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Solución personalizada para su fabricación estéril a granel
TOTALMENTE AUTOMATIZADO
PROTECCIÓN DEL PERSONAL
PROCESO ASÉPTICO
Desafíos con polvo estéril a granel
Varios tipos de contenedores
Las soluciones de Comecer para la manipulación y el llenado asépticos de polvo API a granel en la industria farmacéutica son compatibles con todos los diferentes tipos de recipientes.
Bolsa RTP
Bolsa en forma de botella
PE barril
barril de alu
¿Aislador o RABs?
Un AISLADOR es un sistema de barrera bien definido (físico) que se puede validar para proporcionar una reducción significativa del riesgo de biocontaminación. Un aislador proporciona un aislamiento de Grado A continuo y sin riesgos de su interior del ambiente circundante.
Un RABS es una combinación de barrera física y aerodinámica sobre la zona de proceso aséptico. RABS es una metodología alternativa de control de la contaminación diseñada para ser utilizada en una sala blanca de clasificación superior (Grado B de la UE – mínimo ISO 7) y basada en sistemas de menor complejidad de ingeniería.
¿Por qué Comecer prefiere el aislador?
Dada la separación completa entre los operadores y el área aséptica, es más probable que la solución del aislador se implemente junto con un cierto nivel de automatización cuando los tamaños de los lotes son significativos. Lo mismo cuando la API tiene una necesidad de contención en cierta medida, la solución con aislador es imprescindible. Por otro lado, se pueden adoptar RABs cuando se lleva a cabo una operación extremadamente manual y no se trata de un problema de contención.
Diseño ad hoc del proceso
Todos los procesos de esterilización a granel tienen muchos aspectos en común, sin embargo, cada aplicación tiene sus propios requisitos y limitaciones específicos.
Por esta razón, Comecer rediseña la configuración del sistema ad hoc integrando soluciones recién concebidas a módulos funcionales ya adoptados.
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Statistical cookies are used to monitor the performance of the site, for example, to know the number of pages visited or the number of users who have viewed a particular section. The analysis of these cookies generates anonymous and aggregated statistical data without any reference to the identity of the site's visitors. They are also useful to evaluate any changes and improvements to be made to the site itself.
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