Parametric Release Standards for EO Sterilization | GB\/Z 44877-2024<\/title>\n <meta name=\"description\" content=\"Technical requirements for parametric release in EO sterilization: humidity, concentration, and temperature monitoring per GB\>\n <link href=\"https:\/\/cdnjs.cloudflare.com\/ajax\/libs\/font-awesome\/6.0.0\/css\/all.min.css\" rel=\"stylesheet\">\n <style>\n :root {\n --primary-blue: #004182;\n --bg-light: #f9fbfc;\n --text-main: #2d3436;\n --whatsapp-green: #25D366;\n --border: #e1e8ed;\n }\n\n body {\n font-family: 'Segoe UI', Arial, sans-serif;\n line-height: 1.8;\n color: var(--text-main);\n margin: 0;\n padding: 0;\n background: #fff;\n }\n\n \/* Top Bar with Buttons *\/\n .top-action-bar {\n max-width: 1000px;\n margin: 20px auto;\n padding: 0 20px;\n display: flex;\n justify-content: flex-end;\n gap: 12px;\n }\n\n .btn {\n padding: 10px 22px;\n border-radius: 4px;\n text-decoration: none;\n font-weight: 600;\n font-size: 14px;\n display: inline-flex;\n align-items: center;\n gap: 8px;\n transition: 0.3s;\n }\n .btn-blue { background: var(--primary-blue); color: white; }\n .btn-whatsapp { background: var(--whatsapp-green); color: white; }\n .btn:hover { opacity: 0.9; transform: translateY(-1px); }\n\n \/* Article Wrapper *\/\n .article-container {\n max-width: 850px;\n margin: 0 auto;\n padding: 40px 20px;\n }\n\n h1 { color: var(--primary-blue); font-size: 30px; border-bottom: 3px solid var(--primary-blue); padding-bottom: 15px; margin-bottom: 40px; }\n h2 { font-size: 22px; color: var(--primary-blue); background: var(--bg-light); padding: 12px 20px; border-left: 5px solid var(--primary-blue); margin-top: 40px; }\n h3 { font-size: 18px; color: var(--primary-blue); margin-top: 30px; border-bottom: 1px solid var(--border); padding-bottom: 5px; }\n\n .clause-item { margin-bottom: 25px; padding: 15px; border: 1px solid var(--border); border-radius: 6px; }\n .clause-title { font-weight: bold; color: var(--primary-blue); display: block; margin-bottom: 10px; }\n \n ul { padding-left: 20px; }\n li { margin-bottom: 10px; }\n\n .note-box { background: #fffde7; border-left: 4px solid #fbc02d; padding: 15px; font-size: 14px; margin: 15px 0; color: #5d4037; }\n \n .param-table { width: 100%; border-collapse: collapse; margin: 25px 0; }\n .param-table th { background: var(--primary-blue); color: white; padding: 12px; text-align: left; }\n .param-table td { padding: 12px; border: 1px solid var(--border); font-size: 15px; }\n\n \/* Footer CTA *\/\n .footer-contact {\n text-align: center;\n padding: 50px 20px;\n background: var(--bg-light);\n margin-top: 60px;\n border-top: 1px solid var(--border);\n }\n <\/style>\n<\/head>\n<body>\n\n<div class=\"top-action-bar\">\n <a href=\"https:\/\/zjbocon.com\/contact\/\" class=\"btn btn-blue\"><i class=\"fas fa-envelope\"><\/i> Contact Us<\/a>\n <a href=\"https:\/\/wa.me\/8619975258603\" class=\"btn btn-whatsapp\"><i class=\"fab fa-whatsapp\"><\/i> WhatsApp<\/a>\n<\/div>\n\n<article class=\"article-container\">\n <h1>Technical Requirements for Parametric Release in EO Sterilization<\/h1>\n <p style=\"color: #636e72;\">Guidelines based on GB\/Z 44877-2024 and GB 18279-2023<\/p>\n\n <section>\n <h2>1. Equipment Control and Monitoring Capabilities<\/h2>\n <p>In addition to the requirements of GB 18279-2023 Chapter 10, the equipment must possess the following monitoring capabilities for parametric release:<\/p>\n <div class=\"clause-item\">\n <ul>\n <li><strong>Airflow Management:<\/strong> Pre-conditioning rooms, sterilizers, and aeration rooms must be equipped with air circulation devices, anemometers, or other measures to monitor internal airflow.<\/li>\n <li><strong>Humidity:<\/strong> Direct measurement of chamber humidity during the treatment phase.<\/li>\n <li><strong>Concentration:<\/strong> Direct measurement of Ethylene Oxide (EO) concentration at specified intervals during exposure.<\/li>\n <li><strong>Temperature:<\/strong> Monitoring at a minimum of two independent locations within the chamber.<\/li>\n <\/ul>\n <\/div>\n <p>All monitoring and recording systems must be defined, characterized, and documented. Sensor placement must be representative of the actual chamber state.