{"id":7286,"date":"2025-07-29T12:02:12","date_gmt":"2025-07-29T04:02:12","guid":{"rendered":"https:\/\/zjbocon.com\/?p=7286"},"modified":"2025-10-01T19:30:30","modified_gmt":"2025-10-01T11:30:30","slug":"eto-sterilization-re-qualification","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=7286","title":{"rendered":"ETO Sterilization Re-qualification"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements\">ETO नसबंदी पुन: योग्यता आवश्यकताहरू<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. पुन: योग्यता आवृत्ति<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>न्यूनतम वार्षिक आवश्यकता<\/strong><br>\u2022 At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed<br>\u2022 The scope of re-qualification must be determined and documented<br>\u2022 The review procedure shall be documented<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-2-is-re-qualification-needed-if-no-product-changes-occur\">2. यदि कुनै उत्पादन परिवर्तनहरू भएन भने के पुन: योग्यता आवश्यक छ?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>हो, पुन: योग्यता अझै आवश्यक छ<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. पुन: योग्यता वस्तुहरू<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>केही पूर्व शर्तहरूमा आधारित, निम्न विकल्पहरू उपलब्ध छन्<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>पूर्ण पुन: योग्यता<\/li>\n\n\n\n<li>भौतिक वा माइक्रोबियल पुन: प्रमाणीकरण को लागी आवश्यक छैन<\/li>\n\n\n\n<li>सानो मापन माइक्रोबियल प्रदर्शन प्रमाणीकरण<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>पुन: योग्यताको लागि पूर्व शर्तहरू<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>ख) कुनै पनि<strong>महत्त्वपूर्ण परिवर्तनहरू<\/strong>&nbsp;उत्पादन बाँझोपनलाई असर पार्ने निम्न मा भएको छ:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>उत्पादन डिजाइन<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD (प्रक्रिया चुनौती उपकरण)<\/li>\n\n\n\n<li>आपूर्तिकर्ताहरू<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>कन्फिगरेसन वा निर्माण प्रक्रियाहरू लोड गर्नुहोस्<br>ग)<strong>Bioburden प्रवृत्ति विश्लेषण<\/strong>&nbsp;उत्पादनहरु को;<br>घ) चाहे<strong>तापमान वितरण अध्ययन<\/strong>&nbsp;र स्टेरिलाइजर सञ्चालनले पछिल्लो योग्यतादेखि महत्वपूर्ण परिवर्तनहरू देखाउँछ;<br>ई) चाहे<strong>तापमान वितरण र पुन: परिसंचरण जाँच<\/strong>&nbsp;पूर्व शर्त कक्षहरू वा वायुमण्डलीय क्षेत्रहरूमा अन्तिम योग्यता पछि महत्त्वपूर्ण परिवर्तनहरू देखाउँछन्;<br>f) ETO नसबंदी<strong> प्रक्रिया इतिहास<\/strong>&nbsp;पछिल्लो प्रमाणीकरणले पुन: उत्पादन क्षमता देखाउँछ;<br>छ) चाहे<strong>नियन्त्रण र रोकथाम मर्मत अभिलेखहरू परिवर्तन गर्नुहोस्<\/strong>&nbsp;प्रक्रियालाई असर गर्ने कुनै उपकरण परिमार्जनहरू पुष्टि गर्नुहोस्;<br>ज) चाहे<strong>ETO नसबंदी प्रक्रियामा कुनै परिवर्तन छैन<\/strong>&nbsp;बाँझपन प्रभावित भएको छ;<br>i) यदि<strong>ETO नसबंदी प्रक्रिया विशिष्टताहरू परिवर्तन भयो<\/strong>, re-qualification must include verification of&nbsp;<strong>EO residue limits<\/strong>&nbsp;compliance with regulatory requirements.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Regulatory Standards<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135: 2014<\/strong>&nbsp;<em>(Sec. 9.2: Requalification criteria)<\/em><\/li>\n\n\n\n<li><strong>FDA 21 CFR 211.113<\/strong>&nbsp;<em>(Sterilization process controls)<\/em><\/li>\n\n\n\n<li><strong>EU GMP Annex 1:2022<\/strong>&nbsp;<em>(Sec. 8.5: Revalidation requirements)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>ETO नसबंदी पुन: योग्यता आवश्यकताहरू<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">The re-qualification shall&nbsp;<strong>include a review of chamber performance and annual engineering changes<\/strong>&nbsp;to ensure the original IQ\/OQ results remain valid. The review must cover:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Preconditioning zone temperature\/humidity profiles<\/strong>&nbsp;(if applicable);<\/li>\n\n\n\n<li><strong>Actual empty chamber humidity profiles<\/strong>;<\/li>\n\n\n\n<li><strong>Aeration zone temperatures<\/strong>&nbsp;(if applicable);<\/li>\n\n\n\n<li><strong>Additionally, even if process specifications are met<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>Adverse trends in equipment performance,<\/li>\n\n\n\n<li>Sterility failures;<\/li>\n\n\n\n<li>To determine if re-validation is warranted.