{"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\/eto-sterilization-re-qualification\/","title":{"rendered":"ETO Sterilization Re-qualification"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements\">ETO নির্বীজন পুনরায় যোগ্যতার প্রয়োজনীয়তা<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. পুনরায় যোগ্যতা ফ্রিকোয়েন্সি<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>ন্যূনতম বার্ষিক প্রয়োজনীয়তা<\/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. কোনো পণ্য পরিবর্তন না ঘটলে কি পুনরায় যোগ্যতার প্রয়োজন হয়?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>হ্যাঁ, পুনরায় যোগ্যতা এখনও প্রয়োজন<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. পুনরায় যোগ্যতা আইটেম<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>কিছু পূর্বশর্তের উপর ভিত্তি করে, নিম্নলিখিত বিকল্পগুলি উপলব্ধ<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>সম্পূর্ণ পুনরায় যোগ্যতা<\/li>\n\n\n\n<li>শারীরিক বা মাইক্রোবিয়াল পুনরায় বৈধতা জন্য কোন প্রয়োজন নেই<\/li>\n\n\n\n<li>ছোট আকারের মাইক্রোবিয়াল কর্মক্ষমতা বৈধতা<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>পুনরায় যোগ্যতার জন্য পূর্বশর্ত<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>খ) যে কোন<strong>উল্লেখযোগ্য পরিবর্তন<\/strong>&nbsp;পণ্যের বন্ধ্যাত্বকে প্রভাবিত করে:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>পণ্য নকশা<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD (প্রসেস চ্যালেঞ্জ ডিভাইস)<\/li>\n\n\n\n<li>সরবরাহকারী<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>লোড কনফিগারেশন বা উত্পাদন প্রক্রিয়া<br>গ)<strong>বায়োবর্ডেন প্রবণতা বিশ্লেষণ<\/strong>&nbsp;পণ্যের;<br>ঘ) কিনা<strong>তাপমাত্রা বন্টন অধ্যয়ন<\/strong>&nbsp;এবং জীবাণুনাশক অপারেশন শেষ যোগ্যতা থেকে উল্লেখযোগ্য পরিবর্তন প্রদর্শন করে;<br>e) কিনা<strong>তাপমাত্রা বিতরণ এবং পুনঃসঞ্চালন চেক<\/strong>&nbsp;প্রি-কন্ডিশনিং চেম্বার বা বায়ুচলাচল অঞ্চলে শেষ যোগ্যতার পর থেকে উল্লেখযোগ্য পরিবর্তন দেখায়;<br>চ) ETO নির্বীজন কিনা<strong> প্রক্রিয়া ইতিহাস<\/strong>&nbsp;যেহেতু শেষ বৈধতা প্রজননযোগ্যতা প্রদর্শন করে;<br>ছ) কিনা<strong>নিয়ন্ত্রণ এবং প্রতিরোধমূলক রক্ষণাবেক্ষণ রেকর্ড পরিবর্তন করুন<\/strong>&nbsp;প্রক্রিয়াটিকে প্রভাবিত করে এমন কোনও সরঞ্জামের পরিবর্তন নিশ্চিত করুন না;<br>জ) কিনা<strong>ETO জীবাণুমুক্তকরণ প্রক্রিয়ার কোন পরিবর্তন নেই<\/strong>&nbsp;প্রভাবিত বন্ধ্যাত্ব ঘটেছে;<br>i) যদি<strong>ETO নির্বীজন প্রক্রিয়ার স্পেসিফিকেশন পরিবর্তিত হয়েছে<\/strong>, পুনরায় যোগ্যতা যাচাই অন্তর্ভুক্ত করা আবশ্যক<strong>EO অবশিষ্টাংশ সীমা<\/strong>&nbsp;নিয়ন্ত্রক প্রয়োজনীয়তা সঙ্গে সম্মতি.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>নিয়ন্ত্রক মান<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135:2014<\/strong>&nbsp;<em>(সেক. 9.2: যোগ্যতার মানদণ্ড)<\/em><\/li>\n\n\n\n<li><strong>FDA 21 CFR 211.113<\/strong>&nbsp;<em>(জীবাণুমুক্তকরণ প্রক্রিয়া নিয়ন্ত্রণ)<\/em><\/li>\n\n\n\n<li><strong>EU GMP অ্যানেক্স 1:2022<\/strong>&nbsp;<em>(সেক. 8.5: পুনর্বিবেচনার প্রয়োজনীয়তা)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>ETO নির্বীজন পুনরায় যোগ্যতার প্রয়োজনীয়তা<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">পুনরায় যোগ্যতা হবে<strong>চেম্বারের কর্মক্ষমতা