{"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\">温湿度分布試験<\/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) ETO 滅菌チャンバーの内部表面温度テスト:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>試験中、滅菌チャンバーは空である必要がありますが、滅菌に必要な補助装置を取り付けることができます。滅菌室のドアは閉めておく必要があります。<\/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) ETO 滅菌チャンバー内の温度と湿度のテスト:<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li>試験中、ETO 滅菌チャンバーは空である必要がありますが、滅菌に必要な補助装置を取り付けることができます。滅菌室のドアは閉めておく必要があります。<\/li>\n\n\n\n<li>指定された位置に温湿度センサーを設置し、庫内制御温度と比較します。温度センサーは、チャンバーの加熱されていない部分、キャビネットのドアの近く、蒸気やガスの入口付近など、最大の温度差が発生しやすい場所に設置する必要があります。他のセンサーは、中央、上部、底部、前部、後部を含む、滅菌チャンバーの使用可能な容積全体に均等に配置する必要があります。センサーの数は、GB18279.1 の付録 C の要件を満たす必要があります。<\/li>\n\n\n\n<li>各測定の位置を記録し、潜在的なホット スポットとコールド スポットを特定するために滅菌チャンバーのさまざまな領域の温度と湿度を記録する必要があります。<\/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\">真空排気速度<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>真空ポンプ段階中の真空システムは、空の滅菌チャンバーを -75 kPa 以下まで排気できる必要があります。必要な基準を満たしているかどうかを観察するには、真空テスト入口に圧力計を接続する必要があります。<\/li>\n\n\n\n<li>メーカーは、空負荷条件下で -50 kPa および -75 kPa に達するまでに必要な時間を確認する必要があります。タイミングデバイスを使用して真空ポンプフェーズを監視することができ、指定された時間内に事前設定されたパラメータに到達する必要があります。<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-cabinet-leakage-test\"> ETO 滅菌キャビネットの漏れ試験<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">ETO 滅菌キャビネットの漏れテストには、真空 (負圧) 漏れテストと圧力 (正圧) 漏れテスト (該当する場合) の両方が含まれます。滅菌器の作動圧力が 5 kPa を超える場合は、圧力 (正圧) 漏れテストを実行する必要があります。<\/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\"> ETO 滅菌キャビネット ソフトウェア<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">滅菌プロセス中、滅菌装置ソフトウェアは滅菌プロセスを制御および監視し、滅菌サイクルのパラメータを評価します。したがって、運用認定プロセス中に、滅菌装置ソフトウェアはすべての障害条件 (コンピュータ化された測定および制御システムなど) の下でテストされる必要があります。滅菌器のユーザーマニュアルと装置仕様を参照し、アラーム処理、エラー処理、情報管理、パラメータ設定、履歴記録インターフェース、センサー制御と監視、装置の動作限界に挑戦する条件下での動作制御と監視などの分野でソフトウェア システムの機能をテストします。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more-about-ethylene-oxide-sterilization\">エチレンオキサイド滅菌について詳しく知りたい場合<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">電話：<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">電子メール:<a href=\"mailto:hayley@hzbocon.com\">ヘイリー@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ローカルサイト: 中国浙江省杭州市下沙区財通中新1202号室<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Webサイト：<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\">参考文献<\/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\">安徽省医療機器エチレンオキシド滅菌確認作業ガイド<\/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>ETO 滅菌チャンバーテスト - ETO STERILIZER<\/title>\n<meta name=\"description\" content=\"The temperature setting range of the ETO Sterilization Chamber should be between 30-60\u00b0C. It is recommended to perform temperature\" \>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \>\n<link rel=\"canonical\" href=\"https:\/\/zjbocon.com\/?p=2138\" \>\n<meta property=\"og:locale\" content=\"ja_JP\" \>\n<meta property=\"og:type\" content=\"article\" \>\n<meta property=\"og:title\" content=\"ETO Sterilization Chamber Testing\" \>\n<meta property=\"og: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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