{"id":171525,"date":"2025-03-07T07:41:03","date_gmt":"2025-03-07T07:41:03","guid":{"rendered":"https:\/\/www.maryatech.com\/?post_type=product&p=171525"},"modified":"2025-03-07T07:41:07","modified_gmt":"2025-03-07T07:41:07","slug":"systeme-de-formulation-pharmaceutique","status":"publish","type":"product","link":"https:\/\/www.maryatech.com\/fr\/product\/pharmaceutical-formulation-system\/","title":{"rendered":"Syst\u00e8me de formulation pharmaceutique"},"content":{"rendered":"

Classification du syst\u00e8me de pr\u00e9paration\uff1a<\/h2>\n

1\uff09Syst\u00e8me de pr\u00e9paration g\u00e9n\u00e9rale : Il est utilis\u00e9 pour la pr\u00e9paration chimique g\u00e9n\u00e9rale de petites mol\u00e9cules, comme l'injection aqueuse, l'injection de poudre lyophilis\u00e9e, etc.<\/p>\n

2\uff09Syst\u00e8me de pr\u00e9paration complexe : Il est utilis\u00e9 pour la production de pr\u00e9parations \u00e0 processus complexes, telles que les suspensions, les \u00e9mulsions, les liposomes, les microsph\u00e8res et d'autres pr\u00e9parations sp\u00e9ciales.<\/p>\n

3\uff09Syst\u00e8me de pr\u00e9paration biologique : Il est utilis\u00e9 pour la pr\u00e9paration de toutes sortes de produits appliquant la technologie du g\u00e9nie biologique, tels que la pr\u00e9paration semi-finie d'anticorps, de vaccins, de produits sanguins, de prot\u00e9ines recombinantes, etc. Il peut \u00e9galement \u00eatre utilis\u00e9 pour la production de milieux de culture, de tampons de purification et d'autres pr\u00e9parations liquides auxiliaires.<\/p>\n

4\uff09CIP station system : Il est utilis\u00e9 pour faciliter le nettoyage en ligne des r\u00e9servoirs et des canalisations de divers syst\u00e8mes de pr\u00e9paration et de bior\u00e9acteurs, et peut \u00eatre contr\u00f4l\u00e9 s\u00e9par\u00e9ment ou int\u00e9gr\u00e9 \u00e0 d'autres syst\u00e8mes.<\/p>\n

Caract\u00e9ristiques de performance du syst\u00e8me de pr\u00e9paration\uff1a<\/strong><\/h5>\n

Syst\u00e8me de pr\u00e9paration g\u00e9n\u00e9rale<\/h3>\n
    \n
  1. Le syst\u00e8me peut \u00eatre enti\u00e8rement automatique, avec une conception modulaire, et son installation de suivi et de maintenance est pratique.<\/li>\n
  2. Le syst\u00e8me de contr\u00f4le automatique du CIP et du SIP peut \u00eatre activ\u00e9 \u00e0 l'aide d'une seule touche, ce qui permet de d\u00e9tecter automatiquement la fin du nettoyage et de la st\u00e9rilisation, avec la gestion des recettes, la signature \u00e9lectronique, les enregistrements \u00e9lectroniques, le suivi des audits et d'autres fonctions informatiques.<\/li>\n
  3. Lorsque l'\u00e9quipement fonctionne, il peut contr\u00f4ler la production des param\u00e8tres cl\u00e9s des m\u00e9dicaments (tels que la temp\u00e9rature, l'oxyg\u00e8ne dissous, le pH, etc.), les d\u00e9tecter automatiquement et \u00e9mettre une alarme en cas de conditions sp\u00e9ciales en dehors des param\u00e8tres d\u00e9finis, afin d'\u00e9viter les probl\u00e8mes de qualit\u00e9 des m\u00e9dicaments.<\/li>\n
  4. Le syst\u00e8me respecte les concepts ASME BPE et GMP, r\u00e9pond aux exigences des angles morts 3D et permet une production continue \u00e0 faible taux de r\u00e9sidus.<\/li>\n
  5. Avant de fabriquer l'\u00e9quipement dans notre usine, nous proc\u00e9dons \u00e0 une conception tridimensionnelle individuelle pour rationaliser la disposition des conduites, des vannes, des instruments, etc. dans le syst\u00e8me afin de rendre l'utilisation de l'\u00e9quipement plus conviviale.<\/li>\n<\/ol>\n

