{"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>הסמכה לביצועים פיזיים (PPQ)<\/strong><br>\u2022 It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process.<br><strong>כמה ריצות צריך לבצע תהליך PPQ?<\/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>תקני ייחוס:<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135:2014<\/strong>&nbsp;(אימות עיקור EO של מכשיר רפואי)<\/li>\n\n\n\n<li><strong>הנחיות ה-FDA (2007)<\/strong>: אבטחת סטריליות עבור מוצרים מעוקרים מסוף<\/li>\n\n\n\n<li><strong>EU GMP נספח 1 (2022)<\/strong>: דרישות אימות תהליך עיקור.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-how-is-reproducibility-demonstrated\"><strong>כיצד מודגמת יכולת השחזור?<\/strong><\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th><strong>לֹא.<\/strong><\/th><th><strong>שלב תהליך<\/strong><\/th><th><strong>פָּרִיט<\/strong><\/th><th><strong>שִׁיטָה<\/strong><\/th><\/tr><\/thead><tbody><tr><td><strong>1<\/strong><\/td><td>התניה מוקדמת<\/td><td>הטמפרטורה והלחות של המטען המעוקר נמצאים בטווח שצוין בסוף הטינון<\/td><td>מדוד בתוך המטען<\/td><\/tr><tr><td><strong>2<\/strong><\/td><td>טְעִינָה<\/td><td>מרווח הזמן בין סיום ההתניה המוקדמת לתחילת העיקור צריך להיות בטווח שצוין<\/td><td>אמת את נתוני הזמן המוקלטים<\/td><\/tr><tr><td><strong>3<\/strong><\/td><td>eo עיקור<\/td><td>תחמוצת אתילן (EO) מוכנסת לסטריליזטור בצורת גז<\/td><td>מדוד את טמפרטורת הזרקת הגז<\/td><\/tr><tr><td><strong>4<\/strong><\/td><td>eo עיקור<\/td><td>עליית הלחץ עקב הזרקת גז EO היא בטווח שצוין<\/td><td>מדוד לחץ במהלך הזרקת גז<\/td><\/tr><tr><td><strong>5<\/strong><\/td><td>eo עיקור<\/td><td>ריכוז גז EO בתוך המעקר נמצא בטווח שצוין<\/td><td>Weigh the gas canister before\/after injection and calculate the difference&nbsp;<strong>אוֹ<\/strong>&nbsp;למדוד ישירות את ריכוז הגז בתוך החדר<\/td><\/tr><tr><td><strong>6<\/strong><\/td><td>eo עיקור<\/td><td>טמפרטורת המוצר בתוך העומס היא בטווח שצוין במהלך שלב החשיפה<\/td><td>למדוד את טמפרטורת המוצר<\/td><\/tr><tr><td><strong>7<\/strong><\/td><td>אִוְרוּר<\/td><td>טמפרטורת המוצר בתוך העומס היא בטווח שצוין במהלך שלב האוורור<\/td><td>למדוד את טמפרטורת המוצר<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">בעת הערכת ביצוע בדיקות PPQ, יש לשים לב להיבטים הבאים:<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\">אם אתה רוצה לדעת יותר<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">טֵלֵפוֹן:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">אֶלֶקטרוֹנִי:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">אתר מקומי: חדר 1202, Caitong Zhongxin, מחוז שיאשה, העיר האנגג&#039;ואו, מחוז ג&#039;ג&#039;יאנג, סין<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">אֲתַר אִינטֶרנֶט:<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. Is Re-qualification Needed if No Product Changes\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\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":9080,"url":"https:\/\/zjbocon.com\/?p=9080","url_meta":{"origin":7277,"position":1},"title":"Essential Utilities and Service Requirements for ETO Sterilizers","author":"Bocon Technical Team","date":"2026-01-20","format":false,"excerpt":"The successful operation of an Ethylene Oxide (ETO) sterilizer requires more than just the machine itself; it demands a robust infrastructure of essential utilities, safety systems, and ongoing technical support. 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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. Established in 2006, HZBOCON has committed itself to the design, development, and manufacturing of EO sterilization equipment, catering to a wide array of industries that require effective\u2026","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.png?resize=1050%2C600&ssl=1 3x"},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7277","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/users\/234312599"}],"replies":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=7277"}],"version-history":[{"count":8,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7277\/revisions"}],"predecessor-version":[{"id":8630,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7277\/revisions\/8630"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8477"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7277"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7277"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7277"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}