{"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\/?p=2076","title":{"rendered":"PQ in Ethylene oxide sterilization chamber"},"content":{"rendered":"\n
\"Ethylene<\/figure><\/div>\n\n\n\n

PQ هي مرحلة التحقق من الصحة التي تستخدم غرفة تعقيم أكسيد الإيثيلين لإثبات أن معدات تعقيم أكسيد الإيثيلين تعمل باستمرار وفقًا لمعايير القبول المحددة مسبقًا وتنتج العملية منتجًا معقمًا ويلبي المتطلبات المحددة.<\/p>\n\n\n\n

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

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

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

بشكل عام، يتم تنفيذ MPQ وPPQ في وقت واحد. إذا تم تنفيذ PPQ بالتوازي مع ثلاث عمليات تشغيل MPQ على الأقل، فيجب تنفيذ تشغيل PPQ إضافي واحد على الأقل باستخدام مواصفات عملية الدورة الكاملة. يجب أن يوضح PQ المادي (PPQ) أن معايير القبول المحددة قد تم استيفاؤها طوال فترة الحمل طوال مدة مواصفات العملية الروتينية المقترحة.<\/p>\n\n\n\n

يجب أن يتم تنفيذ PQ عند إدخال منتجات جديدة أو معدلة، أو التعبئة والتغليف، أو تكوين الحمل، أو غرفة تعقيم أكسيد الإيثيلين أو معلمات العملية ما لم يتم توثيق التكافؤ مع منتج أو تعبئة أو تكوين تحميل تم توثيقه بغرفة أو عملية تعقيم أكسيد الإيثيلين.<\/p>\n\n\n\n

التحقق من PQ عملية غرفة تعقيم أكسيد الإيثيلين<\/h2>\n\n\n\n

تتم عملية التحقق من PQ بشكل عام كما يلي: إجراء دورة جزئية أولاً، واختبار حالة العقم للمنتج بعد ذلك
كسور
\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

أداء نصف دورة لإثبات استنساخ عملية التعقيم وتأثير التعقيم؛ إذا تم استخدام طريقة المبالغة، فيجب ألا يكون هناك IPCD إيجابي خلال نصف الدورة. تعتبر EPCD الإيجابية خلال نصف الدورة مقبولة إذا أظهرت مقاومة أكبر من IPCD الذي يوفر
\u201c
التحدي الأسوأ
\u201d
للمعالجة الروتينية.<\/p>\n\n\n\n

يتم تحديد معلمات التعقيم الروتيني عادةً بواسطة معلمات الدورة الكاملة، لذلك يتم إجراء الاختبارات المتبقية بشكل عام خلال الدورة الكاملة لتحديد وقت التهوية المناسب. وبما أن فعالية عملية التعقيم قد تم إثباتها في الدورة الجزئية ونصف الدورة، فيمكن ضمان تأثير التعقيم بواسطة EPCD.<\/p>\n\n\n\n

إذا لم يتم استيفاء متطلبات العقم أو وظائف المنتج، في أي من عمليات التشغيل هذه، فيجب إجراء تحقيق لتحديد ما إذا كانت عمليات التشغيل التأهيلية الإضافية ضرورية. إذا لم يكن من الممكن الحفاظ على معلمات العملية ضمن الحدود المحددة، فيجب إجراء تحقيق. إذا تم إجراء تعديلات، يجب أن تكون عمليات التشغيل الإضافية ضرورية.<\/p>\n\n\n\n

PQ السنوي في عملية غرفة تعقيم أكسيد الإيثيلين<\/h2>\n\n\n\n

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

تقييم التكافؤ<\/h2>\n\n\n\n

1. معادلة العملية؟ معدات تعقيم أكسيد الإيثيلين التي توفر نفس معلمات العملية، بعد أن خضعت معدل الذكاء<\/a> و أوكيو<\/a>، يجب أن يكون مؤهلاً أيضًا.<\/p>\n\n\n\n

