{"id":310,"date":"2023-01-09T05:42:47","date_gmt":"2023-01-09T05:42:47","guid":{"rendered":"https:\/\/www.maryatech.com\/?post_type=product&#038;p=310"},"modified":"2023-01-11T06:41:30","modified_gmt":"2023-01-11T06:41:30","slug":"equipement-disolement-aseptique","status":"publish","type":"product","link":"https:\/\/www.maryatech.com\/fr\/product\/aseptic-isolation-equipment\/","title":{"rendered":"Mat\u00e9riel d'isolement aseptique"},"content":{"rendered":"<h1 class=\"p\"><b>1. Introduction<\/b><\/h1>\n<p class=\"p\">L'\u00e9quipement d'isolation aseptique est sp\u00e9cialement con\u00e7u et fabriqu\u00e9 conform\u00e9ment \u00e0 la norme de gestion de la qualit\u00e9 de la production de m\u00e9dicaments (GMP). Il est utilis\u00e9 dans les m\u00e9dicaments et les produits de soins de sant\u00e9 et n\u00e9cessite un niveau plus \u00e9lev\u00e9 de syst\u00e8me de barri\u00e8re de protection de l'environnement. Le syst\u00e8me d'isolateur pharmaceutique peut maximiser la pollution de la pr\u00e9vention et du contr\u00f4le du produit, prot\u00e9ger la s\u00e9curit\u00e9 de l'op\u00e9rateur et \u00e9viter d'\u00eatre bless\u00e9 par les substances toxiques. Les bons fabricants d'isolateurs pharmaceutiques peuvent fournir des solutions technologiques de contr\u00f4le environnemental parfaites pour les tests aseptiques, la production aseptique et la protection de la production de m\u00e9dicaments hautement allerg\u00e8nes et toxiques.<\/p>\n<p class=\"p\">Les \u00e9quipements d'isolation sont soit scell\u00e9s, soit dot\u00e9s d'un syst\u00e8me de filtration microbiologique (HEPA) pour fournir de l'air et sont autopurifiants. Lorsqu'il est scell\u00e9, on n'utilise que la surface interne nettoy\u00e9e ou le canal de transfert rapide pour le transfert des mat\u00e9riaux. Lorsqu'il est ouvert, les mat\u00e9riaux ne peuvent entrer et sortir que par des ouvertures sp\u00e9cifiques qui ont \u00e9t\u00e9 con\u00e7ues et valid\u00e9es pour \u00e9liminer le transfert de contamination. Il peut \u00eatre utilis\u00e9 pour isoler des m\u00e9langes actifs lors d'op\u00e9rations aseptiques ou pour des traitements de st\u00e9rilisation et d'isolation.<\/p>\n<p class=\"p\">Selon l'utilisation, l'isolateur peut \u00eatre divis\u00e9 en isolateur d'inspection aseptique, isolateur de pesage aseptique, isolateur d'alimentation aseptique, isolateur API, etc ;<\/p>\n<h1 class=\"p\"><b>2. Caract\u00e9ristiques de performance<\/b><\/h1>\n<ul>\n<li>La conception de la machine, les mat\u00e9riaux, la fabrication, l'assemblage, le d\u00e9bogage, etc. r\u00e9pondent aux nouvelles exigences des sp\u00e9cifications de production pharmaceutique GMP ;<\/li>\n<li>La structure de la machine et la plate-forme de travail se trouvent au sommet de la conception de la structure ferm\u00e9e, le syst\u00e8me de st\u00e9rilisation, l'unit\u00e9 de contr\u00f4le int\u00e9gr\u00e9e, le syst\u00e8me d'entr\u00e9e et de sortie d'air et l'unit\u00e9 de filtration d'air sont plus beaux et plus faciles \u00e0 nettoyer et \u00e0 entretenir ;<\/li>\n<li>Le corps de la machine pr\u00e9sente des bords et des angles lisses, et la zone de soudage est polie sans bavure. Conception de l'angle d'arc interne, facile \u00e0 nettoyer ;<\/li>\n<li>Chaque chambre est con\u00e7ue en fonction des exigences fonctionnelles. Les gants sont de taille standard, sans angle mort, et des v\u00eatements sp\u00e9ciaux pour le buste peuvent \u00eatre con\u00e7us ;<\/li>\n<li>La conception des modules de l'\u00e9quipement d'isolation utilise la connexion par trous de rat entre chaque module, chaque partie a des zones importantes \u00e9videntes de gradient de pression diff\u00e9rentielle pour garantir que la diff\u00e9rence de pression par rapport \u00e0 d'autres zones est positive ;<\/li>\n<li>L'\u00e9quipement d'isolation peut \u00eatre con\u00e7u en fonction des besoins pour deux types de fonctionnement unilat\u00e9ral ou bilat\u00e9ral ; l'\u00e9quipement a deux m\u00e9thodes de conception : le type divis\u00e9 et le type int\u00e9gr\u00e9 ;<\/li>\n<li>L'isolateur peut, selon la fonction, augmenter la coque du r\u00e9servoir tampon, le module de sortie ou d'autres \u00e9l\u00e9ments ont \u00e9t\u00e9 combin\u00e9s avec la coque principale, ce qui permet de fabriquer un syst\u00e8me d'isolation personnalis\u00e9 ;<\/li>\n<li>Dispositif d'\u00e9chappement de l'\u00e9quipement, \u00e9liminer l'exc\u00e8s de d\u00e9composition du peroxyde d'hydrog\u00e8ne, \u00e9viter les r\u00e9sidus ;<\/li>\n<li>Niveaux de r\u00e9sidus de PHV : &lt; 1 PPM (niveau de r\u00e9sidus d\u00e9termin\u00e9 par les exigences technologiques) ;<\/li>\n<li>Etanch\u00e9it\u00e9 de la chambre : le taux de fuite de la chambre n'est pas sup\u00e9rieur \u00e0 5% en 10 minutes sous une pression de 500 pa ;<\/li>\n<li>Syst\u00e8me configurable de d\u00e9tection des fuites en ligne pour les gants, pouvant \u00eatre utilis\u00e9 pour la d\u00e9tection en ligne de l'int\u00e9grit\u00e9 