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Línea de llenado aséptica que cubre el proceso de fabricación completo, desde la recepción de la materia prima hasta el embalaje de los radiofármacos en contenedores de plomo blindados.
Todo el ciclo de producción cumple estrictamente con la actual normativa GMP.
La configuración de la línea de llenado aséptica incluye las siguientes celdas blindadas:
la Celda Blindada de Recepción, para la recepción de stock 131I
la campana Flujo Laminar, para la introducción de desechables estériles
la Celda Blindada de Formulación, para la formulación de producto a granel
la Caja de Flujo de Carga, célula no blindada, para desembalar los materiales de relleno y las pruebas de integridad del prefiltro
la Celda Blindada de Llenado, donde se lleva a cabo el llenado del vial de producto
la Micro-Celda Blindada CC, para pruebas de esterilidad e inspección
la Celda Blindada de Inspección y Etiquetado, donde se mide la actividad y los viales de producto etiquetados se entregan al exterior en recipientes de plomo, mediante un sistema de manipulación mecánica.
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