<\/p>\n <\/section>\n\n <section>\n <h2>2. Critical Parameter Specifications<\/h2>\n\n <h3>2.1 Humidity Monitoring<\/h3>\n <p>Humidity can be measured as Relative Humidity (RH) or Absolute Humidity.<\/p>\n \n <ul>\n <li><strong>Relative Humidity:<\/strong> Typically measured using capacitance film technology to determine vapor pressure density at a given temperature.<\/li>\n <li><strong>Absolute Humidity:<\/strong> Measures water concentration in a specific volume of air, often using spectroscopic techniques.<\/li>\n <li><strong>Calibration:<\/strong> Electronic RH sensors (capacitance film) should be calibrated using saturated salt solutions or certified RH generation systems.<\/li>\n <\/ul>\n <div class=\"note-box\">\n <strong>Note:<\/strong> EO exposure causes accuracy drift. Frequent validation or calibration is necessary. If isolated sensors are used, heating or insulation must be applied to prevent internal condensation.\n <\/div>\n\n <h3>2.2 Ethylene Oxide (EO) Concentration<\/h3>\n <p>The accuracy and precision of the EO measurement system must be documented. Two primary techniques are used:<\/p>\n <table class=\"param-table\">\n <thead>\n <tr><th>Technology<\/th><th>Mechanism<\/th><\/tr>\n <\/thead>\n <tbody>\n <tr><td><strong>Spectroscopy (IR)<\/strong><\/td><td>Measures infrared light absorption by EO molecules.<\/td><\/tr>\n <tr><td><strong>Gas Chromatography (GC)<\/strong><\/td><td>Separates EO via a column and quantifies concentration via a standard curve.<\/td><\/tr>\n <\/tbody>\n <\/table>\n \n <p>For measurements taken outside the chamber, additional factors must be addressed:<\/p>\n <ul>\n <li>Pipe length and material compatibility (e.g., specific stainless steel grades).<\/li>\n <li>Leakage potential at connection points.<\/li>\n <li><strong>Heat Tracing:<\/strong> Insulation of sampling lines to minimize condensation risk of EO or water vapor.<\/li>\n <li>Mechanical extraction (pumps or fans) from the chamber.<\/li>\n <\/ul>\n\n <h3>2.3 Temperature Monitoring<\/h3>\n <p>Consistency in instrumentation is required for both parametric and biological indicator release. Parametric release requires <strong>at least two independent monitoring locations<\/strong>.<\/p>\n <div class=\"note-box\">\n If data is averaged, all sensors must be of the same type (e.g., Thermocouples, RTDs, or Pt100) with identical accuracy and precision specifications.\n <\/div>\n <\/section>\n\n <section>\n <h2>3. Process Definition and Performance Qualification (PQ)<\/h2>\n <div class=\"clause-item\">\n <span class=\"clause-title\">3.1 Specification Establishment<\/span>\n Specifications for humidity and EO concentration are established through the analysis of data obtained during process development or PQ.\n <ul>\n <li><strong>Minimum Specifications:<\/strong> Established via microbial and physical PQ studies to ensure the required Sterility Assurance Level (SAL).<\/li>\n <li><strong>Maximum Specifications:<\/strong> Established to ensure product safety, quality, and performance while minimizing EO residuals (per GB\/T 16886.7).<\/li>\n <\/ul>\n <\/div>\n\n <div class=\"clause-item\">\n <span class=\"clause-title\">3.2 Additional PQ Cycles<\/span>\n Parametric release may require additional performance qualification cycles to establish suitable process parameters and tolerances. This includes:\n <ul>\n <li>Cycles at <strong>lower limits<\/strong> of process parameters (humidity, temp, EO) to confirm sterility.<\/li>\n <li>Cycles at <strong>upper limits<\/strong> to evaluate product\/packaging functionality and EO residual levels.<\/li>\n <\/ul>\n <\/div>\n <\/section>\n\n <div class=\"footer-contact\">\n <h3>Expert Technical Support for EO Sterilization<\/h3>\n <p>Need help with sensor calibration or parametric release validation?