{"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\/sv_se\/aseptic-cleanroom-suite-double-module-cgmp\/","title":{"rendered":"Aseptisk renrumssvit (dubbelmodul) 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=\"\/sv_se\/\" target=\"_self\"  >Hem<\/a><\/p>\n<h1 id=\"headline-3-59\" class=\"ct-headline\"><span id=\"span-4-59\" class=\"ct-span\" >Aseptisk renrumssvit (dubbelmodul) 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\">\u00d6versikt<\/h2>\n<div id=\"_rich_text-72-14\" class=\"oxy-rich-text\" >\n<p>Aseptic Cleanroom Suite (dubbelmodul) cGMP-l\u00f6sning har utvecklats f\u00f6r l\u00e4kemedelstillverkare, bioteknikorganisationer, CDMO:er och leverant\u00f6rer av avancerad terapi som kr\u00e4ver helt kontrollerade sterila processmilj\u00f6er.<\/p>\n<p>Anl\u00e4ggningen st\u00f6der aseptiska tillverkningsprocesser d\u00e4r milj\u00f6kontroll, kontamineringsf\u00f6rebyggande \u00e5tg\u00e4rder och validerad driftsprestanda \u00e4r avg\u00f6rande. Varje svit \u00e4r utformad kring processfl\u00f6de, personalf\u00f6rflyttning och material\u00f6verf\u00f6ringskrav f\u00f6r att st\u00f6dja effektiv och efterlevnadsv\u00e4nlig produktionsverksamhet.<\/p>\n<p>Den modul\u00e4ra konfigurationen erbjuder ett h\u00f6gpresterande alternativ till traditionell konstruktion, vilket g\u00f6r det m\u00f6jligt f\u00f6r organisationer att ut\u00f6ka steril tillverkningskapacitet, st\u00f6dja renoveringsprojekt eller introducera ny produktionskapacitet med avsev\u00e4rt minskade programtider och st\u00f6rningar p\u00e5 anl\u00e4ggningen.<\/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\">Viktiga funktioner<\/h2>\n<div id=\"_rich_text-92-34\" class=\"oxy-rich-text\" >\n<ul>\n<li>Kontrollerade aseptiska renrum av klass B och C inneh\u00e5ller isolatorer med h\u00f6gsta sterilitetsniv\u00e5, i klass A-milj\u00f6er<\/li>\n<li>St\u00f6djer renrumsomr\u00e5den av klass C och D<\/li>\n<li>Temperaturkontrollen h\u00e5lls vanligtvis vid 20\u201322 \u00b0C<\/li>\n<li>Relativ luftfuktighet begr\u00e4nsad till 60% RH f\u00f6r att f\u00f6rhindra kondensbildning p\u00e5 ytor<\/li>\n<li>Positivt tryckkaskad i linje med cGMP-krav<\/li>\n<li>Dedikerade luftbehandlingssystem med HEPA H14-filtrering<\/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\">Byggd f\u00f6r efterlevnad<\/h2>\n<div id=\"_rich_text-72-14\" class=\"oxy-rich-text\" >\n<p><strong>Dessa renrumssviter \u00e4r utformade f\u00f6r att uppfylla kraven f\u00f6r:<\/strong><\/p>\n<ul>\n<li>Uppfyller EU GMP-kraven inklusive uppdateringar av bilaga 1<\/li>\n<li>ISO 14644 renrumsstandarder<\/li>\n<li>MHRA och FDA:s riktlinjer f\u00f6r aseptisk tillverkning<\/li>\n<li>BS EN standarder f\u00f6r renrumskonstruktion<\/li>\n<li>COSHH-f\u00f6reskrifter<\/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\">Integrerad utrustning och arbetsfl\u00f6de<\/h2>\n<div id=\"_rich_text-92-34\" class=\"oxy-rich-text\" >\n<p>Anl\u00e4ggningen \u00e4r utformad f\u00f6r att rymma kritisk aseptisk processutrustning, inklusive isolatorer, renrumsm\u00f6bler och processst\u00f6dsystem.<\/p>\n<p>St\u00f6djande omr\u00e5den som f\u00f6rberedelsezoner, kvalitetss\u00e4kringsutrymmen, f\u00f6rvaring och steriliseringsanl\u00e4ggningar kan integreras i v\u00e4rdbyggnaden f\u00f6r att s\u00e4kerst\u00e4lla effektivt arbetsfl\u00f6de och efterlevnad.<\/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\">Valideringsklar enligt design<\/h2>\n<div id=\"_rich_text-72-14\" class=\"oxy-rich-text\" >\n<p><strong>Varje anl\u00e4ggning levereras med fullst\u00e4ndig drifts\u00e4ttning och validering, inklusive:<\/strong><\/p>\n<ul>\n<li>HEPA-filterintegritetstestning<\/li>\n<li>Visualisering av luftfl\u00f6de och verifiering av luftv\u00e4xling<\/li>\n<li>Partikelr\u00e4kning och milj\u00f6\u00f6vervakning<\/li>\n<li>Temperatur- och fuktighetstestning<\/li>\n<li>\u00c5terh\u00e4mtningstestning i renrum<\/li>\n<li>Omfattande dokumentation tillhandah\u00e5lls, inklusive DQ-, IQ- och OQ-protokoll, vilket s\u00e4kerst\u00e4ller fullst\u00e4ndig revisionsberedskap fr\u00e5n dag ett<\/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>Att hitta en l\u00f6sning som fungerar f\u00f6r din life science-organisation b\u00f6rjar h\u00e4r<\/p>\n<\/div>\n<p><a id=\"link_button-149-59\" class=\"ct-link-button\" href=\"\/sv_se\/contact\/\" target=\"_self\"  >Komma i kontakt<\/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 v28.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Aseptic Cleanroom Suite (Double Module) cGMP - Vanguard Life Sciences<\/title>\n<meta name=\"robots\" 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