{"id":2122,"date":"2024-11-06T11:41:22","date_gmt":"2024-11-06T03:41:22","guid":{"rendered":"https:\/\/zjbocon.com\/?p=2122"},"modified":"2025-12-05T10:51:11","modified_gmt":"2025-12-05T02:51:11","slug":"production-of-process-challenge-devices-in-eo-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/","title":{"rendered":"Production of Process Challenge Devices in eo sterilization"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-5b40b406 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\/Turnkey-EO-Sterilisation-Project-1-1024x724.webp\" alt=\"\" class=\"uag-image-8216\" width=\"768\" height=\"1024\" title=\"Turnkey-EO-Sterilisation-Project\" role=\"img\" \><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-1-production-of-process-challenge-devices-pcd\">3.4.1.1 የሂደት ፈታኝ መሳሪያዎችን ማምረት (ፒሲዲ)<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">የሂደት ፈተና መሳሪያ (ፒሲዲ) የተመረጡ የሂደት መለኪያዎችን ግድያ መጠን ለመገምገም የሚያገለግል የማይክሮባዮሎጂ ፈተና ስርዓት ነው። እሱ በተለምዶ ባዮሎጂካዊ አመልካቾችን (ለምሳሌ ፣ ባሲለስ አትሮፋየስ ስፖሬስ ከታወቀ ስፖሬስ ብዛት) የያዘ መሳሪያ ወይም የሙከራ ጥቅል ነው። የ PCD የማምከን ሂደትን መቋቋም በጣም አስቸጋሪ በሆነው የምርት ቦታ ላይ ካለው የተፈጥሮ ተህዋሲያን ጭነት መቋቋም የበለጠ ወይም እኩል መሆን አለበት. የፒሲዲዎች ብዛት በአባሪ ሐ ሠንጠረዥ C.3 በ GB18279.1-2015 የተዘረዘሩትን መስፈርቶች ማሟላት አለበት። ፒሲዲዎች በውስጣዊ PCDs (IPCD) እና ውጫዊ PCDs (EPCD) ተከፋፍለዋል።<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-a-internal-pcd-ipcd-production\">ሀ) የውስጥ PCD (IPCD) ምርት<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">የውስጥ ፒሲዲዎች ብዙውን ጊዜ የምርት ቤተሰብን ለመወከል በኩባንያው የተመረጡ የሕክምና መሣሪያዎች ናቸው። በንድፍ እና በቁሳቁስ ስብጥር ላይ በመመስረት, እነዚህ ምርቶች ለማምከን በጣም አስቸጋሪ ከሆኑት መካከል አንዳንዶቹ ይቆጠራሉ. ባዮሎጂካል አመላካቾች (BI) በምርቱ ውስጥ በጣም አስቸጋሪ በሆነው-ማምከን ቦታ ላይ ተቀምጠዋል, ይህም የማምከን ሂደቱ ሰርጦቹን እንዳይዘጋ ወይም በምርቱ ዲዛይን ውስጥ ጣልቃ እንዳይገባ ያደርጋል.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">የባዮሎጂካል አመልካች (BI) በጣም አስቸጋሪ በሆነው የምርት ቦታ ላይ ያስቀምጡ ወይም የሙከራ ማይክሮ ኦርጋኒዝምን (ለምሳሌ ባሲለስ atrophaeus) መከተብ በጣም አስቸጋሪ የሆኑ የማምከን ሁኔታዎች ባሉበት ቦታ ላይ ይክተቱ። በምርቱ ውስጥ በጣም አስቸጋሪው-ለማምከን ቦታ.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">የተለመዱ አይፒሲዲዎች የሚያካትቱት ግን በእነዚህ ብቻ አይወሰኑም፦<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">የተበከለውን ተሸካሚ እንደ ቀለበቶች፣ ፒስተን ራሶች፣ ማጠቢያዎች ወይም ሲሪንጅ ፒስተን ባሉ ክፍሎች መካከል ማስቀመጥ ረቂቅ ተሕዋስያን ፈተና በካቴተር ብርሃን መሃከል ላይ በማስቀመጥ፣ ከዚያም ማጣበቂያ ፈሳሾችን ወይም ማያያዣዎችን በመጠቀም ካቴተሩን እንደገና ለመሸፈን እና የምርቱን ትክክለኛነት ወደነበረበት ይመልሱ።<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-b-external-pcd-epcd-production\">ለ) ውጫዊ PCD (EPCD) ምርት<\/h3>\n\n\n\n<p class=\"wp-block-paragraph\">ውጫዊ ፒሲዲዎች ከተጫነው ምርት ውጭ ተቀምጠዋል። EPCDs በተለምዶ ለመደበኛ ሂደት ጥቅም ላይ ይውላሉ እና ከህክምናው በኋላ ከጭነቱ ይወጣሉ። የ EPCD ን የፀዳው ምርት ባዮሎጂያዊ ጭነት መቋቋም ከ IPCD መቋቋም ጋር መወዳደር አለበት. EPCD በጭነቱ ውስጥ ለማምከን በጣም አስቸጋሪ የሆነውን ምርት መወከል አለበት።<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">በ EPCD ዎች እና በተበከሉ ምርቶች ናሙናዎች መካከል ያለው ግንኙነት በየጊዜው መከለስ ያለበት በተመረተው ምርት ላይ ምንም አይነት ለውጥ አለመኖሩን እና EPCD አሁንም በጭነቱ ውስጥ በጣም ከባድ የሆነውን የማምከን ምርትን ይወክላል።<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">በፒሲዲ ውስጥ BI ን ሲያስቀምጡ PCD በምርቱ ውስጥ በጣም አስቸጋሪ ከሆነው ቦታ ጋር ቢያንስ ተመሳሳይ የመቋቋም አቅም ሊኖረው ይገባል።<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">የተለመዱ EPCDዎች የሚያካትቱት ግን በእነዚህ ብቻ አይወሰኑም፦<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ባዮሎጂካል አመልካች (BI) በምርት ማሸጊያው ውስጥ ወይም እንደ ፕላስቲክ ከረጢቶች ያሉ አቻዎችን ማስቀመጥ ከዚያም በማኒላ ኤንቨሎፕ ውስጥ ይቀመጣል።የባዮሎጂካል አመልካች በወፍራም ፕላስቲክ ከረጢት ውስጥ ማስቀመጥ የተወሰነ ጊዜ ያህል የታጠፈ።የባዮሎጂያዊ አመልካቹን በተለያዩ የሲሪንጅ ክፍሎች ለምሳሌ በፒስተን ማጠቢያ ወይም ፒስተን ጭንቅላት ውስጥ ያለ ተጨማሪ የፕላስቲክ ቱቦዎች የታሸጉ መኪናዎች ያለ ተጨማሪ መያዣ።<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ከላይ በተጠቀሰው መንገድ የሚመረቱ ፒሲዲዎች ከመደበኛው የምርት ምርቶች ጋር ተመሳሳይ ዘዴዎችን በመጠቀም የታሸጉ፣ በምርቱ ጭነት ውስጥ በእኩል መጠን የተከፋፈሉ እና በ sterilizer ክፍል ውስጥ ያሉ ቀዝቃዛ ቦታዎችን ለመሸፈን ይቀመጣሉ።<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-2-partial-cycle-short-cycle-testing\">3.4.1.2 ከፊል ዑደት (አጭር ዑደት) ሙከራ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">ፒሲዲውን ከመረጡ በኋላ, ተስማሚነቱ በከፊል ዑደት በማካሄድ ይረጋገጣል. የግምገማ ዘዴው እንደሚከተለው ነው.