{"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\/de_de\/aseptic-cleanroom-suite-double-module-cgmp\/","title":{"rendered":"Aseptischer Reinraum (Doppelmodul) cGMP"},"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=\"\/de_de\/\" target=\"_self\"  >Heim<\/a><\/p>\n<h1 id=\"headline-3-59\" class=\"ct-headline\"><span id=\"span-4-59\" class=\"ct-span\" >Aseptischer Reinraum (Doppelmodul) cGMP<\/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\">\u00dcberblick<\/h2>\n<div id=\"_rich_text-72-14\" class=\"oxy-rich-text\" >\n<p>Die Aseptic Cleanroom Suite (Double Module) cGMP-L\u00f6sung wurde f\u00fcr pharmazeutische Hersteller, Biotechnologieunternehmen, CDMOs und Anbieter von neuartigen Therapien entwickelt, die vollst\u00e4ndig kontrollierte sterile Verarbeitungsumgebungen ben\u00f6tigen.<\/p>\n<p>Die Anlage unterst\u00fctzt aseptische Fertigungsprozesse, bei denen Umweltkontrolle, Kontaminationsvermeidung und validierte Betriebsleistung von entscheidender Bedeutung sind. Jede Suite ist auf Prozessabl\u00e4ufe, Personalbewegungen und Materialtransferanforderungen ausgelegt, um einen effizienten und regelkonformen Produktionsbetrieb zu gew\u00e4hrleisten.<\/p>\n<p>Die modulare Bauweise bietet eine leistungsstarke Alternative zur traditionellen Bauweise und erm\u00f6glicht es Unternehmen, die Kapazit\u00e4ten f\u00fcr die sterile Fertigung zu erweitern, Sanierungsprojekte zu unterst\u00fctzen oder neue Produktionskapazit\u00e4ten einzuf\u00fchren \u2013 und das mit deutlich reduzierten Projektlaufzeiten und minimalen Beeintr\u00e4chtigungen vor Ort.<\/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\">Hauptmerkmale<\/h2>\n<div id=\"_rich_text-92-34\" class=\"oxy-rich-text\" >\n<ul>\n<li>Kontrollierte aseptische Reinr\u00e4ume der Klassen B und C beherbergen Isolatoren mit dem h\u00f6chsten Sterilit\u00e4tsgrad, Umgebungen der Klasse A<\/li>\n<li>Unterst\u00fctzung von Reinraumbereichen der Klassen C und D<\/li>\n<li>Die Temperaturregelung wird typischerweise auf 20\u201322 \u00b0C gehalten.<\/li>\n<li>Die relative Luftfeuchtigkeit ist auf 601 % RH begrenzt, um die Bildung von Kondenswasser auf den Oberfl\u00e4chen zu verhindern.<\/li>\n<li>\u00dcberdruckkaskade gem\u00e4\u00df den cGMP-Anforderungen<\/li>\n<li>Spezielle L\u00fcftungssysteme mit HEPA-H14-Filterung<\/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\">Auf Konformit\u00e4t ausgelegt<\/h2>\n<div id=\"_rich_text-72-14\" class=\"oxy-rich-text\" >\n<p><strong>Diese Reinraumsuiten sind so konzipiert, dass sie die Anforderungen folgender Bereiche erf\u00fcllen:<\/strong><\/p>\n<ul>\n<li>EU-GMP-konform einschlie\u00dflich Aktualisierungen in Anhang 1<\/li>\n<li>ISO 14644 Reinraumstandards<\/li>\n<li>Leitlinien der MHRA und FDA zur aseptischen Herstellung<\/li>\n<li>BS EN Reinraumbaunormen<\/li>\n<li>COSHH-Vorschriften<\/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\">Integrierte Ausr\u00fcstung und Arbeitsabl\u00e4ufe<\/h2>\n<div id=\"_rich_text-92-34\" class=\"oxy-rich-text\" >\n<p>Die Anlage ist so konzipiert, dass sie kritische aseptische Verarbeitungsanlagen aufnehmen kann, darunter Isolatoren, Reinraumm\u00f6bel und Prozessunterst\u00fctzungssysteme.<\/p>\n<p>Unterst\u00fctzende Bereiche wie Vorbereitungszonen, Qualit\u00e4tssicherungsr\u00e4ume, Lager- und Sterilisationseinrichtungen k\u00f6nnen in das Hauptgeb\u00e4ude integriert werden, um einen effizienten Arbeitsablauf und die Einhaltung der Vorschriften zu gew\u00e4hrleisten.<\/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\">Validierungsbereit von Grund auf \u2013 so konzipiert<\/h2>\n<div id=\"_rich_text-72-14\" class=\"oxy-rich-text\" >\n<p><strong>Jede Anlage wird mit vollst\u00e4ndiger Inbetriebnahme und Validierung geliefert, einschlie\u00dflich:<\/strong><\/p>\n<ul>\n<li>Integrit\u00e4tspr\u00fcfung von HEPA-Filtern<\/li>\n<li>Visualisierung des Luftstroms und \u00dcberpr\u00fcfung des Luftwechsels<\/li>\n<li>Partikelz\u00e4hlung und Umwelt\u00fcberwachung<\/li>\n<li>Temperatur- und Feuchtigkeitspr\u00fcfung<\/li>\n<li>Reinraum-Wiederherstellungstests<\/li>\n<li>Eine umfassende Dokumentation, einschlie\u00dflich DQ-, IQ- und OQ-Protokollen, wird bereitgestellt, um die volle Auditbereitschaft vom ersten Tag an zu gew\u00e4hrleisten.<\/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>Die Suche nach einer passenden L\u00f6sung f\u00fcr Ihr Life-Sciences-Unternehmen beginnt hier<\/p>\n<\/div>\n<p><a id=\"link_button-149-59\" class=\"ct-link-button\" href=\"\/de_de\/contact\/\" target=\"_self\"  >In Kontakt kommen<\/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 v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ 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