<\/p>\n <div style=\"margin-top: 25px;\">\n <a href=\"https:\/\/zjbocon.com\/contact\/\" class=\"btn btn-blue\">Visit Contact Page<\/a>\n <a href=\"https:\/\/wa.me\/8619975258603\" class=\"btn btn-whatsapp\">Direct WhatsApp Message<\/a>\n <\/div>\n <\/div>\n<\/article>\n\n<\/body>\n<\/html>\n","protected":false},"excerpt":{"rendered":"<p>Technical standards for EO sterilization parametric release per GB\/Z 44877-2024. Covers airflow monitoring, spectroscopic humidity\/EO concentration sensing, temperature uniformity, and PQ bound cycle validation<\/p>\n","protected":false},"author":234312599,"featured_media":9517,"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":"default","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","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[1],"tags":[],"class_list":["post-9526","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"\n<title>Technical Requirements for Parametric Release in EO Sterilization - 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High-precision EO sterilizers are specifically designed to meet the demanding needs\u2026","rel":"","context":"In "Company News"","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\/ethylene-oxide-sterilization-3-scaled.webp?resize=350%2C200&ssl=1","width":350,"height":200,"srcset":"https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-3-scaled.webp?resize=350%2C200&ssl=1 1x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-3-scaled.webp?resize=525%2C300&ssl=1 1.5x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-3-scaled.webp?resize=700%2C400&ssl=1 2x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-3-scaled.webp?resize=1050%2C600&ssl=1 3x, https:\/\/i0.wp.com\/zjbocon.com\/wp-content\/uploads\/2025\/09\/ethylene-oxide-sterilization-3-scaled.webp?resize=1400%2C800&ssl=1 4x"},"classes":[]}],"_links":{"self":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/9526","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=9526"}],"version-history":[{"count":1,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/9526\/revisions"}],"predecessor-version":[{"id":9527,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/posts\/9526\/revisions\/9527"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=\/wp\/v2\/media\/9517"}],"wp:attachment":[{"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=9526"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=9526"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/zjbocon.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=9526"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}<span class ="tr_" id="tr_0" data-source="" data-orig="{"id":9526,"date":"2026-03-17T13:16:15","date_gmt":"2026-03-17T05:16:15","guid":{"rendered":"https:\/\/zjbocon.com\/?p=9526"},"modified":"2026-03-17T13:16:19","modified_gmt":"2026-03-17T05:16:19","slug":"technical-requirements-for-parametric-release-in-eo-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=9526","title":{"rendered":"Technical Requirements for Parametric Release in EO Sterilization"},"content":{"rendered":"\n" data-hidden="y"></span><span class ="tr_" id="tr_1" data-source="" data-orig="\n" data-hidden="y"></span><span class ="tr_" id="tr_2" data-source="" data-orig="\n" data-hidden="y"></span><span class ="tr_" id="tr_3" data-source="" data-orig="\n" data-hidden="y"></span><span class ="tr_" id="tr_4" data-source="" data-orig="\n" data-hidden="y"></span><span class ="tr_" id="tr_5" data-source="" data-orig="\n" data-hidden="y"></span><span class ="tr_" id="tr_6" data-source="" data-orig="Parametric Release Standards for EO Sterilization | GB\/Z 44877-2024" data-hidden="y"></span><span class ="tr_" id="tr_7" data-source="" data-orig="\n" data-hidden="y"></span><span class ="tr_" id="tr_8" data-source="" data-orig="\n" data-hidden="y"></span> <meta name="translation-stats" content='{"total_phrases":11,"translated_phrases":null,"human_translated_phrases":null,"hidden_phrases":null,"hidden_translated_phrases":null,"hidden_translateable_phrases":null,"meta_phrases":2,"meta_translated

