{"id":5756,"date":"2026-10-25T22:49:01","date_gmt":"2026-10-25T22:49:01","guid":{"rendered":"https:\/\/28.feihuaweiye.com\/what-is-aseptic-or-non-aseptic-liquid-filling-machine-validation\/"},"modified":"2026-11-07T06:51:34","modified_gmt":"2026-11-07T06:51:34","slug":"what-is-aseptic-or-non-aseptic-liquid-filling-machine-validation","status":"publish","type":"post","link":"https:\/\/28.feihuaweiye.com\/ko\/what-is-aseptic-or-non-aseptic-liquid-filling-machine-validation\/","title":{"rendered":"What is Aseptic or Non-Aseptic Liquid Filling Machine Validation?"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-post\" data-elementor-id=\"5756\" class=\"elementor elementor-5756\" data-elementor-settings=\"{&quot;ha_cmc_init_switcher&quot;:&quot;no&quot;}\" data-elementor-post-type=\"post\">\n\t\t\t\t<div class=\"elementor-element elementor-element-51e7efc e-con-boxed e-flex e-con e-parent\" data-id=\"51e7efc\" data-element_type=\"container\" data-e-type=\"container\" 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class=\"elementor-element elementor-element-323076a elementor-invisible elementor-widget elementor-widget-image\" data-id=\"323076a\" data-element_type=\"widget\" data-e-type=\"widget\" data-settings=\"{&quot;_animation&quot;:&quot;fadeInUp&quot;}\" data-widget_type=\"image.default\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img fetchpriority=\"high\" decoding=\"async\" width=\"850\" height=\"500\" src=\"https:\/\/28.feihuaweiye.com\/wp-content\/uploads\/2026\/10\/liquid-filling-machine-validation-01.png\" class=\"attachment-full size-full wp-image-5757\" alt=\"\" srcset=\"https:\/\/28.feihuaweiye.com\/wp-content\/uploads\/2026\/10\/liquid-filling-machine-validation-01.png 850w, https:\/\/28.feihuaweiye.com\/wp-content\/uploads\/2026\/10\/liquid-filling-machine-validation-01-300x176.png 300w, https:\/\/28.feihuaweiye.com\/wp-content\/uploads\/2026\/10\/liquid-filling-machine-validation-01-768x452.png 768w, https:\/\/28.feihuaweiye.com\/wp-content\/uploads\/2026\/10\/liquid-filling-machine-validation-01-18x12.png 18w\" sizes=\"(max-width: 850px) 100vw, 850px\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-508741d elementor-widget elementor-widget-post-info\" data-id=\"508741d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"post-info.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<ul class=\"elementor-inline-items elementor-icon-list-items elementor-post-info\">\n\t\t\t\t\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item- elementor-inline-item\" itemprop=\"author\">\n\t\t\t\t\t\t<a href=\"https:\/\/28.feihuaweiye.com\/ko\/author\/admin\/\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-user-circle\" viewBox=\"0 0 496 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path 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elementor-inline-item\" itemprop=\"author datePublished\">\n\t\t\t\t\t\t<a href=\"https:\/\/28.feihuaweiye.com\/ko\/author\/admin\/ https:\/\/28.feihuaweiye.com\/ko\/2026\/10\/25\/\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-fas-calendar\" viewBox=\"0 0 448 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M12 192h424c6.6 0 12 5.4 12 12v260c0 26.5-21.5 48-48 48H48c-26.5 0-48-21.5-48-48V204c0-6.6 5.4-12 12-12zm436-44v-36c0-26.5-21.5-48-48-48h-48V12c0-6.6-5.4-12-12-12h-40c-6.6 0-12 5.4-12 12v52H160V12c0-6.6-5.4-12-12-12h-40c-6.6 0-12 5.4-12 12v52H48C21.5 64 0 85.5 0 112v36c0 6.6 5.4 12 12 12h424c6.6 0 12-5.4 12-12z\"><\/path><\/svg>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-author elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date\">\n\t\t\t\t\t\t\t\t\t\t<time>October 25, 2026<\/time>\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item- elementor-inline-item elementor-icon-list-item elementor-repeater-item- elementor-inline-item elementor-icon-list-item elementor-repeater-item- elementor-inline-item\" itemprop=\"author