Calificación del área de galénicos líquidos de uso externo de un laboratorio farmacéutico nacional
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Date
2020
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Universidad Nacional de Trujillo
Abstract
La calificación del área de galénicos líquidos de uso externo fue realizada en el laboratorio farmacéutico ALKOFARMA E.I.R.L., durante el mes de diciembre de 2018, el propósito fue calificar las salas que se encuentran dentro de esta área con el fin de garantizar mediante pruebas; como presión diferencial, renovaciones de aire por hora, conteo de partículas, temperatura, humedad relativa, luminosidad y control microbiológico; con la finalidad de certificar que el área se encuentra dentro de las especificaciones para ser considerado como clase 100 000 o grado D que es la que corresponde para galénicos líquidos de uso externo. Los datos obtenidos fueron contrastados con las especificaciones dadas por la norma ISO 14644, Informe 32 de la OMS, norma europea UNE 12464, demostrando que el área de galénicos líquidos de uso externo del laboratorio farmacéutico ALKOFARMA E.I.R.L. cumple con las especificaciones para cada una de las pruebas. Se concluye que el área se encuentra calificada.
ABSTRACT The qualification of the area of liquid galenics for external use was carried out in the pharmaceutical laboratory ALKOFARMA E.I.R.L., during the month of December 2018, the purpose was to qualify the rooms that are within this area in order to guarantee through tests; such as differential pressure, air changes per hour, particle count, temperature, relative humidity, luminosity and microbiological control; in order to certify that the area is within the specifications to be considered class 100 000 or grade D, which is the one that corresponds to liquid galenics for external use. The data obtained were contrasted with the specifications given by the ISO 14644, WHO Report 32, European standard UNE 12464, demonstrating that the area of liquid galenics for external use of the pharmaceutical laboratory ALKOFARMA E.I.R.L. meets the specifications for each of the tests. It is concluded that the area is qualified.
ABSTRACT The qualification of the area of liquid galenics for external use was carried out in the pharmaceutical laboratory ALKOFARMA E.I.R.L., during the month of December 2018, the purpose was to qualify the rooms that are within this area in order to guarantee through tests; such as differential pressure, air changes per hour, particle count, temperature, relative humidity, luminosity and microbiological control; in order to certify that the area is within the specifications to be considered class 100 000 or grade D, which is the one that corresponds to liquid galenics for external use. The data obtained were contrasted with the specifications given by the ISO 14644, WHO Report 32, European standard UNE 12464, demonstrating that the area of liquid galenics for external use of the pharmaceutical laboratory ALKOFARMA E.I.R.L. meets the specifications for each of the tests. It is concluded that the area is qualified.
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Keywords
Calificación de áreas. Salas blancas. Conteo de partículas