এবং বার্ষিক প্রকৌশল পরিবর্তনের একটি পর্যালোচনা অন্তর্ভুক্ত<\/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;(যদি প্রযোজ্য হয়);<\/li>\n\n\n\n<li><strong>প্রকৃত খালি চেম্বারের আর্দ্রতা প্রোফাইল<\/strong>;<\/li>\n\n\n\n<li><strong>বায়ুচলাচল অঞ্চলের তাপমাত্রা<\/strong>&nbsp;(যদি প্রযোজ্য হয়);<\/li>\n\n\n\n<li><strong>উপরন্তু, এমনকি যদি প্রক্রিয়া নির্দিষ্টকরণ পূরণ করা হয়<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>সরঞ্জাম কর্মক্ষমতা প্রতিকূল প্রবণতা,<\/li>\n\n\n\n<li>বন্ধ্যাত্ব ব্যর্থতা;<\/li>\n\n\n\n<li>পুনরায় বৈধতা নিশ্চিত করা হয় কিনা তা নির্ধারণ করতে।<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>নির্বীজন বিশেষজ্ঞরা<\/strong>&nbsp;প্রয়োজনের পরিধি নির্ধারণ করবে<strong>শারীরিক এবং মাইক্রোবায়াল পুনরায় বৈধতা<\/strong>&nbsp;পর্যালোচনা ফলাফলের উপর ভিত্তি করে।<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>নির্বীজন পুনরায় যোগ্যতার জন্য সমালোচনামূলক বিবেচনা<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. উল্লেখযোগ্য পরিবর্তনগুলি পরিচালনা করা<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>প্রধান পরিবর্তন<\/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>আইকিউ (ইনস্টলেশন যোগ্যতা)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (অপারেশনাল যোগ্যতা)<\/strong>: প্রভাবিত কার্যকরী পরামিতি পুনরায় পরীক্ষা করুন।<\/li>\n\n\n\n<li><strong>PQ (পারফরম্যান্স যোগ্যতা)<\/strong>: নতুন অবস্থার অধীনে নির্বীজন কার্যকারিতা পুনরায় বৈধতা.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. প্যারামেট্রিক রিলিজের জন্য অতিরিক্ত প্রয়োজনীয়তা<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">সুবিধা ব্যবহারের জন্য<strong>প্যারামেট্রিক রিলিজ<\/strong>&nbsp;(BI পরীক্ষার পরিবর্তে প্রক্রিয়া ডেটার উপর নির্ভর করে):<br>ক)<strong>পুনরায় বৈধতা ফ্রিকোয়েন্সি<\/strong>: সঞ্চালিত হতে হবে<strong>অন্তত বার্ষিক<\/strong>;<br>খ)<strong>পুনরায় বৈধতা সুযোগ<\/strong>: অন্তর্ভুক্ত করতে হবে<strong>মাইক্রোবায়োলজিকাল গবেষণা<\/strong>&nbsp;নিশ্চিত করতে:<\/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\">ক)<strong>জীবাণুমুক্তকরণের প্রধান রক্ষণাবেক্ষণ<\/strong>;<br>খ)<strong>কাঠামোগত, অবস্থান, বা পরিবেশগত পরিবর্তন<\/strong>;<br>গ)<strong>ব্যাখ্যাতীত বন্ধ্যাত্ব ব্যর্থতা<\/strong>;<br>ঘ)<strong>Changes in EO supply\/delivery, diluent, or chamber load configuration<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>শারীরিক বা মাইক্রোবিয়াল রি-যোগ্যতা থেকে অব্যাহতি<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">যখন নিম্নলিখিত শর্ত পূরণ করা হয়:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>কোনো পরিবর্তন নেই<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>চেম্বার কর্মক্ষমতা এবং প্রকৌশল পর্যালোচনা<\/strong>&nbsp;যোগ্য;<\/li>\n\n\n\n<li><strong>রুটিন নির্বীজন প্রক্রিয়া<\/strong>&nbsp;সময়ের মধ্যে নির্ভরযোগ্যভাবে কাজ করেছেন;<br>?<strong>পেশাগত রায়<\/strong>&nbsp;শারীরিক বা মাইক্রোবিয়াল পুনরায় যোগ্যতা নির্ধারণ করতে পারে<strong>প্রয়োজন নেই<\/strong>&nbsp;পরবর্তী পর্যালোচনা পর্যন্ত।