{"id":7268,"date":"2025-07-29T11:23:00","date_gmt":"2025-07-29T03:23:00","guid":{"rendered":"https:\/\/zjbocon.com\/?p=7268"},"modified":"2025-11-25T18:14:06","modified_gmt":"2025-11-25T10:14:06","slug":"performance-qualification-pq-mpq-in-eto-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=7268","title":{"rendered":"Performance Qualification (PQ)- mpq in eto sterilization"},"content":{"rendered":"\n<div class=\"wp-block-uagb-image uagb-block-cdd67fc0 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-6-1024x1024.webp\" alt=\"\" class=\"uag-image-8486\" width=\"1024\" height=\"1024\" title=\"eto-sterilizer-6\" role=\"img\" \><\/figure><\/div>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-methods\"><strong>طريقا<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-bioburden-method-lethality-confirmation\"><strong>1. Bioburden طريقو: Lethality جي تصديق<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>? Direct Count\/Enumeration Method<\/strong><\/li>\n\n\n\n<li><strong>؟ فريڪشن- ناڪاري طريقو<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-2-overkill-method-demonstrating-12-log-reduction\"><strong>2. Overkill جو طريقو: نمايان ڪرڻ؟ 12-لاگ گھٽائڻ<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>؟ اڌ چڪر جو طريقو<\/strong><\/li>\n\n\n\n<li><strong>؟ سائيڪل جي ترقي جو طريقو<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-key-terms\"><strong>اهم شرطون<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>بائيو بارڊن<\/strong><\/li>\n\n\n\n<li><strong>12-لاگ گھٽائڻ<\/strong><\/li>\n\n\n\n<li><strong>ڊي قدر<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>طريقن جو جائزو<\/strong><\/h3>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>1. اڌ چڪر جو طريقو (بنيادي اصول &#8211; ڳڻپ)<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>نظرياتي شروعاتي بايو برڊن: 10؟<\/li>\n\n\n\n<li><strong>ٽيسٽ جا معيار:<\/strong>\n<ul class=\"wp-block-list\">\n<li>1 ڊوڙڻ جي اجازت ڏني وئي بقايا سان (&#8220;جزوي چڪر&#8221; يا &#8220;مختصر چڪر&#8221;)<\/li>\n\n\n\n<li>3 اڌ-چڪر صفر بچيلن سان گهربل<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>2. سائيڪل جي حساب ڪتاب جو طريقو<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>گهربل آهي<strong>ڄاڻايل شروعاتي بايو بارڊن &amp; موت جي شرح<\/strong><\/li>\n\n\n\n<li>طريقو چونڊ جو بنياد: ڏسو<em>فريڪشن- ناڪاري طريقو<\/em><\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>3. سڌي ڳڻپ جو طريقو<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>گهربل آهي<strong>ڄاڻايل شروعاتي بايو بارڊن<\/strong><\/li>\n\n\n\n<li><strong>ٽيسٽ جا معيار:<\/strong>\n<ul class=\"wp-block-list\">\n<li>1 بغير جراثيم جي رن (ڪنٽرول)<\/li>\n\n\n\n<li>1 رن جو مظاهرو ڪري رهيو آهي؟ 4-لاگ گهٽتائي<\/li>\n\n\n\n<li>وچولي گھٽتائي جي سطح سان 3 رنسون<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>4. فريڪشن-منفي طريقو<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>گهربل آهي<strong>ڄاڻايل شروعاتي بايو بارڊن<\/strong><\/li>\n\n\n\n<li><strong>شمارياتي ماڊل:<\/strong>\n<ul class=\"wp-block-list\">\n<li><strong>A3.2 HSKP<\/strong>&nbsp;(Holcomb-Spearman-Karber Procedure)<\/li>\n\n\n\n<li><strong>A3.3 SMCP<\/strong>&nbsp;(اسٽمبو-مرفي-ڪوچران پروسيس)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>حياتياتي اشارن جا قسم (BIs)<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Strip\/Disk BI<\/strong><br>Strip\/Disk BI<em>Microorganism-coated carrier (e.g., paper\/filter disk) requiring transfer to growth media for incubation.<\/em><\/li>\n\n\n\n<li><strong>امپول تي ٻڌل BI<\/strong><br><em>شيشي جو امپول جنهن ۾ اسپورز ۽ الڳ گروٿ ميڊيم هجي (چالو ڪرڻ لاءِ دستي ڪرشنگ جي ضرورت آهي).<\/em><\/li>\n\n\n\n<li><br><strong>پاڻمرادو BI<\/strong><br><em>انٽيگريٽيڊ يونٽ: اسپور پٽي + هڪ شيشي ۾ واڌ وچولي (ڪپريشن ذريعي چالو ڪرڻ).<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">جيڪڏھن توھان وڌيڪ ڄاڻڻ چاھيو ٿا<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">فون:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">اي ميل:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">مقامي سائيٽ: ڪمرو 1202، Caitong Zhongxin، Xiasha ضلعي، Hangzhou شهر، Zhejiang صوبي، چين<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ويب سائيٽ:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>طريقا 1. بايو برڊن جو طريقو: ليٿالٽي جي تصديق 2. اوور ڪِل جو طريقو: نمايان ڪرڻ؟&hellip;]<\/p>\n","protected":false},"author":234312599,"featured_media":8461,"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":"","background-image":"","background-repeat":"repeat","background-position":"center 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Bioburden Method: Lethality Confirmation 2. Overkill Method: Demonstrating ?12-Log Reduction Key Terms Methods Overview 1. Half-Cycle Method (Basic [&hellip;]","jetpack_likes_enabled":true,"jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/pgZDV6-1Te","jetpack-related-posts":[{"id":2013,"url":"https:\/\/zjbocon.com\/?p=2013","url_meta":{"origin":7268,"position":0},"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\/?cat=133124"},"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":7286,"url":"https:\/\/zjbocon.com\/?p=7286","url_meta":{"origin":7268,"position":1},"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\/?cat=133125"},"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":7277,"url":"https:\/\/zjbocon.com\/?p=7277","url_meta":{"origin":7268,"position":2},"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":9080,"url":"https:\/\/zjbocon.com\/?p=9080","url_meta":{"origin":7268,"position":3},"title":"Essential Utilities and Service Requirements for ETO Sterilizers","author":"Bocon Technical Team","date":"2026-01-20","format":false,"excerpt":"The successful operation of an Ethylene Oxide (ETO) sterilizer requires more than just the machine itself; it demands a robust infrastructure of essential utilities, safety systems, and ongoing technical support. Ensuring these requirements are met is critical for process efficiency, operator safety, and regulatory compliance (such as ISO 11135). 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Established in 2006, HZBOCON has committed itself to the design, development, and manufacturing of EO sterilization equipment, catering to a wide array of industries that require effective\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\/2024\/11\/eto-sterilizer-hzbocon-4.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-4.png?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.png?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.png?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2024\/11\/eto-sterilizer-hzbocon-4.png?resize=1050%2C600&ssl=1 3x"},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7268","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=7268"}],"version-history":[{"count":7,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7268\/revisions"}],"predecessor-version":[{"id":8792,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/7268\/revisions\/8792"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/8461"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=7268"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=7268"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=7268"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}