{"id":2076,"date":"2024-10-31T11:28:17","date_gmt":"2024-10-31T03:28:17","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2076"},"modified":"2025-12-05T11:11:54","modified_gmt":"2025-12-05T03:11:54","slug":"ethylene-oxide-sterilization-chamber","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/ethylene-oxide-sterilization-chamber\/","title":{"rendered":"PQ in Ethylene oxide sterilization chamber"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-73bd6582 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\/2024\/10\/tp2.jpg\" alt=\"Ethylene oxide sterilization chamber\" class=\"uag-image-971\" width=\"514\" height=\"358\" title=\"Ethylene role =\"img\" \><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">PQ 是验证阶段，使用环氧乙烷灭菌室来证明环氧乙烷灭菌设备始终按照预定的验收标准运行，并且该过程产生的产品是无菌的并满足指定的要求。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">PQ should be carried out for each new process and\/or product to be validated to demonstrate that the process complies with identified acceptance criteria and is capable of delivering the required SAL to the product.PQ consists of both microbiological and physical performance qualifications and is performed in the Ethylene oxide sterilization equipment used to sterilize the product.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">During PQ process, the package of the product and loading mode of the product\u00a0should be specified;\u00a0Select representative products or materials whose packaging and material composition can cover all the product to be sterilized or the entire product family.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">During PQ process, the package of the product and loading mode of the product\u00a0should be specified;\u00a0Select representative products or materials whose packaging and material composition can cover all the product to be sterilized or the entire product family.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">一般来说，MPQ 和 PPQ 是同时执行的。如果 PPQ 与至少 3 次 MPQ 运行并行执行，则应使用全循环工艺规范至少执行 1 次附加 PPQ 运行。物理 PQ (PPQ) 应证明在建议的常规过程规范的持续时间内，整个负载均满足指定的验收标准。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">应在引入新的或修改的产品、包装、负载配置、环氧乙烷灭菌室或工艺参数时执行 PQ，除非已记录与先前验证的产品、包装、负载配置环氧乙烷灭菌室或工艺的等效性。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-pq-verification-ethylene-oxide-sterilization-chamber-process\">PQ验证环氧乙烷灭菌室流程<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">PQ验证的流程一般为：先进行分次循环，然后测试产品的无菌状态<br>分数<br>\u00a0cycle sterilization; compare the EO resistance relationship between IPCD, EPCD and representative products (the expected result is EPCD > IPCD > Product,); Refer to ISO-11737-2 for the test requirements involved in the fractional cycle.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">进行半循环，证明灭菌过程和灭菌效果的再现性；如果使用过度杀伤方法，则在半周期期间不应出现正 IPCD。如果表现出比 IPCD 更大的电阻，则半周期期间的正 EPCD 是可以接受的<br>\u201c<br>最坏情况的挑战<br>\u201d<br>用于日常处理。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">常规灭菌参数通常由全循环参数确定，因此一般在全循环期间进行残余挑战以确定合适的曝气时间。由于灭菌过程的有效性已在分数循环和半循环中得到证明，因此EPCD可以保证灭菌效果。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">如果在任何这些运行中未满足无菌或产品功能要求，则应进行调查以确定是否需要进行额外的资格运行。如果工艺参数无法维持在规定的限度内，则应进行调查。如果进行修改，则必须进行额外的运行。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-annual-pq-in-ethylene-oxide-sterilization-chamber-process\">环氧乙烷灭菌室过程中的年度 PQ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Review of PQ should assessment that the sterilization process remains valid for the designated product.Reduced MPQ\/PPQ can be necessary in certain situations, e.g. to verify continued appropriateness of the resistance of the internal PCD in the product load to the resistance of the product bioburden, or, after a defined interval, to provide evidence that there has been no inadvertent change since the previous requalification study. This would typically include, minimally,one fractional or half cycle exposure including load temperature and humidity measurements. Fractional cycles in a developmental chamber can also be used to support a requalification program, but requalification of the production chamber should be performed in the production chamber.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-assessment-of-equivalence\">等效性评估<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">1.工艺等效性？环氧乙烷灭菌设备提供相同的工艺参数，经过 <a href=\"https:\/\/zjbocon.com\/iq-in-eto-sterilization-process\/\">智商<\/a> 和 <a href=\"https:\/\/zjbocon.com\/oq-in-eto-sterilization-machine\/\">氧气质量<\/a>, 均应合格。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">2.以与原始室相同的方式，或使用减少的MPQ来证明提供所需水平的微生物致死率和PPQ来证明负载的温度和湿度均匀性以及生产室的控制。应记录并记录降低资格的理由。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3. 应确定不同地理位置对产品或负载特性的影响。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">4. 工艺等效性是一种用于证明由两件或多套环氧乙烷灭菌设备提供相同的经过验证的灭菌工艺的方法。它不要求设备在物理上完全相同。即使设备提供的参数在统计上不相同，如果它们都能够在定义的、经过验证的过程限制内运行过程，那么所提供的过程仍然是等效的<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">5. 多台设备之间的过程等效旨在最大限度地减少验证过程所需的测试量。灭菌过程应在一个室中进行验证。如果其余设备已经过安装鉴定（IQ）和操作鉴定（OQ）（见 9.2 和 9.3），则其余设备可以减少 PQ。等效性还可用于减少多件设备的重新鉴定。用于提供灭菌过程的设备通常由腔室或房间以及辅助控制系统组成。灭菌工艺设备可能位于给定的加工设施内或多个设施之间。该设备可以独立使用以提供相同的工艺条件，并且可以是完全相同的设计，或者辅助设备的尺寸或范围可能不同。<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">6. 多台设备之间的过程等效旨在最大限度地减少验证过程所需的测试量。灭菌过程应在一个室中进行验证。如果其余设备已经过安装鉴定（IQ）和操作鉴定（OQ）（见 9.2 和 9.3），则其余设备可以减少 PQ。等效性还可用于减少多件设备的重新鉴定。用于提供灭菌过程的设备通常由腔室或房间以及辅助控制系统组成。灭菌工艺设备可能位于给定的加工设施内或多个设施之间。该设备可以独立使用以提供相同的工艺条件，并且可以是完全相同的设计，或者辅助设备的尺寸或范围可能不同。<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">如果您想了解更多 <\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">电话：<a href=\"https:\/\/wa.me\/8619975258603\">+86-19975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">电子邮件：<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">办公室地址:浙江省杭州市下沙财通中心1202

