Evaluación de la temperatura y humedad en un almacén de materia prima de un laboratorio farmacéutico, Perú 2021
No Thumbnail Available
Date
2021
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
Universidad Nacional de Trujillo
Abstract
Preservar las condiciones adecuadas de almacenamiento de las materias primas contribuye a la fabricación de productos farmacéuticos seguros, eficaces y de buena calidad. Por lo que, el objetivo del presente trabajo fue evaluar la temperatura y humedad en un almacén de materia prima de un laboratorio farmacéutico peruano en 2021. Para ello, se realizó estudios mediante el uso de registradores patrones calibrados (dataloggers), los cuales estuvieron ubicados en zonas específicas por un periodo de 72 horas (3 días). El intervalo de toma de datos de los registradores fue de 5 minutos tanto para la temperatura como para la humedad. Los valores de temperatura y humedad se encontraron comprendidos dentro de los criterios de aceptación, ≤ 25 °C y ≤ 75 % respectivamente. Con una TCM promedio de 22.8°C y con zonas críticas ubicadas en zona 1 y 6. Por tanto, se concluyó que el almacén de materia prima del laboratorio farmacéutico presenta una correcta distribución de temperatura y humedad que cumple con las especificaciones establecidas por DIGEMID.
Abstract Preserving adequate storage conditions for raw materials contribute to the manufacture of safe, effective and of good quality of pharmaceutical products. Therefore, the objective of this work was to evaluate the temperature and humidity in a raw material warehouse of a peruvian pharmaceutical laboratory in 2021. For this, studies were carried out using calibrated standard recorders (dataloggers), which were located in specific areas for a period of 72 hours (3 days). The data logger interval was 5 minutes for both temperature and humidity. The temperature and humidity values were found within the acceptance criteria, ≤ 25 ° C and ≤ 75% respectively. With an average TCM of 22.8 ° C and with critical zones located in zones 1 and 6. Therefore, it was concluded that the pharmaceutical laboratory's raw material warehouse presents a correct temperature and humidity distribution that meets the specifications established by DIGEMID.
Abstract Preserving adequate storage conditions for raw materials contribute to the manufacture of safe, effective and of good quality of pharmaceutical products. Therefore, the objective of this work was to evaluate the temperature and humidity in a raw material warehouse of a peruvian pharmaceutical laboratory in 2021. For this, studies were carried out using calibrated standard recorders (dataloggers), which were located in specific areas for a period of 72 hours (3 days). The data logger interval was 5 minutes for both temperature and humidity. The temperature and humidity values were found within the acceptance criteria, ≤ 25 ° C and ≤ 75% respectively. With an average TCM of 22.8 ° C and with critical zones located in zones 1 and 6. Therefore, it was concluded that the pharmaceutical laboratory's raw material warehouse presents a correct temperature and humidity distribution that meets the specifications established by DIGEMID.
Description
Keywords
Almacenamiento, temperatura, humedad, materia prima, laboratorio farmacéutico.