Qué hacemos
En Vivunt Pharma Europe ofrecemos servicios de Contract Development Manufacturing especializado en medicamentos oncológicos estériles en viales líquidos y liofilizados empleando tecnología de vanguardia.
Nuestro pipeline de desarrollo incluye 10 medicamentos oncológicos estériles.
Nuestra Tecnología
Cumplimos con los estándares más exigentes de la industria,
respaldado por la certificación del nuevo Anexo 1 EU GMP.
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Sistema de elaboración de soluciones automatizado.
Con CIP, SIP, DIP y test de integridad de filtros, que garantizan la esterilidad en cada etapa de elaboración del producto.
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Liofilizador con sistema automático de carga y descarga de viales bajo clase A.
Ofrece un ambiente controlado y aséptico para la realización de dicho proceso, asegurando la estabilidad e integridad de cada lote.
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Cerrado de viales automático.
Garantizando un sellado hermético y seguro para cada vial.
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Control de Procesos Automático (IPC).
El sistema IPC asegura la calidad en cada paso del proceso de elaboración:
Monitoreo continuo de clase A y B.
Control de volumen de llenado por balanza dinámica.
Control de particulado y hermeticidad online 100% no destructivo.
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Control de Calidad y Microbiología.
Laboratorios completamente equipados para análisis de materias primas y productos terminados, incluyendo cámaras de APS y estabilidad.
Capacidad Instalada
Nuestra planta farmacéutica ha sido construida con los más altos
estándares de la industria y equipada con tecnología de vanguardia