工厂地址：浙江省嘉兴市嘉善县罗星同济未来邨6幢厂房 <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">网站：<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>PQ 是验证阶段，使用环氧乙烷灭菌室来证明环氧乙烷灭菌设备始终按照预定的验收标准运行，并且该过程产生的产品是无菌的并满足指定的要求。<\/p>\n","protected":false},"author":234312599,"featured_media":8489,"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 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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-2076","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>环氧乙烷灭菌室中的 PQ - ETO STERILIZER<\/title>\n<meta name=\"description\" content=\"PQ is the stage of validation that uses Ethylene oxide sterilization chamber to demonstrate equipment\" \>\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\/ethylene-oxide-sterilization-chamber\/\" \>\n<meta property=\"og:locale\" content=\"zh_CN\" \>\n<meta property=\"og:type\" content=\"article\" \>\n<meta property=\"og:title\" content=\"PQ in Ethylene oxide sterilization chamber\" \>\n<meta property=\"og:description\" content=\"PQ is the stage of validation that uses Ethylene oxide sterilization chamber to demonstrate equipment\" \>\n<meta property=\"og:url\" content=\"https:\/\/zjbocon.com\/ethylene-oxide-sterilization-chamber\/\" \>\n<meta property=\"og:site_name\" content=\"ETO STERILIZER\" \>\n<meta 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Learn why they are essential for medical and industrial sterilization.","rel":"","context":"\u5728\u201cCompany News\u201d\u4e2d","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\/2024\/11\/ethylene-oxide-sterilization-21.webp?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":2471,"url":"https:\/\/zjbocon.com\/safety-requirements-for-using-ethylene-oxide-in-sterilization\/","url_meta":{"origin":2076,"position":1},"title":"Safety Requirements for Using Ethylene Oxide in sterilization","author":"Bocon Technical Team","date":"2024-12-23","format":false,"excerpt":"when Ethylene Oxide in sterilization chamber should be equipped with fire prevention facilities. Ethylene oxide cylinders should be stored separately in a dry, well-ventilated room, with strict prohibition of smoking and open flames. The lighting in the sterilization chamber should be explosion-proof, and any electrical appliances that may cause electric\u2026","rel":"","context":"\u5728\u201cCompany News\u201d\u4e2d","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\/2024\/10\/Electrical-Scale.png?resize=350%2C200","width":350,"height":200},"classes":[]},{"id":9665,"url":"https:\/\/zjbocon.com\/automatic-conveyor-transmission-system-for-ethylene-oxide-eo-sterilization\/","url_meta":{"origin":2076,"position":2},"title":"Automatic Conveyor Transmission System for Ethylene Oxide (EO) Sterilization","author":"Bocon Technical Team","date":"2026-06-10","format":false,"excerpt":"Automatic Conveyor System for Ethylene Oxide (EO) Sterilization | Technical Guide Automatic Conveyor Transmission System for Ethylene Oxide (EO) Sterilization Innovating safety and efficiency in full-process industrial Ethylene Oxide (EO) Sterilization logistics. Optimize Your EO Sterilization Logistics 1. Project Design Requirements for Ethylene Oxide (EO) Sterilization Logistics This automated project\u2026","rel":"","context":"\u7c7b\u4f3c\u6587\u7ae0","block_context":{"text":"\u7c7b\u4f3c\u6587\u7ae0","link":""},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Automatic-Sterilizer-Chamber-Conveyor-1.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Automatic-Sterilizer-Chamber-Conveyor-1.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Automatic-Sterilizer-Chamber-Conveyor-1.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/Automatic-Sterilizer-Chamber-Conveyor-1.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":2453,"url":"https:\/\/zjbocon.com\/microbial-killing-performance-of-ethylene-oxide-sterilizers\/","url_meta":{"origin":2076,"position":3},"title":"Microbial Killing Performance of Ethylene Oxide Sterilizers","author":"Bocon Technical Team","date":"2024-12-20","format":false,"excerpt":"Note 1: The Ethylene Oxide sterilization conditions must be obtained through validation confirmation and should be verified with monitoring and routine control during each sterilization cycle. The requirements for validation and routine control are outlined in GB 18279. 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