Ligne de remplissage aseptique couvrant le processus complet de production, depuis la réception des matières premières jusqu’à l’emballage des produits radiopharmaceutiques dans des conteneurs blindés en plomb.
L’ensemble du cycle de production est strictement conforme à la réglementation actuelles en matière de BPF (GMP).
La configuration de la ligne de remplissage aseptique comprend les cellules chaudes suivantes :
la cellule chaude de réception, pour la réception du stock de 131I
la hotte à flux laminaire, pour l’introduction des consommables stériles
la cellule chaude de formulation, pour la formulation du produit en vrac
le caisson de chargement, cellule non blindée pour le déballage du matériel de remplissage et le test d’intégrité du préfiltre
la cellule chaude de remplissage, où s’effectue le remplissage des flacons de produit
la micro-cellule chaude QC, pour les tests de stérilité et l’inspection
la cellule d’inspection et d’étiquetage, où l’activité est mesurée et les flacons de produit étiquetés sont évacués à l’extérieur dans des pots en plomb au moyen d’un système de manutention mécanique.
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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