{"id":2013,"date":"2024-10-28T10:57:16","date_gmt":"2024-10-28T02:57:16","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2013"},"modified":"2024-11-06T14:09:45","modified_gmt":"2024-11-06T06:09:45","slug":"eto-sterilization-2","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=2013","title":{"rendered":"Purpose for eto sterilization validation"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" id=\"h-1-purpose-for-validation-eto-sterilization\">१.<strong>Purpose\u00a0for validation<\/strong> eto नसबंदी<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">1.1.ईटीओ नसबंदी प्रमाणीकरण प्रमाण प्राप्त गर्दछ कि ETO नसबंदीको लागि प्रयोग गरिएका उपकरणहरू यसको स्पेसिफिकेशन अनुसार प्रदान गरिएको र स्थापना गरिएको छ र स्थिर रूपमा पूर्वनिर्धारित सीमा भित्र काम गर्न सक्छ र पूर्वनिर्धारित मापदण्ड अनुसार लगातार प्रदर्शन गर्दछ र यसैले उत्पादन यसको विशिष्टता पूरा गर्दछ।<\/p>\n\n\n\n<div class=\"wp-block-uagb-image uagb-block-4162e3c7 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\"><a class=\"\" href=\"https:\/\/zjbocon.com\/qualification-services\/\" target=\"\" rel=\"noopener\"><img loading=\"lazy\" decoding=\"async\" src=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp\" alt=\"eto sterilization validation\" class=\"uag-image-1359\" width=\"800\" height=\"400\" title=\"Qualification_Services (2)\" role=\"img\" \><\/a><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\">१.२<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">यो भागले ETO नसबंदी प्रक्रियाको विकास, प्रमाणीकरण र नियमित नियन्त्रणका लागि आवश्यकताहरू निर्दिष्ट गर्दछ र यसलाई ISO 11135 जस्ता सान्दर्भिक नियामक आवश्यकताहरूको पालना गर्न मार्गदर्शन प्रदान गर्दछ।<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-2-scope\">2. दायरा<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">2.1.ETO स्टेरिलाइजेशनमा प्रयोग गरिएका सान्दर्भिक उपकरणहरू (पूर्वस्थिति कोठा? स्टेरिलाइजर? एरेसन कोठा? इन्क्यूबेटर, आदि)।<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-terms-and-definitions\">3. सर्तहरू र परिभाषाहरू<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">3.1.?IQ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">स्थापना योग्यता: IQ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">३.२.?OQ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">सञ्चालन योग्यता: OQ<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.3.?PQ(MPQ\/PPQ)<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Performance qualification:PQ(Microbiological PQ\/Physical PQ )<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">३.४.: योग्यता<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">३.५: बायोबर्डन<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.6.: जैविक सूचक<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">३.७.: भिन्नात्मक चक्र<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.8.: आधा चक्र<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.9.: पूर्ण चक्र<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.10.PCD: प्रक्रिया चुनौती उपकरण<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.11.: उत्पादन र उत्पादन परिवार<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.12.?: Usable volume\/Product load volume<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.13.: बाँझपन<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">3.14.SAL: बाँझपन आश्वासन स्तर<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-4-responsibilities\">4. जिम्मेवारीहरू<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">4.1 eto स्टेरिलाइजेशन प्रमाणीकरण इन्जिनियर प्रमाणीकरण प्रोटोकलको मस्यौदा तयार गर्न जिम्मेवार छ, र प्रशिक्षित कर्मचारीहरू र प्रयोगहरू प्रमाणीकरण प्रदर्शन गर्न र प्रमाणीकरण पूरा गर्न सहयोग गर्न सान्दर्भिक डाटा सङ्कलन गर्न जिम्मेवार छन्।<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-5-procedure\">5. प्रक्रिया<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">5.1.IQ लाई स्टेरिलाइजेशन उपकरण र कुनै सहायक वस्तुहरू तिनीहरूको स्पेसिफिकेशन अनुसार आपूर्ति र स्थापना गरिएको छ भनेर देखाउनको लागि गरिएको छ। IQ प्रदर्शन गर्नु अघि, उपकरण निर्माताले उपकरणहरू सामान्य रूपमा डेलिभर भएको सुनिश्चित गर्न FAT र SAT सञ्चालन गर्नेछ।<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-references\">सन्दर्भहरू<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><a href=\"https:\/\/www.iso.org\/obp\/ui\/#iso:std:iso:11135:ed-2:v1:en\">ISO 11135:2014&nbsp;Sterilization of health-care products \u2014 Ethylene oxide \u2014 Requirements for the development, validation and routine control of a sterilization process for medical devices<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>1.Purpose\u00a0for validation eto sterilization 1.1.the obtain of eto sterilization validation evidence that the equipment used for ETO sterilization has been 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Re-qualification Frequency \u2022\u00a0Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed\u2022 The scope of re-qualification must be determined and documented\u2022 The review procedure shall be documented 2. Is Re-qualification Needed if No Product Changes\u2026","rel":"","context":"In &quot;Company News&quot;","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\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":8772,"url":"https:\/\/zjbocon.com\/?p=8772","url_meta":{"origin":2013,"position":4},"title":"ETO STERILIZATION Safety Guidelines: Best Practices for Using Ethylene Oxide as a Sterilant","author":"Bocon Technical Team","date":"2025-11-25","format":false,"excerpt":"Ethylene oxide (ETO STERILIZATION) is widely used as a low-temperature sterilant in industries like healthcare, pharmaceuticals, and biotechnology. 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