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ሀ) በአሰራር ግምገማው ውጤት መሰረት ለፒሲዲዎች፣ የፈተና ናሙናዎች እና ዳሳሾች የምደባ ዘዴዎችን ይወስኑ። የፒሲዲዎች ቁጥር እና ስርጭት በቂ መሆን አለበት። የተመረጠው EPCD ለወትሮው የማምከን ሂደትን ለመከታተል ጥቅም ላይ የሚውል ከሆነ በእቅዱ እና በሂደቱ መሰረት በምርቱ ጭነት ላይ መቀመጥ አለበት.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ለ) በባዮሎጂካል አመልካች በዲ እሴት ፣ ST ጊዜ እና በ KT ጊዜ ላይ በመመርኮዝ አጭር የተጋላጭ ጊዜ ያዘጋጁ። ሌሎች መለኪያዎች በመደበኛ የማምከን ሂደት መለኪያዎች ዝቅተኛ ገደብ መሞከር አለባቸው. የፈተናው ዘዴ የ GB18281.2 አባሪ ሀን መመልከት አለበት። የተጋላጭነት ጊዜ ካለቀ በኋላ ምርቱን, IPCD እና EPCD ለጥቃቅን ተክሎች ያስወግዱ እና ውጤቱን ይመልከቱ.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">የእርሻ ውጤቶቹ የ PCD መቋቋም በምርቱ ውስጥ በጣም ከባድ-ለማምከን ቦታ ካለው ባዮሎጂያዊ ጭነት መቋቋም የበለጠ ወይም እኩል መሆኑን ማሳየት አለባቸው።<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">IPCD እና EPCD በከፊል አሉታዊ መሆን አለባቸው; ሙሉ በሙሉ አሉታዊ ወይም ሙሉ በሙሉ አወንታዊ ውጤት የፈተና አለመሳካትን ያሳያል.የ IPCD መቋቋም ከምርቱ የበለጠ መሆን አለበት, እና የ EPCD መቋቋም ከ IPCD የበለጠ ወይም እኩል መሆን አለበት.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ውጤቶቹ የሚጠበቁትን ካላሟሉ, ምክንያቱን ይመርምሩ. በተለምዶ የ PCD መቋቋም ወይም የማምከን መለኪያዎች ማስተካከያዎች ያስፈልጋሉ, ከዚያም ውጤቱ ከተጠበቀው ጋር እስኪጣጣም ድረስ እንደገና መሞከር. ሦስቱም (ምርት፣ IPCD እና EPCD) ምንም ዓይነት ረቂቅ ተሕዋስያን ካላሳዩ የኢኦ ተጋላጭነት ጊዜን በአግባቡ ይቀንሱ እና እንደገና ይሞክሩ። ሁሉም የማይክሮባዮሎጂ እድገት ካሳዩ የኢኦ ተጋላጭነት ጊዜን ይጨምሩ እና እንደገና ይሞክሩ።<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-3-half-cycle-testing\">3.4.1.3 የግማሽ ዑደት ሙከራ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">የአጭር-ዑደት ሙከራን በተሳካ ሁኔታ ካጠናቀቁ በኋላ፣ የ EO የማምከን ሂደትን ውጤታማነት (SAL = 10^-6) እና መራባትን ለማሳየት ሶስት ተከታታይ ተከታታይ የግማሽ ዑደት ሙከራዎችን ያካሂዱ። የግምገማ ዘዴው እንደሚከተለው ነው.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">የባዮሎጂካል አመልካች sterilityን እንደ መደበኛ ያቀናብሩ እና ሌሎች የማምከን ሂደት መለኪያዎችን ወደ መደበኛው የማምከን መመዘኛዎች ዝቅተኛ ወሰን ያቀናብሩ (ለምሳሌ ፣ በተገለጸው ክልል ውስጥ የቅድመ-ህክምና ሽግግር ጊዜ)። የመጀመሪያውን የማምከን ሂደት የማምከን ተጋላጭነት ጊዜን ቀስ በቀስ በግማሽ ይቀንሱ እና ከተለያዩ የማምከን ጊዜያት በኋላ ባዮሎጂያዊ አመላካቾችን ከ PCD ያስወግዱ። ፅንስ እስካልተረጋገጠ ድረስ በንፁህ አከባቢ ውስጥ ያዳብሩዋቸው. በጣም አጭር የማምከን ጊዜ (ወሳኙ ጊዜ) በዚህ መንገድ የሚወሰነው የግማሽ ዑደት ጊዜ ነው, እና ቢያንስ ሁለት ተጨማሪ ሙከራዎች በተመሳሳይ አጭር ጊዜ መከናወን አለባቸው.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">All three test results should show complete inactivation of all biological indicators (initial colony count no less than 1\u00d710^6) to confirm the minimum effective EO exposure time. The exposure time in the routine sterilization process should be at least twice this minimum time.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">የባዮሎጂካል አመልካች የእርሻ ውጤቶች ሁሉንም IPCDs እና EPCDs አሉታዊ ማሳየት አለባቸው። የአጭር-ዑደት ሙከራው የ EPCD ተቃውሞ ከ IPCD የበለጠ መሆኑን ካሳየ EPCD ከፊል አዎንታዊነት ሊያሳይ ይችላል.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ውጤቶቹ የሚጠበቁትን ካላሟሉ ምክንያቱን ይመርምሩ እና ውጤቶቹ ከሚጠበቀው ጋር እስኪመሳሰሉ ድረስ እንደገና ከመሞከርዎ በፊት የማምከን መለኪያዎችን ያስተካክሉ።<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ለምሳሌ፥<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">የመጀመሪያው የግማሽ-ዑደት የማምከን ተጋላጭነት ጊዜ 4 ሰዓት ነው እንበል። የጸዳ ከሆነ ለቀጣዩ ፈተና የተጋላጭነት ጊዜን ወደ 2 ሰዓታት ይቀንሱ; ረቂቅ ተሕዋስያን እድገት ከተከሰተ, በ 4-ሰዓት ተጋላጭነት ላይ በመመርኮዝ የተጋላጭነት ጊዜን ይጨምሩ.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">የሁለተኛው ግማሽ-ዑደት የማምከን የተጋላጭነት ጊዜ 2 ሰዓት ነው እንበል. የጸዳ ከሆነ ለቀጣዩ ፈተና የተጋላጭነት ጊዜን ወደ 1 ሰዓት ይቀንሱ; የማይክሮባላዊ እድገት ከተከሰተ, የተጋላጭነት ጊዜን ወደ 3 ሰዓታት ያራዝሙ.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">የሦስተኛው ግማሽ-ዑደት የማምከን የተጋላጭነት ጊዜ 3 ሰዓት ነው እንበል. ንፁህ ከሆነ የ3-ሰዓት ሙከራውን ሁለት ጊዜ ይድገሙት። ሁሉም ውጤቶች ንፁህ ከሆኑ፣ 3 ሰዓቶች እንደ ትንሹ ውጤታማ ጊዜ ያረጋግጡ። ረቂቅ ተሕዋስያን እድገት ከተፈጠረ, ሙከራውን በ 4-ሰዓት ተጋላጭነት ይድገሙት, እና ሁሉም ውጤቶች ንጹህ ከሆኑ, 4 ሰዓቶች እንደ ዝቅተኛው ውጤታማ ጊዜ ያረጋግጡ.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-3-4-1-4-full-cycle-testing\">3.4.1.4 ሙሉ ዑደት ሙከራ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">የሙሉ ዑደት ሙከራ በሚደረግበት ጊዜ የኢኦ የተጋላጭነት ጊዜን በግማሽ ዑደት ሁለት ጊዜ በትንሹ ውጤታማ ጊዜ እና ሌሎች መለኪያዎች የማምከን ሂደቱን አስተማማኝነት እና መራባትን ለማረጋገጥ ከመደበኛ የማምከን መለኪያዎች በላይኛው ወሰን ያዘጋጁ።