2. بنفس طريقة الحجرة الأصلية، أو باستخدام MPQ مخفض يوضح تسليم المستوى المطلوب من الفتك الميكروبيولوجي وPPQ لإظهار توحيد درجة الحرارة والرطوبة للحمل والتحكم بواسطة غرفة الإنتاج. ويجب تسجيل وتوثيق الأساس المنطقي لهذا المؤهل المخفض.<\/p>\n\n\n\n

3. يجب تحديد تأثير المواقع الجغرافية المختلفة على خصائص المنتج أو الحمولة.<\/p>\n\n\n\n

4. تكافؤ العملية هو أسلوب يستخدم لإثبات أن نفس عملية التعقيم المعتمدة يتم تسليمها بواسطة قطعتين أو أكثر من قطعتين أو مجموعتين من معدات التعقيم بأكسيد الإيثيلين. لا يتطلب أن تكون المعدات متطابقة ماديًا. حتى إذا كانت المعلمات التي تقدمها المعدات غير متطابقة إحصائيًا، فإن العمليات المقدمة يمكن أن تظل متكافئة إذا كانت جميعها قادرة على تشغيل العملية ضمن حدود العملية المحددة والمتحقق من صحتها<\/p>\n\n\n\n

5. يهدف تكافؤ العملية بين قطع متعددة من المعدات إلى تقليل كمية الاختبارات المطلوبة لتأهيل العملية. وينبغي التحقق من صحة عملية التعقيم في غرفة واحدة. يمكن أن تخضع المعدات المتبقية لـ PQ مخفض إذا خضعت المعدات المتبقية لتأهيل التركيب (IQ) والتأهيل التشغيلي (OQ) (انظر 9.2 و9.3). ويمكن أيضًا استخدام التكافؤ لتقليل إعادة تأهيل عدة قطع من المعدات. تتكون المعدات المستخدمة لإجراء عملية التعقيم عادةً من حجرة أو غرفة وأنظمة تحكم إضافية. قد تكون معدات عملية التعقيم موجودة داخل منشأة معالجة معينة أو بين عدة منشآت. ويمكن استخدام هذه المعدات بشكل مستقل لتقديم نفس ظروف العملية ويمكن أن تكون بنفس التصميم تمامًا أو قد تختلف في الحجم أو في مدى المعدات المساعدة.<\/p>\n\n\n\n

6. يهدف تكافؤ العملية بين قطع متعددة من المعدات إلى تقليل كمية الاختبارات المطلوبة لتأهيل العملية. وينبغي التحقق من صحة عملية التعقيم في غرفة واحدة. يمكن أن تخضع المعدات المتبقية لـ PQ مخفض إذا خضعت المعدات المتبقية لتأهيل التركيب (IQ) والتأهيل التشغيلي (OQ) (انظر 9.2 و9.3). ويمكن أيضًا استخدام التكافؤ لتقليل إعادة تأهيل عدة قطع من المعدات. تتكون المعدات المستخدمة لإجراء عملية التعقيم عادةً من حجرة أو غرفة وأنظمة تحكم إضافية. قد تكون معدات عملية التعقيم موجودة داخل منشأة معالجة معينة أو بين عدة منشآت. ويمكن استخدام هذه المعدات بشكل مستقل لتقديم نفس ظروف العملية ويمكن أن تكون بنفس التصميم تمامًا أو قد تختلف في الحجم أو في مدى المعدات المساعدة.<\/p>\n\n\n\n

إذا كنت تريد معرفة المزيد <\/h2>\n\n\n\n

هاتف:+8619975258603<\/a><\/p>\n\n\n\n

بريد إلكتروني:هايلي@hzbocon.com<\/a><\/p>\n\n\n\n

الموقع المحلي: الغرفة 1202، Caitong Zhongxin، منطقة Xiasha، مدينة Hangzhou، مقاطعة Zhejiang، الصين<\/p>\n\n\n\n

موقع إلكتروني:hzbocon.com<\/a>zjbocon.com<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

PQ هي مرحلة التحقق من الصحة التي تستخدم غرفة تعقيم أكسيد الإيثيلين لإثبات أن معدات تعقيم أكسيد الإيثيلين تعمل باستمرار وفقًا لمعايير القبول المحددة مسبقًا وتنتج العملية منتجًا معقمًا ويلبي المتطلبات المحددة.<\/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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