{"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\/performance-qualificationpq-ppq-in-eo-sterilization\/","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>PPQ(신체 성능 자격)<\/strong><br>\u2022 It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process.<br><strong>PPQ 프로세스는 몇 번의 실행을 수행해야 합니까?<\/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>참조 표준:<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135:2014<\/strong>&nbsp;(의료기기 EO 멸균 검증)<\/li>\n\n\n\n<li><strong>FDA 지침(2007)<\/strong>: 최종멸균제품의 무균성 보증<\/li>\n\n\n\n<li><strong>EU GMP 부속서 1(2022)<\/strong>: 멸균 공정 검증 요구 사항.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-how-is-reproducibility-demonstrated\"><strong>재현성은 어떻게 입증됩니까?<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>아니요.<\/strong><\/th><th><strong>프로세스 단계<\/strong><\/th><th><strong>목<\/strong><\/th><th><strong>방법<\/strong><\/th><\/tr><\/thead><tbody><tr><td><strong>1<\/strong><\/td><td>사전 조건화<\/td><td>사전 컨디셔닝 종료 시 멸균된 부하의 온도 및 습도가 규정 범위 내에 있습니다.<\/td><td>부하 내부 측정<\/td><\/tr><tr><td><strong>2<\/strong><\/td><td>로드 중<\/td><td>사전 컨디셔닝 종료부터 멸균 시작까지의 시간 간격은 지정된 범위 내에 있어야 합니다.<\/td><td>녹화된 시간 데이터 확인<\/td><\/tr><tr><td><strong>3<\/strong><\/td><td>EO 살균<\/td><td>산화에틸렌(EO)은 기체 형태로 멸균기에 도입됩니다.<\/td><td>가스 주입 온도 측정<\/td><\/tr><tr><td><strong>4<\/strong><\/td><td>EO 살균<\/td><td>EO 가스 주입으로 인한 압력 상승은 규정 범위 이내입니다.<\/td><td>가스 주입 중 압력 측정<\/td><\/tr><tr><td><strong>5<\/strong><\/td><td>EO 살균<\/td><td>멸균기 내부의 EO 가스 농도가 규정 범위 이내입니다.<\/td><td>Weigh the gas canister before\/after injection and calculate the difference&nbsp;<strong>또는<\/strong>&nbsp;챔버 내부의 가스 농도를 직접 측정<\/td><\/tr><tr><td><strong>6<\/strong><\/td><td>EO 살균<\/td><td>노출 단계 동안 부하 내부의 제품 온도가 지정된 범위 내에 있습니다.<\/td><td>제품 온도 측정<\/td><\/tr><tr><td><strong>7<\/strong><\/td><td>통기<\/td><td>통기 단계 중 부하 내부의 제품 온도가 지정된 범위 내에 있습니다.<\/td><td>제품 온도 측정<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">PPQ 테스트 실행을 평가할 때 다음 측면에 유의해야 합니다.<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\">더 알고 싶다면<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">핸드폰:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">이메일:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">현지 사이트: 중국 절강성 항저우시 샤사구 차이통 중신 1202호<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">웹사이트:<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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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? 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