<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ጥቅም ላይ የሚውሉት የሙቀት እና የእርጥበት መጠን ዳሳሾች በ GB18279.1 ውስጥ አባሪ C መስፈርቶችን ማሟላት አለባቸው, በእኩል መጠን በማምከን ጭነት ውስጥ ይሰራጫሉ. የሙቀት ዳሳሽ አቀማመጥ ነጥቦች በኦፕሬሽናል ብቃት (OQ) ወቅት ሁለቱንም ቀዝቃዛ እና ሙቅ ቦታዎችን በስቴሪዘር ክፍል ውስጥ ማካተት አለባቸው።<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ከሙከራው በኋላ የምርቱ እና የኢ.ሲ.ዲ.ዲ የእርሻ ውጤቶች ሙሉ በሙሉ መካንነት (ሁሉም አሉታዊ) ማሳየት አለባቸው።<\/p>\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<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><th>ISO 11135፡2014<\/th><td>Sterilization of health-care products \u2013 Ethylene oxide \u2013 Requirements for the development, validation and routine control of a sterilization process for medical devices<\/td><\/tr><tr><th>ISO 14161፡2009<\/th><td>Sterilization of health care products \u2014 Biological indicators \u2014 Guidance for the selection, use and interpretation of results<\/td><\/tr><tr><th>ISO 10993-7፡2008<\/th><td>Biological evaluation of medical devices \u2014 Part 7: Ethylene oxide sterilization residuals<\/td><\/tr><tr><th>ISO 11737-1: 2018<\/th><td>Sterilization of health care products \u2014 Microbiological methods \u2013 Part 1: Determination of a population of microorganisms on products<\/td><\/tr><tr><th>ISO 11737-2፡2009<\/th><td>Sterilization of medical devices \u2014 Microbiological methods \u2014 Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process<\/td><\/tr><tr><th>AAMI TIR16:2017<\/th><td>የኢትሊን ኦክሳይድ ማምከን የማይክሮባዮሎጂ ገጽታዎች<\/td><\/tr><\/tbody><\/table><\/figure>\n","protected":false},"excerpt":{"rendered":"<p>የሂደት ፈተና መሳሪያ (ፒሲዲ) የተመረጡ የሂደት መለኪያዎችን ግድያ መጠን ለመገምገም የሚያገለግል የማይክሮባዮሎጂ ፈተና ስርዓት ነው። እሱ በተለምዶ ባዮሎጂካዊ አመልካቾችን (ለምሳሌ ፣ ባሲለስ አትሮፋየስ ስፖሬስ ከታወቀ ስፖሬስ ብዛት) የያዘ መሳሪያ ወይም የሙከራ ጥቅል ነው። የ PCD የማምከን ሂደትን መቋቋም በጣም አስቸጋሪ በሆነው የምርት ቦታ ላይ ካለው የተፈጥሮ ተህዋሲያን ጭነት መቋቋም የበለጠ ወይም እኩል መሆን አለበት. የፒሲዲዎች ብዛት በአባሪ ሐ ሠንጠረዥ C.3 በ GB18279.1-2015 የተዘረዘሩትን መስፈርቶች ማሟላት አለበት። ፒሲዲዎች በውስጣዊ PCDs (IPCD) እና ውጫዊ PCDs (EPCD) ተከፋፍለዋል።<\/p>\n","protected":false},"author":234312599,"featured_media":8417,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_uag_custom_page_level_css":"","site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[133124],"tags":[],"class_list":["post-2122","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-eto-sterilizer"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>በ eo sterilization ውስጥ የሂደት ፈታኝ መሳሪያዎችን ማምረት - ETO STERILIZER<\/title>\n<meta name=\"description\" content=\"A Process Challenge Device (PCD) is a microbiological challenge system used to evaluate the kill rate of selected process parameters.\" \>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \>\n<link rel=\"canonical\" href=\"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/\" \>\n<meta property=\"og:locale\" content=\"en_US\" \>\n<meta property=\"og:type\" content=\"article\" \>\n<meta property=\"og:title\" content=\"Production of Process Challenge Devices in eo sterilization\" \>\n<meta property=\"og:description\" content=\"A Process Challenge Device (PCD) is a microbiological challenge system used to evaluate the kill rate of selected process parameters.