{"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\">Rekwiżiti ta&#039; Rikwalifikazzjoni ta&#039; Sterilizzazzjoni ETO<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. Frekwenza ta&#039; kwalifika mill-ġdid<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Rekwiżit minimu annwali<\/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. Hija meħtieġa kwalifika mill-ġdid jekk ma jseħħx tibdil fil-prodott?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Iva, kwalifika mill-ġdid għadha meħtieġa<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. Oġġetti ta&#039; kwalifika mill-ġdid<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Ibbażat fuq ċerti prekundizzjonijiet, l-għażliet li ġejjin huma disponibbli<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Rikwalifikazzjoni sħiħa<\/li>\n\n\n\n<li>Ebda ħtieġa għal ri-validazzjoni fiżika jew mikrobjali<\/li>\n\n\n\n<li>Validazzjoni tal-prestazzjoni mikrobjali fuq skala żgħira<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Prerekwiżiti għal kwalifika mill-ġdid<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>b) Jekk hemm<strong>bidliet sinifikanti<\/strong>&nbsp;li jaffettwaw l-isterilità tal-prodott seħħew fi:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Disinn tal-prodott<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD (Apparat għall-Isfida tal-Proċess)<\/li>\n\n\n\n<li>Fornituri<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>Konfigurazzjonijiet ta &#039;tagħbija jew proċessi ta&#039; manifattura<br>c)<strong>Analiżi tat-tendenza tal-bijopiż<\/strong>&nbsp;tal-prodotti;<br>d) Jekk<strong>studji tad-distribuzzjoni tat-temperatura<\/strong>&nbsp;u l-operat tal-isterilizzatur juri bidliet sinifikanti mill-aħħar kwalifika;<br>e) Jekk<strong>distribuzzjoni tat-temperatura u kontrolli ta&#039; ċirkolazzjoni mill-ġdid<\/strong>&nbsp;f&#039;kmamar ta&#039; prekondizzjonament jew żoni ta&#039; arjazzjoni juru bidliet sinifikanti mill-aħħar kwalifika;<br>f) Jekk Sterilizzazzjoni ETO<strong> istorja tal-proċess<\/strong>&nbsp;peress li l-aħħar validazzjoni turi r-riproduċibbiltà;<br>g) Jekk<strong>kontroll tal-bidla u rekords tal-manutenzjoni preventiva<\/strong>&nbsp;tikkonferma l-ebda modifika tat-tagħmir li jaffettwa l-proċess;<br>h) Jekk<strong>ebda tibdil fil-proċess ta&#039; Sterilizzazzjoni ETO<\/strong>&nbsp;seħħew l-isterilità li jaffettwaw;<br>i) Jekk<strong>L-ispeċifikazzjonijiet tal-proċess ta &#039;Sterilizzazzjoni ETO nbidlu<\/strong>, kwalifika mill-ġdid għandha tinkludi verifika ta<strong>Limiti tar-residwi EO<\/strong>&nbsp;konformità mar-rekwiżiti regolatorji.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Standards Regolatorji<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135:2014<\/strong>&nbsp;<em>(Taqsima 9.2: Kriterji ta&#039; kwalifika mill-ġdid)<\/em><\/li>\n\n\n\n<li><strong>FDA 21 CFR 211.113<\/strong>&nbsp;<em>(Kontrolli tal-proċess ta&#039; sterilizzazzjoni)<\/em><\/li>\n\n\n\n<li><strong>EU GMP Anness 1:2022<\/strong>&nbsp;<em>(Taqsima 8.5: Rekwiżiti ta&#039; validazzjoni mill-ġdid)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>Rekwiżiti ta&#039; Rikwalifikazzjoni ta&#039; Sterilizzazzjoni ETO<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Il-kwalifika mill-ġdid għandha<strong>jinkludu reviżjoni tal-prestazzjoni tal-kamra u bidliet annwali fl-inġinerija<\/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;(jekk applikabbli);<\/li>\n\n\n\n<li><strong>Profili attwali tal-umdità tal-kamra vojta<\/strong>;<\/li>\n\n\n\n<li><strong>Temperaturi taż-żona ta &#039;arjazzjoni<\/strong>&nbsp;(jekk applikabbli);<\/li>\n\n\n\n<li><strong>Barra minn hekk, anke jekk jintlaħqu l-ispeċifikazzjonijiet tal-proċess<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>Xejriet avversi fil-prestazzjoni tat-tagħmir,<\/li>\n\n\n\n<li>Ħsarat fl-isterilità;<\/li>\n\n\n\n<li>Biex jiġi determinat jekk il-validazzjoni mill-ġdid hijiex iġġustifikata.