{"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 प्रमाणीकरणको चरण हो जसले इथिलीन अक्साइड नसबंदी कक्ष प्रयोग गर्दछ कि इथिलीन अक्साइड नसबंदी उपकरणहरू पूर्वनिर्धारित स्वीकृति मापदण्ड र प्रक्रियाले एक उत्पादन उत्पादन गर्दछ जुन बाँझ छ र निर्दिष्ट आवश्यकताहरू पूरा गर्दछ।<\/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

सामान्यतया, MPQ र PPQ एकै साथ गरिन्छ। यदि PPQ कम्तिमा तीन MPQ रनहरूसँग समानान्तर रूपमा प्रदर्शन गरिएको छ भने, पूर्ण चक्र प्रक्रिया विशिष्टता प्रयोग गरेर न्यूनतम एक अतिरिक्त PPQ रन प्रदर्शन गरिनेछ। भौतिक PQ (PPQ) ले प्रस्तावित दिनचर्या प्रक्रिया विशिष्टताको अवधिको लागि निर्दिष्ट स्वीकृति मापदण्डहरू पूरा भएको देखाउनेछ।<\/p>\n\n\n\n

PQ नयाँ वा परिमार्जित उत्पादनहरू, प्याकेजिङ, लोड कन्फिगरेसन, इथिलीन अक्साइड स्टेरिलाइजेशन चेम्बर वा प्रक्रिया प्यारामिटरहरूको परिचयमा प्रदर्शन गरिनेछ जबसम्म पहिले प्रमाणित उत्पादन, प्याकेजिङ्ग, लोड कन्फिगरेसन इथिलीन अक्साइड स्टेरिलाइजेशन च्याम्बरन्ट वा प्रक्रिया कागजात गरिएको छैन।<\/p>\n\n\n\n

PQ प्रमाणीकरण इथिलीन अक्साइड नसबंदी कक्ष प्रक्रिया<\/h2>\n\n\n\n

PQ प्रमाणिकरणको प्रक्रिया सामान्यतया निम्नानुसार हुन्छ: पहिले आंशिक चक्र प्रदर्शन गर्नुहोस्, र त्यसपछि उत्पादनको बाँझोपन स्थिति परीक्षण गर्नुहोस्।
अंशात्मक
\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

नसबंदी प्रक्रिया र नसबंदी प्रभाव को पुनरुत्पादन प्रमाणित गर्न आधा चक्र प्रदर्शन गर्नुहोस्; यदि ओभरकिल विधि प्रयोग गरिन्छ भने, आधा-चक्रमा कुनै सकारात्मक IPCD हुनु हुँदैन। आधा चक्रको समयमा सकारात्मक EPCD स्वीकार्य हुन्छ यदि IPCD प्रदान गर्ने भन्दा बढी प्रतिरोध प्रदर्शन गरेको छ भने।
\u201c
सबैभन्दा खराब अवस्थामा चुनौती
\u201d
नियमित प्रशोधनको लागि।<\/p>\n\n\n\n

नियमित नसबंदी मापदण्डहरू सामान्यतया पूर्ण चक्र मापदण्डहरू द्वारा निर्धारण गरिन्छ, त्यसैले अवशिष्ट चुनौतीहरू सामान्यतया पूर्ण चक्रको समयमा उपयुक्त वातन समय निर्धारण गर्न गरिन्छ। नसबंदी प्रक्रियाको प्रभावकारिता अंश चक्र र आधा चक्रमा प्रमाणित भएकोले, EPCD द्वारा नसबंदी प्रभाव सुनिश्चित गर्न सकिन्छ।<\/p>\n\n\n\n

यदि, यी मध्ये कुनै पनि रनहरूमा, बाँझपन वा उत्पादन कार्यक्षमता आवश्यकताहरू पूरा भएन भने, थप योग्यता रनहरू आवश्यक छ कि छैन भनेर निर्धारण गर्नको लागि अनुसन्धान सञ्चालन गरिनुपर्छ। यदि प्रक्रिया मापदण्डहरू परिभाषित सीमा भित्र कायम गर्न सकिँदैन भने, एक अनुसन्धान सञ्चालन गर्नुपर्छ। यदि परिमार्जन गरियो भने, थप रनहरू आवश्यक हुनुपर्छ।<\/p>\n\n\n\n

इथिलीन अक्साइड नसबंदी कक्ष प्रक्रियामा वार्षिक 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

समानताको मूल्याङ्कन<\/h2>\n\n\n\n

1. प्रक्रिया समानता? Ethylene अक्साइड नसबंदी उपकरण जसले समान प्रक्रिया प्यारामिटरहरू प्रदान गर्दछ, पार गरिसकेपछि IQ<\/a> र OQ<\/a>, पनि योग्य हुनुपर्छ।<\/p>\n\n\n\n

2. मूल चेम्बर जस्तै समान रूपमा, वा उत्पादन कक्ष द्वारा लोड र नियन्त्रणको तापमान र आर्द्रता एकरूपता प्रदर्शन गर्न माइक्रोबायोलोजिकल घातकता र PPQ को आवश्यक स्तरको डेलिभरी प्रदर्शन गर्ने कम MPQ प्रयोग गरी। यो घटाइएको योग्यताको औचित्य अभिलेख र दस्तावेजीकरण गरिनेछ।<\/p>\n\n\n\n

3. उत्पादन वा लोड गुणहरूमा विभिन्न भौगोलिक स्थानहरूको प्रभाव निर्धारण गरिनेछ।<\/p>\n\n\n\n