\" \>\n<meta property=\"og:url\" content=\"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/\" \>\n<meta property=\"og:site_name\" content=\"ETO STERILIZER\" \>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/profile.php?id=100088482339878\" \>\n<meta property=\"article:author\" content=\"https:\/\/www.facebook.com\/profile.php?id=100088482339878\" \>\n<meta property=\"article:published_time\" content=\"2024-11-06T03:41:22+00:00\" \>\n<meta property=\"article:modified_time\" content=\"2025-12-05T02:51:11+00:00\" \>\n<meta property=\"og:image\" content=\"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-scaled.webp\" \>\n\t<meta property=\"og:image:width\" content=\"2560\" \>\n\t<meta property=\"og:image:height\" content=\"1920\" \>\n\t<meta property=\"og:image:type\" content=\"image\/webp\" \>\n<meta name=\"author\" content=\"Bocon Technical Team\" \>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \>\n<meta name=\"twitter:creator\" content=\"@BoconAnd\" \>\n<meta name=\"twitter:site\" content=\"@BoconAnd\" \>\n<meta name=\"twitter:label1\" content=\"Written by\" \>\n\t<meta name=\"twitter:data1\" content=\"Bocon Technical Team\" \>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \>\n\t<meta name=\"twitter:data2\" content=\"7 minutes\" \>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"TechArticle\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/production-of-process-challenge-devices-in-eo-sterilization\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/production-of-process-challenge-devices-in-eo-sterilization\\\/\"},\"author\":{\"name\":\"Bocon Technical Team\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#\\\/schema\\\/person\\\/f12be028b8ae9843a4396dcc8012b425\"},\"headline\":\"Production of Process Challenge Devices in eo sterilization\",\"datePublished\":\"2024-11-06T03:41:22+00:00\",\"dateModified\":\"2025-12-05T02:51:11+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/production-of-process-challenge-devices-in-eo-sterilization\\\/\"},\"wordCount\":1392,\"commentCount\":0,\"publisher\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/production-of-process-challenge-devices-in-eo-sterilization\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/zjbocon.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/ethylene-oxide-sterilization-18-scaled.webp\",\"articleSection\":[\"ETO STERILIZER\"],\"inLanguage\":\"am\",\"potentialAction\":[{\"@type\":\"CommentAction\",\"name\":\"Comment\",\"target\":[\"https:\\\/\\\/zjbocon.com\\\/production-of-process-challenge-devices-in-eo-sterilization\\\/#respond\"]}]},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/production-of-process-challenge-devices-in-eo-sterilization\\\/\",\"url\":\"https:\\\/\\\/zjbocon.com\\\/production-of-process-challenge-devices-in-eo-sterilization\\\/\",\"name\":\"Production of Process Challenge Devices in eo sterilization - ETO STERILIZER\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/production-of-process-challenge-devices-in-eo-sterilization\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/production-of-process-challenge-devices-in-eo-sterilization\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/zjbocon.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/ethylene-oxide-sterilization-18-scaled.webp\",\"datePublished\":\"2024-11-06T03:41:22+00:00\",\"dateModified\":\"2025-12-05T02:51:11+00:00\",\"description\":\"A Process Challenge Device (PCD) is a microbiological challenge system used to evaluate the kill rate of selected process parameters.\",\"breadcrumb\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/production-of-process-challenge-devices-in-eo-sterilization\\\/#breadcrumb\"},\"inLanguage\":\"am\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/zjbocon.com\\\/production-of-process-challenge-devices-in-eo-sterilization\\\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"am\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/production-of-process-challenge-devices-in-eo-sterilization\\\/#primaryimage\",\"url\":\"https:\\\/\\\/zjbocon.