Validación concurrente del proceso de manufactura de Vinagre Bully de un laboratorio farmacéutico nacional
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Date
2022
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Universidad Nacional de Trujillo
Abstract
El actual trabajo tuvo como objetivo, validar el proceso de manufactura de Vinagre Bully dentro de las instalaciones de un laboratorio farmacéutico nacional; para conseguir el objetivo se trabajó con 3 lotes consecutivos (A, B y C) de 500 mL respectivamente. Se muestreó 200 mL del granel durante el proceso de fabricación a los 10, 15 y 20 minutos de agitación. En el inicio, medio y final del proceso de envasado se muestreó la misma cantidad y por último 125 muestras del producto terminado por cada lote. Para realizar la validación se consideraron las especificaciones establecidas por el laboratorio y la USP 2021. Los parámetros a determinar fueron la capacidad de proceso (Cp) y el índice de capacidad de proceso (Cpk) en las etapas de fabricación y envasado. Los resultados obtenidos fueron: En el ensayo de contenido de ácido acético en la etapa de fabricación a los 20 minutos de agitación, el lote A tuvo menor desviación estándar promedio (0.009) y concentración promedio de 2.998 g por cada 100 mL de Vinagre Bully, el Cp promedio fue de 6.02 y el Cpk 5.95. Durante los 10 y 15 minutos de agitación en la etapa de fabricación el lote B obtuvo menor desviación estándar de (0.011), promedio de concentración de Ácido acético de 2.988 g por cada 100 mL, Cp 6.02 y Cpk 5.65. Por otra parte, el lote C en la etapa de envasado para el ensayo de valoración fue el que mostró menor desviación estándar (0,013), concentración de Ácido acético promedio de 3.007 g por cada 100 mL, Cp 5.33 y Cpk 5.14. En el ensayo de volumen promedio el lote A mostró una desviación estándar de 0,751, promedio de llenado de 503.53 mL, Cp 2.16 y Cpk 1.53; respecto al ensayo de contenido de etanol a los 10 minutos de agitación el lote B mostró menor desviación estándar (0,091); promedio de contenido de etanol de 50.10 g para cada 100 mL; Cp 8.59 y Cpk 8.16. Los lotes evaluados cumplieron con las características organolépticas contempladas en las especificaciones olor, color y aspecto característico. Se concluyó que los parámetros sometidos a análisis, cumplen con las especificaciones establecidas por el establecimiento y la bibliografía de referencia; por tanto, el proceso de manufactura queda validado.
ABSTRACT The objective of the current work was to validate the manufacturing process of Vinegar Bully within the facilities of a national pharmaceutical laboratory; To achieve the objective, we worked with 3 consecutive batches (A, B and C) of 500 mL respectively. 200 mL of the bulk was sampled during the manufacturing process at 10, 15 and 20 minutes of agitation. At the beginning, middle and end of the packaging process, the same amount was sampled and finally 125 samples of the finished product for each batch. To carry out the validation, the specifications established by the laboratory and USP 2021 were considered. The parameters to be determined were the process capacity (Cp) and the process capacity index (Cpk) in the manufacturing and packaging stages. The results obtained were: In the acetic acid content test in the manufacturing stage at 20 minutes of agitation, batch A had the lowest average standard deviation (0.009) and average concentration of 2.998 g per 100 mL of Bully Vinegar, the average Cp was 6.02 and the Cpk 5.95. During the 10 and 15 minutes of agitation in the manufacturing stage, batch B obtained a lower standard deviation of (0.011), average acetic acid concentration of 2.988 g per 100 mL, Cp 6.02 and Cpk 5.65. On the other hand, batch C in the packaging stage for the evaluation test was the one that showed the lowest standard deviation (0.013), average acetic acid concentration of 3.007 g per 100 mL, Cp 5.33 and Cpk 5.14. In the average volume test, lot A showed a standard deviation of 0.751, average filling of 503.53 mL, Cp 2.16 and Cpk 1.53; Regarding the ethanol content test at 10 minutes of agitation, batch B showed a lower standard deviation (0.091); average ethanol content of 50.10 g for each 100 mL; Cp 8.59 and Cpk 8.16. The batches evaluated met the organoleptic characteristics contemplated in the odor, color and characteristic appearance specifications. It was concluded that the parameters submitted to analysis comply with the specifications established by the establishment and the reference bibliography; therefore, the manufacturing process is validated.
ABSTRACT The objective of the current work was to validate the manufacturing process of Vinegar Bully within the facilities of a national pharmaceutical laboratory; To achieve the objective, we worked with 3 consecutive batches (A, B and C) of 500 mL respectively. 200 mL of the bulk was sampled during the manufacturing process at 10, 15 and 20 minutes of agitation. At the beginning, middle and end of the packaging process, the same amount was sampled and finally 125 samples of the finished product for each batch. To carry out the validation, the specifications established by the laboratory and USP 2021 were considered. The parameters to be determined were the process capacity (Cp) and the process capacity index (Cpk) in the manufacturing and packaging stages. The results obtained were: In the acetic acid content test in the manufacturing stage at 20 minutes of agitation, batch A had the lowest average standard deviation (0.009) and average concentration of 2.998 g per 100 mL of Bully Vinegar, the average Cp was 6.02 and the Cpk 5.95. During the 10 and 15 minutes of agitation in the manufacturing stage, batch B obtained a lower standard deviation of (0.011), average acetic acid concentration of 2.988 g per 100 mL, Cp 6.02 and Cpk 5.65. On the other hand, batch C in the packaging stage for the evaluation test was the one that showed the lowest standard deviation (0.013), average acetic acid concentration of 3.007 g per 100 mL, Cp 5.33 and Cpk 5.14. In the average volume test, lot A showed a standard deviation of 0.751, average filling of 503.53 mL, Cp 2.16 and Cpk 1.53; Regarding the ethanol content test at 10 minutes of agitation, batch B showed a lower standard deviation (0.091); average ethanol content of 50.10 g for each 100 mL; Cp 8.59 and Cpk 8.16. The batches evaluated met the organoleptic characteristics contemplated in the odor, color and characteristic appearance specifications. It was concluded that the parameters submitted to analysis comply with the specifications established by the establishment and the reference bibliography; therefore, the manufacturing process is validated.
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Keywords
Vinagre Bully, Validación, Parámetros, Capacidad de proceso, Indice de capacidad de proceso