{"id":171483,"date":"2025-03-07T05:11:31","date_gmt":"2025-03-07T05:11:31","guid":{"rendered":"https:\/\/www.maryatech.com\/?post_type=product&#038;p=171483"},"modified":"2025-03-07T05:11:36","modified_gmt":"2025-03-07T05:11:36","slug":"ligne-de-production-de-tringlerie-isolateur","status":"publish","type":"product","link":"https:\/\/www.maryatech.com\/fr\/product\/linkage-production-line-isolator\/","title":{"rendered":"Isolateur de la ligne de production de tringlerie"},"content":{"rendered":"<p>Ses principales fonctions sont les suivantes<br \/>\nAssurance de la st\u00e9rilit\u00e9 : Lors de la production de pr\u00e9parations st\u00e9riles (telles que les injections et les produits biologiques), maintenir un environnement propre de classe A afin d'\u00e9viter toute contamination microbienne.<br \/>\nPr\u00e9vention et contr\u00f4le de la contamination crois\u00e9e : Lors de la production d'IPA ou de m\u00e9dicaments hautement actifs (tels que les m\u00e9dicaments cytotoxiques et les hormones), il convient d'\u00e9viter les fuites de substances nocives et de prot\u00e9ger la s\u00e9curit\u00e9 du personnel et de l'environnement.<br \/>\nStabilit\u00e9 des processus : R\u00e9duire l'intervention humaine et l'impact des fluctuations environnementales sur la qualit\u00e9 des produits.<\/p>\n<p>Performances et caract\u00e9ristiques<\/p>\n<ol>\n<li><strong><b>Un portefeuille de produits complet :<\/b><\/strong>syst\u00e8mes d'isolation pour l'injection d'eau, l'injection de poudre, les seringues pr\u00e9-remplies et les lignes de production de poudre st\u00e9rile ;<\/li>\n<li><strong><b>Environnement stable et fiable :<\/b><\/strong>environnement fiable et stable de classe A, qui r\u00e9pond aux exigences cGMP, FDA, ISO, ISPE et de la pharmacop\u00e9e ;<\/li>\n<li><strong><b>Nouvelle technologie VHPS :<\/b><\/strong>le dernier H<sub>2<\/sub>O<sub>2<\/sub>\u00a0qui permet une st\u00e9rilisation rapide, le contr\u00f4le de la concentration et de la saturation en H<sub>2<\/sub>O<sub>2<\/sub>, avec une bonne reproductibilit\u00e9 de la st\u00e9rilisation ;<\/li>\n<li><strong><b>Syst\u00e8me de contr\u00f4le intelligent :<\/b><\/strong>Syst\u00e8me de contr\u00f4le Siemens PLC+IPC ; alarmes intelligentes de pression, H<sub>2<\/sub>O<sub>2<\/sub>\u00a0la concentration de la solution, la temp\u00e9rature et l'humidit\u00e9, la vitesse de l'air et d'autres param\u00e8tres de surveillance ; le syst\u00e8me dispose d'un contr\u00f4le d'acc\u00e8s \u00e0 plusieurs niveaux ; il est conforme aux exigences de la FDA 21 CFR part 11 ;<\/li>\n<li><strong><b>Mode de contr\u00f4le ind\u00e9pendant de la temp\u00e9rature et de l'humidit\u00e9 :<\/b><\/strong>Gr\u00e2ce au syst\u00e8me de climatisation ind\u00e9pendant int\u00e9gr\u00e9, la temp\u00e9rature et l'humidit\u00e9 internes de la chambre ne sont pas affect\u00e9es par l'environnement ext\u00e9rieur ;<\/li>\n<li><strong><b>MOCK-UP :<\/b><\/strong>service complet de v\u00e9rification du mod\u00e8le en bois, qualification ergonomique du fonctionnement et service d'affichage du mod\u00e8le en 3D au milieu du projet.<\/li>\n<li><strong><b>Soutien au d\u00e9veloppement des processus de st\u00e9rilisation : <\/b><\/strong>des services de qualification et de validation pour le d\u00e9veloppement du cycle de st\u00e9rilisation de l'ensemble du processus peuvent \u00eatre fournis ;<\/li>\n<li><strong><b>Personnalisation :<\/b><\/strong>prendre en charge la conception de syst\u00e8mes d'isolation personnalis\u00e9s et fournir des solutions syst\u00e9matiques d'isolation en circuit ferm\u00e9 ainsi que des services de certification CE ;<\/li>\n<li><strong><b>Syst\u00e8me de surveillance int\u00e9gr\u00e9 : <\/b><\/strong>des syst\u00e8mes int\u00e9gr\u00e9s de surveillance de la temp\u00e9rature et de l'humidit\u00e9, de la pression diff\u00e9rentielle, de la vitesse de l'air, de H<sub>2<\/sub>O<sub>2<\/sub>concentration, r\u00e9seau optique, particules et bact\u00e9ries viables en suspension dans l'air, etc ;<\/li>\n<li><strong><b>Plusieurs solutions de transfert st\u00e9riles :<\/b><\/strong>Des solutions de transfert st\u00e9rile multiples et combin\u00e9es sont disponibles pour r\u00e9pondre aux besoins de production diversifi\u00e9s des clients ;<\/li>\n<li><strong><b>Soutien tout au long du cycle de vie :<\/b><\/strong>couvrant la consultation, la conception de projets, la conception de sch\u00e9mas d'installation et la conception de v\u00e9rification, etc ;<\/li>\n<li><strong><b>D\u00e9tecteur de fuites sans fil pour gants : <\/b><\/strong>Un d\u00e9tecteur de fuites de gants filaire \u00e0 t\u00eates multiples ou un d\u00e9tecteur de fuites de gants sans fil est disponible en option ;<\/li>\n<li><strong><b>Service CDCV :<\/b><\/strong>le d\u00e9veloppement de cycles de st\u00e9rilisation, les \u00e9tudes de validation et les services ;<\/li>\n<\/ol>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>","protected":false},"excerpt":{"rendered":"<p>L'isolateur de ligne de production pharmaceutique est un syst\u00e8me de barri\u00e8re physique hautement ferm\u00e9, utilis\u00e9 pour isoler compl\u00e8tement les op\u00e9rateurs, l'environnement ext\u00e9rieur et les zones de processus cl\u00e9s (telles que le remplissage, l'emballage, le pesage, etc.) pendant le processus de production pharmaceutique afin de prot\u00e9ger la s\u00e9curit\u00e9 du personnel et de l'environnement.<\/p>","protected":false},"featured_media":171498,"template":"","meta":{"om_disable_all_campaigns":false,"_templately_pack_id":"","_templately_imported_at":"","_templately_source":"","_templately_import_session_id":"","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":"default","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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