Calificación de salas limpias del área de fabricación, envasado y acondicionado de semisólidos en un laboratorio farmacéutico nacional
No Thumbnail Available
Date
2024-10
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Universidad Nacional de Trujillo
Abstract
El presente trabajo tuvo como objetivo calificar las salas limpias del área de fabricación, envasado y acondicionado de semisólidos en un laboratorio farmacéutico nacional. Para ello, se realizaron diversas pruebas ambientales, tales como el recuento de partículas, las renovaciones de aire por hora, la temperatura, la humedad relativa, la intensidad de luz, la presión diferencial y el recuento microbiológico. El recuento de partículas mostró valores no superiores a 3 520 000 partículas de 0,5 µm y 29 000 partículas de 5,0 µm. Las renovaciones de aire por hora fueron superiores a 20, mientras que la temperatura se mantuvo por debajo de los 30°C y la humedad relativa por debajo del 80%. La intensidad de luz fue superior a los 500 lux, las presiones diferenciales se encontraron por encima de 0,03 inH₂O, y el recuento microbiológico estuvo dentro de los límites aceptables tanto para microorganismos aerobios como para hongos y levaduras. Las pruebas se realizaron conforme a la norma ISO 14644-1 y el Manual de Buenas Prácticas de Manufactura, demostrando que las áreas evaluadas cumplen con los requisitos para ser consideradas de grado D en condiciones de reposo. En conclusión, las salas limpias del área de fabricación, envasado y acondicionado de semisólidos están calificadas para su uso en los procesos de manufactura farmacéutica, garantizando un ambiente controlado y adecuado para la producción de productos seguros y de calidad.
ABSTRACT The objective of this work was to qualify the clean rooms in the manufacturing, packaging and conditioning area of semisolids in a national pharmaceutical laboratory. To this end, various environmental tests were carried out, such as particle count, air changes per hour, temperature, relative humidity, light intensity, differential pressure and microbiological count. The particle count showed values not exceeding 3 520 000 0,5 µm particles and 29 000 5,0 µm particles. Air changes per hour were greater than 20, while the temperature remained below 30°C and the relative humidity below 80%. The light intensity was greater than 500 lux, the differential pressures were above 0.03 inH₂O, and the microbiological count was within acceptable limits for both aerobic microorganisms and fungi and yeasts. The tests were carried out in accordance with the ISO 14644-1 standard and the Good Manufacturing Practices Manual, demonstrating that the evaluated areas meet the requirements to be considered grade D in rest conditions. In conclusion, the clean rooms in the semisolid manufacturing, packaging and conditioning area are qualified for use in pharmaceutical manufacturing processes, guaranteeing a controlled and adequate environment for the production of safe and quality products.
ABSTRACT The objective of this work was to qualify the clean rooms in the manufacturing, packaging and conditioning area of semisolids in a national pharmaceutical laboratory. To this end, various environmental tests were carried out, such as particle count, air changes per hour, temperature, relative humidity, light intensity, differential pressure and microbiological count. The particle count showed values not exceeding 3 520 000 0,5 µm particles and 29 000 5,0 µm particles. Air changes per hour were greater than 20, while the temperature remained below 30°C and the relative humidity below 80%. The light intensity was greater than 500 lux, the differential pressures were above 0.03 inH₂O, and the microbiological count was within acceptable limits for both aerobic microorganisms and fungi and yeasts. The tests were carried out in accordance with the ISO 14644-1 standard and the Good Manufacturing Practices Manual, demonstrating that the evaluated areas meet the requirements to be considered grade D in rest conditions. In conclusion, the clean rooms in the semisolid manufacturing, packaging and conditioning area are qualified for use in pharmaceutical manufacturing processes, guaranteeing a controlled and adequate environment for the production of safe and quality products.
Description
Keywords
Calificación. Salas limpias. Semisólidos. Envasado. Acondicionamiento