MANUELA Isolateur blindé à débit laminaire pour la médecine nucléaire
MANUELA est une cellule blindée permettant la manipulation de médicaments radio, en particulier, pour le fractionnement d’isotopes émettant des positrons.
Cellule chaude blindée à débit laminaire pour la médecine nucléaire
Points forts
Conception modulaire et configuration flexible
Écran tactile pour cellule chaude et système 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)
Calibreur de dose (disponible en version 2 Ci ou 20 Ci) avec console à écran tactile
Prédisposition pour l’installation des sondes Geiger pour la mesure de la radioactivité présente dans la cellule
La machine offre des solutions techniques exclusives qui garantissent des performances uniques en termes de :
Stérilité : la zone de travail à flux d’air laminaire (Classe A d’après les BPF (GMP) courantes européennes) permet la manipulation de produits radiopharmaceutiques dans des conditions de sécurité absolue pour le produit
Radioprotection : pour la précision et l’exhaustivité des blindages, la concentration des opérations dans un seul environnement fermé, la décontamination de toutes les surfaces de travail
Ergonomie : tous les composants requis pour la préparation des doses sont placés dans la gamme d’action à disposition de l’opérateur
Sécurité : l’environnement de travail en pression négative garantit la meilleure protection à l’opérateur, le flux laminaire interne est situé dans la zone frontale de la boîte et garantit la meilleure protection du médicament radiopharmaceutique
Gestion des paramètres critiques : l’isolateur est équipé d’un panneau de commandes moderne permettant de vérifier, modifier et exporter les paramètres internes de la cellule, les notifications et les alarmes
Polyvalence : la largeur de la chambre interne et la forme de la surface de travail permettent l’installation de modules de synthèse automatique ou de fractionneurs pour les seringues et les flacons
Durabilité : la haute qualité des composants utilisés assure une durée de vie prolongée et la régularité des performances.
ISO 45001 Health and Safety Management System
ISO 14001 & ISO 50001 Environmental and energetic management system
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Radiopharma
Pharma
ATMP Thérapie génique et cellulaire
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