{"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 የማምከን ድጋሚ ብቃት መስፈርቶች<\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-re-qualification-frequency\">1. የድጋሚ ብቃት ድግግሞሽ<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>ዝቅተኛው አመታዊ መስፈርት<\/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. ምንም የምርት ለውጦች ካልተከሰቱ ድጋሚ ብቃት ያስፈልጋል?<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>አዎ፣ እንደገና መመዘኛ አሁንም ያስፈልጋል<\/strong><\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-3-re-qualification-items\">3. የድጋሚ ብቃት እቃዎች<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>በተወሰኑ ቅድመ ሁኔታዎች ላይ በመመስረት, የሚከተሉት አማራጮች ይገኛሉ<\/strong>:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ሙሉ ድጋሚ ብቃት<\/li>\n\n\n\n<li>አካላዊ ወይም ማይክሮቢያዊ ዳግም ማረጋገጫ አያስፈልግም<\/li>\n\n\n\n<li>አነስተኛ መጠን ያለው የማይክሮባላዊ አፈፃፀም ማረጋገጫ<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>ለድጋሚ ብቃት ቅድመ ሁኔታዎች<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">a) The following must be reviewed\/tested:<br>ለ) ምንም ይሁን<strong>ጉልህ ለውጦች<\/strong>&nbsp;የምርት መካንነት ላይ ተጽእኖ ያሳድራል፡-<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>የምርት ንድፍ<\/li>\n\n\n\n<li>Manufacturing\/packaging materials<\/li>\n\n\n\n<li>PCD (የሂደት ፈታኝ መሣሪያ)<\/li>\n\n\n\n<li>አቅራቢዎች<\/li>\n\n\n\n<li>Manufacturing areas\/facilities<\/li>\n\n\n\n<li>የመጫኛ አወቃቀሮችን ወይም የምርት ሂደቶችን<br>ሐ)<strong>የባዮበርደን አዝማሚያ ትንተና<\/strong>&nbsp;የምርቶች;<br>መ) እንደሆነ<strong>የሙቀት ስርጭት ጥናቶች<\/strong>&nbsp;እና sterilizer ክወና የመጨረሻ ብቃት ጀምሮ ጉልህ ለውጦች ያሳያል;<br>ሠ) እንደሆነ<strong>የሙቀት ማከፋፈያ እና የዳግም ዝውውር ቼኮች<\/strong>&nbsp;በቅድመ ሁኔታ ክፍሎች ወይም የአየር ማራዘሚያ ዞኖች ከመጨረሻው መመዘኛ በኋላ ከፍተኛ ለውጦችን ያሳያሉ;<br>ረ) ETO ማምከን ይሁን<strong> ሂደት ታሪክ<\/strong>&nbsp;የመጨረሻው ማረጋገጫ እንደገና መራባትን ስለሚያሳይ;<br>ሰ) እንደሆነ<strong>የቁጥጥር ለውጥ እና የመከላከያ ጥገና መዝገቦች<\/strong>&nbsp;በሂደቱ ላይ ተጽዕኖ የሚያሳድሩ የመሳሪያ ማሻሻያዎችን ያረጋግጡ;<br>ሰ) እንደሆነ<strong>በ ETO የማምከን ሂደት ላይ ምንም ለውጦች የሉም<\/strong>&nbsp;የፅንስ መጨንገፍ ተከስቷል;<br>i) ከሆነ<strong>ETO የማምከን ሂደት መግለጫዎች ተለውጠዋል<\/strong>, ድጋሚ ብቃት ማረጋገጫ ማካተት አለበት<strong>የኢኦ ቀሪ ገደቦች<\/strong>&nbsp;የቁጥጥር መስፈርቶችን ማክበር.<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>የቁጥጥር ደረጃዎች<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ISO 11135፡2014<\/strong>&nbsp;<em>( ሰከንድ 9.2፡ የማሟያ መስፈርት)<\/em><\/li>\n\n\n\n<li><strong>ኤፍዲኤ 21 CFR 211.113<\/strong>&nbsp;<em>(የማምከን ሂደት መቆጣጠሪያዎች)<\/em><\/li>\n\n\n\n<li><strong>የአውሮፓ ህብረት ጂኤምፒ አባሪ 1፡2022<\/strong>&nbsp;<em>(ሴክ. 8.5፡ የማረጋገጫ መስፈርቶች)<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-eto-sterilization-re-qualification-requirements-0\"><strong>ETO የማምከን ድጋሚ ብቃት መስፈርቶች<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">ድጋሚ ብቃት ይኖረዋል<strong>የክፍል አፈጻጸም ግምገማ እና ዓመታዊ የምህንድስና ለውጦችን ያካትቱ<\/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;(የሚመለከተው ከሆነ);<\/li>\n\n\n\n<li><strong>ትክክለኛው ባዶ ክፍል እርጥበት መገለጫዎች<\/strong>;<\/li>\n\n\n\n<li><strong>የአየር ማናፈሻ ዞን ሙቀቶች<\/strong>&nbsp;(የሚመለከተው ከሆነ);<\/li>\n\n\n\n<li><strong>በተጨማሪም ፣ ምንም እንኳን የሂደቱ ዝርዝሮች ቢሟሉም።<\/strong>, inspections must be triggered by:\n<ul class=\"wp-block-list\">\n<li>በመሣሪያዎች አፈፃፀም ላይ አሉታዊ አዝማሚያዎች ፣<\/li>\n\n\n\n<li>የመራቢያ አለመሳካቶች;<\/li>\n\n\n\n<li>እንደገና ማረጋገጥ ዋስትና ያለው መሆኑን ለመወሰን።