Solución oftálmica estéril de Latanoprost 0,005%: Validación del proceso de fabricación
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Date
2024
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Universidad Nacional de Trujillo
Abstract
El presente trabajo de investigación tuvo como objetivo validar el proceso de fabricación del producto Latanoprost 0,005% solución oftálmica estéril durante los meses de noviembre y diciembre del año 2022; demostrando la mejora continua del proceso de fabricación cambiando la filtración esterilizante de intermitente a continua optimizando el tiempo de fabricación de 8 horas a 6 horas y mejorando la eficiencia del proceso asegurando que los resultados obtenidos del producto granel se encuentren dentro de las especificaciones establecidas según protocolo de validación. Para ello, previo proceso de validación, se verificó la calificación de áreas, personal, máquinas y equipos, calibración de equipos e instrumentos analíticos encontrándose todo conforme; durante todo el proceso, se evaluó los parámetros de control encontrándose dentro de las especificaciones técnicas; la temperatura al iniciar el proceso de 70°C ± 10°C y al finalizar de 25°C ± 5 °C; de igual forma la velocidad de agitación encontrándose dentro de especificación de 600 ± 10 Revoluciones por minuto. Se recolectaron muestras de los tres lotes evaluados al finalizar el proceso de fabricación a las cuales se realizaron ensayos fisicoquímicos y/o pruebas tales como: Peso específico, pH, identificación, contenido de Latanoprost, controles microbiológicos y aspecto, además se evaluó el volumen promedio envasado del producto en proceso todos encontrándose dentro de especificación. El peso específico se encontró dentro de los límites de aceptación (1,055 g/mL – 1,095 g/mL), las valoraciones de Latanoprost se encontraron dentro de los límites de aceptación de 0,0450 mg/mL – 0,0550 mg/mL (90% – 110%), concluyendo que el proceso de fabricación validado es confiable asegurando un proceso reproducible y seguro de emplear con el tiempo.
ABSTRACT The objective of this research work was to validate the manufacturing process of the product Latanoprost 0.005% sterile ophthalmic solution during the months of November and December 2022; demonstrating the continuous improvement of the manufacturing process by changing the sterilizing filtration from intermittent to continuous, optimizing the manufacturing time from 8 hours to 6 hours and improving the efficiency of the process, ensuring that the results obtained from the bulk product are within the specifications established according to the validation protocol. For this purpose, prior to the validation process, the qualification of areas, personnel, machines and equipment, calibration of equipment and analytical instruments were verified and found to be in compliance; during the entire process, the control parameters were evaluated and found to be within the technical specifications; the temperature at the beginning of the process was 70°C ± 10°C and at the end 25°C ± 5°C; likewise, the agitation speed was found to be within the specification of Revolutions per minute. Samples were collected from the three lots evaluated at the end of the manufacturing process and were subjected to physicochemical tests and/or tests such as: specific weight, pH, identification, latanoprost content, microbiological controls and appearance, and the average packaged volume of the product in process was also evaluated, all of which were within specification. The specific weight was found within the acceptance limits (1.055 g/mL - 1.095 g/mL), the Latanoprost titrations were found within the acceptance limits of 0.0450 mg/mL - 0.0550 mg/mL (90% - 110%), concluding that the validated manufacturing process is reliable ensuring a reproducible and safe process to be used over time.
ABSTRACT The objective of this research work was to validate the manufacturing process of the product Latanoprost 0.005% sterile ophthalmic solution during the months of November and December 2022; demonstrating the continuous improvement of the manufacturing process by changing the sterilizing filtration from intermittent to continuous, optimizing the manufacturing time from 8 hours to 6 hours and improving the efficiency of the process, ensuring that the results obtained from the bulk product are within the specifications established according to the validation protocol. For this purpose, prior to the validation process, the qualification of areas, personnel, machines and equipment, calibration of equipment and analytical instruments were verified and found to be in compliance; during the entire process, the control parameters were evaluated and found to be within the technical specifications; the temperature at the beginning of the process was 70°C ± 10°C and at the end 25°C ± 5°C; likewise, the agitation speed was found to be within the specification of Revolutions per minute. Samples were collected from the three lots evaluated at the end of the manufacturing process and were subjected to physicochemical tests and/or tests such as: specific weight, pH, identification, latanoprost content, microbiological controls and appearance, and the average packaged volume of the product in process was also evaluated, all of which were within specification. The specific weight was found within the acceptance limits (1.055 g/mL - 1.095 g/mL), the Latanoprost titrations were found within the acceptance limits of 0.0450 mg/mL - 0.0550 mg/mL (90% - 110%), concluding that the validated manufacturing process is reliable ensuring a reproducible and safe process to be used over time.
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Keywords
Validación, fabricación, Latanoprost, proceso, filtración esterilizante, filtración intermitente.