{"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 ариутгагч дахин мэргэшлийн шаардлага<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. Дахин мэргэшлийн давтамж<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Жилийн хамгийн бага шаардлага<\/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. Бүтээгдэхүүний өөрчлөлт гарахгүй бол дахин мэргэшүүлэх шаардлагатай юу?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Тийм ээ, дахин мэргэшсэн байдал шаардлагатай хэвээр байна<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. Дахин мэргэшлийн зүйл<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Тодорхой урьдчилсан нөхцөл дээр үндэслэн дараахь сонголтууд боломжтой<\/strong>::<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Бүрэн дахин мэргэшүүлэх<\/li>\n\n\n\n<li>Биеийн болон микробик дахин баталгаажуулалт хийх шаардлагагүй<\/li>\n\n\n\n<li>Жижиг хэмжээний микробын гүйцэтгэлийн баталгаажуулалт<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Дахин мэргэшлийн урьдчилсан нөхцөл<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>б) Ямар ч байгаа эсэх<strong>чухал тохиолдолд тохиолдол<\/strong>&nbsp;Бүтээгдэхүүний ариутгалд нөлөөлсөн тохиолдолд:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Бүтээгдэхүүний дизайн<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD (Процессын сорилтын төхөөрөмж)<\/li>\n\n\n\n<li>Ороно эгч<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>Тохируулга эсвэл үйлдвэрлэлийн үйл явцыг ачаалах<br>в)<strong>Bioburden чиг хандлагын дүн шинжилгээ<\/strong>&nbsp;бүтээгдэхүүний;<br>г) эсэх<strong>температур тараах судалгааг<\/strong>&nbsp;стерлизаторын ажиллагаа нь хамгийн сүүлийн мэргэшлийн ач холбогдолтой өөрчлөлтийг харуулж байна;<br>e) эсэх<strong>температур тараах болон дахин эргэлтийн шалгалт<\/strong>&nbsp;Урьдчилан сэргийлэх танхимд эсвэл AREAL ALONS нь сүүлийн мэргэшлийн талаар мэдэгдэхүйц өөрчлөлтийг харуулдаг;<br>е) eto ариутгах ууссан эсэх<strong> боловсруулах түүх<\/strong>&nbsp;Сүүлийн баталгаажуулалт нь нөхөн үржихүйн байдлыг харуулж байна.<br>g) эсэх<strong>Хяналт, урьдчилан сэргийлэх засварын бүртгэлийг өөрчлөх<\/strong>&nbsp;Энэ үйл явцад нөлөөлөх төхөөрөмжийн өөрчлөлтийг баталгаажуулах;<br>h) эсэх<strong>ETO ариутгах процессын явцад ямар ч өөрчлөлт ороогүй болно<\/strong>&nbsp;Ариутгаас урьдчилан сэргийлэх арга хэмжээ гарсан;<br>i) Хэрэв<strong>ETO стеро ариутгалын үйл явцын тодорхойлолт өөрчлөгдсөн<\/strong>, дахин мэргэшүүлэх нь баталгаажуулалтыг багтаах ёстой<strong>EO Restue-ийн хязгаарлалт<\/strong>&nbsp;зохицуулалтын шаардлагыг дагаж мөрдөх.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Зохицуулалтын стандарт<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135:2014<\/strong>&nbsp;<em>(SEC. 9.2: Нөхцөл байдлын шалгуур)<\/em><\/li>\n\n\n\n<li><strong>FDA 21 CFR 211.113<\/strong>&nbsp;<em>(Ариутгагч процесс хяналт)<\/em><\/li>\n\n\n\n<li><strong>EU GMP Хавсралт 1: 2022<\/strong>&nbsp;<em>(8.5: Дахин баталгаажуулах шаардлага)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>ETO ариутгагч дахин мэргэшлийн шаардлага<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Дахин мэргэшүүлэх<strong>Танхимын гүйцэтгэл, жилийн инженерийн өөрчлөлтийг хянах<\/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;(боломжтой бол);<\/li>\n\n\n\n<li><strong>Бодит хоосон камерын чийгшлийн профайл<\/strong>;;<\/li>\n\n\n\n<li><strong>Агаарын бүсийн температур<\/strong>&nbsp;(боломжтой бол);<\/li>\n\n\n\n<li><strong>ДЭЛГЭРЭНГҮЙ БОЛОМЖТОЙ БОЛОМЖТОЙ БОЛОМЖТОЙ БОЛОМЖТОЙ<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>Тоног төхөөрөмжийн гүйцэтгэлд сөрөг чиг хандлага,<\/li>\n\n\n\n<li>Ариутгалын бүтэлгүйтэл;<\/li>\n\n\n\n<li>Дахин баталгаажуулах баталгаатай эсэхийг тодорхойлох.