{"id":7286,"date":"2025-07-29T12:02:12","date_gmt":"2025-07-29T04:02:12","guid":{"rendered":"https:\/\/zjbocon.com\/?p=7286"},"modified":"2025-10-01T19:30:30","modified_gmt":"2025-10-01T11:30:30","slug":"eto-sterilization-re-qualification","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=7286","title":{"rendered":"ETO Sterilization Re-qualification"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements\">متطلبات إعادة تأهيل تعقيم ETO<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. تكرار إعادة التأهيل<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>الحد الأدنى من المتطلبات السنوية<\/strong><br>\u2022 At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed<br>\u2022 The scope of re-qualification must be determined and documented<br>\u2022 The review procedure shall be documented<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-2-is-re-qualification-needed-if-no-product-changes-occur\">2. هل يلزم إعادة التأهيل في حالة عدم حدوث تغييرات في المنتج؟<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>نعم، لا يزال مطلوبا إعادة التأهيل<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. بنود إعادة التأهيل<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>بناءً على شروط مسبقة معينة، تتوفر الخيارات التالية<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>إعادة التأهيل الكامل<\/li>\n\n\n\n<li>لا حاجة لإعادة التحقق الجسدي أو الميكروبي<\/li>\n\n\n\n<li>التحقق من صحة الأداء الميكروبي على نطاق صغير<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>الشروط الأساسية لإعادة التأهيل<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>ب) ما إذا كان أي<strong>تغييرات كبيرة<\/strong>&nbsp;حدثت حالات تؤثر على عقم المنتج في:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>تصميم المنتج<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD (جهاز تحدي العملية)<\/li>\n\n\n\n<li>الموردين<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>تحميل التكوينات أو عمليات التصنيع<br>ج)<strong>تحليل اتجاه العبء الحيوي<\/strong>&nbsp;من المنتجات؛<br>د) سواء<strong>دراسات توزيع درجات الحرارة<\/strong>&nbsp;وتظهر عملية التعقيم تغييرات كبيرة منذ التأهيل الأخير؛<br>ه) سواء<strong>فحص توزيع درجة الحرارة وإعادة التدوير<\/strong>&nbsp;في غرف التهيئة المسبقة أو مناطق التهوية تظهر تغييرات كبيرة منذ التأهيل الأخير؛<br>و) ما إذا كان تعقيم ETO<strong> تاريخ العملية<\/strong>&nbsp;منذ التحقق الأخير يدل على إمكانية تكرار نتائج؛<br>ز) سواء<strong>سجلات التحكم في التغيير والصيانة الوقائية<\/strong>&nbsp;التأكد من عدم وجود تعديلات على المعدات تؤثر على العملية؛<br>ح) سواء<strong>لا توجد تعديلات على عملية التعقيم ETO<\/strong>&nbsp;حدث تأثير على العقم.<br>ط) إذا<strong>تم تغيير مواصفات عملية التعقيم ETO<\/strong>، يجب أن تتضمن إعادة التأهيل التحقق من<strong>حدود بقايا EO<\/strong>&nbsp;الامتثال للمتطلبات التنظيمية.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>المعايير التنظيمية<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>آيزو 11135:2014<\/strong>&nbsp;<em>(المادة 9.2: معايير إعادة التأهيل)<\/em><\/li>\n\n\n\n<li><strong>ادارة الاغذية والعقاقير 21 CFR 211.113<\/strong>&nbsp;<em>(ضوابط عملية التعقيم)<\/em><\/li>\n\n\n\n<li><strong>ملحق GMP للاتحاد الأوروبي 1:2022<\/strong>&nbsp;<em>(المادة 8.5: متطلبات إعادة التحقق)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>متطلبات إعادة تأهيل تعقيم ETO<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">يجب إعادة التأهيل<strong>تتضمن مراجعة لأداء الغرفة والتغييرات الهندسية السنوية<\/strong>&nbsp;to ensure the original IQ\/OQ results remain valid. The review must cover:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Preconditioning zone temperature\/humidity profiles<\/strong>&nbsp;(إن أمكن)؛<\/li>\n\n\n\n<li><strong>ملفات تعريف الرطوبة الفعلية للغرفة الفارغة<\/strong>;<\/li>\n\n\n\n<li><strong>درجات حرارة منطقة التهوية<\/strong>&nbsp;(إن أمكن)؛<\/li>\n\n\n\n<li><strong>بالإضافة إلى ذلك، حتى لو تم استيفاء مواصفات العملية<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>الاتجاهات السلبية في أداء المعدات،<\/li>\n\n\n\n<li>فشل العقم.<\/li>\n\n\n\n<li>لتحديد ما إذا كان هناك ما يبرر إعادة التحقق من الصحة.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>خبراء التعقيم<\/strong>&nbsp;يجب أن تحدد نطاق المطلوب<strong>إعادة التحقق الفيزيائي والميكروبي<\/strong>&nbsp;بناء على نتائج المراجعة.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>اعتبارات حاسمة لإعادة تأهيل التعقيم<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. التعامل مع التغييرات الهامة<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>تغييرات كبيرة<\/strong>&nbsp;are identified during re-qualification, re-execution of IQ\/OQ\/PQ may be required:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>الذكاء (تأهيل التثبيت)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (التأهيل التشغيلي)<\/strong>: إعادة اختبار المعلمات الوظيفية المتأثرة.<\/li>\n\n\n\n<li><strong>PQ (تأهيل الأداء)<\/strong>: إعادة التحقق من فعالية التعقيم في ظل الظروف الجديدة.