{"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\">ЭТО стерилизаций угыч квалификацийым йодмаш-влак<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. Переквалификаций Чӱчкыдылык<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Идалыкыште эн изи йодмаш<\/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. Продукт вашталтыш уке гын, уэш квалификаций кӱлеш мо?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Да, переквалификаций эше кӱлеш<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. Переквалификаций пункт-влак<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Южо ончылгоч условий негызеш тыгай вариант-влак улыт<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Тӱрыс переквалификаций<\/li>\n\n\n\n<li>Физический але микробный угыч тергымаш ок кӱл<\/li>\n\n\n\n<li>Изи масштабан микроб паша лектышым тергымаш<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Переквалификацийлан ончылгоч йодмаш-влак<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>б) Кеч-могай<strong>кугу вашталтыш-влак<\/strong>&nbsp;продуктын стерильностьшым локтылшо тыгай лийын:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Продуктын дизайнже<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD (Процесс ӱчашымаш ӱзгар)<\/li>\n\n\n\n<li>Поставщик-влак<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>Нагрузко конфигураций але производствышто процесс<br>в)<strong>Бионагрузко тенденций анализ<\/strong>&nbsp;продукцийын;<br>г) Мо<strong>температур шеледымаш шымлымаш<\/strong>&nbsp;да стерилизатор дене пашам ыштыме пытартыш квалификаций деч вара кугу вашталтышым ончыктат;<br>д) мо<strong>температур шеледымаш да рециркуляция тергымаш<\/strong>&nbsp;ончылгоч ямдылыме камерыште але аэраций зонышто пытартыш квалификаций деч вара кугу вашталтышым ончыктат;<br>е) ЭТО стерилизаций мо<strong> процесс историй<\/strong>&nbsp;пытартыш тергымаш деч вара воспроизводимостьым ончыкта;<br>ж) Мо<strong>вашталтышым контроль да профилактике обслуживатлыме записи<\/strong>&nbsp;процесслан эҥгекым ыштыше оборудованийын вашталтышыже уке манын пеҥгыдемдыза;<br>з) мо<strong>ЭТО стерилизаций процессыште вашталтыш уке<\/strong>&nbsp;стерильностьлан эҥгекым ыштыше лийыныт;<br>и) гын<strong>ETO стерилизаций процесс спецификация вашталтын<\/strong>, угыч квалификаций тергымашым пурташ кӱлеш<strong>ЭО кодын чекше<\/strong>&nbsp;нормативный йодмаш дене келшышын.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Нормативный стандарт-влак<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135:2014<\/strong>&nbsp;<em>(9.2 ужаш: Переквалификаций критерий-влак)<\/em><\/li>\n\n\n\n<li><strong>FDA 21 CFR 211.113<\/strong>&nbsp;<em>(Стерилизаций процесс контроль)<\/em><\/li>\n\n\n\n<li><strong>ЕС GMP приложений 1:2022<\/strong>&nbsp;<em>(8.5 ужаш: Уэш пеҥгыдемдыме йодмаш-влак)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>ЭТО стерилизаций угыч квалификацийым йодмаш-влак<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Переквалификаций лийшаш<strong>камерын паша лектышыжым да идалыкаш инженер вашталтышым лончылымашым пурташ<\/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;(уке гын);<\/li>\n\n\n\n<li><strong>Чын яра камерын вӱдыжгылык профильже-влак<\/strong>;<\/li>\n\n\n\n<li><strong>Аэраций зонышто температур<\/strong>&nbsp;(уке гын);<\/li>\n\n\n\n<li><strong>Тидын деч моло, процесс спецификация шукталтеш гынат<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>Оборудованийын паша лектышыштыже уда тенденций,<\/li>\n\n\n\n<li>Стерильность локтылалтмаш;<\/li>\n\n\n\n<li>Уэш тергымаш кӱлеш мо манын рашемдаш.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Стерилизаций шотышто эксперт-влак<\/strong>&nbsp;кӱлеш кумдыкым рашемдышаш<strong>физический да микробный угыч тергымаш<\/strong>&nbsp;обзор лектыш негызеш.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Стерилизацийлан кӱлешан шонымаш-влак Переквалификаций<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Кӱлешан вашталтышым обрабатыватлымаш<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>кугу вашталтыш-влак<\/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 (монтаж квалификаций)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (оперативный квалификаций)<\/strong>: Влиянийым ыштыше функциональный параметр-влакым уэш тергымаш.<\/li>\n\n\n\n<li><strong>PQ (Паша лектыш)<\/strong>: У условийыште стерилизацийын пайдалыкшым уэш пеҥгыдемдаш.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Параметрический лукмашлан ешартыш йодмаш-влак<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Кучылтмо объект-влаклан<strong>параметрический лукмаш<\/strong>&nbsp;(BI тергымаш олмеш процесс данныйлан эҥертен):<br>ик)<strong>Уэш тергымаш чӱчкыдылык<\/strong>: Ышташ кӱлеш<strong>кеч ий еда<\/strong>;<br>б)<strong>Уэш тергымаш сферыште<\/strong>: Пураш кӱлеш<strong>микробиологий шымлымаш<\/strong>&nbsp;пеҥгыдемдаш:<\/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\">ик)<strong>Стерилизаторын тӱҥ обслуживатлыме пашаже<\/strong>;<br>б)<strong>Структур, вер, але йырым-йырысе пӱртӱс вашталтыш<\/strong>;<br>в)<strong>Умылтарыдыме стерильность локтылалтмаш<\/strong>;<br>г)<strong>Changes in EO supply\/delivery, diluent, or chamber load configuration<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Физический але микробный переквалификаций деч эрыкан<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Тыгай условий-влак шукталтме годым:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Вашталтыш уке<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>Камерын паша лектышыже да инженерный обзоржо<\/strong>&nbsp;квалификациян улыт;<\/li>\n\n\n\n<li><strong>Тыглай стерилизаций процесс-влак<\/strong>&nbsp;жапыште ӱшанлын пашам ыштеныт;<br>?<strong>Профессионал аклымаш<\/strong>&nbsp;физический але микробный переквалификацийым рашемден кертеш<strong>ок кӱл<\/strong>&nbsp;вес обзор марте.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Микроб-влакын паша лектышыштым шот дене ыштыме квалификаций<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Ойыртемалтше случайлаште кӱлеш лийын кертеш<\/strong>, гай:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Продукт бионагрузко дене таҥастарымаште БИ-влакын умбакыже келшен толмыштым тергымаш;<\/li>\n\n\n\n<li>Доказательствым пуымо, уке<strong>шоныдымо вашталтыш-влак<\/strong>&nbsp;палемдыме жап деч вара ончычсо (пере)квалификаций шымлымаш деч вара лийын.<br>\u2022&nbsp;<strong>Общий йодмаш-влак (минимум)<\/strong>:<\/li>\n\n\n\n<li>Бир<strong>кӱчык але пел цикл дене куржталмаш<\/strong>;<\/li>\n\n\n\n<li>Включатлаш<strong>температур ден вӱдыжгылыкым висымаш<\/strong>&nbsp;стерилизоватлыме арвер-влак.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">ТЫЙ ЭШТЕ ПАЛЫШЕ КОНЧЕТ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Телефон:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Электрон почто:<a href=\"mailto:hayley@hzbocon.com\">хейли@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Верысе вер: 1202 пӧлем, Цайтун Чжунсинь, Сяша район, Ханчжоу ола, Чжэцзян провинций, Китай<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Веб-сайт:<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}]}}