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Ариутгах мэргэжилтэн<\/strong>&nbsp;Шаардлагатай цар хүрээг тодорхойлох болно<strong>Бие махбодийн болон микробийн дахин баталгаажуулалт<\/strong>&nbsp;тойм үр дүнд үндэслэн.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Ариутгалтын дахин мэргэшлийн чухал асуудлыг шийдвэрлэх<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Ихээхэн өөрчлөлтийг зохицуулах<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>том өөрчлөлт<\/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 (Суулгах чадвар)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (Үйл ажиллагааны мэргэшил)<\/strong>: Нөлөөлөлд өртсөн функциональ параметрүүд.<\/li>\n\n\n\n<li><strong>PQ (гүйцэтгэлийн мэргэшил)<\/strong>: Шинэ нөхцөлд ариутгагч үр дүнг дахин баталгаажуулах.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Параметрик хувилбар гаргахад нэмэлт шаардлага<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Хэрэгцээний зориулалтаар<strong>Параметрийн хувилбар<\/strong>&nbsp;(BI тест хийхээс илүүтэйгээр боловсруулалтад найдах):<br>Ч )т)<strong>Баталгаварчлалын давтамж<\/strong>: Гүйцэтгэх ёстой<strong>Дор хаяж жилд<\/strong>;;<br>b)<strong>Баталгаварчлалын цар хүрээ дахин<\/strong>: Оруулах ёстой<strong>Микробиологийн судалгаа<\/strong>&nbsp;Баталгаажуулах:<\/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\">Ч )т)<strong>Ариутгагчийн гол засвар үйлчилгээ<\/strong>;;<br>b)<strong>Бүтцийн, байршил, хүрээлэн буй орчны өөрчлөлт<\/strong>;;<br>в)<strong>Тайлбарлагдаагүй ариутгалын алдаа<\/strong>;;<br>г)<strong>Changes in EO supply\/delivery, diluent, or chamber load configuration<\/strong>Байна уу.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Бие махбодийн болон микробик дахин дахин мэргэшлийн чөлөөлөлт<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Дараахь нөхцөл хангагдсан үед:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Өөрчлөлтөд ямар ороогүй<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>Танхимын гүйцэтгэл, инженерийн тойм<\/strong>&nbsp;мэргэшсэн;<\/li>\n\n\n\n<li><strong>Ариутгах ариутгалын үйл явц<\/strong>&nbsp;хугацаанд найдвартай ажилласан;<br>Чи?<strong>Мэргэжлийн шөл<\/strong>&nbsp;физик эсвэл микробийн дахин мэргэшлийг тодорхойлохыг тодорхойлж болно<strong>шаардлагагүй<\/strong>&nbsp;дараагийн тойм хүртэл.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Хязгаарлагдмал микробияцийн гүйцэтгэлийн шаардлага<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Тодорхой тохиолдолд шаардлагатай байж болно<\/strong>, жишээ нь:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Bioburden-тай харьцуулахад BIS-ийн тохиролцсон байдлыг үргэлжлүүлэн баталгаажуулах;<\/li>\n\n\n\n<li>Үгүй гэдгийг нотлох баримт өгөх<strong>Найраагүй өөрчлөлтүүд<\/strong>&nbsp;өмнөх (RE) шалгалтын дараа тодорхой хугацааны интервалын дараа суралцсан.<br>\u2022&nbsp;<strong>Ерөнхий шаардлага (доод тал нь)<\/strong>::<\/li>\n\n\n\n<li>Нэг<strong>Богино мөчлөг эсвэл хагас мөчлөг ажиллуулдаг<\/strong>;;<\/li>\n\n\n\n<li>Оролцуулах<strong>температур ба чийгшлийн хэмжилт<\/strong>&nbsp;ариутгасан зүйлсийн.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">ТА ИЛҮҮ МЭДЭХИЙГ ХҮСВЭЛ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Утас:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Имэйл:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Орон нутгийн сайт: Хятад, Жэжян муж, Ханжоу хот, Шиаша дүүрэг, Кайтон Жүншин, 1202 тоот<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Вэбсайт:<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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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}]}}