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. متطلبات إضافية للإصدار البارامتري<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">للمرافق باستخدام<strong>الافراج عن المعلمة<\/strong>&nbsp;(الاعتماد على بيانات العملية بدلاً من اختبار ذكاء الأعمال):<br>أ)<strong>تكرار إعادة التحقق من الصحة<\/strong>: يجب أن يتم<strong>على الأقل سنويا<\/strong>;<br>ب)<strong>نطاق إعادة التحقق<\/strong>: يجب أن تشمل<strong>الدراسات الميكروبيولوجية<\/strong>&nbsp;للتأكيد:<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Situations Requiring Full Requalification (IQ\/OQ\/PQ):<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">أ)<strong>الصيانة الرئيسية لجهاز التعقيم<\/strong>;<br>ب)<strong>التغيرات الهيكلية أو الموقعية أو البيئية<\/strong>;<br>ج)<strong>فشل العقم غير المبررة<\/strong>;<br>د)<strong>Changes in EO supply\/delivery, diluent, or chamber load configuration<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>الإعفاء من إعادة التأهيل البدني أو الميكروبي<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">عند استيفاء الشروط التالية:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>لا تغييرات<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>أداء الغرفة والمراجعة الهندسية<\/strong>&nbsp;مؤهلون؛<\/li>\n\n\n\n<li><strong>عمليات التعقيم الروتينية<\/strong>&nbsp;عملت بشكل موثوق خلال الفترة؛<br>؟<strong>الحكم المهني<\/strong>&nbsp;قد تحدد أن إعادة التأهيل الجسدي أو الميكروبي هو<strong>غير مطلوب<\/strong>&nbsp;حتى المراجعة القادمة.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>مؤهلات الأداء الميكروبي محدودة النطاق<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>قد تكون مطلوبة في حالات محددة<\/strong>، مثل:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>التحقق من استمرار ملاءمة الـ BIs بالنسبة للعبء الحيوي للمنتج؛<\/li>\n\n\n\n<li>تقديم الأدلة على أن لا<strong>تغييرات غير مقصودة<\/strong>&nbsp;حدثت منذ دراسة التأهيل (إعادة) السابقة بعد فترة زمنية محددة.<br>\u2022&nbsp;<strong>المتطلبات العامة (كحد أدنى)<\/strong>:<\/li>\n\n\n\n<li>واحد<strong>تشغيل دورة قصيرة أو نصف دورة<\/strong>;<\/li>\n\n\n\n<li>مشتمل<strong>قياسات درجة الحرارة والرطوبة<\/strong>&nbsp;من العناصر المعقمة.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">إذا كنت تريد معرفة المزيد<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">هاتف:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">بريد إلكتروني:<a href=\"mailto:hayley@hzbocon.com\">هايلي@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">الموقع المحلي: الغرفة 1202، Caitong Zhongxin، منطقة Xiasha، مدينة Hangzhou، مقاطعة Zhejiang، الصين<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">موقع إلكتروني:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n\n\n\n<div class=\"wp-block-uagb-image uagb-block-9d7632fc 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-9-1024x1024.webp\" alt=\"\" class=\"uag-image-8487\" width=\"1024\" height=\"1024\" title=\"eto-sterilizer-9\" role=\"img\" \><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ETO Sterilization Re-qualification Requirements 1. 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https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":7277,"url":"https:\/\/zjbocon.com\/?p=7277","url_meta":{"origin":7286,"position":3},"title":"Performance Qualification(pq)-ppq in eo sterilization","author":"Bocon Technical Team","date":"2025-07-29","format":false,"excerpt":"Physical Performance Qualification (PPQ)\u2022 It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process.How many runs should the PPQ process perform?\u2022 To demonstrate process reproducibility, at least 3 runs are required;\u2022 If 3 half-cycles were run during the MPQ process, then at least 1 additional\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-11.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":2332,"url":"https:\/\/zjbocon.com\/?p=2332","url_meta":{"origin":7286,"position":4},"title":"Terms and definitions of eto gas sterilization","author":"Bocon Technical Team","date":"2024-11-26","format":false,"excerpt":"For the purposes of this document, the following terms and definitions apply in ethylene oxide sterilization 3.1 Aeration part of the eto gas sterilization process during which ethylene oxide and\/or its reaction products desorb from the medical device until predetermined levels are reached \u00a0 Note 1 to entry: This can\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\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=700%2C400&ssl=1 2x, 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It is recommended to perform temperature distribution testing of the sterilizer's internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.","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\/2025\/09\/cropped-cropped-hzbocon.png?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286","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=7286"}],"version-history":[{"count":12,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286\/revisions"}],"predecessor-version":[{"id":8613,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286\/revisions\/8613"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8487"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7286"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7286"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7286"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}