datePublished\">\n\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-clock\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M256 8C119 8 8 119 8 256s111 248 248 248 248-111 248-248S393 8 256 8zm0 448c-110.5 0-200-89.5-200-200S145.5 56 256 56s200 89.5 200 200-89.5 200-200 200zm61.8-104.4l-84.9-61.7c-3.1-2.3-4.9-5.9-4.9-9.7V116c0-6.6 5.4-12 12-12h32c6.6 0 12 5.4 12 12v141.7l66.8 48.6c5.4 3.9 6.5 11.4 2.6 16.8L334.6 349c-3.9 5.3-11.4 6.5-16.8 2.6z\"><\/path><\/svg>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-author elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-time\">\n\t\t\t\t\t\t\t\t\t\t<time>10:49 pm<\/time>\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t<\/li>\n\t\t\t\t<li class=\"elementor-icon-list-item elementor-repeater-item- elementor-inline-item elementor-icon-list-item elementor-repeater-item- elementor-inline-item elementor-icon-list-item elementor-repeater-item- elementor-inline-item elementor-icon-list-item elementor-repeater-item- elementor-inline-item\" itemprop=\"author datePublished commentCount\">\n\t\t\t\t\t\t<a href=\"https:\/\/28.feihuaweiye.com\/ko\/author\/admin\/ https:\/\/28.feihuaweiye.com\/ko\/2026\/10\/25\/ https:\/\/28.feihuaweiye.com\/ko\/what-is-aseptic-or-non-aseptic-liquid-filling-machine-validation\/#respond\">\n\t\t\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-icon\">\n\t\t\t\t\t\t\t\t<svg aria-hidden=\"true\" class=\"e-font-icon-svg e-far-comment-dots\" viewBox=\"0 0 512 512\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\"><path d=\"M144 208c-17.7 0-32 14.3-32 32s14.3 32 32 32 32-14.3 32-32-14.3-32-32-32zm112 0c-17.7 0-32 14.3-32 32s14.3 32 32 32 32-14.3 32-32-14.3-32-32-32zm112 0c-17.7 0-32 14.3-32 32s14.3 32 32 32 32-14.3 32-32-14.3-32-32-32zM256 32C114.6 32 0 125.1 0 240c0 47.6 19.9 91.2 52.9 126.3C38 405.7 7 439.1 6.5 439.5c-6.6 7-8.4 17.2-4.6 26S14.4 480 24 480c61.5 0 110-25.7 139.1-46.3C192 442.8 223.2 448 256 448c141.4 0 256-93.1 256-208S397.4 32 256 32zm0 368c-26.7 0-53.1-4.1-78.4-12.1l-22.7-7.2-19.5 13.8c-14.3 10.1-33.9 21.4-57.5 29 7.3-12.1 14.4-25.7 19.9-40.2l10.6-28.1-20.6-21.8C69.7 314.1 48 282.2 48 240c0-88.2 93.3-160 208-160s208 71.8 208 160-93.3 160-208 160z\"><\/path><\/svg>\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<span class=\"elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-author elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-date elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-time elementor-icon-list-text elementor-post-info__item elementor-post-info__item--type-comments\">\n\t\t\t\t\t\t\t\t\t\tNo Comments\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t<\/a>\n\t\t\t\t<\/li>\n\t\t\t\t<\/ul>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7ab156d elementor-widget elementor-widget-text-editor\" data-id=\"7ab156d\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t\t\t\t\t\t\n<p>Liquid filling machine validation is the documented process of proving that a filling line, alone or as part of an integrated liquid manufacturing system, consistently fills containers within predefined specifications and protects the product\u2019s quality attributes, including sterility and container closure integrity where they apply, throughout routine production. The objective is to show that the equipment, operated under defined conditions, repeatedly delivers conforming product over time.