4. प्रक्रिया समानता भनेको एउटै प्रमाणित नसबंदी प्रक्रिया दुई वा बढी टुक्राहरू वा इथिलीन अक्साइड नसबंदी उपकरणको सेटहरूद्वारा डेलिभर गरिएको छ भनेर देखाउन प्रयोग गरिने विधि हो। यो आवश्यक छैन कि उपकरण भौतिक रूपमा समान हुनुपर्छ। यदि उपकरणहरूद्वारा डेलिभर गरिएका प्यारामिटरहरू सांख्यिकीय रूपमा समान छैनन् भने, डेलिभर गरिएका प्रक्रियाहरू अझै पनि बराबर हुन सक्छन् यदि तिनीहरू सबै परिभाषित, मान्य प्रक्रिया सीमाहरू भित्र प्रक्रिया चलाउन सक्षम छन्।<\/p>\n\n\n\n

5. उपकरणका धेरै टुक्राहरू बीचको प्रक्रियाको समानता प्रक्रियालाई योग्य बनाउन आवश्यक परीक्षणको मात्रा कम गर्नको लागि हो। नसबंदी प्रक्रिया एक कक्ष मा मान्य हुनुपर्छ। यदि बाँकी उपकरणहरूले स्थापना योग्यता (IQ) र परिचालन योग्यता (OQ) (हेर्नुहोस् 9.2 र 9.3) पार गरिसकेका छन् भने बाँकी उपकरणहरूले PQ घटाउन सक्छन्। उपकरणका धेरै टुक्राहरूको पुन: योग्यता घटाउन पनि समानता प्रयोग गर्न सकिन्छ। एक नसबंदी प्रक्रिया डेलिभर गर्न प्रयोग गरिने उपकरणहरूमा सामान्यतया चेम्बर वा कोठा र सहायक नियन्त्रण प्रणालीहरू हुन्छन्। नसबंदी प्रक्रिया उपकरणहरू दिइएको प्रशोधन सुविधा भित्र वा धेरै सुविधाहरू बीचमा अवस्थित हुन सक्छ। यो उपकरण समान प्रक्रिया अवस्थाहरू प्रदान गर्न स्वतन्त्र रूपमा प्रयोग गर्न सकिन्छ र ठ्याक्कै एउटै डिजाइन हुन सक्छ वा आकार वा सहायक उपकरणहरूको हदमा फरक हुन सक्छ।<\/p>\n\n\n\n

6. उपकरणका धेरै टुक्राहरू बीचको प्रक्रियाको समानता प्रक्रियालाई योग्य बनाउन आवश्यक परीक्षणको मात्रा कम गर्नको लागि हो। नसबंदी प्रक्रिया एक कक्ष मा मान्य हुनुपर्छ। यदि बाँकी उपकरणहरूले स्थापना योग्यता (IQ) र परिचालन योग्यता (OQ) (हेर्नुहोस् 9.2 र 9.3) पार गरिसकेका छन् भने बाँकी उपकरणहरूले PQ घटाउन सक्छन्। उपकरणका धेरै टुक्राहरूको पुन: योग्यता घटाउन पनि समानता प्रयोग गर्न सकिन्छ। एक नसबंदी प्रक्रिया डेलिभर गर्न प्रयोग गरिने उपकरणहरूमा सामान्यतया चेम्बर वा कोठा र सहायक नियन्त्रण प्रणालीहरू हुन्छन्। नसबंदी प्रक्रिया उपकरणहरू दिइएको प्रशोधन सुविधा भित्र वा धेरै सुविधाहरू बीचमा अवस्थित हुन सक्छ। यो उपकरण समान प्रक्रिया अवस्थाहरू प्रदान गर्न स्वतन्त्र रूपमा प्रयोग गर्न सकिन्छ र ठ्याक्कै एउटै डिजाइन हुन सक्छ वा आकार वा सहायक उपकरणहरूको हदमा फरक हुन सक्छ।<\/p>\n\n\n\n

यदि तपाईं थप जान्न चाहनुहुन्छ भने <\/h2>\n\n\n\n

फोन:+८६१९९७५२५८६०३<\/a><\/p>\n\n\n\n

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

स्थानीय साइट: कोठा 1202, Caitong Zhongxin, Xiasha जिल्ला, Hangzhou शहर, Zhejiang प्रान्त, चीन<\/p>\n\n\n\n

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

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

PQ प्रमाणीकरणको चरण हो जसले इथिलीन अक्साइड नसबंदी कक्ष प्रयोग गर्दछ कि इथिलीन अक्साइड नसबंदी उपकरणहरू पूर्वनिर्धारित स्वीकृति मापदण्ड र प्रक्रियाले एक उत्पादन उत्पादन गर्दछ जुन बाँझ छ र निर्दिष्ट आवश्यकताहरू पूरा गर्दछ।<\/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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Note 2: This testing method is also applicable to A class Ethylene\u2026","rel":"","context":"In "Company News"","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/?cat=133125"},"img":{"alt_text":"eto sterilizer","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":2448,"url":"https:\/\/zjbocon.com\/?p=2448","url_meta":{"origin":2076,"position":4},"title":"eto sterilization Chamber Temperature Distribution Testing","author":"Bocon Technical Team","date":"2024-12-20","format":false,"excerpt":"The temperature of representative areas on the inner surfaces should be measured and recorded using temperature recording instruments that comply with the requirements of Appendix B.","rel":"","context":"In "Company News"","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\/ethylene-oxide-sterilization-54.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-54.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-54.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-54.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-54.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":3100,"url":"https:\/\/zjbocon.com\/?p=3100","url_meta":{"origin":2076,"position":5},"title":"How Does Ethylene Oxide Gas Sterilization Kill Microorganisms?","author":"Bocon Technical Team","date":"2025-02-05","format":false,"excerpt":"How Does Ethylene Oxide Gas Sterilization Work? 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