{"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 توثیق کا وہ مرحلہ ہے جو Ethylene oxide sterilization chamber کو یہ ظاہر کرنے کے لیے استعمال کرتا ہے کہ Ethylene oxide sterilization کا سامان پہلے سے طے شدہ قبولیت کے معیار کے مطابق کام کرتا ہے اور اس عمل سے ایک ایسی پروڈکٹ حاصل ہوتی ہے جو جراثیم سے پاک ہے اور مخصوص ضروریات کو پورا کرتی ہے۔<\/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 پر، MPQ اور PPQ ایک ساتھ انجام دیے جاتے ہیں۔ اگر PPQ کو کم از کم تین MPQ رنز کے ساتھ متوازی طور پر انجام دیا جاتا ہے، تو مکمل سائیکل کے عمل کی تفصیلات کا استعمال کرتے ہوئے کم از کم ایک اضافی PPQ رن انجام دیا جائے گا۔ فزیکل PQ (PPQ) یہ ظاہر کرے گا کہ تجویز کردہ معمول کے عمل کی تفصیلات کی مدت کے لیے مخصوص قبولیت کے معیار پورے بوجھ کے دوران پورے ہوتے ہیں۔<\/p>\n\n\n\n

PQ کو نئی یا تبدیل شدہ مصنوعات، پیکیجنگ، لوڈ کنفیگریشن، ایتھیلین آکسائیڈ سٹرلائزیشن چیمبر یا پروسیس پیرامیٹرز کے تعارف پر انجام دیا جائے گا جب تک کہ پہلے سے توثیق شدہ پروڈکٹ، پیکیجنگ، لوڈ کنفیگریشن ایتھیلین آکسائیڈ سٹرلائزیشن چیمبرنٹ یا عمل کو دستاویزی شکل نہ دی گئی ہو۔<\/p>\n\n\n\n

PQ کی تصدیق ایتھیلین آکسائڈ نسبندی چیمبر کا عمل<\/h2>\n\n\n\n

PQ کی تصدیق کا عمل عام طور پر اس طرح ہے: پہلے ایک جزوی سائیکل انجام دیں، اور بعد میں مصنوعات کی بانجھ پن کی کیفیت کی جانچ کریں۔
جزوی
\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

نس بندی کے عمل اور نس بندی کے اثر کی تولیدی صلاحیت کو ثابت کرنے کے لیے نصف سائیکل انجام دیں۔ اگر اوور کِل کا طریقہ استعمال کیا جاتا ہے، تو نصف سائیکل کے دوران کوئی مثبت آئی پی سی ڈی نہیں ہونا چاہیے۔ نصف سائیکل کے دوران مثبت ای پی سی ڈی قابل قبول ہے اگر آئی پی سی ڈی فراہم کرنے والے آئی پی سی ڈی سے زیادہ مزاحمت کا مظاہرہ کیا ہو۔
\u201c
بدترین کیس چیلنج
\u201d
معمول کی پروسیسنگ کے لئے.<\/p>\n\n\n\n

معمول کی نس بندی کے پیرامیٹرز کا تعین عام طور پر پورے سائیکل کے پیرامیٹرز سے کیا جاتا ہے، لہذا مناسب ہوا کے وقت کا تعین کرنے کے لیے عام طور پر مکمل سائیکل کے دوران بقایا چیلنجز کیے جاتے ہیں۔ چونکہ نس بندی کے عمل کی تاثیر فرکشن سائیکل اور آدھے چکروں میں ثابت ہوئی ہے، اس لیے EPCD کے ذریعے نس بندی کے اثر کو یقینی بنایا جا سکتا ہے۔<\/p>\n\n\n\n

اگر، ان میں سے کسی بھی رن میں، بانجھ پن یا مصنوعات کی فعالیت کے تقاضے پورے نہیں ہوتے ہیں، تو اس بات کا تعین کرنے کے لیے تفتیش کی جانی چاہیے کہ آیا اضافی قابلیت کی دوڑیں ضروری ہیں۔ اگر عمل کے پیرامیٹرز کو متعین حدود کے اندر برقرار نہیں رکھا جا سکتا ہے، تو تحقیقات کی جانی چاہیے۔ اگر ترمیم کی جاتی ہے تو، اضافی رنز کی ضرورت ہوگی.<\/p>\n\n\n\n

ایتھیلین آکسائیڈ نس بندی چیمبر کے عمل میں سالانہ 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

مساوات کی تشخیص<\/h2>\n\n\n\n

1. عمل کی مساوات؟ ایتھیلین آکسائیڈ نس بندی کا سامان جو عمل کے ایک جیسے پیرامیٹرز فراہم کرتا ہے، گزرنے کے بعد عقل<\/a> اور او کیو<\/a>، یا تو اہل ہونا چاہئے۔<\/p>\n\n\n\n

2. اصل چیمبر کی طرح، یا کم شدہ MPQ کا استعمال جو مائیکرو بائیولوجیکل مہلکیت اور PPQ کی مطلوبہ سطح کی فراہمی کو ظاہر کرتا ہے تاکہ پروڈکشن چیمبر کے ذریعہ بوجھ اور کنٹرول کے درجہ حرارت اور نمی کی یکسانیت کا مظاہرہ کیا جاسکے۔ اس کمی کی اہلیت کی دلیل کو ریکارڈ اور دستاویز کیا جائے گا۔<\/p>\n\n\n\n