<\/p>\n<p>Every major GMP framework asks for the same thing in different words. WHO\u2019s guidelines on validation (TRS 1019, Annex 3) set out qualification and validation as a lifecycle, with a dedicated appendix on<span style=\"color: #993300;\"><strong> Qualification<\/strong><\/span>. In th<span style=\"color: #993300;\">e<a href=\"\/white-paper-on-21-cfr-part-11-compliance-for-pharmaceutical-liquid-filling-and-capping-machines\/\" style=\"color: #993300;\"><strong> US, 21 CFR 211.68(a)<\/strong><\/a><\/span> requires automatic and mechanical equipment to be \u201croutinely calibrated, inspected, or checked according to a written program\u201d , and FDA\u2019s process validation guidance describes the three-stage lifecycle of process design, process qualification and continued process verification. For sterile lines, the revised <strong>EU GMP Annex 1<\/strong>, published in August 2022 and in operation from 25 August 2023, adds the contamination control strategy (CCS) as the frame around every filling decision.<\/p>\n<p>Qualification:<br\/>\nEquipment qualification (DQ, IQ, OQ, PQ) is about the machine and its utilities: that the design meets GMP, that it is installed as designed, that it operates across its specified ranges, and that it performs with production materials or qualified substitutes under normal operating conditions.<\/p>\n<!--[googlesitekit-end-of-content]-->\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cd27972 elementor-post-navigation-borders-yes elementor-widget elementor-widget-post-navigation\" data-id=\"cd27972\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"post-navigation.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div 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for=\"cxb_hp_1a572bd\">Leave this field empty<\/label>\n                        <input type=\"text\" id=\"cxb_hp_1a572bd\" name=\"cxb_form_hp\"\n                               tabindex=\"-1\" autocomplete=\"off\" value=\"\" \/>\n                    <\/div>\n                    <input type=\"hidden\" name=\"cxb_form_hp_on\" value=\"1\" \/>\n                \n                                <input type=\"hidden\" name=\"cxb_form_rendered_at\" class=\"cxb-form-rendered-at\" value=\"\" \/>\n                <input type=\"hidden\" name=\"cxb_form_min_seconds\" value=\"3\" \/>\n\n                \n                \n                <div class=\"cxb-form-actions\">\n                    <button type=\"submit\" class=\"cxb-form-submit\">\n                        Submit Inquiry                    <\/button>\n                <\/div>\n\n                \n                                    <div class=\"cxb-form-message\" role=\"alert\" aria-live=\"polite\" style=\"display:none;\"><\/div>\n                            <\/form>\n        <\/div>\n        \t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Liquid filling machine validation is the documented process of proving that a filling line, alone or as part of an [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5757,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[108],"tags":[],"class_list":["post-5756","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-gmp-fda-validation"],"_links":{"self":[{"href":"https:\/\/28.feihuaweiye.com\/ko\/wp-json\/wp\/v2\/posts\/5756","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/28.feihuaweiye.com\/ko\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/28.feihuaweiye.com\/ko\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/28.feihuaweiye.com\/ko\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/28.feihuaweiye.com\/ko\/wp-json\/wp\/v2\/comments?post=5756"}],"version-history":[{"count":1,"href":"https:\/\/28.feihuaweiye.com\/ko\/wp-json\/wp\/v2\/posts\/5756\/revisions"}],"predecessor-version":[{"id":6463,"href":"https:\/\/28.feihuaweiye.com\/ko\/wp-json\/wp\/v2\/posts\/5756\/revisions\/6463"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/28.feihuaweiye.com\/ko\/wp-json\/wp\/v2\/media\/5757"}],"wp:attachment":[{"href":"https:\/\/28.feihuaweiye.com\/ko\/wp-json\/wp\/v2\/media?parent=5756"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/28.feihuaweiye.com\/ko\/wp-json\/wp\/v2\/categories?post=5756"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/28.feihuaweiye.com\/ko\/wp-json\/wp\/v2\/tags?post=5756"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}