{"id":2122,"date":"2024-11-06T11:41:22","date_gmt":"2024-11-06T03:41:22","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2122"},"modified":"2025-12-05T10:51:11","modified_gmt":"2025-12-05T02:51:11","slug":"production-of-process-challenge-devices-in-eo-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/","title":{"rendered":"Production of Process Challenge Devices in eo sterilization"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-5b40b406 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\/Turnkey-EO-Sterilisation-Project-1-1024x724.webp\" alt=\"\" class=\"uag-image-8216\" width=\"768\" height=\"1024\" title=\"Turnkey-EO-Sterilisation-Project\" role=\"img\" \><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-1-production-of-process-challenge-devices-pcd\">3.4.1.1 پروسيس چيلنج ڊوائيسز جي پيداوار (PCD)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">هڪ پروسيس چيلنج ڊيوائس (پي سي ڊي) هڪ مائڪروبيولوجيڪل چيلنج سسٽم آهي جيڪو استعمال ڪيو ويو آهي چونڊيل عمل جي پيٽرولن جي مارڻ جي شرح کي جانچڻ لاءِ. اهو عام طور تي هڪ ڊوائيس يا ٽيسٽ پيڪيج آهي جنهن ۾ حياتياتي اشارن تي مشتمل آهي (مثال طور، بيسلس ايٽروفائيس اسپورس سان گڏ ڄاڻايل اسپور جي ڳڻپ). sterilization جي عمل کي PCD جي مزاحمت پيداوار جي سڀ کان ڏکيو-کي-نصابي ڪرڻ واري علائقي ۾ قدرتي مائڪروبيل لوڊ جي مزاحمت کان وڌيڪ يا برابر هجڻ گهرجي. PCDs جو مقدار GB18279.1-2015 ۾ ضميمه C جي جدول C.3 ۾ بيان ڪيل ضرورتن کي پورو ڪرڻ گھرجي. PCDs اندروني PCDs (IPCD) ۽ خارجي PCDs (EPCD) ۾ ورهايل آهن.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-internal-pcd-ipcd-production\">a) اندروني پي سي ڊي (IPCD) پيداوار<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">اندروني PCDs عام طور تي طبي ڊوائيس آھن جيڪي ڪمپني پاران چونڊيل آھن ھڪڙي پيداوار جي خاندان جي نمائندگي ڪرڻ لاء. ڊزائن ۽ مواد جي جوڙجڪ جي بنياد تي، انهن شين کي سمجهيا وڃن ٿا ڪجهه تمام ڏکيو sterilize ڪرڻ لاء. حياتياتي اشارا (BI) پراڊڪٽ جي sterilize جي سڀ کان مشڪل پوزيشن تي رکيا ويا آهن، انهي کي يقيني بڻائڻ ته نسبندي جي عمل چينلن کي بلاڪ نه ڪري يا پيداوار جي ڊيزائن سان مداخلت نه ڪري.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">بايولوجيڪل انڊيڪيٽر (BI) کي پراڊڪٽ جي sterilize ڪرڻ لاءِ تمام ڏکي علائقي ۾ رکو، يا ٽيسٽ مائڪرو آرگنزم (مثال طور، Bacillus atrophaeus) کي ان جاءِ تي لڳايو، جتي جراثيم کي حاصل ڪرڻ لاءِ سڀ کان وڌيڪ مشڪل حالتن ۾. جيڪڏھن BI يا ٽيسٽ مائڪرو آرگنزم کي سخت ترين جڳھ تي رکي سگھجي ٿو، ۽ ھڪڙو متبادل ڊيوائس ٺاھي سگھي ٿو ھڪڙو sterilize ڪرڻ واري جاءِ اندر. رڪاوٽ سسٽم، انهي کي يقيني بڻائي ٿو ته اهو ساڳيو مزاحمت آهي جيئن پيداوار ۾ سخت کان سخت-جڙيل جڳهه.