{"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\/performance-qualification-pq-mpq-in-eto-sterilization\/","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>Izindlela<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-bioburden-method-lethality-confirmation\"><strong>1. Indlela ye-Bioburden: Ukuqinisekisa Ukufa<\/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>? Indlela Yengxenyana-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. Indlela Ye-Overkill: Ukubonisa ?12-Log Ukuncishiswa<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>? Indlela Yomjikelezo Wesigamu<\/strong><\/li>\n\n\n\n<li><strong>? Indlela Yokuthuthukisa Umjikelezo<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-key-terms\"><strong>Imigomo Ebalulekile<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>I-Bioburden<\/strong><\/li>\n\n\n\n<li><strong>12-log ukunciphisa<\/strong><\/li>\n\n\n\n<li><strong>I-D-value<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Uhlolojikelele lwezindlela<\/strong><\/h3>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>1. Indlela Yomjikelezo Wohhafu (Isimiso Esiyisisekelo &#8211; Ukubala Kokugijima)<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>I-bioburden yokuqala yethiyori: 10?<\/li>\n\n\n\n<li><strong>Imibandela Yokuhlola:<\/strong>\n<ul class=\"wp-block-list\">\n<li>1 ukugijima nabasindile kuvunyelwe (&#8220;ingxenye yomjikelezo&#8221; noma &#8220;umjikelezo omfushane&#8221;)<\/li>\n\n\n\n<li>Imijikelezo enguhhafu engu-3 enabasindile abaziro abadingekayo<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>2. Indlela Yokubalwa Komjikelezo<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Idinga<strong>i-bioburden yokuqala eyaziwayo &amp; izinga lokufa<\/strong><\/li>\n\n\n\n<li>Isisekelo sokukhetha indlela: Bheka<em>Indlela Yengxenyana-Negative<\/em><\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>3. Indlela yokubala Okuqondile<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Idinga<strong>i-bioburden yokuqala eyaziwayo<\/strong><\/li>\n\n\n\n<li><strong>Imibandela Yokuhlola:<\/strong>\n<ul class=\"wp-block-list\">\n<li>1 gijima ngaphandle kwe-sterilant (control)<\/li>\n\n\n\n<li>1 run ekhombisa ?4-log ukunciphisa<\/li>\n\n\n\n<li>3 igijima namazinga okunciphisa amaphakathi<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>4. Indlela Yengxenyana-Negative<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Idinga<strong>i-bioburden yokuqala eyaziwayo<\/strong><\/li>\n\n\n\n<li><strong>Amamodeli Ezibalo:<\/strong>\n<ul class=\"wp-block-list\">\n<li><strong>A3.2 HSKP<\/strong>&nbsp;(Inqubo ye-Holcomb-Spearman-Karber)<\/li>\n\n\n\n<li><strong>A3.3 SMCP<\/strong>&nbsp;(Inqubo ye-Stumbo-Murphy-Cochran)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Izinhlobo Zezinkomba Zebhayoloji (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>I-Ampoule-based BI<\/strong><br><em>I-ampoule yengilazi equkethe izinhlamvu kanye nendawo yokukhula ehlukene (idinga ukuchotshozwa okwenziwa ngesandla ukuze isebenze).<\/em><\/li>\n\n\n\n<li><br><strong>I-BI Ezimele<\/strong><br><em>Iyunithi ehlanganisiwe: I-Spore strip + ukukhula okuphakathi ku-vial eyodwa (ukwenziwa kusebenze ngokuminyanisa).<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">UMA UFUNA UKWAZI OKWENGEZIWE<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">Ucingo:<a href=\"https:\/\/wa.me\/8619975258603\">+8619975258603<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">I-imeyili:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Indawo Yendawo: Igumbi 1202, Caitong Zhongxin, Xiasha District, Hangzhou City, Zhejiang Province, China<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Iwebhusayithi:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Izindlela 1. Indlela ye-Bioburden: Ukuqinisekisa Ukufa 2. Indlela Yokufeketha: Ukubonisa ?12-Log Ukwehliswa Kwemigomo Ebalulekile Izindlela Uhlolojikelele 1. Indlela Yomjikelezo Wohhafu (Okuyisisekelo [&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>Ukufaneleka Kokusebenza (PQ)- mpq ku-eto inzalo - 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\/performance-qualification-pq-mpq-in-eto-sterilization\/\" \>\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. 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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":7277,"url":"https:\/\/zjbocon.com\/performance-qualificationpq-ppq-in-eo-sterilization\/","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\/category\/company-news\/"},"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\/essential-utilities-and-service-requirements-for-eto-sterilizers\/","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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