{"id":9526,"date":"2026-03-17T13:16:15","date_gmt":"2026-03-17T05:16:15","guid":{"rendered":"https:\/\/zjbocon.com\/?p=9526"},"modified":"2026-03-17T13:16:19","modified_gmt":"2026-03-17T05:16:19","slug":"technical-requirements-for-parametric-release-in-eo-sterilization","status":"publish","type":"post","link":"https:\/\/zjbocon.com\/?p=9526","title":{"rendered":"Technical Requirements for Parametric Release in EO Sterilization"},"content":{"rendered":"\n\n\n\n \n \n Parametric Release Standards for EO Sterilization | GB\/Z 44877-2024<\/title>\n <meta name=\"description\" content=\"Technical requirements for parametric release in EO sterilization: humidity, concentration, and temperature monitoring per GB\>\n <link href=\"https:\/\/cdnjs.cloudflare.com\/ajax\/libs\/font-awesome\/6.0.0\/css\/all.min.css\" rel=\"stylesheet\">\n <style>\n :root {\n --primary-blue: #004182;\n --bg-light: #f9fbfc;\n --text-main: #2d3436;\n --whatsapp-green: #25D366;\n --border: #e1e8ed;\n }\n\n body {\n font-family: 'Segoe UI', Arial, sans-serif;\n line-height: 1.8;\n color: var(--text-main);\n margin: 0;\n padding: 0;\n background: #fff;\n }\n\n \/* Top Bar with Buttons *\/\n .top-action-bar {\n max-width: 1000px;\n margin: 20px auto;\n padding: 0 20px;\n display: flex;\n justify-content: flex-end;\n gap: 12px;\n }\n\n .btn {\n padding: 10px 22px;\n border-radius: 4px;\n text-decoration: none;\n font-weight: 600;\n font-size: 14px;\n display: inline-flex;\n align-items: center;\n gap: 8px;\n transition: 0.3s;\n }\n .btn-blue { background: var(--primary-blue); color: white; }\n .btn-whatsapp { background: var(--whatsapp-green); color: white; }\n .btn:hover { opacity: 0.9; transform: translateY(-1px); }\n\n \/* Article Wrapper *\/\n .article-container {\n max-width: 850px;\n margin: 0 auto;\n padding: 40px 20px;\n }\n\n h1 { color: var(--primary-blue); font-size: 30px; border-bottom: 3px solid var(--primary-blue); padding-bottom: 15px; margin-bottom: 40px; }\n h2 { font-size: 22px; color: var(--primary-blue); background: var(--bg-light); padding: 12px 20px; border-left: 5px solid var(--primary-blue); margin-top: 40px; }\n h3 { font-size: 18px; color: var(--primary-blue); margin-top: 30px; border-bottom: 1px solid var(--border); padding-bottom: 5px; }\n\n .clause-item { margin-bottom: 25px; padding: 15px; border: 1px solid var(--border); border-radius: 6px; }\n .clause-title { font-weight: bold; color: var(--primary-blue); display: block; margin-bottom: 10px; }\n \n ul { padding-left: 20px; }\n li { margin-bottom: 10px; }\n\n .note-box { background: #fffde7; border-left: 4px solid #fbc02d; padding: 15px; font-size: 14px; margin: 15px 0; color: #5d4037; }\n \n .param-table { width: 100%; border-collapse: collapse; margin: 25px 0; }\n .param-table th { background: var(--primary-blue); color: white; padding: 12px; text-align: left; }\n .param-table td { padding: 12px; border: 1px solid var(--border); font-size: 15px; }\n\n \/* Footer CTA *\/\n .footer-contact {\n text-align: center;\n padding: 50px 20px;\n background: var(--bg-light);\n margin-top: 60px;\n border-top: 1px solid var(--border);\n }\n <\/style>\n<\/head>\n<body>\n\n<div class=\"top-action-bar\">\n <a href=\"https:\/\/zjbocon.com\/contact\/\" class=\"btn btn-blue\"><i class=\"fas fa-envelope\"><\/i> Contact Us<\/a>\n <a href=\"https:\/\/wa.me\/8619975258603\" class=\"btn btn-whatsapp\"><i class=\"fab fa-whatsapp\"><\/i> WhatsApp<\/a>\n<\/div>\n\n<article class=\"article-container\">\n <h1>Technical Requirements for Parametric Release in EO Sterilization<\/h1>\n <p style=\"color: #636e72;\">Guidelines based on GB\/Z 44877-2024 and GB 18279-2023<\/p>\n\n <section>\n <h2>1. Equipment Control and Monitoring Capabilities<\/h2>\n <p>In addition to the requirements of GB 18279-2023 Chapter 10, the equipment must possess the following monitoring capabilities for parametric release:<\/p>\n <div class=\"clause-item\">\n <ul>\n <li><strong>Airflow Management:<\/strong> Pre-conditioning rooms, sterilizers, and aeration rooms must be equipped with air circulation devices, anemometers, or other measures to monitor internal airflow.<\/li>\n <li><strong>Humidity:<\/strong> Direct measurement of chamber humidity during the treatment phase.<\/li>\n <li><strong>Concentration:<\/strong> Direct measurement of Ethylene Oxide (EO) concentration at specified intervals during exposure.<\/li>\n <li><strong>Temperature:<\/strong> Monitoring at a minimum of two independent locations within the chamber.<\/li>\n <\/ul>\n <\/div>\n <p>All monitoring and recording systems must be defined, characterized, and documented. Sensor placement must be representative of the actual chamber state.