{"id":309,"date":"2026-08-26T02:28:12","date_gmt":"2026-08-26T02:28:12","guid":{"rendered":"https:\/\/fenggu-bio.com\/eu-gmp-annex-1\/"},"modified":"2026-08-26T02:35:00","modified_gmt":"2026-08-26T02:35:00","slug":"eu-gmp-annex-1","status":"publish","type":"post","link":"https:\/\/fenggu-bio.com\/ru\/eu-gmp-annex-1\/","title":{"rendered":"EU GMP Annex 1: What It Means for Isolators, RABS and Cleanroom Equipment"},"content":{"rendered":"<style>\n.entry-title,.ast-single-post .entry-header{display:none!important}\n.fg-art{font-family:-apple-system,BlinkMacSystemFont,\"Segoe UI\",Roboto,\"Helvetica Neue\",Arial,sans-serif;color:#1e2838;line-height:1.72;max-width:820px;margin:0 auto;padding:0 22px;font-size:16.5px}\n.fg-art .fg-eyebrow{display:inline-block;background:#e3ecfa;color:#003AA1;font-weight:700;font-size:12px;letter-spacing:.7px;padding:5px 13px;border-radius:20px;text-transform:uppercase;margin:34px 0 14px}\n.fg-art h1{font-size:33px;line-height:1.2;color:#002B78;margin:0 0 12px;font-weight:800}\n.fg-art .meta{font-size:13.5px;color:#7a8699;margin:0 0 26px;border-bottom:1px solid #e6ebf3;padding-bottom:18px}\n.fg-art h2{font-size:23px;color:#002B78;margin:38px 0 12px;line-height:1.28}\n.fg-art p{margin:0 0 16px}\n.fg-art .lead{font-size:18px;color:#3a4658}\n.fg-art figure{margin:26px 0}\n.fg-art img{width:100%;border-radius:12px;box-shadow:0 6px 22px rgba(0,58,161,.12);display:block}\n.fg-art figcaption{font-size:13px;color:#7a8699;margin-top:9px;text-align:center}\n.fg-art table{border-collapse:collapse;width:100%;margin:22px 0;font-size:14.5px}\n.fg-art th,.fg-art td{border:1px solid #d7dfea;padding:11px 14px;text-align:left;vertical-align:top}\n.fg-art thead th{background:#002B78;color:#fff;font-weight:700}\n.fg-art tbody th{background:#eff4fb;color:#002B78;font-weight:700;width:24%}\n.fg-art tbody tr:nth-child(even) td{background:#f7f9fc}\n.fg-art ul{margin:0 0 16px;padding-left:22px}.fg-art li{margin:7px 0}\n.fg-art .fg-cta{background:linear-gradient(120deg,#002B78,#003AA1);color:#fff;border-radius:14px;padding:30px 28px;margin:38px 0 10px;text-align:center}\n.fg-art .fg-cta h3{color:#fff;font-size:22px;margin:0 0 8px}\n.fg-art .fg-cta p{color:#dce7f7;margin:0 0 18px;font-size:15.5px}\n.fg-art .fg-btn{display:inline-block;background:#EC001B;color:#fff;padding:13px 28px;border-radius:6px;font-weight:600;font-size:15.5px;text-decoration:none;margin:0 6px 8px}\n.fg-art .fg-btn.o{background:transparent;border:2px solid rgba(255,255,255,.7)}\n.fg-art a{color:#003AA1;text-decoration:underline}\n.fg-art .fg-cta a{text-decoration:none;color:#fff}\n@media(max-width:640px){.fg-art h1{font-size:26px}.fg-art th,.fg-art td{padding:9px 10px;font-size:13.5px}.fg-art tbody th{width:34%}}\n<\/style>\n<article class=\"fg-art\">\n<span class=\"fg-eyebrow\">Regulatory<\/span><\/p>\n<h1>EU GMP Annex 1: What It Means for Isolators, RABS and Cleanroom Equipment<\/h1>\n<div class=\"meta\">By Fenggu Medical Equipment &middot; Pharmaceutical Isolation &amp; Containment<\/div>\n<p class=\"lead\">EU GMP Annex 1 &mdash; &#8220;Manufacture of Sterile Medicinal Products&#8221; &mdash; is the reference standard for sterile pharmaceutical manufacturing in Europe, and it shapes equipment decisions worldwide. The 2022 revision put a formal <strong>Contamination Control Strategy (CCS)<\/strong> at the centre and strongly encourages barrier technologies such as isolators and RABS. This guide summarises the parts of Annex 1 that drive equipment selection, without turning it into legal advice.<\/p>\n<figure>\n<img width=\"900\" height=\"675\" decoding=\"async\" src=\"\/wp-content\/uploads\/site\/cutout-orabs.jpg\" alt=\"Open RABS barrier system aligned with EU GMP Annex 1 principles\"><figcaption>Annex 1 favours separating the operator from the critical zone with barrier technology.<\/figcaption><\/figure>\n<h2>What is Annex 1?<\/h2>\n<p>Annex 1 is part of the EU Good Manufacturing Practice (GMP) guidelines governing the manufacture of sterile medicinal products &mdash; injectables, ophthalmics, biologics and other products that must be sterile. The current version was published in 2022 and came into effect in 2023; it is more prescriptive than its predecessors and is widely referenced by manufacturers who also work to FDA cGMP expectations.<\/p>\n<h2>The Contamination Control Strategy (CCS)<\/h2>\n<p>The defining idea of the revision is the <strong>CCS<\/strong>: a documented, facility-wide plan that identifies every contamination risk and the controls that manage it &mdash; from facility and equipment design to personnel, utilities, cleaning and monitoring. Equipment is not chosen in isolation; each item must be justified as part of this overall strategy. Barrier systems, bio-decontamination and pressure regimes all become elements of the CCS.