ARGO-T 2.0 Système de distribution de fioles fermées
ARGO-T (TRANSSEPTAL) est un nouveau système de distribution fermé et automatique capable de remplir une fiole par le percement d’un obturateur en caoutchouc. L’équipement est conçu pour distribuer des radio-traceurs utilisés dans les diagnostics TEP et TEMP et thérapies métaboliques. Le système ARGO est conforme aux recommandations des BPF (GMP) courantes pour le remplissage de flacons fermés.
ARGO-T (Transseptal) Système de distribution de fioles fermé pour production radiopharma | Comecer
Points forts
Distribution en flacons fermés
Aiguille de remplissage avec filtre stérile
Précision du volume distribué
Conformité aux BPF
Kit stérile jetable
Illuminate™ MI : Plateforme d’intelligence manufacturière IIoT et gestion de l’atelier de fabrication
Ce dispositif fait partie de la famille des distributeurs ARGO qui ont la particularité de permettre la perforation automatique du flacon à l’aide d’une aiguille. Le support flexible garantit la possibilité d’adapter facilement le distributeur à différents formats de flacons. Il est généralement intégré dans des isolateurs blindés de classe A équipés de manipulateurs, assurant ainsi une ergonomie et une commodité absolues, totalement conformes aux recommandations cGMP.
Caractéristiques techniques principales
Distribution à volume contrôlé au moyen d’une seringue de pompage intégrée au kit jetable
Aiguille conçue spécifiquement pour percer et remplir avec une aiguille d’évent intégrée munie d’un filtre stérile de 0,22 μm
Dimensions compactes et faible poids pour faciliter le déplacement et le positionnement au sein de la zone de travail
Distribution précise du volume dans la limite de 5 % pour les volumes entre 1 et 10 ml
Imprimante d’étiquettes pour flacon et conteneur blindé
Lecteur de code-barres
Calcul de la concentration et formulation du volume initial de substances radio-pharmaceutiques avec l’unité de formulation
Test du filtre de stérilisation et du point de bulle en ligne.
ISO 45001 Health and Safety Management System
ISO 14001 & ISO 50001 Environmental and energetic management system
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