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">عام IPCDs شامل آهن، پر محدود نه آهن:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">آلودگي واري ڪيريئر کي اجزاء جي وچ ۾ رکڻ، جهڙوڪ رِنگ، پسٽن هيڊ، واشر، يا سرنج جي پسٽن. مائڪرو آرگنزم جي چيلنج کي ڪيٿيٽر ليمن جي وچ ۾ رکڻ، پوءِ ڪيٿيٽر کي ريٽ ڪرڻ ۽ پراڊڪٽ جي سالميت کي بحال ڪرڻ لاءِ چپپڻ وارو سالوينٽس يا ڪنيڪٽر استعمال ڪرڻ. مائيڪرو آرگنزم کي چيلينج ڪرڻ واري جاءِ تي.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-b-external-pcd-epcd-production\">ب) خارجي PCD (EPCD) پيداوار<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">ٻاهرين PCDs لوڊ ٿيل پراڊڪٽ جي ٻاهرئين پاسي رکيل آهن. EPCDs عام طور تي معمولي پروسيسنگ لاء استعمال ڪيا ويا آهن ۽ علاج کان پوء لوڊ مان حاصل ڪيا ويا آهن. EPCD جي مزاحمت کي sterilized پيداوار جي حياتياتي لوڊ ڪرڻ لاء IPCD جي مزاحمت سان مقابلو ڪيو وڃي. اي پي سي ڊي کي پڻ نمائندگي ڪرڻ گهرجي سڀ کان وڌيڪ ڏکيو-جڙيل شين جي لوڊ ۾.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">EPCDs ۽ آلوده پراڊڪٽ جي نمونن جي وچ ۾ لاڳاپو وقتي طور تي جائزو وٺڻ گهرجي انهي کي يقيني بڻائڻ لاءِ ته sterilized پراڊڪٽ ۾ ڪا به تبديلي نه آئي آهي ۽ اهو ته EPCD اڃا تائين نمائندگي ڪري ٿو سڀ کان وڌيڪ ڏکيو پراڊڪٽ لوڊ ۾ sterilize.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">جڏهن هڪ پي سي ڊي ۾ BI رکيل هجي، پي سي ڊي کي گهٽ ۾ گهٽ ساڳيو مزاحمت هجڻ گهرجي جيئن پروڊڪٽ ۾ سڀ کان وڌيڪ ڏکيو جڳهه کي جراثيم ڪرڻ لاء.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">عام EPCDs شامل آهن، پر محدود نه آهن:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">هڪ حياتياتي اشاري (BI) کي پراڊڪٽ جي پيڪنگنگ يا ان جي برابر جي اندر رکڻ، جهڙوڪ پلاسٽڪ جي ٿيلهي، جنهن کي پوءِ منيلا لفافي جي اندر رکيو وڃي ٿو. هڪ ٿلهي پلاسٽڪ جي ٿيلهي ۾ هڪ حياتياتي اشاري رکڻ جنهن کي هڪ مخصوص تعداد ۾ فولڊ ڪيو ويو آهي. هڪ سرنج جي مختلف حصن ۾ حياتياتي اشاري کي رکڻ، جهڙوڪ پلاسٽڪ جي ٿلهي ۾ پيل ٽيوب يا هيڊ پيسنگ ۾. آلوده ڪيريئر، اضافي پيڪنگنگ سان يا بغير.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">مٿي ڏنل طريقي سان پيدا ڪيل PCDs ساڳيا طريقا استعمال ڪندي پيڪيج ٿيل آهن جيئن باقاعده پيداوار جي شين جي، هڪجهڙائي سان پروڊڪٽ جي لوڊ اندر ورهايو وڃي، ۽ اسٽيلائزر چيمبر جي اندر سرد جڳهن کي ڍڪڻ لاء پوزيشن رکي ٿي.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-2-partial-cycle-short-cycle-testing\">3.4.1.2 جزوي چڪر (مختصر سائيڪل) جاچ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">PCD چونڊڻ کان پوء، جزوي چڪر کي هلائڻ سان ان جي مناسبيت جي تصديق ڪئي وئي آهي. تشخيص جو طريقو هن ريت آهي:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">a) آپريشنل تشخيص جي نتيجن جي بنياد تي PCDs، ٽيسٽ نموني، ۽ سينسر لاء جڳھ جي طريقن جو تعين ڪريو. PCDs جو تعداد ۽ تقسيم ڪافي هجڻ گھرجي. جيڪڏهن چونڊيل EPCD استعمال ڪيو ويندو آهي معمولي نسبندي جي عمل جي نگراني لاء، ان کي پلان ۽ طريقيڪار جي مطابق پيداوار جي لوڊ تي رکڻ گهرجي.