<\/p>\n<h2>Barrier systems: isolators and RABS<\/h2>\n<p>Annex 1 makes clear that technologies which separate operators from the critical zone should be considered to reduce the risk of microbial contamination from people. In practice this means <a href=\"\/ru\/products\/aseptic-filling-isolator\/\">isolators<\/a> and <a href=\"\/ru\/products\/open-rabs-orabs\/\">RABS<\/a>. Choosing between them is itself part of the CCS &mdash; see <a href=\"\/ru\/isolator-vs-rabs\/\">Isolator vs RABS<\/a> for how the two compare on assurance, background grade and cost.<\/p>\n<h2>Cleanroom grades and air<\/h2>\n<p>Annex 1 uses cleanliness grades A, B, C and D, with Grade A being the critical zone for aseptic operations. These grades map to particle limits similar to <a href=\"\/ru\/iso-14644-cleanroom-classification\/\">ISO 14644-1 classification<\/a>. The standard emphasises unidirectional airflow protecting the critical zone, defined pressure cascades between rooms, and HEPA filtration &mdash; delivered by equipment such as laminar-flow hoods, filling-line laminar units and airtight doors that maintain the pressure boundary.<\/p>\n<h2>Bio-decontamination and transfer<\/h2>\n<p>A validatable, residue-free bio-decontamination method is central to isolator and closed-RABS operation. Vaporized hydrogen peroxide is the usual choice &mdash; see <a href=\"\/ru\/what-is-vhp-decontamination\/\">What Is VHP Decontamination<\/a>. Material entering the critical zone must also be handled without breaking containment, using a <a href=\"\/ru\/products\/vhp-pass-box\/\">VHP pass box<\/a> or an <a href=\"\/ru\/products\/airlock-vhp-sterilization\/\">airlock with VHP sterilization<\/a> for larger loads.<\/p>\n<h2>Environmental monitoring and QC<\/h2>\n<p>Annex 1 expects thorough environmental and process monitoring, and sterility testing remains a release requirement for many products. A <a href=\"\/ru\/products\/sterility-test-isolator\/\">sterility test isolator<\/a> provides the controlled Grade A environment such testing needs while protecting the sample from false positives.<\/p>\n<h2>What Annex 1 means for your equipment list<\/h2>\n<table>\n<thead>\n<tr>\n<th>Annex 1 theme<\/th>\n<th>Typical equipment<\/th>\n<\/tr>\n<\/thead>\n<tbody>\n<tr>\n<th>Operator separation<\/th>\n<td>Aseptic filling isolators, open\/closed RABS<\/td>\n<\/tr>\n<tr>\n<th>Bio-decontamination<\/th>\n<td>VHP generators and VHP-integrated barriers<\/td>\n<\/tr>\n<tr>\n<th>Contained material transfer<\/th>\n<td>VHP pass boxes, airlocks, transfer valves\/RTP<\/td>\n<\/tr>\n<tr>\n<th>Air and pressure control<\/th>\n<td>Laminar-flow units, HEPA terminals, airtight doors<\/td>\n<\/tr>\n<tr>\n<th>QC \/ release<\/th>\n<td>Sterility test isolators<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p>None of this equipment is compliant on its own &mdash; compliance comes from the design, qualification (DQ\/IQ\/OQ\/PQ) and the documented CCS around it. Fenggu equipment is engineered to support these principles; the certifications and qualification package for any specific project are confirmed per order.<\/p>\n<div class=\"fg-cta\">\n<h3>Building an Annex 1-aligned aseptic line?<\/h3>\n<p>Share your process and cleanroom layout, and our engineers will help specify isolators, RABS, transfer and VHP equipment that fit your contamination control strategy.<\/p>\n<p><a class=\"fg-btn\" href=\"\/ru\/products\/aseptic-filling-isolator\/\">View Isolators &amp; RABS<\/a><br \/>\n<a class=\"fg-btn o\" href=\"\/ru\/contact\/\">Talk to an Engineer<\/a>\n<\/div>\n<\/article>","protected":false},"excerpt":{"rendered":"<p>Regulatory EU GMP Annex 1: What It Means for Isolators, RABS and Cleanroom Equipment By Fenggu Medical Equipment &middot; Pharmaceutical [&hellip;]<\/p>\n","protected":false},"author":0,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"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":""}},"footnotes":""},"categories":[1],"tags":[],"class_list":["post-309","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/fenggu-bio.com\/ru\/wp-json\/wp\/v2\/posts\/309","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/fenggu-bio.com\/ru\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/fenggu-bio.com\/ru\/wp-json\/wp\/v2\/types\/post"}],"replies":[{"embeddable":true,"href":"https:\/\/fenggu-bio.com\/ru\/wp-json\/wp\/v2\/comments?post=309"}],"version-history":[{"count":2,"href":"https:\/\/fenggu-bio.com\/ru\/wp-json\/wp\/v2\/posts\/309\/revisions"}],"predecessor-version":[{"id":311,"href":"https:\/\/fenggu-bio.com\/ru\/wp-json\/wp\/v2\/posts\/309\/revisions\/311"}],"wp:attachment":[{"href":"https:\/\/fenggu-bio.com\/ru\/wp-json\/wp\/v2\/media?parent=309"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/fenggu-bio.com\/ru\/wp-json\/wp\/v2\/categories?post=309"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/fenggu-bio.com\/ru\/wp-json\/wp\/v2\/tags?post=309"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}