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/ethylene-oxide-sterilization-18-scaled.webp\",\"contentUrl\":\"https:\\\/\\\/zjbocon.com\\\/wp-content\\\/uploads\\\/2025\\\/09\\\/ethylene-oxide-sterilization-18-scaled.webp\",\"width\":2560,\"height\":1920},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/production-of-process-challenge-devices-in-eo-sterilization\\\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/zjbocon.com\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Production of Process Challenge Devices in eo sterilization\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#website\",\"url\":\"https:\\\/\\\/zjbocon.com\\\/\",\"name\":\"ETO STERILIZER\",\"description\":\"One-stop Solution Supplier of Ethylene Oxide Sterilization\",\"publisher\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/zjbocon.com\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"am\"},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#organization\",\"name\":\"ETO STERILIZER\",\"url\":\"https:\\\/\\\/zjbocon.com\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"am\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#\\\/schema\\\/logo\\\/image\\\/\",\"url\":\"https:\\\/\\\/zjbocon.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/logo-1.webp\",\"contentUrl\":\"https:\\\/\\\/zjbocon.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/logo-1.webp\",\"width\":180,\"height\":60,\"caption\":\"ETO STERILIZER\"},\"image\":{\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#\\\/schema\\\/logo\\\/image\\\/\"},\"sameAs\":[\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=100088482339878\",\"https:\\\/\\\/x.com\\\/BoconAnd\",\"https:\\\/\\\/www.linkedin.com\\\/in\\\/--06a221139\\\/\"]},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/zjbocon.com\\\/#\\\/schema\\\/person\\\/f12be028b8ae9843a4396dcc8012b425\",\"name\":\"Bocon Technical Team\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"am\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/d7a825658be227f26b237e519f8541e05aabc9ff27b8eec4544a233a48c53be0?s=96&d=identicon&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/d7a825658be227f26b237e519f8541e05aabc9ff27b8eec4544a233a48c53be0?s=96&d=identicon&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/d7a825658be227f26b237e519f8541e05aabc9ff27b8eec4544a233a48c53be0?s=96&d=identicon&r=g\",\"caption\":\"Bocon Technical Team\"},\"sameAs\":[\"https:\\\/\\\/zjbocon.com\\\/\",\"https:\\\/\\\/www.facebook.com\\\/profile.php?id=100088482339878\",\"https:\\\/\\\/www.linkedin.com\\\/in\\\/\\\/hayley--968190269\\\/\"],\"url\":\"https:\\\/\\\/zjbocon.com\\\/author\\\/15657615935a\\\/\"}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"Production of Process Challenge Devices in eo sterilization - ETO STERILIZER","description":"A Process Challenge Device (PCD) is a microbiological challenge system used to evaluate the kill rate of selected process parameters.","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/","og_locale":"en_US","og_type":"article","og_title":"Production of Process Challenge Devices in eo sterilization","og_description":"A Process Challenge Device (PCD) is a microbiological challenge system used to evaluate the kill rate of selected process parameters.","og_url":"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/","og_site_name":"ETO STERILIZER","article_publisher":"https:\/\/www.facebook.com\/profile.php?id=100088482339878","article_author":"https:\/\/www.facebook.com\/profile.php?id=100088482339878","article_published_time":"2024-11-06T03:41:22+00:00","article_modified_time":"2025-12-05T02:51:11+00:00","og_image":[{"width":2560,"height":1920,"url":"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-scaled.webp","type":"image\/webp"}],"author":"Bocon Technical Team","twitter_card":"summary_large_image","twitter_creator":"@BoconAnd","twitter_site":"@BoconAnd","twitter_misc":{"Written by":"Bocon Technical Team","Est. reading time":"7 