{"id":8782,"date":"2026-05-06T10:14:05","date_gmt":"2026-05-06T10:14:05","guid":{"rendered":"https:\/\/www.q-bitallifesciences.com\/?page_id=7470"},"modified":"2026-06-24T13:49:06","modified_gmt":"2026-06-24T13:49:06","slug":"aseptic-cleanroom-suite-double-module-cgmp","status":"publish","type":"page","link":"https:\/\/www.vanguardlifesciences.co.uk\/fr_fr\/aseptic-cleanroom-suite-double-module-cgmp\/","title":{"rendered":"Salle blanche aseptique (module double) conforme aux BPF"},"content":{"rendered":"<section id=\"section-2-59\" class=\"ct-section\" style=\"background-image:url(https:\/\/www.vanguardlifesciences.co.uk\/wp-content\/uploads\/sites\/9\/2023\/05\/boulders-right.png);background-size: auto;\" >\n<div class=\"ct-section-inner-wrap\">\n<div id=\"div_block-8-59\" class=\"ct-div-block\" ><a id=\"link_text-6-59\" class=\"ct-link-text\" href=\"\/fr_fr\/\" target=\"_self\"  >Maison<\/a><\/p>\n<h1 id=\"headline-3-59\" class=\"ct-headline\"><span id=\"span-4-59\" class=\"ct-span\" >Salle blanche aseptique (module double) conforme aux BPF<\/span><\/h1>\n<\/div>\n<\/div>\n<\/section>\n<section id=\"section-68-14-text-left-white\" class=\"ct-section\" >\n<div class=\"ct-section-inner-wrap\">\n<div id=\"new_columns-69-14text-left-white\" class=\"ct-new-columns\" >\n<div id=\"div_block-70-14\" class=\"ct-div-block\" >\n<h2 id=\"headline-71-14\" class=\"ct-headline\">Aper\u00e7u<\/h2>\n<div id=\"_rich_text-72-14\" class=\"oxy-rich-text\" >\n<p>La solution Aseptic Cleanroom Suite (Double Module) cGMP a \u00e9t\u00e9 d\u00e9velopp\u00e9e pour les fabricants pharmaceutiques, les organisations de biotechnologie, les CDMO et les fournisseurs de th\u00e9rapies avanc\u00e9es n\u00e9cessitant des environnements de traitement st\u00e9riles enti\u00e8rement contr\u00f4l\u00e9s.<\/p>\n<p>L&#039;installation prend en charge les proc\u00e9d\u00e9s de fabrication aseptique o\u00f9 la ma\u00eetrise de l&#039;environnement, la pr\u00e9vention de la contamination et la validation des performances op\u00e9rationnelles sont essentielles. Chaque suite est con\u00e7ue en fonction des flux de production, des d\u00e9placements du personnel et des exigences de transfert de mati\u00e8res afin de garantir des op\u00e9rations de production efficaces et conformes aux normes.<\/p>\n<p>La configuration modulaire offre une alternative performante \u00e0 la construction traditionnelle, permettant aux organisations d&#039;accro\u00eetre leur capacit\u00e9 de production st\u00e9rile, de soutenir des projets de r\u00e9novation ou d&#039;introduire de nouvelles capacit\u00e9s de production avec des d\u00e9lais de programme et des perturbations sur site consid\u00e9rablement r\u00e9duits.