     <\/p>\n

    Syst\u00e8me de pr\u00e9paration complexe<\/h3>\n
      \n
    1. Nous utiliserons le logiciel d'analyse des fluides ANSYS pour simuler la situation r\u00e9elle du fluide dans le r\u00e9servoir et pour s\u00e9lectionner les agitateurs et les cisailles appropri\u00e9s, afin de garantir que le processus de laboratoire puisse \u00eatre transf\u00e9r\u00e9 sans probl\u00e8me \u00e0 la production \u00e0 grande \u00e9chelle.<\/li>\n
    2. Nous utiliserons des pompes de transfert de phase huileuse et aqueuse de haute pr\u00e9cision pour contr\u00f4ler strictement le rapport de m\u00e9lange de la phase huileuse et aqueuse afin de garantir l'effet d'\u00e9mulsification.<\/li>\n
    3. S'il existe des mati\u00e8res premi\u00e8res dangereuses pour la production de produits pharmaceutiques, nous installerons des isolateurs dans la zone d'alimentation du syst\u00e8me de pr\u00e9paration afin de garantir la st\u00e9rilit\u00e9 du processus d'alimentation en API et la protection du personnel.<\/li>\n
    4. Les cuves de m\u00e9lange sont disponibles dans des formes sp\u00e9ciales permettant d'obtenir des volumes de m\u00e9lange minimaux tr\u00e8s faibles.<\/li>\n
    5. Pour les produits en suspension, nous adopterons la conception d'un pipeline de circulation afin d'\u00e9viter que la composition du produit ne soit in\u00e9gale en raison de la s\u00e9dimentation des particules en suspension dans l'agent pharmaceutique caus\u00e9e par un remplissage de longue dur\u00e9e.<\/li>\n<\/ol>\n

       <\/p>\n

      Syst\u00e8me de pr\u00e9paration biologique<\/h3>\n
        \n
      1. Le syst\u00e8me de pr\u00e9paration communique avec le syst\u00e8me de fermentation et le syst\u00e8me de purification, et peut fournir automatiquement le milieu de culture et le liquide auxiliaire purifi\u00e9 \u00e0 l'endroit sp\u00e9cifi\u00e9, et peut \u00eatre commut\u00e9 de mani\u00e8re flexible.<\/li>\n
      2. Le cadre en acier et les r\u00e9servoirs du syst\u00e8me de pr\u00e9paration peuvent \u00eatre plac\u00e9s dans des zones de classe C et de classe B respectivement, ce qui r\u00e9duit le risque de contamination d\u00fb \u00e0 la manipulation par le personnel.<\/li>\n
      3. Nous utilisons des vannes doubles et une unit\u00e9 de r\u00e9troaction des vannes dans les parties cl\u00e9s de l'\u00e9quipement, afin d'\u00e9viter tout risque de contamination crois\u00e9e entre le nettoyage et le pipeline de mat\u00e9riaux.<\/li>\n
      4. Le syst\u00e8me est \u00e9quip\u00e9 d'un r\u00e9servoir de collecte aseptique et la cartouche de filtration des liquides peut \u00eatre test\u00e9e en ligne apr\u00e8s le SIP, conform\u00e9ment aux BPF de l'UE et \u00e0 la FDA.<\/li>\n<\/ol>\n

        L'\u00e9quipement adopte un syst\u00e8me de contr\u00f4le automatique SCADA, qui peut surveiller et contr\u00f4ler l'\u00e9quipement de terrain \u00e0 tout moment, et r\u00e9aliser l'acquisition de donn\u00e9es, le contr\u00f4le de l'\u00e9quipement, la mesure, le r\u00e9glage des param\u00e8tres et toutes sortes d'alarmes de signal, etc. dans la salle de contr\u00f4le centrale.<\/p>","protected":false},"excerpt":{"rendered":"

        Le syst\u00e8me de formulation pharmaceutique est un type d'\u00e9quipement pharmaceutique utilis\u00e9 pour m\u00e9langer et distribuer des liquides en ajoutant un IPA \u00e0 un solvant tel que l'eau pour injection, puis en le formulant en un agent pharmaceutique qui r\u00e9pond \u00e0 la concentration souhait\u00e9e apr\u00e8s agitation, chauffage, st\u00e9rilisation et filtration.<\/p>","protected":false},"featured_media":171526,"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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