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"TechArticle","@id":"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/#article","isPartOf":{"@id":"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/"},"author":{"name":"Bocon Technical Team","@id":"https:\/\/zjbocon.com\/#\/schema\/person\/f12be028b8ae9843a4396dcc8012b425"},"headline":"Production of Process Challenge Devices in eo sterilization","datePublished":"2024-11-06T03:41:22+00:00","dateModified":"2025-12-05T02:51:11+00:00","mainEntityOfPage":{"@id":"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/"},"wordCount":1392,"commentCount":0,"publisher":{"@id":"https:\/\/zjbocon.com\/#organization"},"image":{"@id":"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/#primaryimage"},"thumbnailUrl":"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-scaled.webp","articleSection":["ETO STERILIZER"],"inLanguage":"am","potentialAction":[{"@type":"CommentAction","name":"Comment","target":["https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/#respond"]}]},{"@type":"WebPage","@id":"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/","url":"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/","name":"Production of Process Challenge Devices in eo sterilization - ETO STERILIZER","isPartOf":{"@id":"https:\/\/zjbocon.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/#primaryimage"},"image":{"@id":"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/#primaryimage"},"thumbnailUrl":"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-scaled.webp","datePublished":"2024-11-06T03:41:22+00:00","dateModified":"2025-12-05T02:51:11+00:00","description":"A Process Challenge Device (PCD) is a microbiological challenge system used to evaluate the kill rate of selected process parameters.","breadcrumb":{"@id":"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/#breadcrumb"},"inLanguage":"am","potentialAction":[{"@type":"ReadAction","target":["https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/"]}]},{"@type":"ImageObject","inLanguage":"am","@id":"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/#primaryimage","url":"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-scaled.webp","contentUrl":"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-scaled.webp","width":2560,"height":1920},{"@type":"BreadcrumbList","@id":"https:\/\/zjbocon.com\/production-of-process-challenge-devices-in-eo-sterilization\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/zjbocon.com\/"},{"@type":"ListItem","position":2,"name":"Production of Process Challenge Devices in eo sterilization"}]},{"@type":"WebSite","@id":"https:\/\/zjbocon.com\/#website","url":"https:\/\/zjbocon.com\/","name":"ETO STERILIZER","description":"One-stop Solution Supplier of Ethylene Oxide Sterilization","publisher":{"@id":"https:\/\/zjbocon.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/zjbocon.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"am"},{"@type":"Organization","@id":"https:\/\/zjbocon.com\/#organization","name":"ETO STERILIZER","url":"https:\/\/zjbocon.com\/","logo":{"@type":"ImageObject","inLanguage":"am","@id":"https:\/\/zjbocon.com\/#\/schema\/logo\/image\/","url":"https:\/\/zjbocon.com\/wp-content\/uploads\/2024\/10\/logo-1.webp","contentUrl":"https:\/\/zjbocon.com\/wp-content\/uploads\/2024\/10\/logo-1.webp","width":180,"height":60,"caption":"ETO STERILIZER"},"image":{"@id":"https:\/\/zjbocon.com\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.facebook.com\/profile.php?id=100088482339878","https:\/\/x.com\/BoconAnd","https:\/\/www.linkedin.com\/in\/--06a221139\/"]},{"@type":"Person","@id":"https:\/\/zjbocon.com\/#\/schema\/person\/f12be028b8ae9843a4396dcc8012b425","name":"Bocon Technical