<\/p>\n<\/div>\n<\/div>\n<div id=\"div_block-74-14\" class=\"ct-div-block\" ><img decoding=\"async\"  id=\"image-75-14\" alt=\"\" src=\"https:\/\/www.vanguardlifesciences.co.uk\/wp-content\/uploads\/sites\/9\/2026\/06\/RENDER-RESIZE-FOR-WEBSITE.png\" class=\"ct-image\"\/><\/div>\n<\/div>\n<\/div>\n<\/section>\n<section id=\"section-88-34-blue\" class=\"ct-section\" >\n<div class=\"ct-section-inner-wrap\">\n<div id=\"new_columns-89-34-blue\" class=\"ct-new-columns\" >\n<div id=\"div_block-94-34\" class=\"ct-div-block\" ><img decoding=\"async\"  id=\"image-95-34\" alt=\"\" src=\"https:\/\/www.vanguardlifesciences.co.uk\/wp-content\/uploads\/sites\/9\/2026\/06\/RENDER-RESIZE-FOR-WEBSITE-1.png\" class=\"ct-image\"\/><\/div>\n<div id=\"div_block-90-34\" class=\"ct-div-block\" >\n<h2 id=\"headline-91-34\" class=\"ct-headline\">Caract\u00e9ristiques principales<\/h2>\n<div id=\"_rich_text-92-34\" class=\"oxy-rich-text\" >\n<ul>\n<li>Les salles blanches aseptiques de classe B et C abritent des isolateurs garantissant le plus haut niveau de st\u00e9rilit\u00e9, dans des environnements de classe A.<\/li>\n<li>Zones de salles blanches de classe C et D<\/li>\n<li>La temp\u00e9rature est g\u00e9n\u00e9ralement maintenue entre 20 et 22 \u00b0C.<\/li>\n<li>L&#039;humidit\u00e9 relative est limit\u00e9e \u00e0 60% HR afin d&#039;\u00e9viter la formation de condensation sur les surfaces.<\/li>\n<li>Cascade de pression positive conforme aux exigences des BPF<\/li>\n<li>Syst\u00e8mes de traitement d&#039;air d\u00e9di\u00e9s avec filtration HEPA H14<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section id=\"section-68-14-text-left-white\" class=\"ct-section\" >\n<div class=\"ct-section-inner-wrap\">\n<div id=\"new_columns-69-14text-left-white\" class=\"ct-new-columns\" >\n<div id=\"div_block-70-14\" class=\"ct-div-block\" >\n<h2 id=\"headline-71-14\" class=\"ct-headline\">Con\u00e7u pour la conformit\u00e9<\/h2>\n<div id=\"_rich_text-72-14\" class=\"oxy-rich-text\" >\n<p><strong>Ces salles blanches sont con\u00e7ues pour r\u00e9pondre aux exigences de\u00a0:<\/strong><\/p>\n<ul>\n<li>Conforme aux BPF de l&#039;UE, y compris les mises \u00e0 jour de l&#039;annexe 1<\/li>\n<li>Normes de salles blanches ISO 14644<\/li>\n<li>Directives de fabrication aseptique de la MHRA et de la FDA<\/li>\n<li>normes de construction de salles blanches BS EN<\/li>\n<li>R\u00e9glementation COSHH<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div id=\"div_block-74-14\" class=\"ct-div-block\" ><img decoding=\"async\"  id=\"image-75-14\" alt=\"\" src=\"https:\/\/www.vanguardlifesciences.co.uk\/wp-content\/uploads\/sites\/9\/2026\/02\/2-14.png\" class=\"ct-image\"\/><\/div>\n<\/div>\n<\/div>\n<\/section>\n<section id=\"section-88-34-blue\" class=\"ct-section\" >\n<div class=\"ct-section-inner-wrap\">\n<div id=\"new_columns-89-34-blue\" class=\"ct-new-columns\" >\n<div id=\"div_block-94-34\" class=\"ct-div-block\" ><img decoding=\"async\"  id=\"image-95-34\" alt=\"\" src=\"https:\/\/www.vanguardlifesciences.co.uk\/wp-content\/uploads\/sites\/9\/2025\/08\/MCA18.jpeg\" class=\"ct-image\"\/><\/div>\n<div id=\"div_block-90-34\" class=\"ct-div-block\" >\n<h2 id=\"headline-91-34\" class=\"ct-headline\">\u00c9quipements et flux de travail int\u00e9gr\u00e9s<\/h2>\n<div id=\"_rich_text-92-34\" class=\"oxy-rich-text\" >\n<p>L&#039;installation est con\u00e7ue pour accueillir les \u00e9quipements critiques de traitement aseptique, notamment les isolateurs, le mobilier de salle blanche et les syst\u00e8mes de support de processus.