<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>সীমিত-স্কেল মাইক্রোবিয়াল কর্মক্ষমতা যোগ্যতা<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>নির্দিষ্ট ক্ষেত্রে প্রয়োজন হতে পারে<\/strong>, যেমন:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>পণ্যের বায়োবর্ডেনের সাপেক্ষে BI-এর অব্যাহত উপযুক্ততা যাচাই করা;<\/li>\n\n\n\n<li>প্রমাণ প্রদান যে না<strong>অনিচ্ছাকৃত পরিবর্তন<\/strong>&nbsp;একটি সংজ্ঞায়িত সময়ের ব্যবধানের পরে পূর্ববর্তী (পুনরায়) যোগ্যতা অধ্যয়নের পর থেকে ঘটেছে।<br>\u2022&nbsp;<strong>সাধারণ প্রয়োজনীয়তা (সর্বনিম্ন)<\/strong>:<\/li>\n\n\n\n<li>এক<strong>ছোট-চক্র বা অর্ধ-চক্র চালানো<\/strong>;<\/li>\n\n\n\n<li>সহ<strong>তাপমাত্রা এবং আর্দ্রতা পরিমাপ<\/strong>&nbsp;জীবাণুমুক্ত আইটেম.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">আপনি আরো জানতে চান<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">ফোন:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ইমেইল:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">স্থানীয় সাইট: রুম 1202, ক্যাটং ঝংক্সিন, জিয়াশা জেলা, হাংঝো শহর, ঝেজিয়াং প্রদেশ, চীন<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ওয়েবসাইট:<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. Re-qualification Frequency \u2022&nbsp;Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, 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Ensuring these requirements are met is critical for process efficiency, operator safety, and regulatory compliance (such as ISO 11135). 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sterilization chamber","author":"Bocon Technical 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\/category\/eto-sterilizer\/"},"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\/performance-qualificationpq-ppq-in-eo-sterilization\/","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\/category\/company-news\/"},"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\/terms-and-definitions-of-eto-gas-sterilization\/","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\/category\/eto-sterilizer\/"},"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":2138,"url":"https:\/\/zjbocon.com\/eto-sterilization-chamber-testing\/","url_meta":{"origin":7286,"position":5},"title":"ETO Sterilization Chamber Testing","author":"Bocon Technical Team","date":"2024-11-07","format":false,"excerpt":"The temperature setting range of the ETO Sterilization Chamber should be between 30-60\u00b0C. 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\/category\/eto-sterilizer\/"},"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\/wp-json\/wp\/v2\/posts\/7286","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/users\/234312599"}],"replies":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/comments?post=7286"}],"version-history":[{"count":12,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/posts\/7286\/revisions"}],"predecessor-version":[{"id":8613,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/posts\/7286\/revisions\/8613"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/media\/8487"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/media?parent=7286"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/categories?post=7286"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/tags?post=7286"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}