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Sterilization experts<\/strong>&nbsp;shall define the scope of required&nbsp;<strong>भौतिक र माइक्रोबियल पुन: प्रमाणीकरण<\/strong>&nbsp;समीक्षा परिणामहरूमा आधारित।<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>नसबंदी पुन: योग्यताको लागि महत्वपूर्ण विचारहरू<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. महत्त्वपूर्ण परिवर्तनहरू ह्यान्डलिङ<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>प्रमुख परिवर्तनहरू<\/strong>&nbsp;are identified during re-qualification, re-execution of IQ\/OQ\/PQ may be required:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>IQ (स्थापना योग्यता)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (सञ्चालन योग्यता)<\/strong>: प्रभावित कार्यात्मक प्यारामिटरहरू पुन: परीक्षण गर्नुहोस्।<\/li>\n\n\n\n<li><strong>PQ (कार्यसम्पादन योग्यता)<\/strong>: नयाँ सर्तहरूमा नसबंदी प्रभावकारिता पुन: प्रमाणीकरण गर्नुहोस्।<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. प्यारामेट्रिक रिलीजको लागि अतिरिक्त आवश्यकताहरू<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">प्रयोग गर्ने सुविधाहरूको लागि<strong>प्यारामेट्रिक रिलीज<\/strong>&nbsp;(BI परीक्षणको सट्टा प्रक्रिया डेटामा भर पर्दै):<br>क)<strong>पुन: प्रमाणीकरण आवृत्ति<\/strong>: प्रदर्शन गर्नुपर्छ<strong>कम्तिमा वार्षिक रूपमा<\/strong>;<br>ख)<strong>पुन: प्रमाणीकरण दायरा<\/strong>: समावेश गर्नुपर्छ<strong>सूक्ष्मजीवविज्ञान अध्ययन<\/strong>&nbsp;पुष्टि गर्न:<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Situations Requiring Full Requalification (IQ\/OQ\/PQ):<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">क)<strong>स्टेरिलाइजरको मुख्य मर्मतसम्भार<\/strong>;<br>ख)<strong>संरचनात्मक, स्थान, वा वातावरणीय परिवर्तनहरू<\/strong>;<br>ग)<strong>अस्पष्ट बाँझपन विफलताहरू<\/strong>;<br>घ)<strong>Changes in EO supply\/delivery, diluent, or chamber load configuration<\/strong>।<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>भौतिक वा माइक्रोबियल पुन: योग्यताबाट छुट<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">जब निम्न सर्तहरू पूरा हुन्छन्:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>कुनै परिवर्तन छैन<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>च्याम्बर प्रदर्शन र ईन्जिनियरिङ् समीक्षा<\/strong>&nbsp;योग्य छन्;<\/li>\n\n\n\n<li><strong>नियमित नसबंदी प्रक्रियाहरू<\/strong>&nbsp;अवधिमा भरपर्दो रूपमा सञ्चालन भएको छ;<br>?<strong>व्यावसायिक निर्णय<\/strong>&nbsp;भौतिक वा माइक्रोबियल पुन: योग्यता हो भनेर निर्धारण गर्न सक्छ<strong>आवश्यक छैन<\/strong>&nbsp;अर्को समीक्षा सम्म।<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>सीमित-स्केल माइक्रोबियल प्रदर्शन योग्यता<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>विशेष अवस्थामा आवश्यक हुन सक्छ<\/strong>, जस्तै:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>उत्पादन बायोबर्डन सापेक्ष BIs को निरन्तर उपयुक्तता प्रमाणित गर्दै;<\/li>\n\n\n\n<li>छैन भन्ने प्रमाण प्रस्तुत गर्दै<strong>अनपेक्षित परिवर्तनहरू<\/strong>&nbsp;एक परिभाषित समय अन्तराल पछि अघिल्लो (पुनः) योग्यता अध्ययन पछि भयो।<br>\u2022&nbsp;<strong>सामान्य आवश्यकताहरू (न्यूनतम)<\/strong>:<\/li>\n\n\n\n<li>एक<strong>छोटो चक्र वा आधा-चक्र रन<\/strong>;<\/li>\n\n\n\n<li>सहित<strong>तापमान र आर्द्रता मापन<\/strong>&nbsp;जीवाणुरहित वस्तुहरूको।