità mqiegħda f&#039;pożizzjonijiet speċifikati biex tqabbel mat-temperatura ta &#039;kontroll ġewwa l-kamra. Is-sensuri tat-temperatura għandhom jitqiegħdu f&#039;postijiet li x&#039;aktarx jirrappreżentaw id-differenzi massimi tat-temperatura, bħal partijiet mhux imsaħħna tal-kamra, ħdejn il-bibien tal-kabinett, u ħdejn punti tad-dħul tal-fwar jew tal-gass. Sensuri oħra għandhom ikunu mqassma b&#039;mod uniformi madwar il-volum użabbli tal-kamra tal-isterilizzazzjoni, inklużi n-nofs, fuq, isfel, quddiem u wara. In-numru ta &#039;sensors għandu jissodisfa r-rekwiżiti fl-Appendiċi C ta&#039; GB18279.1.<\/li>\n\n\n\n<li>Il-pożizzjoni ta &#039;kull kejl għandha tiġi rreġistrata, u t-temperatura u l-umdità f&#039;żoni differenti tal-kamra tal-isterilizzazzjoni għandhom jiġu rreġistrati biex jiġu identifikati hot spots potenzjali u punti kesħin.<\/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\">Rata tal-Ippumpjar tal-Vakwu<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Is-sistema tal-vakwu matul il-fażi tal-ippumpjar tal-vakwu għandha tkun kapaċi tevakwa l-kamra tal-isterilizzazzjoni vojta għal -75 kPa jew inqas. Gauge tal-pressjoni għandu jkun imqabbad mad-daħla tat-test tal-vakwu biex josserva jekk jissodisfax l-istandard meħtieġ.<\/li>\n\n\n\n<li>Il-manifattur għandu jikkonferma l-ħin meħtieġ biex jilħaq -50 kPa u -75 kPa taħt kundizzjonijiet ta &#039;tagħbija vojta. Apparat tal-ħin jista &#039;jintuża biex jimmonitorja l-fażi tal-ippumpjar tal-vakwu, u l-parametri ssettjati minn qabel għandhom jintlaħqu fiż-żmien speċifikat.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-cabinet-leakage-test\"> Test ta &#039;Tnixxija tal-Kabinett ta&#039; Sterilizzazzjoni ETO<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">It-test tat-tnixxija tal-Kabinett tal-Isterilizzazzjoni ETO jinkludi kemm ittestjar tat-tnixxija tal-vakwu (pressjoni negattiva) kif ukoll ittestjar tat-tnixxija tal-pressjoni (pressjoni pożittiva) (jekk applikabbli). Meta l-pressjoni tax-xogħol tal-isterilizzatur tkun akbar minn 5 kPa, għandu jitwettaq test ta &#039;tnixxija tal-pressjoni (pressjoni pożittiva).<\/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 tal-Kabinett ta &#039;Sterilizzazzjoni ETO<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Matul il-proċess ta &#039;sterilizzazzjoni, is-softwer tat-tagħmir ta&#039; sterilizzazzjoni se jikkontrolla u jimmonitorja l-proċess ta &#039;sterilizzazzjoni u jevalwa l-parametri taċ-ċiklu ta&#039; sterilizzazzjoni. Għalhekk, matul il-proċess ta &#039;kwalifika operattiva, is-softwer tat-tagħmir ta&#039; sterilizzazzjoni għandu jiġi ttestjat taħt il-kundizzjonijiet kollha ta &#039;falliment (bħal sistemi ta&#039; kejl u kontroll kompjuterizzati). Irreferi għall-manwal tal-utent u l-ispeċifikazzjonijiet tat-tagħmir tal-isterilizzatur, u ttestja l-funzjonijiet tas-sistema tas-softwer f’oqsma bħall-immaniġġjar tal-allarm, l-ipproċessar tal-iżbalji, il-ġestjoni tal-informazzjoni, issettjar tal-parametri, interfaces ta’ rekords storiċi, kontroll u monitoraġġ tas-sensuri, u kontroll u monitoraġġ operazzjonali taħt kundizzjonijiet li jisfidaw il-limiti operattivi tat-tagħmir.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">JEKK TIXTIEQ TAF AKTAR Dwar l-Isterilizzazzjoni tal-Ossidu tal-Etilene<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefon:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sit Lokali: Kamra 1202, Caitong Zhongxin, Distrett Xiasha, Belt Hangzhou, Provinċja ta &#039;Zhejiang, Ċina<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Websajt:<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\">Referenzi<\/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\">Gwida tax-xogħol tal-konferma tal-isterilizzazzjoni tal-apparat mediku tal-Provinċja ta &#039;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>Ittestjar tal-Kamra ta&#039; Sterilizzazzjoni ETO - STERILIZZATOR 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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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 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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. 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