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ب) جي بنياد تي ڊي قدر، ST وقت، ۽ ڪي ٽي جي حياتياتي اشاري جي وقت، مقرر ڪريو ننڍو نمائش جو وقت. ٻين پيٽرولن کي معمولي نسبندي جي عمل جي پيراگراف جي هيٺين حد تي جانچڻ گهرجي. امتحان جو طريقو GB18281.2 جي ضميمه A ڏانهن رجوع ڪرڻ گهرجي. نمائش جو وقت ختم ٿيڻ کان پوء، پيداوار کي هٽايو، IPCD، ۽ EPCD مائڪروبيل پوکي لاء ۽ نتيجن جو مشاهدو ڪريو.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">پوکيءَ جي نتيجن مان ظاهر ٿئي ٿو ته PCD جي مزاحمت پيداوار ۾ سخت کان sterilize هنڌ جي حياتياتي لوڊ مزاحمت کان وڌيڪ يا برابر آهي:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IPCD ۽ EPCD جزوي طور منفي هجڻ گهرجي؛ مڪمل طور تي منفي يا مڪمل طور تي مثبت نتيجو امتحان جي ناڪامي جي نشاندهي ڪندو. IPCD جي مزاحمت پيداوار کان وڌيڪ هجڻ گهرجي، ۽ EPCD جي مزاحمت IPCD کان وڌيڪ يا برابر هجڻ گهرجي.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">جيڪڏهن نتيجا اميدن کي پورا نه ڪن، سبب جي تحقيق ڪريو. عام طور تي، پي سي ڊي جي مزاحمت يا نسبندي جي پيٽرولن کي ترتيب ڏيڻ جي ضرورت آهي، بعد ۾ ٻيهر جانچ ڪندي جيستائين نتيجا اميدن سان ٺهڪندڙ نه هجن. جيڪڏهن سڀئي ٽي (پراڊڪٽ، IPCD، ۽ EPCD) ڪو به مائڪروبيل ترقي نه ڏيکاري، EO نمائش واري وقت کي مناسب طور تي گھٽايو ۽ ٻيهر ٽيسٽ ڪريو. جيڪڏهن سڀ ڏيکاريو مائڪروبيل ترقي، EO نمائش جو وقت وڌايو ۽ ٻيهر ٽيسٽ ڪريو.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-3-half-cycle-testing\">3.4.1.3 اڌ-سائيڪل جاچ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">ڪاميابيءَ سان مختصر-سائيڪل ٽيسٽ مڪمل ڪرڻ کان پوءِ، EO نسبندي جي عمل جي تاثير (SAL = 10^-6) ۽ ٻيهر پيداواري صلاحيت کي ظاهر ڪرڻ لاءِ لڳاتار ٽي لڳاتار اڌ چڪر جا ٽيسٽ هلايو. تشخيص جو طريقو هن ريت آهي:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">حياتياتي اشاري جي sterility کي معيار جي طور تي مقرر ڪريو، ۽ ٻين نس بندي جي عمل جي پيٽرولن کي معمولي نسبندي جي پيراگراف جي هيٺين حد تائين مقرر ڪريو (مثال طور، مخصوص حد جي اندر علاج کان اڳ واري منتقلي وقت). شروعاتي نسبندي واري عمل جي sterilization جي نمائش واري وقت کي تدريجي طور تي اڌ ڪريو ۽ مختلف جراثيم واري وقت کان پوء PCD مان حياتياتي اشارن کي هٽايو. انهن کي جراثيم کان پاڪ ماحول ۾ پوکيو جيستائين جراثيم جي تصديق نه ٿئي. گھٽ ۾ گھٽ نسبندي جو وقت (نازڪ وقت) اھڙيءَ طرح طئي ڪيو ويندو اڌ چڪر جو وقت، ۽ گھٽ ۾ گھٽ ٻه وڌيڪ ٽيسٽون ساڳئي مختصر وقت سان ڪيون وڃن.