<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">यदि तपाईं थप जान्न चाहनुहुन्छ भने<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">फोन:<a href=\"https:\/\/wa.me\/8619975258603\">+८६१९९७५२५८६०३<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">इमेल:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">स्थानीय साइट: कोठा 1202, Caitong Zhongxin, Xiasha जिल्ला, Hangzhou शहर, Zhejiang प्रान्त, चीन<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">वेबसाइट:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n\n\n\n<div class=\"wp-block-uagb-image uagb-block-9d7632fc 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\/eto-sterilizer-9-1024x1024.webp\" alt=\"\" class=\"uag-image-8487\" width=\"1024\" height=\"1024\" title=\"eto-sterilizer-9\" role=\"img\" \><\/figure><\/div>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n","protected":false},"excerpt":{"rendered":"<p>ETO Sterilization Re-qualification Requirements 1. 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Team","date":"2024-10-31","format":false,"excerpt":"PQ is the stage of validation that uses Ethylene oxide sterilization chamber to demonstrate that the Ethylene oxide sterilization equipment consistently operates in accordance with predetermined acceptance criteria and the process yields a product that is sterile and meets the specified requirements.","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-1.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":7277,"url":"https:\/\/zjbocon.com\/?p=7277","url_meta":{"origin":7286,"position":3},"title":"Performance Qualification(pq)-ppq in eo sterilization","author":"Bocon Technical Team","date":"2025-07-29","format":false,"excerpt":"Physical Performance Qualification (PPQ)\u2022 It shall be demonstrated that all specified acceptance criteria are reproducible throughout the entire process.How many runs should the PPQ process perform?\u2022 To demonstrate process reproducibility, at least 3 runs are required;\u2022 If 3 half-cycles were run during the MPQ process, then at least 1 additional\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-11.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":2332,"url":"https:\/\/zjbocon.com\/?p=2332","url_meta":{"origin":7286,"position":4},"title":"Terms and definitions of eto gas sterilization","author":"Bocon Technical Team","date":"2024-11-26","format":false,"excerpt":"For the purposes of this document, the following terms and definitions apply in ethylene oxide sterilization 3.1 Aeration part of the eto gas sterilization process during which ethylene oxide and\/or its reaction products desorb from the medical device until predetermined levels are reached \u00a0 Note 1 to entry: This can\u2026","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-11.webp?resize=700%2C400&ssl=1 2x, 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It is recommended to perform temperature distribution testing of the sterilizer's internal surface and temperature and humidity distribution testing inside the sterilization chamber to ensure the effectiveness of the heating and humidifying systems.","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/?cat=133124"},"img":{"alt_text":"","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/cropped-cropped-hzbocon.png?resize=350%2C200&ssl=1","width":350,"height":200},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/users\/234312599"}],"replies":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=7286"}],"version-history":[{"count":12,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286\/revisions"}],"predecessor-version":[{"id":8613,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7286\/revisions\/8613"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8487"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7286"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7286"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7286"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}