Série BBST COMBO Cellule chaude de synthèse et de distribution
La Cellule chaude BBST COMBO est une cellule chaude de synthèse et de distribution spécialement conçue pour combiner en un système un boîtier blindé pour les modules de synthèse et un système de fractionnement dans des conditions stériles, conformément avec les normes cGMP.
Série BBST COMBO - Cellule chaude de synthèse et de distribution
Points forts
Conception modulaire et configuration flexible
Écran tactile pour cellule chaude et système de distribution
Conçu pour accueillir des modules automatiques ou des systèmes de fractionnement dans des conditions stériles
Système de collecte des déchets liquides
Système de collecte des déchets solides
Calibreur de dose (disponible en version 2 Ci ou 20 Ci) avec console à écran tactile
Conformité aux BPF
Illuminate™ MI : Plateforme d’intelligence manufacturière IIoT et gestion de l’atelier de fabrication.
La cellule chaude de synthèse et de distribution est équipée des éléments suivants :
une chambre principale blindée (zone de distribution), maintenue en classe A « LAF » par un système combiné d’ « étanchéité à l’air – flux laminaire »
une pré-chambre (classe B), avec deux ports de gants
une chambre blindée (zone de synthèse) (classe B), avec un compartiment technique supérieur
un système d’extraction de flacons/seringues (classe B)
une zone de déchets solides et liquides (classe B)
Grâce à ces caractéristiques, ainsi qu’aux équipements de mesure, la cellule chaude est appropriée pour la production et la préparation des doses de médicaments radioactifs, conformément aux normes BPF (GMP) européennes.
Caractéristiques de la cellule chaude de synthèse et de distribution
Connexions étanches pour les liquides radioactifs
Lignes d’alimentation du liquide fabriquées en acier inoxydable AISI 316L avec des vannes d’arrêt à bille
Connexions test DOP (test de fuite du filtre)
Réglage automatique de la pression interne par vannes modulantes
Télé-pinces à haute sensibilité (mouvement par roulements à billes)
Test de point de bulle semi-automatique contrôlé par écran tactile
Connexions VPHP avec cellules chaudes et pré-chambres (vannes manuelles, automatiques en option)
Libérez tout le potentiel de Série BBST COMBO avec l’intelligence de fabrication Illuminate™
Utilisez les données en temps réel sur les performances des machines pour savoir où concentrer les efforts afin de réduire les temps d'arrêt, d'optimiser le débit de la ligne, d'améliorer la qualité des produits et d'apporter des améliorations durables à la production. En savoir plus »
ISO 45001 Health and Safety Management System
ISO 14001 & ISO 50001 Environmental and energetic management system
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