de plusieurs gants en m\u00eame temps ;<\/li>\n<li>Possibilit\u00e9 de configurer diff\u00e9rentes \u00e9tag\u00e8res pour diff\u00e9rentes utilisations ;<\/li>\n<li>L'isolateur peut \u00eatre \u00e9quip\u00e9 de plusieurs pistolets \u00e0 eau de nettoyage, le fluide de nettoyage pouvant \u00eatre de l'eau (les m\u00e9dicaments hautement actifs peuvent utiliser un solvant inactiv\u00e9) et de l'air comprim\u00e9 ;<\/li>\n<li>Syst\u00e8me configurable d'entr\u00e9e\/sortie de sacs (BIBO), filtres de remplacement s\u00fbrs, garantissant la s\u00e9curit\u00e9 des personnes et de l'environnement lors des changements de processus ;<\/li>\n<li>Syst\u00e8me configurable de g\u00e9n\u00e9rateur VHP int\u00e9gr\u00e9 sans g\u00e9n\u00e9rateur VHP externe, mieux \u00e9vapor\u00e9 en gaz, le peroxyde d'hydrog\u00e8ne liquide pour obtenir un meilleur effet de st\u00e9rilisation, temp\u00e9rature programm\u00e9e de st\u00e9rilisation, accus\u00e9 d'\u00eatre humide ;<\/li>\n<li>Peut \u00eatre configur\u00e9 pour surveiller la concentration en peroxyde d'hydrog\u00e8ne des gaz, des particules de poussi\u00e8re et des bact\u00e9ries planctoniques ;<\/li>\n<li>Valve RTP configurable, pour un transfert aseptique des mat\u00e9riaux ;<\/li>\n<li>Le dispositif de chargement automatique du peroxyde d'hydrog\u00e8ne de l'\u00e9quipement peut \u00eatre configur\u00e9, l'ajout de liquide peut se faire automatiquement en fonction des conditions de st\u00e9rilisation ;<\/li>\n<li>Syst\u00e8me configurable de d\u00e9tection des concentrations \u00e9lev\u00e9es et faibles, d\u00e9tection de la concentration de peroxyde d'hydrog\u00e8ne dans le processus de st\u00e9rilisation ;<\/li>\n<li>Syst\u00e8me de d\u00e9shumidification configurable, faisant circuler l'air \u00e0 travers le dispositif de d\u00e9shumidification \u00e0 l'int\u00e9rieur de l'isolateur, r\u00e9duisant l'humidit\u00e9 relative \u00e0 l'int\u00e9rieur de l'isolateur, efficacit\u00e9 de la st\u00e9rilisation VHP ;<\/li>\n<li>Fonctions du syst\u00e8me de contr\u00f4le : contr\u00f4le automatique de la pression du gaz, contr\u00f4le automatique de la teneur en eau et en oxyg\u00e8ne, circulation auto-adaptative de l'air de nettoyage, vitesse variable en continu, conseils de s\u00e9curit\u00e9, diagnostic des d\u00e9faillances, stockage des donn\u00e9es, protection par mot de passe et autres fonctions ;<\/li>\n<\/ul>\n<ul>\n<li>Le syst\u00e8me d'isolateur st\u00e9rile dans l'industrie pharmaceutique peut s'amarrer aux diff\u00e9rents \u00e9quipements, accessoires et int\u00e9grations, r\u00e9aliser les diff\u00e9rentes fonctions et exigences technologiques, la conception personnalis\u00e9e ;<\/li>\n<\/ul>","protected":false},"excerpt":{"rendered":"<p>Les isolateurs pharmaceutiques aseptiques sont enti\u00e8rement scell\u00e9s pour contr\u00f4ler et traiter les produits pharmaceutiques et biologiques dans un \u00e9tat st\u00e9rile. Une op\u00e9ration compl\u00e8te peut n\u00e9cessiter un syst\u00e8me d'isolateurs pour s\u00e9parer l'ensemble du processus des sources possibles de contamination, telles que les \u00e9quipements environnants et les op\u00e9rateurs.<\/p>","protected":false},"featured_media":588,"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":"default","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":"default","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 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-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":"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":""},"mobile":{"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":""}}},"product_brand":[],"product_cat":[83,15],"product_tag":[],"class_list":["post-310","product","type-product","status-publish","has-post-thumbnail","product_cat-aseptic-isolation-equipment","product_cat-uncategorized","desktop-align-left","tablet-align-left","mobile-align-left","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.2 (Yoast SEO v28.6) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Aseptic isolation equipment - Shanghai Marya<\/title>\n<meta name=\"description\" content=\"Aseptic pharmaceutical isolators is fully sealed to control and process pharmaceuticals and biological products into a sterile state.\" \/>\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.maryatech.com\/fr\/produit\/equipement-disolement-aseptique\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Aseptic isolation equipment\" \/>\n<meta property=\"og:description\" content=\"High-end sterile pharmaceutical filling lines manufacturer, with core strengths in complying with EU GMP\/FDA certification, serving multinational pharmaceutical companies.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.maryatech.com\/fr\/produit\/equipement-disolement-aseptique\/\" \/>\n<meta property=\"og:site_name\" content=\"Shanghai Marya Pharmaceutical Engineering &amp; 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