{"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 تصديق جو مرحلو آهي جيڪو استعمال ڪري ٿو ايٿيلين آڪسائيڊ اسٽريلائيزيشن چيمبر کي اهو ظاهر ڪرڻ لاءِ ته ايٿيلين آڪسائيڊ اسٽريلائيزيشن جو سامان مستقل طور تي اڳواٽ قبوليت جي معيار جي مطابق هلندي آهي ۽ اهو عمل هڪ پيداوار پيدا ڪري ٿو جيڪو جراثيم کان پاڪ آهي ۽ مخصوص گهرجن کي پورو ڪري ٿو.<\/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

عام طور تي، MPQ ۽ PPQ گڏ ڪيا ويندا آهن. جيڪڏهن PPQ گهٽ ۾ گهٽ ٽن MPQ رن سان متوازي طور تي انجام ڏنو ويندو آهي، ته پوء گهٽ ۾ گهٽ هڪ اضافي PPQ رن کي مڪمل چڪر جي عمل جي وضاحتن کي استعمال ڪندي انجام ڏنو ويندو. جسماني PQ (PPQ) ڏيکاري ٿو ته مخصوص قبوليت جا معيار پيش ڪيل معمول جي عمل جي تفصيل جي مدت جي پوري لوڊ دوران پورا ڪيا ويا آهن.<\/p>\n\n\n\n

PQ نئين يا تبديل ٿيل پراڊڪٽس، پيڪنگنگ، لوڊ ڪنفگريشن، ايٿيلين آڪسائيڊ اسٽريلائيزيشن چيمبر يا پروسيس پيرا ميٽرز جي تعارف تي ڪيو ويندو جيستائين اڳئين تصديق ٿيل پراڊڪٽ، پيڪنگنگ، لوڊ ڪنفيگريشن ايٿيلين آڪسائيڊ اسٽريلائيزيشن چيمبرن يا عمل کي دستاويز ڪيو ويو هجي.<\/p>\n\n\n\n

PQ جي تصديق Ethylene oxide sterilization chamber process<\/h2>\n\n\n\n

PQ جي تصديق جو عمل عام طور تي هن ريت آهي: پهرين هڪ جزوي چڪر کي انجام ڏيو، ۽ بعد ۾ پيداوار جي sterility حيثيت کي جانچيو.
جزوي
\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

sterilization جي عمل ۽ sterilization اثر جي reproducibility ثابت ڪرڻ لاء اڌ چڪر انجام؛ جيڪڏهن اوور ڪِل جو طريقو استعمال ڪيو وڃي ته پوءِ اڌ چڪر دوران ڪو به مثبت IPCD نه هجڻ گهرجي. اڌ چڪر دوران مثبت EPCD جيڪڏهن IPCD جي ڀيٽ ۾ وڌيڪ مزاحمت جو مظاهرو ڪيو هجي ته قابل قبول آهي.
\u201c
بدترين ڪيس جو چئلينج
\u201d
معمولي پروسيسنگ لاء.<\/p>\n\n\n\n

معمولي نسبندي جا پيرا ميٽر عام طور تي مڪمل چڪر جي پيٽرولن جي ذريعي طئي ڪيا ويندا آهن، تنهنڪري بقايا چئلينج عام طور تي مڪمل چڪر دوران ڪيا ويندا آهن مناسب هوا جي وقت جو تعين ڪرڻ لاءِ. جيئن ته نسبندي جي عمل جي تاثير کي جزوي چڪر ۽ اڌ چڪر ۾ ثابت ڪيو ويو آهي، EPCD ذريعي نسبندي اثر کي يقيني بڻائي سگهجي ٿو.<\/p>\n\n\n\n

جيڪڏهن، انهن مان ڪنهن به ڊوڙ ۾، sterility يا پيداوار جي ڪارڪردگي جون گهرجون پوريون نه ٿيون ٿين، هڪ تحقيق ٿيڻ گهرجي ته اهو طئي ڪرڻ لاءِ ته ڇا اضافي قابليت جي ڊوڙ ضروري آهي. جيڪڏهن پروسيس جي پيٽرولن کي مقرر ڪيل حدن اندر برقرار نٿو رکي سگهجي، هڪ تحقيق ٿيڻ گهرجي. جيڪڏهن تبديليون ڪيون وينديون آهن، اضافي رنون لازمي هونديون.<\/p>\n\n\n\n

Ethylene oxide sterilization chamber process ۾ سالياني PQ<\/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

برابري جو اندازو<\/h2>\n\n\n\n

1. Process Equivalence؟ Ethylene آڪسائيڊ اسٽريلائيزيشن جو سامان جيڪو ساڳيو عمل پيرا ميٽرز فراهم ڪري ٿو، گذري چڪو آهي IQ<\/a> ۽ او ق<\/a>، يا ته قابل هوندو.<\/p>\n\n\n\n

2. ساڳئي طريقي سان اصل چيمبر وانگر، يا گھٽتائي MPQ استعمال ڪندي جيڪا پيداوار چيمبر پاران لوڊ ۽ ڪنٽرول جي گرمي ۽ نمي جي هڪجهڙائي کي ظاهر ڪرڻ لاء مائڪروبيولوجيڪل ليٿليٽي ۽ PPQ جي گهربل سطح جي پهچائڻ کي ظاهر ڪري ٿي. ھن گھٽتائي جي قابليت جو دليل رڪارڊ ڪيو ويندو ۽ دستاويز ڪيو ويندو.<\/p>\n\n\n\n

