Control de calidad de material de envase primario de un laboratorio nacional
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Date
2021
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Universidad Nacional de Trujillo
Abstract
En el presente informe se determinó la calidad de los materiales de envase primario de un laboratorio nacional, durante el año 2020. Se evaluó un lote de materiales de envase de frascos, tapa con pulsador y cánula, bomba pulverizadora mecánica y tapa antipolvo, para ello se empleó las tablas de Planes de Muestreo Simple para Inspección Normal o General y los niveles de calidad aceptable (AQL). En la clasificación de defectos estandarizados en la industria que se da por defecto crítico, defecto mayor y defecto menor, se llevó a cabo desde la inspección hasta el análisis del dicho material. La metodología se realizó a base de pruebas fisicoquímicas en frascos según USP-42 y también se evaluó mediante pruebas por atributos en el material de envase primario, según norma propia del laboratorio nacional. Se concluye que la calidad de los materiales de envase primario cumple con todas las especificaciones técnicas establecidas por norma propia de la empresa y según USP-42.
ABSTRACT This report determined the quality of the primary packaging materials of a national laboratory during the year 2020. A batch of packaging materials of vials, push-button cap and cannula, mechanical spray pump and dust cap was evaluated, using the tables of Simple Sampling Plans for Normal or General Inspection and the acceptable quality levels (AQL). In the classification of standardized defects in the industry that is given by critical defect, major defect and minor defect, it was carried out from the inspection to the analysis of the material. The methodology was carried out based on physicochemical tests in bottles according to USP-42 and was also evaluated by attribute tests on the primary packaging material, according to the national laboratory's own standard. It is concluded that the quality of the primary packaging materials complies with all the technical specifications established by the company's own standard and according to USP-42.
ABSTRACT This report determined the quality of the primary packaging materials of a national laboratory during the year 2020. A batch of packaging materials of vials, push-button cap and cannula, mechanical spray pump and dust cap was evaluated, using the tables of Simple Sampling Plans for Normal or General Inspection and the acceptable quality levels (AQL). In the classification of standardized defects in the industry that is given by critical defect, major defect and minor defect, it was carried out from the inspection to the analysis of the material. The methodology was carried out based on physicochemical tests in bottles according to USP-42 and was also evaluated by attribute tests on the primary packaging material, according to the national laboratory's own standard. It is concluded that the quality of the primary packaging materials complies with all the technical specifications established by the company's own standard and according to USP-42.
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Keywords
material, envase primario, control, calidad, frascos