{"id":7277,"date":"2025-07-29T11:36:51","date_gmt":"2025-07-29T03:36:51","guid":{"rendered":"https:\/\/zjbocon.com\/?p=7277"},"modified":"2025-10-14T13:06:47","modified_gmt":"2025-10-14T05:06:47","slug":"performance-qualificationpq-ppq-in-eo-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=7277","title":{"rendered":"Performance Qualification(pq)-ppq in eo sterilization"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-f0a65e63 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-3-1024x1024.webp\" alt=\"\" class=\"uag-image-8478\" width=\"1024\" height=\"1024\" title=\"eto-sterilizer-3\" role=\"img\" \><\/figure><\/div>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td><strong>Physical Performance Qualification (PPQ)<\/strong><br>\u2022 It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process.<br><strong>How many runs should the PPQ process perform?<\/strong><br>\u2022 To demonstrate process reproducibility, at least 3 runs are required;<br>\u2022 If 3 half-cycles were run during the MPQ process, then at least 1 additional run with full exposure time shall be performed.<br><\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-reference-standards\"><strong>Reference Standards:<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135:2014<\/strong>&nbsp;(Medical device EO sterilization validation)<\/li>\n\n\n\n<li><strong>FDA Guidance (2007)<\/strong>: Sterility Assurance for Terminal Sterilized Products<\/li>\n\n\n\n<li><strong>EU GMP Annex 1 (2022)<\/strong>: Sterilization process validation requirements.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-how-is-reproducibility-demonstrated\"><strong>How is Reproducibility Demonstrated?<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>No.<\/strong><\/th><th><strong>Process Step<\/strong><\/th><th><strong>Item<\/strong><\/th><th><strong>Method<\/strong><\/th><\/tr><\/thead><tbody><tr><td><strong>1<\/strong><\/td><td>Ончылгоч ямдылыме<\/td><td>Temperature and humidity of the sterilized load are within the specified range at the end of preconditioning<\/td><td>Measure inside the load<\/td><\/tr><tr><td><strong>2<\/strong><\/td><td>Loading<\/td><td>The time interval between the end of preconditioning and the start of sterilization should be within the specified range<\/td><td>Verify recorded time data<\/td><\/tr><tr><td><strong>3<\/strong><\/td><td>eo Sterilization<\/td><td>Ethylene oxide (EO) is introduced into the sterilizer in gaseous form<\/td><td>Measure gas injection temperature<\/td><\/tr><tr><td><strong>4<\/strong><\/td><td>eo Sterilization<\/td><td>Pressure increase due to EO gas injection is within the specified range<\/td><td>Measure pressure during gas injection<\/td><\/tr><tr><td><strong>5<\/strong><\/td><td>eo Sterilization<\/td><td>EO gas concentration inside the sterilizer is within the specified range<\/td><td>Weigh the gas canister before\/after injection and calculate the difference&nbsp;<strong>але<\/strong>&nbsp;directly measure gas concentration inside the chamber<\/td><\/tr><tr><td><strong>6<\/strong><\/td><td>eo Sterilization<\/td><td>Product temperature inside the load is within the specified range during the exposure phase<\/td><td>Measure product temperature<\/td><\/tr><tr><td><strong>7<\/strong><\/td><td>Аэраций<\/td><td>Product temperature inside the load is within the specified range during the aeration phase<\/td><td>Measure product temperature<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">When evaluating the execution of PPQ testing, the following aspects should be noted:<br>\u2022 Does the number of temperature and humidity probes meet requirements?<br>\u2022 Are the (temperature and humidity) probes placed inside the loaded packages and positioned at the worst-case locations (most difficult-to-sterilize positions)?<br>\u2022 Is the temperature of the product load within the specified range?<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">ТЫЙ ЭШТЕ ПАЛЫШЕ КОНЧЕТ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Телефон:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Электрон почто:<a href=\"mailto:hayley@hzbocon.com\">хейли@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Верысе вер: 1202 пӧлем, Цайтун Чжунсинь, Сяша район, Ханчжоу ола, Чжэцзян провинций, Китай<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Веб-сайт:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Physical Performance Qualification (PPQ)\u2022 It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process.How many [&hellip;]<\/p>\n","protected":false},"author":234312599,"featured_media":8477,"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":"","background-image":"","background-repeat":"repeat","background-position":"center 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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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Bioburden Method: Lethality Confirmation ? Direct Count\/Enumeration Method ? Fraction-Negative Method 2. Overkill Method: Demonstrating ?12-Log Reduction ? Half-Cycle Method ? Cycle Development Method Key Terms Bioburden 12-log reduction D-value Methods Overview 1. Half-Cycle Method (Basic Principle - Run Count) Theoretical initial bioburden: 10? Test Criteria: 1 run\u2026","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-57-scaled.webp?resize=1400%2C800&ssl=1 4x"},"classes":[]},{"id":2094,"url":"https:\/\/zjbocon.com\/?p=2094","url_meta":{"origin":7277,"position":5},"title":"ETO Sterilizer Manufacturer-HZBOCON","author":"Bocon Technical Team","date":"2024-11-04","format":false,"excerpt":"Hangzhou Bocon Mechanical and Electrical Equipment Co., Ltd., commonly referred to as HZBOCON, stands out as a dedicated Ethylene Oxide (EO\/ETO) sterilizer manufacturer. 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