3. مصنوعات یا لوڈ کی خصوصیات پر مختلف جغرافیائی مقامات کے اثر و رسوخ کا تعین کیا جائے گا۔<\/p>\n\n\n\n

4. پروسیس ایکویلنس ایک طریقہ ہے جو یہ ظاہر کرنے کے لیے استعمال کیا جاتا ہے کہ ایک ہی توثیق شدہ نس بندی کے عمل کو دو یا دو سے زیادہ ٹکڑوں یا ایتھیلین آکسائیڈ سٹرلائزیشن کے آلات کے سیٹ کے ذریعے فراہم کیا جاتا ہے۔ اس کی ضرورت نہیں ہے کہ سامان جسمانی طور پر ایک جیسا ہو۔ یہاں تک کہ اگر سامان کے ذریعہ فراہم کردہ پیرامیٹرز اعدادوشمار کے لحاظ سے یکساں نہیں ہیں، تب بھی فراہم کردہ عمل مساوی ہوسکتے ہیں اگر وہ تمام عمل کو متعین، توثیق شدہ عمل کی حدود کے اندر چلانے کے قابل ہوں۔<\/p>\n\n\n\n

5. ساز و سامان کے متعدد ٹکڑوں کے درمیان عمل کی مساوات کا مقصد عمل کو اہل بنانے کے لیے درکار جانچ کی مقدار کو کم کرنا ہے۔ نس بندی کے عمل کی توثیق ایک چیمبر میں کی جانی چاہیے۔ اگر بقیہ سامان انسٹالیشن کی اہلیت (IQ) اور آپریشنل اہلیت (OQ) سے گزر چکا ہے تو باقی سامان کم PQ سے گزر سکتا ہے (دیکھیں 9.2 اور 9.3)۔ سازوسامان کے کئی ٹکڑوں کی قابلیت کو کم کرنے کے لیے بھی مساوات کا استعمال کیا جا سکتا ہے۔ نس بندی کے عمل کی فراہمی کے لیے استعمال ہونے والا سامان عام طور پر ایک چیمبر یا کمرہ اور ذیلی کنٹرول سسٹم پر مشتمل ہوتا ہے۔ جراثیم کشی کے عمل کا سامان کسی دی گئی پروسیسنگ سہولت کے اندر یا کئی سہولیات کے درمیان واقع ہو سکتا ہے۔ یہ سامان آزادانہ طور پر ایک ہی عمل کے حالات فراہم کرنے کے لیے استعمال کیا جا سکتا ہے اور بالکل ایک جیسا ڈیزائن ہو سکتا ہے یا سائز میں یا ذیلی آلات کی حد میں مختلف ہو سکتا ہے۔<\/p>\n\n\n\n

6. آلات کے متعدد ٹکڑوں کے درمیان عمل کی مساوات کا مقصد عمل کو قابلیت دینے کے لیے درکار جانچ کی مقدار کو کم کرنا ہے۔ نس بندی کے عمل کی توثیق ایک چیمبر میں کی جانی چاہیے۔ اگر بقیہ سامان انسٹالیشن کی اہلیت (IQ) اور آپریشنل اہلیت (OQ) سے گزر چکا ہے تو باقی سامان کم PQ سے گزر سکتا ہے (دیکھیں 9.2 اور 9.3)۔ سازوسامان کے کئی ٹکڑوں کی قابلیت کو کم کرنے کے لیے بھی مساوات کا استعمال کیا جا سکتا ہے۔ نس بندی کے عمل کی فراہمی کے لیے استعمال ہونے والا سامان عام طور پر ایک چیمبر یا کمرہ اور ذیلی کنٹرول سسٹم پر مشتمل ہوتا ہے۔ جراثیم کشی کے عمل کا سامان کسی دی گئی پروسیسنگ سہولت کے اندر یا کئی سہولیات کے درمیان واقع ہو سکتا ہے۔ یہ سامان آزادانہ طور پر ایک ہی عمل کے حالات فراہم کرنے کے لیے استعمال کیا جا سکتا ہے اور بالکل ایک جیسا ڈیزائن ہو سکتا ہے یا سائز میں یا ذیلی آلات کی حد میں مختلف ہو سکتا ہے۔<\/p>\n\n\n\n

اگر آپ مزید جاننا چاہتے ہیں <\/h2>\n\n\n\n

فون:+8619975258603<\/a><\/p>\n\n\n\n

ای میل:hayley@hzbocon.com<\/a><\/p>\n\n\n\n

مقامی سائٹ: کمرہ 1202، Caitong Zhongxin، Xiasha ڈسٹرکٹ، Hangzhou City، Zhejiang Province، China<\/p>\n\n\n\n

ویب سائٹ:hzbocon.com<\/a>zjbocon.com<\/a><\/p>\n\n\n\n

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

PQ توثیق کا وہ مرحلہ ہے جو Ethylene oxide sterilization chamber کو یہ ظاہر کرنے کے لیے استعمال کرتا ہے کہ Ethylene oxide sterilization کا سامان پہلے سے طے شدہ قبولیت کے معیار کے مطابق کام کرتا ہے اور اس عمل سے ایک ایسی پروڈکٹ حاصل ہوتی ہے جو جراثیم سے پاک ہے اور مخصوص ضروریات کو پورا کرتی ہے۔<\/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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