Validación del sistema de purificación de agua de una planta de gasas estériles
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Date
2024
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Universidad Nacional de Trujillo
Abstract
La presente tesis tiene como objetivo validar el sistema de purificación de agua de una planta de fabricación de gasas estériles. Este proceso implicó la elaboración y ejecución del protocolo de validación; una evaluación minuciosa del diseño, la instalación y el desempeño operativo del sistema de purificación para confirmar que produce constantemente agua de la pureza requerida para su uso en los procesos de esterilización y fabricación. Los pasos clave incluyen la Calificación de la Instalación (IQ) para verificar que el sistema está instalado correctamente, la Calificación Operativa (OQ) para garantizar que funciona según lo previsto en condiciones normales de funcionamiento, y la Calificación del Desempeño (PQ); para esto se realizaron análisis fisicoquímicos y microbiológicos de muestras en 5 puntos de agua potable y 4 puntos de agua purificada durante 2 fases. Las pruebas realizadas a cada muestra fueron aspecto, pH, conductividad, recuento microbiano y detección de patógenos. Los resultados obtenidos en cada prueba indicaron que el agua obtenida del sistema de purificación se mantiene dentro de las especificaciones establecidas en las Farmacopeas Británica, Americana y el Ministerio de Salud. En conclusión, de acuerdo a los resultados obtenidos se demuestra que el sistema de purificación de agua de una planta de gasas estériles se encuentra validado y bajo control.
ABSTRACT This thesis aims to validate the water purification system of a sterile gauze manufacturing plant. This process involves the development and execution of the validation protocol; thorough evaluation of the design, installation and operational performance of the purification system to confirm that it consistently produces water of the required purity for use in the sterilization and manufacturing processes. Key steps include Installation Qualification (IQ) to verify that the system is installed correctly, Operational Qualification (OQ) to ensure that it performs as intended under normal operating conditions, and Performance Qualification (PQ). For this, physico-chemical and microbiological analyses of samples were carried out in 5 points of drinking water and 4 points of purified water during 2 phases.The tests performed on each sample were appearance, pH, conductivity, microbial count and pathogen detection. The results obtained in each test indicated that the water obtained from the purification system remains within the specifications established in the British and American Pharmacopoeias and the Ministry of Health. In conclusion, according to the results obtained, it is demonstrated that the water purification system of a sterile gauze plant is validated and under control.
ABSTRACT This thesis aims to validate the water purification system of a sterile gauze manufacturing plant. This process involves the development and execution of the validation protocol; thorough evaluation of the design, installation and operational performance of the purification system to confirm that it consistently produces water of the required purity for use in the sterilization and manufacturing processes. Key steps include Installation Qualification (IQ) to verify that the system is installed correctly, Operational Qualification (OQ) to ensure that it performs as intended under normal operating conditions, and Performance Qualification (PQ). For this, physico-chemical and microbiological analyses of samples were carried out in 5 points of drinking water and 4 points of purified water during 2 phases.The tests performed on each sample were appearance, pH, conductivity, microbial count and pathogen detection. The results obtained in each test indicated that the water obtained from the purification system remains within the specifications established in the British and American Pharmacopoeias and the Ministry of Health. In conclusion, according to the results obtained, it is demonstrated that the water purification system of a sterile gauze plant is validated and under control.
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Keywords
Calificación. Validación. Agua purificada. Esterilidad.