{"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>I metudi<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-bioburden-method-lethality-confirmation\"><strong>1. Metudu Bioburden: Conferma di Letalità<\/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>? Metudu Fraction-Negative<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-2-overkill-method-demonstrating-12-log-reduction\"><strong>2. Metudu Overkill: Dimostrazione ?12-Log Reduction<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>? Metudu di mezzu ciclu<\/strong><\/li>\n\n\n\n<li><strong>? Metudu di sviluppu di u ciclu<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-key-terms\"><strong>Termini chjave<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Bioburden<\/strong><\/li>\n\n\n\n<li><strong>Riduzzione di 12 log<\/strong><\/li>\n\n\n\n<li><strong>valore D<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Panoramica di i metudi<\/strong><\/h3>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>1. Metudu Half-Cycle (principiu di basa &#8211; Run Count)<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Bioburden iniziale teorica: 10?<\/li>\n\n\n\n<li><strong>Critères de test :<\/strong>\n<ul class=\"wp-block-list\">\n<li>1 corsa cù sopravviventi permessi (&#8220;ciclu parziale&#8221; o &#8220;ciculu cortu&#8221;)<\/li>\n\n\n\n<li>3 semicicli cù zero sopravviventi necessarii<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>2. Metudu di calculu di ciclu<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Esige<strong>bioburden iniziale cunnisciuta &amp; tassu di letalità<\/strong><\/li>\n\n\n\n<li>Basi di selezzione di u metudu: Vede<em>Metudu Fraction-Negative<\/em><\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>3. Metudu Count Direct<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Esige<strong>bioburden iniziale cunnisciuta<\/strong><\/li>\n\n\n\n<li><strong>Critères de test :<\/strong>\n<ul class=\"wp-block-list\">\n<li>1 corsa senza sterilizzante (cuntrollu)<\/li>\n\n\n\n<li>1 run chì dimustra una riduzione di 4 log<\/li>\n\n\n\n<li>3 corse cù livelli di riduzzione intermedi<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>4. Metudu Fraction-Negative<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Esige<strong>bioburden iniziale cunnisciuta<\/strong><\/li>\n\n\n\n<li><strong>Modelli statistici:<\/strong>\n<ul class=\"wp-block-list\">\n<li><strong>A3.2 HSKP<\/strong>&nbsp;(Procedura Holcomb-Spearman-Karber)<\/li>\n\n\n\n<li><strong>A3.3 SMCP<\/strong>&nbsp;(Procedura Stumbo-Murphy-Cochran)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Tipi di indicatori biologichi (BI)<\/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>BI à base d&#039;ampoules<\/strong><br><em>Ampoule di vetru chì cuntene spori è un mediu di crescita separatu (necessita una frantumazione manuale per attivà).<\/em><\/li>\n\n\n\n<li><br><strong>BI autonome<\/strong><br><em>Unità integrata: Striscia di spore + mediu di crescita in una sola fiala (attivazione per compressione).<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">SE VOGLIA SAPERNE DI PIÙ<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Telefonu:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">E-mail:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Situ lucale: Room 1202, Caitong Zhongxin, District Xiasha, Hangzhou City, Zhejiang Province, China<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">situ web:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Metudu 1. Metudu Bioburden: Conferma di Letalità 2. Metudu Overkill: Dimostrazione di ?12-Log Reduction Termini Chjave Metudu Panoramica 1. Metudu di Metà Ciclu (Basic [&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 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-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":"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":""},"mobile":{"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":""}},"_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","default_image_id":0,"enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[133125,133124],"tags":[],"class_list":["post-7268","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company-news","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>Performance Qualification (PQ) - mpq in etosterilization - ETO STERILIZER<\/title>\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\/?p=7268\" \>\n<meta property=\"og:locale\" content=\"en_US\" \>\n<meta property=\"og:type\" content=\"article\" \>\n<meta property=\"og:title\" content=\"Performance Qualification (PQ)- mpq in eto sterilization\" \>\n<meta property=\"og:description\" content=\"Methods 1. 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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}]}}