3. پراڊڪٽ يا لوڊ ملڪيت تي مختلف جاگرافيائي هنڌن جو اثر طئي ڪيو ويندو.<\/p>\n\n\n\n

4. عمل جي برابري هڪ طريقو آهي جيڪو اهو ظاهر ڪرڻ لاءِ استعمال ڪيو ويندو آهي ته ساڳي تصديق ٿيل نسبندي واري عمل کي ٻن يا وڌيڪ ٽڪرن يا ايٿيلين آڪسائيڊ اسٽريلائيزيشن سامان جي سيٽن ذريعي پهچايو ويندو آهي. اهو ضروري ناهي ته سامان جسماني طور تي هڪجهڙائي هجي. ايستائين جو سامان پاران فراهم ڪيل پيرا ميٽرس شمارياتي طور تي هڪجهڙا نه هوندا آهن، ترسيل عمل اڃا به برابر ٿي سگهن ٿا جيڪڏهن اهي سڀئي قابل آهن عمل کي هلائڻ جي قابل، مقرر ڪيل، تصديق ٿيل عمل جي حدن اندر.<\/p>\n\n\n\n

5. سامان جي ڪيترن ئي ٽڪرن جي وچ ۾ عمل جي برابري جو مقصد پروسيس کي قابليت حاصل ڪرڻ لاءِ گهربل ٽيسٽ جي مقدار کي گھٽائڻ آهي. نسبندي جي عمل کي هڪ چيمبر ۾ تصديق ڪيو وڃي. باقي سامان گھٽجي سگھي ٿو PQ جي صورت ۾ باقي سامان تنصيب جي قابليت (IQ) ۽ آپريشنل قابليت (OQ) (ڏسو 9.2 ۽ 9.3). سامان جي ڪيترن ئي ٽڪرن جي قابليت کي گھٽائڻ لاءِ مساوات پڻ استعمال ڪري سگھجي ٿي. نسبندي جي عمل کي پهچائڻ لاءِ استعمال ٿيندڙ سامان عام طور تي چيمبر يا ڪمري ۽ ضمني ڪنٽرول سسٽم تي مشتمل هوندو آهي. sterilization پروسيسنگ سامان هڪ ڏنل پروسيسنگ سهولت جي اندر يا ڪيترن ئي سهولتن جي وچ ۾ واقع ٿي سگهي ٿو. هي سامان ساڳيو پروسيسنگ حالتن کي پهچائڻ لاء آزاد طور تي استعمال ڪري سگهجي ٿو ۽ بلڪل ساڳيو ڊزائن ٿي سگهي ٿو يا سائيز ۾ مختلف ٿي سگهي ٿو يا اضافي سامان جي حد ۾.<\/p>\n\n\n\n

6. سامان جي ڪيترن ئي ٽڪرن جي وچ ۾ پروسيس جي برابري جو مقصد پروسيس کي قابليت حاصل ڪرڻ لاءِ گهربل ٽيسٽ جي مقدار کي گھٽائڻ آهي. نسبندي جي عمل کي هڪ چيمبر ۾ تصديق ڪيو وڃي. باقي سامان گھٽجي سگھي ٿو PQ جي صورت ۾ باقي سامان تنصيب جي قابليت (IQ) ۽ آپريشنل قابليت (OQ) (ڏسو 9.2 ۽ 9.3). سامان جي ڪيترن ئي ٽڪرن جي قابليت کي گھٽائڻ لاءِ مساوات پڻ استعمال ڪري سگھجي ٿي. نسبندي جي عمل کي پهچائڻ لاءِ استعمال ٿيندڙ سامان عام طور تي چيمبر يا ڪمري ۽ ضمني ڪنٽرول سسٽم تي مشتمل هوندو آهي. sterilization پروسيسنگ سامان هڪ ڏنل پروسيسنگ سهولت جي اندر يا ڪيترن ئي سهولتن جي وچ ۾ واقع ٿي سگهي ٿو. هي سامان ساڳيو پروسيسنگ حالتن کي پهچائڻ لاء آزاد طور تي استعمال ڪري سگهجي ٿو ۽ بلڪل ساڳيو ڊزائن ٿي سگهي ٿو يا سائيز ۾ مختلف ٿي سگهي ٿو يا اضافي سامان جي حد ۾.<\/p>\n\n\n\n

جيڪڏھن توھان وڌيڪ ڄاڻڻ چاھيو ٿا <\/h2>\n\n\n\n

فون:+8619975258603<\/a><\/p>\n\n\n\n

اي ميل:hayley@hzbocon.com<\/a><\/p>\n\n\n\n

مقامي سائيٽ: ڪمرو 1202، Caitong Zhongxin، Xiasha ضلعي، Hangzhou شهر، Zhejiang صوبي، چين<\/p>\n\n\n\n

ويب سائيٽ:hzbocon.com<\/a>zjbocon.com<\/a><\/p>\n\n\n\n

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

PQ تصديق جو مرحلو آهي جيڪو استعمال ڪري ٿو ايٿيلين آڪسائيڊ اسٽريلائيزيشن چيمبر کي اهو ظاهر ڪرڻ لاءِ ته ايٿيلين آڪسائيڊ اسٽريلائيزيشن جو سامان مستقل طور تي اڳواٽ قبوليت جي معيار جي مطابق هلندي آهي ۽ اهو عمل هڪ پيداوار پيدا ڪري ٿو جيڪو جراثيم کان پاڪ آهي ۽ مخصوص گهرجن کي پورو ڪري ٿو.<\/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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