Team","image":{"@type":"ImageObject","inLanguage":"am","@id":"https:\/\/secure.gravatar.com\/avatar\/d7a825658be227f26b237e519f8541e05aabc9ff27b8eec4544a233a48c53be0?s=96&d=identicon&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/d7a825658be227f26b237e519f8541e05aabc9ff27b8eec4544a233a48c53be0?s=96&d=identicon&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/d7a825658be227f26b237e519f8541e05aabc9ff27b8eec4544a233a48c53be0?s=96&d=identicon&r=g","caption":"Bocon Technical Team"},"sameAs":["https:\/\/zjbocon.com\/","https:\/\/www.facebook.com\/profile.php?id=100088482339878","https:\/\/www.linkedin.com\/in\/\/hayley--968190269\/"],"url":"https:\/\/zjbocon.com\/author\/15657615935a\/"}]}},"jetpack_publicize_connections":[],"jetpack_featured_media_url":"https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-scaled.webp","uagb_featured_image_src":{"full":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-scaled.webp",2560,1920,false],"thumbnail":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-150x150.webp",150,150,true],"medium":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-300x225.webp",300,225,true],"medium_large":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-768x576.webp",768,576,true],"large":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-1024x768.webp",1024,768,true],"1536x1536":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-1536x1152.webp",1536,1152,true],"2048x2048":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-2048x1536.webp",2048,1536,true],"woocommerce_thumbnail":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-600x600.webp",600,600,true],"woocommerce_single":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-600x450.webp",600,450,true],"woocommerce_gallery_thumbnail":["https:\/\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-18-100x100.webp",100,100,true]},"uagb_author_info":{"display_name":"Bocon Technical Team","author_link":"https:\/\/zjbocon.com\/author\/15657615935a\/"},"uagb_comment_info":34,"uagb_excerpt":"A Process Challenge Device (PCD) is a microbiological challenge system used to evaluate the kill rate of selected process parameters. It is typically a device or test package containing biological indicators (e.g., Bacillus atrophaeus spores with known spore count). The resistance of the PCD to the sterilization process should be greater than or equal to&hellip;","jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pgZDV6-ye","jetpack-related-posts":[{"id":2332,"url":"https:\/\/zjbocon.com\/terms-and-definitions-of-eto-gas-sterilization\/","url_meta":{"origin":2122,"position":0},"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":2013,"url":"https:\/\/zjbocon.com\/eto-sterilization-2\/","url_meta":{"origin":2122,"position":1},"title":"Purpose for eto sterilization validation","author":"Bocon Technical Team","date":"2024-10-28","format":false,"excerpt":"1.Purpose\u00a0for validation eto sterilization 1.1.the obtain of eto sterilization validation evidence that the equipment used for ETO sterilization has been provided and installed in accordance with its specification and can stably operate within predetermined limits and consistently performs in accordance with predetermined criteria and thereby yields product meeting its specification.