ESTUDIO DE ESTABILIDAD DEL FACTOR ESTIMULADOR DE COLONIAS DE GRANULOCITOS EN BOLSAS PLÁSTICAS FLEXBOY. | STUDY OF STABILITY OF THE GRANULOCYTE COLONY STIMULATING FACTOR (RG-CSF) IN FLEXBOY PLASTIC BAGS

Spanish; Castilian. Se realizó un estudio de estabilidad del Ingrediente Farmacéutico Activo el rG-CSF en bolsas plásticas flexibles de etil vinil acetato de 50 mL, estériles y listas para el uso,proveedor STEDIM, con el objetivo de establecer el período de validez en este sistema de envase a la temperatura de 2-8oC. Las muestras fueron tomadas de tres lotes producidos a escala industrial que cumplieron los requisitos de calidad especificados por control de la calidad. El producto muestreado fue ensayado de acuerdo al Cronograma de Ensayos de Estabilidad en los tiempos: 0, 4, 8 y 12 meses. Fueron realizados los ensayos siguientes: Características Organolépticas, Actividad Biológica, Concentración de Proteínas, Focalización Isoeléctrica, Electroforesis, Western Blotting, HPLC, pH, Esterilidad y Pirógenos. Todos los resultados obtenidos en cada ensayo cumplieron con el criterio de aceptación para este producto sin presentar diferencias significativas entre las medias obtenidas en cada análisis, por lo que se puede afirmar que el Ingrediente Farmacéutico Activo de rG-CSF es estable en bolsas durante 12 meses. El nuevo sistema de envase aseguró la esterilidad de este producto parenteral, así como su estabilidad física y química durante su conservación.

English. A stability study of the Active Pharmaceutical Ingredient of the rG-CSF in sterile ready-to-use 50 mL ethyl vinyl acetate flexible plastic bags, STEDIM supplier, with the aim of establishing the shelf life in this packaging system at 2-8 oC.Samples were taken from three batches produced at industrial scale that met the quality requirements specified by quality control. The sampled product was tested according to the Stability Testing Schedule at the times: 0, 4, 8 and 12 months. The following tests were performed: Organoleptic Characteristics, Biological Activity, Protein Concentration, IsoelectricA stability study of the Active Pharmaceutical Ingredient of the rG-CSF in sterile ready-to-use 50 mL ethyl vinyl acetate flexible plastic bags, STEDIM supplier, with the aim of establishing the shelf life in this packaging system at 2-8 oC.Samples were taken from three batches produced at industrial scale that met the quality requirements specified by quality control. The sampled product was tested according to the Stability Testing Schedule at the times: 0, 4, 8 and 12 months. The following tests were performed: Organoleptic Characteristics, Biological Activity, Protein Concentration, Isoelectric Targeting, Electrophoresis, Western Blotting, HPLC, pH, Sterility and Pyrogens. All the results obtained in each assay met the acceptance criterion for this product without presenting significant differences between the means obtained in each analysis, so it can be stated that the rG-CSF API is stable in this kind of bags for 12 months. The new packaging system ensured the sterility of this parenteral product, as well as its physical and chemical stability during its conservation.