Validación Concurrente del Proceso de Manufactura del Producto Alcohol gel 70° en un Laboratorio Nacional, Lima 2021
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Date
2021
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Universidad Nacional de Trujillo
Abstract
Este trabajo tuvo como objetivo realizar la validación concurrente del proceso de manufactura del producto alcohol gel 70° en un laboratorio nacional, Lima 2021. Se evaluaron la capacidad de proceso (Cp), capacidad del proceso real (Cpk), en los parámetros de volumen promedio, concentración de alcohol etílico y viscosidad, para lo cual se trabajaron con los siguientes lotes: 2030411, 2030511 y 2030591 en presentación de 1000mL.Los resultados obtenidos al calcular la capacidad de proceso (Cp) y la capacidad de proceso real (Cpk) en los distintos parámetros fueron : 2.95, 2.07, 2.30 y 1.43, 1.03, 1.23 con respecto al análisis volumen promedio; 20.16, 22.79, 28.95 y 12.35, 15.71, 14.92 para el análisis de viscosidad respectivamente. En el análisis de la capacidad de proceso (Cp) para el parámetro de viscosidad se obtuvo como resultado que todas las muestras se encuentran dentro del rango de especificación 20000 – 50000 centipoise de viscosidad. En el análisis de la concentración de alcohol etílico en los tres lotes: 20411,20511 y 20591 los cuales dieron como resultado de todas las muestras un valor de 70°, todos los lotes tienen calidad de seis sigmas, encontrándose dentro del rango específico de Cp: 1≤ Cp ≤ 1.33. Por lo tanto, se concluye la conformidad de la validación cumpliendo con los parámetros establecidos para el análisis presentándonos un proceso óptimo.
ABSTRACT The objective of this work was to carry out the concurrent validation of the 70 ° alcohol gel product manufacturing process in a national laboratory, Lima 2021. The process capacity (Cp) and the real process capacity (Cpk) were evaluated in the volume parameters average, ethyl alcohol concentration and viscosity, for which the following batches were worked: 2030411, 2030511 and 2030591 in 1000mL presentation The results obtained when calculating the process capacity (Cp) and the actual process capacity (Cpk) in the different parameters they were: 2.95, 2.07, 2.30 and 1.43, 1.03, 1.23 with respect to the average volume analysis; 20.16, 22.79, 28.95 and 12.35, 15.71, 14.92 for the viscosity analysis respectively. In the analysis of the process capacity (Cp) for the viscosity parameter, it was obtained as a result that all the samples are within the specification range of 20,000 - 50,000 centipoise of viscosity. In the analysis of the concentration of ethyl alcohol in the three batches: 20411, 20511 and 20591, which resulted in all samples a value of 70 °, all batches have quality of six sigmas, being within the specific range of Cp : 1≤ Cp ≤ 1.33. Therefore, the conformity of the validation is concluded, complying with the parameters established for the analysis, presenting us with an optimal process.
ABSTRACT The objective of this work was to carry out the concurrent validation of the 70 ° alcohol gel product manufacturing process in a national laboratory, Lima 2021. The process capacity (Cp) and the real process capacity (Cpk) were evaluated in the volume parameters average, ethyl alcohol concentration and viscosity, for which the following batches were worked: 2030411, 2030511 and 2030591 in 1000mL presentation The results obtained when calculating the process capacity (Cp) and the actual process capacity (Cpk) in the different parameters they were: 2.95, 2.07, 2.30 and 1.43, 1.03, 1.23 with respect to the average volume analysis; 20.16, 22.79, 28.95 and 12.35, 15.71, 14.92 for the viscosity analysis respectively. In the analysis of the process capacity (Cp) for the viscosity parameter, it was obtained as a result that all the samples are within the specification range of 20,000 - 50,000 centipoise of viscosity. In the analysis of the concentration of ethyl alcohol in the three batches: 20411, 20511 and 20591, which resulted in all samples a value of 70 °, all batches have quality of six sigmas, being within the specific range of Cp : 1≤ Cp ≤ 1.33. Therefore, the conformity of the validation is concluded, complying with the parameters established for the analysis, presenting us with an optimal process.
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Keywords
Validación, Alcohol gel 70°