{"id":8205,"date":"2026-06-25T09:52:02","date_gmt":"2026-06-25T02:52:02","guid":{"rendered":"https:\/\/airfiltech.vn\/air-filtech-nang-cap-he-thong-loc-khi-phong-sach-cho-nha-may-duoc-pham-dat-tieu-chuan-eu-gmp-annex-1\/"},"modified":"2026-08-25T10:07:28","modified_gmt":"2026-08-25T03:07:28","slug":"air-filtech-nang-cap-he-thong-loc-khi-phong-sach-cho-nha-may-duoc-pham-dat-tieu-chuan-eu-gmp-annex-1","status":"publish","type":"post","link":"https:\/\/airfiltech.vn\/en\/air-filtech-upgrades-cleanroom-air-filtration-system-at-pharmaceutical-plant-to-eu-gmp-annex-1\/","title":{"rendered":"Air Filtech Upgrades Cleanroom Air Filtration System at Pharmaceutical Plant to EU GMP Annex 1"},"content":{"rendered":"<h2>Air Filtech Completes Cleanroom Air Filtration Upgrade to EU GMP Annex 1 Standards for a Pharmaceutical Factory in Binh Duong<\/h2>\n<p>Air Filtech has recently completed a comprehensive cleanroom air filtration system upgrade for a pharmaceutical factory in Binh Duong Industrial Park, enabling the system to meet the <strong>EU GMP Annex 1 (2022 revision)<\/strong> requirements \u2014 mandatory standards for pharmaceutical manufacturing facilities supplying the European market.<\/p>\n<h3>Project Scope<\/h3>\n<p>The project included the replacement and upgrade of the air filtration system for four cleanroom areas classified as <strong>Grade A\/B\/C\/D<\/strong>, covering a total area of more than <strong>1,200 m\u00b2<\/strong>.<\/p>\n<p>Air Filtech implemented a comprehensive solution including:<\/p>\n<ul>\n<li><strong>Camfil H14 HEPA filters<\/strong> for Grade A and Grade B areas, achieving a filtration efficiency of \u226599.995% at MPPS in accordance with EN 1822.<\/li>\n<li><strong>Terminal Housing Green<\/strong> \u2014 an Air Filtech specialized product \u2014 installed throughout the ceiling area of the sterile compounding cleanroom.<\/li>\n<li>A tiered positive-pressure control system maintaining a differential pressure of \u226515 Pa between cleanroom grades.<\/li>\n<li>Optimized airflow direction and contamination control in accordance with EU GMP Annex 1 requirements.<\/li>\n<\/ul>\n<h3>Customer Feedback<\/h3>\n<p>Mr. Nguyen Van Minh \u2014 the factory\u2019s Technical Director \u2014 shared:<\/p>\n<blockquote><p>&#8220;After Air Filtech completed the upgrade, we passed our first GMP inspection by the European regulatory authority without any observations requiring corrective action. This achievement was the result of thorough preparation with Air Filtech, from the design stage through to final acceptance.&#8221;<\/p><\/blockquote>\n<h3>Testing and Handover<\/h3>\n<p>The entire project was handed over with a complete set of technical documentation to support GMP assessment:<\/p>\n<ul>\n<li><strong>IQ\/OQ (Installation Qualification \/ Operational Qualification)<\/strong> documentation.<\/li>\n<li>Results of HEPA filter leak and integrity testing using the <strong>DOP\/PAO test<\/strong> method.<\/li>\n<li>A plan for periodic HEPA filter inspection every 12 months in accordance with EU GMP Annex 1 requirements.<\/li>\n<\/ul>\n<h3>Trusted Partner in Clean Air Filtration<\/h3>\n<p>Air Filtech is currently a cleanroom air filtration solutions provider for more than <strong>30 factories<\/strong> across the pharmaceutical, food, and semiconductor industries in Vietnam.<\/p>\n<p><strong>\u2192 Learn more about cleanroom solutions:<\/strong> <a href=\"https:\/\/airfiltech.vn\/giai-phap\/khi-sach-cleanroom\">airfiltech.vn\/giai-phap\/khi-sach-cleanroom<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Air Filtech Completes Cleanroom Air Filtration Upgrade to EU GMP Annex 1 Standards for a Pharmaceutical Factory in Binh Duong Air Filtech has recently completed a comprehensive cleanroom air filtration system upgrade for a pharmaceutical factory in Binh Duong Industrial Park, enabling the system to meet the EU GMP Annex 1 (2022 revision) requirements \u2014 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[396,336],"tags":[397,351,399,400,387],"class_list":["post-8205","post","type-post","status-publish","format-standard","hentry","category-giai-phap-khi-sach-cleanroom","category-pharmaceuticals","tag-air-filtech","tag-cleanroom","tag-duoc-pham","tag-eu-gmp","tag-hepa"],"acf":[],"_links":{"self":[{"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/posts\/8205","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=8205"}],"version-history":[{"count":2,"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/posts\/8205\/revisions"}],"predecessor-version":[{"id":8207,"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/posts\/8205\/revisions\/8207"}],"wp:attachment":[{"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/media?parent=8205"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/categories?post=8205"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/airfiltech.vn\/en\/wp-json\/wp\/v2\/tags?post=8205"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}