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">All three test results should show complete inactivation of all biological indicators (initial colony count no less than 1\u00d710^6) to confirm the minimum effective EO exposure time. The exposure time in the routine sterilization process should be at least twice this minimum time.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">حياتياتي اشاري پوکڻ جا نتيجا سڀني IPCDs ۽ EPCDs کي منفي ڏيکارڻ گهرجن. جيڪڏهن مختصر چڪر واري ٽيسٽ ڏيکاري ٿي ته اي پي سي ڊي جي مزاحمت IPCD کان وڌيڪ آهي، اي پي سي ڊي شايد جزوي مثبتيت ڏيکاري ٿي.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">جيڪڏهن نتيجا اميدن تي پورا نه ٿا اچن، سبب جي تحقيق ڪريو ۽ عام طور تي ٻيهر ٽيسٽ ڪرڻ کان اڳ نسبندي جي پيراگراف کي ترتيب ڏيو جيستائين نتيجا اميدن سان ترتيب نه ڏين.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">مثال:<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">فرض ڪريو پهرين اڌ چڪر جي نس بندي جي نمائش جو وقت 4 ڪلاڪ آهي. جيڪڏهن جراثيم کان پاڪ آهي، ايندڙ ٽيسٽ لاءِ نمائش جو وقت 2 ڪلاڪن تائين گھٽايو؛ جيڪڏهن مائڪروبيل ترقي ٿئي ٿي، 4 ڪلاڪ جي نمائش جي بنياد تي نمائش جو وقت وڌايو.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">فرض ڪريو ٻئي اڌ چڪر جي نسبندي جي نمائش جو وقت 2 ڪلاڪ آهي. جيڪڏهن جراثيم کان پاڪ آهي، ايندڙ ٽيسٽ لاءِ نمائش جو وقت 1 ڪلاڪ تائين گھٽايو؛ جيڪڏهن مائڪروبيل ترقي ٿئي ٿي، نمائش جي وقت کي 3 ڪلاڪن تائين وڌايو.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">فرض ڪريو ٽيون اڌ-سائيڪل نسبندي جي نمائش جو وقت 3 ڪلاڪ آهي. جيڪڏهن جراثيم، 3-ڪلاڪ ٽيسٽ ٻه ڀيرا ورجائي. جيڪڏهن سڀئي نتيجا جراثيم کان پاڪ آهن، تصديق ڪريو 3 ڪلاڪ گهٽ ۾ گهٽ مؤثر وقت جي طور تي. جيڪڏهن مائڪروبيل جي واڌ ٿئي ٿي، ٽيسٽ کي 4 ڪلاڪ جي نمائش سان ورجايو، ۽ جيڪڏهن سڀئي نتيجا جراثيم کان پاڪ آهن، تصديق ڪريو 4 ڪلاڪ گهٽ ۾ گهٽ اثرائتو وقت.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-4-full-cycle-testing\">3.4.1.4 مڪمل سائيڪل جاچ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">مڪمل چڪر جي جاچ دوران، EO نمائش جو وقت مقرر ڪريو اڌ چڪر جي گھٽ ۾ گھٽ اثرائتي وقت کان ٻه ڀيرا، ۽ ٻين پيٽرولن کي معمولي نسبندي جي پيراگراف جي مٿئين حد تائين مقرر ڪيو وڃي ته نسبندي جي عمل جي اعتبار ۽ ٻيهر پيداوار جي تصديق ڪرڻ لاء.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">استعمال ٿيل درجه حرارت ۽ نمي سينسرز جو تعداد GB18279.1 ۾ ضميمه سي جي ضرورتن کي پورو ڪرڻ گهرجي، هڪ جيتري طور تي نسبندي لوڊ ۾ ورهايل آهي. گرمي پد سينسر جي جڳھ جي پوائنٽن ۾ شامل ٿيڻ گھرجي سرد ​​۽ گرم جڳهون ٻنهي کي اسٽريلائيزر چيمبر اندر آپريشنل قابليت (OQ) دوران.