{"id":8069,"date":"2026-06-28T05:04:07","date_gmt":"2026-06-27T22:04:07","guid":{"rendered":"https:\/\/airfiltech.vn\/gmp-va-eu-gmp-yeu-cau-gi-ve-he-thong-loc-khi-phong-sach\/"},"modified":"2026-08-20T20:33:27","modified_gmt":"2026-08-20T13:33:27","slug":"gmp-va-eu-gmp-yeu-cau-gi-ve-he-thong-loc-khi-phong-sach","status":"publish","type":"post","link":"https:\/\/airfiltech.vn\/en\/what-do-gmp-and-eu-gmp-require-for-cleanroom-air-filtration-systems\/","title":{"rendered":"What Do GMP and EU GMP Require for Cleanroom Air Filtration Systems?"},"content":{"rendered":"<h2>GMP and EU GMP Requirements for Cleanroom Air Filtration Systems<\/h2>\n<p>In the pharmaceutical industry, air quality control is not merely a technical requirement \u2014 it is a mandatory legal condition. GMP (Good Manufacturing Practice) and EU GMP Annex 1 (2022 revision) set strict standards for cleanroom classification, air change rates, filter efficiency, and periodic testing protocols for each production area.<\/p>\n<h3>1. Cleanroom Classification under Pharmaceutical GMP<\/h3>\n<p>GMP divides manufacturing environments into four grades:<\/p>\n<ul>\n<li><strong>Grade A:<\/strong> Direct product contact zones (filling, open vials, aseptic compounding) \u2014 equivalent to ISO Class 5. Requires unidirectional airflow \u22650.45 m\/s and HEPA H14 filters.<\/li>\n<li><strong>Grade B:<\/strong> Background environment for Grade A \u2014 ISO Class 5 (in operation), \u226520 ACH, HEPA H13\/H14.<\/li>\n<li><strong>Grade C:<\/strong> Less critical preparation steps \u2014 ISO Class 7 (in operation), \u226515 ACH, HEPA filtration.<\/li>\n<li><strong>Grade D:<\/strong> Support areas and primary packaging \u2014 ISO Class 8, F9\/H10 filtration.<\/li>\n<\/ul>\n<h3>2. Specific Requirements under EU GMP Annex 1 (2022)<\/h3>\n<p>The 2022 revision emphasises the <strong>Contamination Control Strategy (CCS)<\/strong> \u2014 a comprehensive contamination management framework in which the HVAC system and filters play a central role. Key requirements include:<\/p>\n<ul>\n<li><strong>HEPA filter integrity testing:<\/strong> DOP\/PAO testing at least every 12 months.<\/li>\n<li><strong>Air distribution:<\/strong> The system must not create dead zones or turbulence within Grade A areas.<\/li>\n<li><strong>Positive pressure cascade:<\/strong> Grade A &gt; B &gt; C &gt; D, with \u226510\u201315 Pa differential pressure between grades.<\/li>\n<li><strong>Continuous particle monitoring:<\/strong> Required in Grade A and B areas during production.<\/li>\n<\/ul>\n<h3>3. Air Filtech Solutions for Pharmaceutical Facilities<\/h3>\n<p>Air Filtech supplies a complete filtration chain designed to support compliance with GMP and EU GMP Annex 1 requirements:<\/p>\n<ul>\n<li><strong>G4\/M5 pre-filters:<\/strong> Protect HEPA filters and extend system service life.<\/li>\n<li><strong>F7\/F9 intermediate filters:<\/strong> Capture fine particles and support Grade C\/D filtration requirements.<\/li>\n<li><strong>Camfil HEPA H13\/H14:<\/strong> Globally trusted filtration solutions with efficiency of \u226599.95\u201399.995% at MPPS.<\/li>\n<li><strong>Terminal Housing Green:<\/strong> Air Filtech&#8217;s 304 stainless steel terminal housing, designed for easy filter replacement and suitable for Grade A\/B ceiling installation.<\/li>\n<li><strong>FFU (Fan Filter Unit):<\/strong> Suitable for mobile Grade A zones and laminar flow workstations.<\/li>\n<\/ul>\n<p>All HEPA\/ULPA products carry EN 1822 certification with batch-specific test certificates.<\/p>\n<p>Air Filtech has deployed GMP-compliant air filtration systems at numerous pharmaceutical plants in Vietnam, including:<\/p>\n<ul>\n<li><strong>DHG Pharmaceutical Company (Can Tho)<\/strong> \u2014 Upgraded HVAC systems for Grade A\/B cleanrooms to support EU GMP Annex 1 compliance.<\/li>\n<li><strong>Imexpharm Pharmaceutical Plant (Dong Thap)<\/strong> \u2014 Installed HEPA H14 filters and Terminal Housing throughout aseptic compounding areas.<\/li>\n<li><strong>Central Pharmaceutical Company No. 1 (Hanoi)<\/strong> \u2014 Implemented a comprehensive filtration solution across three manufacturing plants.<\/li>\n<\/ul>\n<p>Each project includes complete IQ\/OQ documentation to support GMP qualification and inspection requirements.<\/p>\n<p><strong>Free Consultation:<\/strong><br \/>\nHotline: <a href=\"tel:0899944666\">08 999 44 666<\/a><br \/>\nEmail: <a href=\"mailto:info@airfiltech.vn\">info@airfiltech.vn<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Going green and reducing your carbon footprint are important steps towards creating a more sustainable future for our planet. There are many simple changes that you can make in your daily life that can have a significant impact on reducing your carbon footprint and helping the environment.<\/p>\n","protected":false},"author":1,"featured_media":7881,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[336],"tags":[352],"class_list":["post-8069","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharmaceuticals","tag-gmp"],"acf":[],"_links":{"self":[{"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/posts\/8069","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/comments?post=8069"}],"version-history":[{"count":1,"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/posts\/8069\/revisions"}],"predecessor-version":[{"id":8070,"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/posts\/8069\/revisions\/8070"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/media\/7881"}],"wp:attachment":[{"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/media?parent=8069"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/categories?post=8069"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/tags?post=8069"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}