<\/p>\n <\/section>\n\n <section>\n <h2>2. Critical Parameter Specifications<\/h2>\n\n <h3>2.1 Humidity Monitoring<\/h3>\n <p>Humidity can be measured as Relative Humidity (RH) or Absolute Humidity.<\/p>\n \n <ul>\n <li><strong>Relative Humidity:<\/strong> Typically measured using capacitance film technology to determine vapor pressure density at a given temperature.<\/li>\n <li><strong>Absolute Humidity:<\/strong> Measures water concentration in a specific volume of air, often using spectroscopic techniques.<\/li>\n <li><strong>Calibration:<\/strong> Electronic RH sensors (capacitance film) should be calibrated using saturated salt solutions or certified RH generation systems.<\/li>\n <\/ul>\n <div class=\"note-box\">\n <strong>Note:<\/strong> EO exposure causes accuracy drift. Frequent validation or calibration is necessary. If isolated sensors are used, heating or insulation must be applied to prevent internal condensation.\n <\/div>\n\n <h3>2.2 Ethylene Oxide (EO) Concentration<\/h3>\n <p>The accuracy and precision of the EO measurement system must be documented. Two primary techniques are used:<\/p>\n <table class=\"param-table\">\n <thead>\n <tr><th>Technology<\/th><th>Mechanism<\/th><\/tr>\n <\/thead>\n <tbody>\n <tr><td><strong>Spectroscopy (IR)<\/strong><\/td><td>Measures infrared light absorption by EO molecules.<\/td><\/tr>\n <tr><td><strong>Gas Chromatography (GC)<\/strong><\/td><td>Separates EO via a column and quantifies concentration via a standard curve.<\/td><\/tr>\n <\/tbody>\n <\/table>\n \n <p>For measurements taken outside the chamber, additional factors must be addressed:<\/p>\n <ul>\n <li>Pipe length and material compatibility (e.g., specific stainless steel grades).<\/li>\n <li>Leakage potential at connection points.<\/li>\n <li><strong>Heat Tracing:<\/strong> Insulation of sampling lines to minimize condensation risk of EO or water vapor.<\/li>\n <li>Mechanical extraction (pumps or fans) from the chamber.<\/li>\n <\/ul>\n\n <h3>2.3 Temperature Monitoring<\/h3>\n <p>Consistency in instrumentation is required for both parametric and biological indicator release. Parametric release requires <strong>at least two independent monitoring locations<\/strong>.<\/p>\n <div class=\"note-box\">\n If data is averaged, all sensors must be of the same type (e.g., Thermocouples, RTDs, or Pt100) with identical accuracy and precision specifications.\n <\/div>\n <\/section>\n\n <section>\n <h2>3. Process Definition and Performance Qualification (PQ)<\/h2>\n <div class=\"clause-item\">\n <span class=\"clause-title\">3.1 Specification Establishment<\/span>\n Specifications for humidity and EO concentration are established through the analysis of data obtained during process development or PQ.\n <ul>\n <li><strong>Minimum Specifications:<\/strong> Established via microbial and physical PQ studies to ensure the required Sterility Assurance Level (SAL).<\/li>\n <li><strong>Maximum Specifications:<\/strong> Established to ensure product safety, quality, and performance while minimizing EO residuals (per GB\/T 16886.7).<\/li>\n <\/ul>\n <\/div>\n\n <div class=\"clause-item\">\n <span class=\"clause-title\">3.2 Additional PQ Cycles<\/span>\n Parametric release may require additional performance qualification cycles to establish suitable process parameters and tolerances. This includes:\n <ul>\n <li>Cycles at <strong>lower limits<\/strong> of process parameters (humidity, temp, EO) to confirm sterility.<\/li>\n <li>Cycles at <strong>upper limits<\/strong> to evaluate product\/packaging functionality and EO residual levels.<\/li>\n <\/ul>\n <\/div>\n <\/section>\n\n <div class=\"footer-contact\">\n <h3>Expert Technical Support for EO Sterilization<\/h3>\n <p>Need help with sensor calibration or parametric release validation?<\/p>\n <div style=\"margin-top: 25px;\">\n <a href=\"https:\/\/zjbocon.com\/contact\/\" class=\"btn btn-blue\">Visit Contact Page<\/a>\n <a href=\"https:\/\/wa.me\/8619975258603\" class=\"btn btn-whatsapp\">Direct WhatsApp Message<\/a>\n <\/div>\n <\/div>\n<\/article>\n\n<\/body>\n<\/html>\n","protected":false},"excerpt":{"rendered":"<p>Technical standards for EO sterilization parametric release per GB\/Z 44877-2024. 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