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">امتحان کان پوء، پيداوار جي پوکي جا نتيجا ۽ EPCD مڪمل sterility (سڀ منفي) ڏيکارڻ گهرجي.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">جيڪڏھن توھان وڌيڪ ڄاڻڻ چاھيو ٿا<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">فون:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">اي ميل:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">مقامي سائيٽ: ڪمرو 1202، Caitong Zhongxin، Xiasha ضلعي، Hangzhou شهر، Zhejiang صوبي، چين<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ويب سائيٽ:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th>ISO 11135:2014<\/th><td>Sterilization of health-care products \u2013 Ethylene oxide \u2013 Requirements for the development, validation and routine control of a sterilization process for medical devices<\/td><\/tr><tr><th>ISO 14161: 2009<\/th><td>Sterilization of health care products \u2014 Biological indicators \u2014 Guidance for the selection, use and interpretation of results<\/td><\/tr><tr><th>ISO 10993-7:2008<\/th><td>Biological evaluation of medical devices \u2014 Part 7: Ethylene oxide sterilization residuals<\/td><\/tr><tr><th>ISO 11737-1: 2018<\/th><td>Sterilization of health care products \u2014 Microbiological methods \u2013 Part 1: Determination of a population of microorganisms on products<\/td><\/tr><tr><th>ISO 11737-2:2009<\/th><td>Sterilization of medical devices \u2014 Microbiological methods \u2014 Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process<\/td><\/tr><tr><th>AAMI TIR 16:2017<\/th><td>ethylene oxide sterilization جي microbiological پهلو<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>هڪ پروسيس چيلنج ڊيوائس (پي سي ڊي) هڪ مائڪروبيولوجيڪل چيلنج سسٽم آهي جيڪو استعمال ڪيو ويو آهي چونڊيل عمل جي پيٽرولن جي مارڻ جي شرح کي جانچڻ لاءِ. اهو عام طور تي هڪ ڊوائيس يا ٽيسٽ پيڪيج آهي جنهن ۾ حياتياتي اشارن تي مشتمل آهي (مثال طور، بيسلس ايٽروفائيس اسپورس سان گڏ ڄاڻايل اسپور جي ڳڻپ). sterilization جي عمل کي PCD جي مزاحمت پيداوار جي سڀ کان ڏکيو-کي-نصابي ڪرڻ واري علائقي ۾ قدرتي مائڪروبيل لوڊ جي مزاحمت کان وڌيڪ يا برابر هجڻ گهرجي. PCDs جو مقدار GB18279.1-2015 ۾ ضميمه C جي جدول C.3 ۾ بيان ڪيل ضرورتن کي پورو ڪرڻ گھرجي. PCDs اندروني PCDs (IPCD) ۽ خارجي PCDs (EPCD) ۾ ورهايل آهن.<\/p>\n","protected":false},"author":234312599,"featured_media":8417,"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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center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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