<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>Esperti ta &#039;sterilizzazzjoni<\/strong>&nbsp;għandha tiddefinixxi l-ambitu ta&#039; meħtieġ<strong>ri-validazzjoni fiżika u mikrobjali<\/strong>&nbsp;ibbażat fuq ir-riżultati tar-reviżjoni.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Konsiderazzjonijiet Kritiċi għal Sterilizzazzjoni Ri-kwalifika<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. Immaniġġjar Bidliet Sinifikattivi<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>bidliet kbar<\/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 (Kwalifikazzjoni ta&#039; Installazzjoni)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (Kwalifiki Operazzjonali)<\/strong>: Ittestja mill-ġdid il-parametri funzjonali affettwati.<\/li>\n\n\n\n<li><strong>PQ (Kwalifikazzjoni tal-Prestazzjoni)<\/strong>: Ivvalida mill-ġdid l-effikaċja tal-isterilizzazzjoni taħt kundizzjonijiet ġodda.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. Rekwiżiti Addizzjonali għal Rilaxx Parametriku<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">Għall-faċilitajiet li jużaw<strong>rilaxx parametriku<\/strong>&nbsp;(jisserraħ fuq id-dejta tal-proċess aktar milli fuq l-ittestjar tal-BI):<br>a)<strong>Frekwenza tal-validazzjoni mill-ġdid<\/strong>: Għandu jitwettaq<strong>mill-inqas kull sena<\/strong>;<br>b)<strong>Ambitu ta&#039; validazzjoni mill-ġdid<\/strong>: Għandhom jinkludu<strong>studji mikrobijoloġiċi<\/strong>&nbsp;biex tikkonferma:<\/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\">a)<strong>Manutenzjoni ewlenija tal-isterilizzatur<\/strong>;<br>b)<strong>Bidliet strutturali, fil-post, jew ambjentali<\/strong>;<br>c)<strong>Nuqqasijiet ta &#039;sterilità mhux spjegati<\/strong>;<br>d)<strong>Changes in EO supply\/delivery, diluent, or chamber load configuration<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Eżenzjoni minn Ri-kwalifika Fiżika jew Mikrobika<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Meta jiġu sodisfatti l-kundizzjonijiet li ġejjin:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>L-ebda tibdil<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>Reviżjoni tal-prestazzjoni tal-kamra u tal-inġinerija<\/strong>&nbsp;huma kwalifikati;<\/li>\n\n\n\n<li><strong>Proċessi ta &#039;sterilizzazzjoni ta&#039; rutina<\/strong>&nbsp;ħadmu b&#039;mod affidabbli matul il-perjodu;<br>?<strong>Ġudizzju professjonali<\/strong>&nbsp;jistgħu jiddeterminaw li l-kwalifika mill-ġdid fiżika jew mikrobjali hija<strong>mhux meħtieġ<\/strong>&nbsp;sal-reviżjoni li jmiss.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Kwalifikazzjoni tal-Prestazzjoni Mikrobika fuq Skala Limitata<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>Jista&#039; jkun meħtieġ f&#039;każijiet speċifiċi<\/strong>, bħal:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Il-verifika tal-adegwatezza kontinwa tal-BIs relattiva għall-bijopiż tal-prodott;<\/li>\n\n\n\n<li>Provvediment li le<strong>bidliet mhux intenzjonati<\/strong>&nbsp;seħħ mill-istudju ta’ (ri)kwalifika preċedenti wara intervall ta’ żmien definit.<br>\u2022&nbsp;<strong>Rekwiżiti ġenerali (mill-inqas)<\/strong>:<\/li>\n\n\n\n<li>Wieħed<strong>ġirja fuq ċiklu qasir jew nofs ċiklu<\/strong>;<\/li>\n\n\n\n<li>Inkluż<strong>kejl tat-temperatura u l-umdità<\/strong>&nbsp;ta’ oġġetti sterilizzati.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">Jekk trid tkun taf aktar<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefon:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Email:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Sit Lokali: Kamra 1202, Caitong Zhongxin, Distrett Xiasha, Belt Hangzhou, Provinċja ta &#039;Zhejiang, Ċina<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Websajt:<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}]}}