\u2026","rel":"","context":"In &quot;ETO STERILIZER&quot;","block_context":{"text":"ETO STERILIZER","link":"https:\/\/zjbocon.com\/category\/eto-sterilizer\/"},"img":{"alt_text":"eto sterilization validation","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=350%2C200","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=350%2C200 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=525%2C300 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/Qualification_Services-2.webp?resize=700%2C400 2x"},"classes":[]},{"id":2076,"url":"https:\/\/zjbocon.com\/ethylene-oxide-sterilization-chamber\/","url_meta":{"origin":2122,"position":2},"title":"PQ in Ethylene oxide 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":7286,"url":"https:\/\/zjbocon.com\/eto-sterilization-re-qualification\/","url_meta":{"origin":2122,"position":3},"title":"ETO Sterilization Re-qualification","author":"Bocon Technical Team","date":"2025-07-29","format":false,"excerpt":"ETO Sterilization Re-qualification Requirements 1. Re-qualification Frequency \u2022\u00a0Minimum annual requirement\u2022 At least once per year, verification data, subsequent re-validation data, and routine processing data must be reviewed\u2022 The scope of re-qualification must be determined and documented\u2022 The review procedure shall be documented 2. Is Re-qualification Needed if No Product Changes\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-9.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/eto-sterilizer-9.webp?resize=1050%2C600&ssl=1 3x"},"classes":[]},{"id":2453,"url":"https:\/\/zjbocon.com\/microbial-killing-performance-of-ethylene-oxide-sterilizers\/","url_meta":{"origin":2122,"position":4},"title":"Microbial Killing Performance of Ethylene Oxide Sterilizers","author":"Bocon Technical Team","date":"2024-12-20","format":false,"excerpt":"Note 1: The Ethylene Oxide sterilization conditions must be obtained through validation confirmation and should be verified with monitoring and routine control during each sterilization cycle. The requirements for validation and routine control are outlined in GB 18279. Note 2: This testing method is also applicable to A class Ethylene\u2026","rel":"","context":"In &quot;Company News&quot;","block_context":{"text":"Company News","link":"https:\/\/zjbocon.com\/category\/company-news\/"},"img":{"alt_text":"eto sterilizer","src":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/10\/banner__.webp?resize=700%2C400&ssl=1 2x"},"classes":[]},{"id":9276,"url":"https:\/\/zjbocon.com\/9276-2\/","url_meta":{"origin":2122,"position":5},"title":"Sterilization Compatibility of Sterile Barrier Systems","author":"Bocon Technical Team","date":"2026-02-06","format":false,"excerpt":"Sterilization Compatibility of Sterile Barrier Systems Technical White Paper 1. Introduction The compatibility between sterile barrier systems (SBS) and sterilization processes is a critical engineering consideration in medical device packaging design. Inappropriate material-process combinations may lead to insufficient sterilant penetration, material degradation, or loss of microbial barrier integrity. This technical\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\/2024\/11\/eto-sterilizer-hzbocon-5.png?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-5.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-5.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-5.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-5.png?resize=1050%2C600&ssl=1 3x"},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/posts\/2122","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=2122"}],"version-history":[{"count":6,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/posts\/2122\/revisions"}],"predecessor-version":[{"id":8881,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/posts\/2122\/revisions\/8881"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/media\/8417"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/media?parent=2122"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/categories?post=2122"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/wp-json\/wp\/v2\/tags?post=2122"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}