{"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>طریقے<\/strong><\/h2>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-1-bioburden-method-lethality-confirmation\"><strong>1. بائیو برڈن طریقہ: مہلکیت کی تصدیق<\/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>? فریکشن-منفی طریقہ<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-2-overkill-method-demonstrating-12-log-reduction\"><strong>2. اوور کِل کا طریقہ: 12-لاگ میں کمی کا مظاہرہ کرنا<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>? نصف سائیکل کا طریقہ<\/strong><\/li>\n\n\n\n<li><strong>? سائیکل کی ترقی کا طریقہ<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-key-terms\"><strong>کلیدی شرائط<\/strong><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>بائیو برڈن<\/strong><\/li>\n\n\n\n<li><strong>12 لاگ کمی<\/strong><\/li>\n\n\n\n<li><strong>ڈی ویلیو<\/strong><\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>طریقوں کا جائزہ<\/strong><\/h3>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>1. نصف سائیکل کا طریقہ (بنیادی اصول &#8211; رن کاؤنٹ)<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>نظریاتی ابتدائی bioburden: 10؟<\/li>\n\n\n\n<li><strong>ٹیسٹ کا معیار:<\/strong>\n<ul class=\"wp-block-list\">\n<li>زندہ بچ جانے والوں کے ساتھ 1 دوڑ کی اجازت ہے (&#8220;جزوی سائیکل&#8221; یا &#8220;مختصر سائیکل&#8221;)<\/li>\n\n\n\n<li>صفر زندہ بچ جانے والوں کے ساتھ 3 ہاف سائیکل درکار ہیں۔<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>2. سائیکل کیلکولیشن کا طریقہ<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>کی ضرورت ہے۔<strong>معلوم ابتدائی بائیو برڈن &amp; مہلک شرح<\/strong><\/li>\n\n\n\n<li>طریقہ انتخاب کی بنیاد: دیکھیں<em>فریکشن-منفی طریقہ<\/em><\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>3. براہ راست گنتی کا طریقہ<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>کی ضرورت ہے۔<strong>معلوم ابتدائی بائیو برڈن<\/strong><\/li>\n\n\n\n<li><strong>ٹیسٹ کا معیار:<\/strong>\n<ul class=\"wp-block-list\">\n<li>جراثیم سے پاک 1 رن (کنٹرول)<\/li>\n\n\n\n<li>1 رن 4 لاگ کمی کا مظاہرہ کر رہا ہے۔<\/li>\n\n\n\n<li>درمیانی کمی کی سطح کے ساتھ 3 رنز<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\"><strong>4. فریکشن-منفی طریقہ<\/strong><\/h4>\n\n\n\n<ul class=\"wp-block-list\">\n<li>کی ضرورت ہے۔<strong>معلوم ابتدائی بائیو برڈن<\/strong><\/li>\n\n\n\n<li><strong>شماریاتی ماڈلز:<\/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;(سٹمبو-مرفی-کوکرن طریقہ کار)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>حیاتیاتی اشارے کی اقسام (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>ایمپول پر مبنی BI<\/strong><br><em>گلاس ایمپول جس میں بیضہ جات اور الگ گروتھ میڈیم ہوتے ہیں (چالو کرنے کے لیے دستی کرشنگ کی ضرورت ہوتی ہے)۔<\/em><\/li>\n\n\n\n<li><br><strong>خود ساختہ BI<\/strong><br><em>انٹیگریٹڈ یونٹ: ایک شیشی میں بیضہ کی پٹی + گروتھ میڈیم (کمپریشن کے ذریعے چالو کرنا)۔<\/em><\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-if-you-want-to-know-more\">اگر آپ مزید جاننا چاہتے ہیں<\/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\">ای میل:<a href=\"mailto:hayley@hzbocon.com\">hayley@hzbocon.com<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">مقامی سائٹ: کمرہ 1202، Caitong Zhongxin، Xiasha ڈسٹرکٹ، Hangzhou City، Zhejiang Province، China<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">ویب سائٹ:<a href=\"https:\/\/www.hzbocon.com\/\">hzbocon.com<\/a><a href=\"https:\/\/zjbocon.com\/\">zjbocon.com<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Methods 1. Bioburden Method: Lethality Confirmation 2. Overkill Method: Demonstrating ?12-Log Reduction Key Terms Methods Overview 1. Half-Cycle Method (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>کارکردگی کی اہلیت (PQ) - eto sterilization میں mpq - 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}]}}