<\/p>\n<p>Des zones de soutien telles que les zones de pr\u00e9paration, les espaces d&#039;assurance qualit\u00e9, les installations de stockage et de st\u00e9rilisation peuvent \u00eatre int\u00e9gr\u00e9es au sein du b\u00e2timent h\u00f4te afin de garantir un flux de travail efficace et la conformit\u00e9.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/section>\n<section id=\"section-68-14-text-left-white\" class=\"ct-section\" >\n<div class=\"ct-section-inner-wrap\">\n<div id=\"new_columns-69-14text-left-white\" class=\"ct-new-columns\" >\n<div id=\"div_block-70-14\" class=\"ct-div-block\" >\n<h2 id=\"headline-71-14\" class=\"ct-headline\">Pr\u00eat pour la validation d\u00e8s sa conception<\/h2>\n<div id=\"_rich_text-72-14\" class=\"oxy-rich-text\" >\n<p><strong>Chaque installation est livr\u00e9e avec une mise en service et une validation compl\u00e8tes, comprenant\u00a0:<\/strong><\/p>\n<ul>\n<li>test d&#039;int\u00e9grit\u00e9 des filtres HEPA<\/li>\n<li>Visualisation du flux d&#039;air et v\u00e9rification du renouvellement d&#039;air<\/li>\n<li>Comptage de particules et surveillance environnementale<\/li>\n<li>Tests de temp\u00e9rature et d&#039;humidit\u00e9<\/li>\n<li>tests de r\u00e9cup\u00e9ration en salle blanche<\/li>\n<li>Une documentation compl\u00e8te est fournie, incluant les protocoles DQ, IQ et OQ, garantissant une pr\u00e9paration compl\u00e8te \u00e0 l&#039;audit d\u00e8s le premier jour.<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<div id=\"div_block-74-14\" class=\"ct-div-block\" ><img decoding=\"async\"  id=\"image-75-14\" alt=\"\" src=\"https:\/\/www.vanguardlifesciences.co.uk\/wp-content\/uploads\/sites\/9\/2025\/02\/Vanguard-Ribbon-Cutting-Drone-Photography-2-scaled.jpg\" class=\"ct-image\"\/><\/div>\n<\/div>\n<\/div>\n<\/section>\n<section id=\"section-144-59\" class=\"ct-section\" >\n<div class=\"ct-section-inner-wrap\">\n<div id=\"new_columns-145-59\" class=\"ct-new-columns\" >\n<div id=\"div_block-146-59\" class=\"ct-div-block\" >\n<div id=\"_rich_text-9-63\" class=\"oxy-rich-text\" >\n<p>Trouver une solution adapt\u00e9e \u00e0 votre organisation des sciences de la vie commence ici.<\/p>\n<\/div>\n<p><a id=\"link_button-149-59\" class=\"ct-link-button\" href=\"\/fr_fr\/contact\/\" target=\"_self\"  >Entrer en contact<\/a><\/div>\n<div id=\"div_block-150-59\" class=\"ct-div-block\" ><img decoding=\"async\"  id=\"image-151-59\" alt=\"\" src=\"https:\/\/www.vanguardlifesciences.co.uk\/wp-content\/uploads\/sites\/9\/2026\/02\/1-13.png\" class=\"ct-image\"\/><\/div>\n<\/div>\n<\/div>\n<\/section>","protected":false},"excerpt":{"rendered":"","protected":false},"author":11,"featured_media":7425,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-8782","page","type-page","status-publish","format-standard","has-post-thumbnail","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Aseptic Cleanroom Suite (Double Module) cGMP - Vanguard Life Sciences<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.vanguardlifesciences.co.uk\/fr_fr\/aseptic-cleanroom-suite-double-module-cgmp\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta 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