<\/li>\n<\/ul>\n<\/li>\n\n\n\n<li><strong>የማምከን ባለሙያዎች<\/strong>&nbsp;የሚፈለገውን ስፋት ይገልፃል።<strong>የአካላዊ እና ጥቃቅን ድጋሚ ማረጋገጫ<\/strong>&nbsp;በግምገማ ውጤቶች ላይ በመመስረት.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>የማምከን ዳግመኛ ብቃትን በተመለከተ ወሳኝ ጉዳዮች<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>1. ጉልህ ለውጦችን ማስተናገድ<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022 If&nbsp;<strong>ዋና ለውጦች<\/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 (የመጫኛ ብቃት)<\/strong>: Verify modified equipment\/software installation.<\/li>\n\n\n\n<li><strong>OQ (የስራ ብቃት)<\/strong>ተጽዕኖ የተደረገባቸውን የተግባር መለኪያዎችን እንደገና ሞክር።<\/li>\n\n\n\n<li><strong>PQ (የአፈጻጸም ብቃት)<\/strong>በአዳዲስ ሁኔታዎች የማምከን ውጤታማነትን እንደገና ያረጋግጡ።<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>2. ለፓራሜትሪክ መለቀቅ ተጨማሪ መስፈርቶች<\/strong><\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">ለሚጠቀሙት መገልገያዎች<strong>ፓራሜትሪክ መለቀቅ<\/strong>&nbsp;(ከ BI ሙከራ ይልቅ በሂደት ውሂብ ላይ መተማመን)<br>ሀ)<strong>የድጋሚ ማረጋገጫ ድግግሞሽ<\/strong>: መከናወን አለበት<strong>ቢያንስ በየዓመቱ<\/strong>;<br>ለ)<strong>የዳግም ማረጋገጫ ወሰን<\/strong>: ማካተት አለበት<strong>የማይክሮባዮሎጂ ጥናቶች<\/strong>&nbsp;ለማረጋገጥ፡-<\/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\">ሀ)<strong>የማምከን ዋና ጥገና<\/strong>;<br>ለ)<strong>መዋቅራዊ፣ አካባቢ ወይም የአካባቢ ለውጦች<\/strong>;<br>ሐ)<strong>የማይታወቅ የፅንስ አለመሳካቶች<\/strong>;<br>መ)<strong>Changes in EO supply\/delivery, diluent, or chamber load configuration<\/strong>.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>ከአካላዊ ወይም ማይክሮቢያል ዳግም መመዘኛ ነፃ መሆን<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">የሚከተሉት ሁኔታዎች ሲሟሉ፡-<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>ምንም ለውጦች የሉም<\/strong>&nbsp;in product, packaging, equipment\/services, or processes;<\/li>\n\n\n\n<li><strong>የቻምበር አፈፃፀም እና የምህንድስና ግምገማ<\/strong>&nbsp;ብቁ ናቸው;<\/li>\n\n\n\n<li><strong>መደበኛ የማምከን ሂደቶች<\/strong>&nbsp;በጊዜው ውስጥ በአስተማማኝ ሁኔታ ሰርተዋል;<br>?<strong>ሙያዊ ፍርድ<\/strong>&nbsp;አካላዊ ወይም ማይክሮቢያዊ ድጋሚ ብቃት መሆኑን ሊወስን ይችላል።<strong>አያስፈልግም<\/strong>&nbsp;እስከሚቀጥለው ግምገማ ድረስ.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>የተገደበ የማይክሮባይል አፈጻጸም ብቃት<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">\u2022&nbsp;<strong>በተወሰኑ ጉዳዮች ላይ ሊያስፈልግ ይችላል<\/strong>፣ እንደ፥<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ከምርት ባዮ ሸክም አንጻር የቢኤስ ቀጣይነት ያለው መሆኑን ማረጋገጥ፤<\/li>\n\n\n\n<li>የለም የሚል ማስረጃ ማቅረብ<strong>ያልተጠበቁ ለውጦች<\/strong>&nbsp;ከተወሰነ የጊዜ ክፍተት በኋላ ካለፈው (ዳግም) የብቃት ጥናት ጀምሮ ተከስቷል።<br>\u2022&nbsp;<strong>አጠቃላይ መስፈርቶች (ቢያንስ)<\/strong>:<\/li>\n\n\n\n<li>አንድ<strong>የአጭር-ዑደት ወይም የግማሽ ዑደት ሩጫ<\/strong>;<\/li>\n\n\n\n<li>ጨምሮ<strong>የሙቀት እና የእርጥበት መጠን መለኪያዎች<\/strong>&nbsp;sterilized ንጥሎች.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">የበለጠ ማወቅ ከፈለጉ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">ስልክ፡<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ኢሜይል፡-<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">የአካባቢ ቦታ፡ ክፍል 1202፣ ካይቶንግ ዞንግክሲን፣ ዢያሻ አውራጃ፣ ሃንግዙ ከተማ፣ ዢጂያንግ ግዛት፣ ቻይና<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ድህረገፅ፥<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}]}}