Control del proceso de manufactura de pastillas analgésicas – antiinflamatorias: bencidamina clorhidrato pastillas 3 mg en un laboratorio nacional
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Date
2021
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Universidad Nacional de Trujillo
Abstract
El presente informe de prácticas pre-profesionales tuvo por finalidad describir el desarrollo del control en proceso de manufactura de pastillas analgésicas-antiinflamatorias: bencidamina clorhidrato 3 mg en un laboratorio nacional. El proceso de manufactura controlado desde la dispensación de materia prima e insumos, fabricación y acondicionado. Se realizaron ensayos al producto tales como peso el cual para las pastillas a granel la especificación es 1,6-2,0 g/pastilla y para producto envasado la especificación es 7,4-9,6 g/sobre; y se evaluó también el aspecto. Además se realizó prueba de hermeticidad al producto en empaque primario, en el cual debemos obtener el 100% de sobres evaluado conformes; así también se analizó el aspecto y contenido del empaque primario. Los datos obtenidos del proceso de manufactura en sus distintas etapas fueron analizados y comparados según los criterios de aceptación para cada etapa. Se concluye que el proceso cumplió con las especificaciones establecidas
ABSTRACT The purpose of this report of pre-professional practices aimed to describe the development of control during the manufacturing process of analgesic-anti-inflammatory pills: benzidamine hydrochloride 3 mg in a national laboratory. The controlled manufacturing process from the dispensing of raw materials and inputs, manufacturing and conditioning. Product tests were performed such as weight, which for bulk tablets the specification is 1.6 - 2.0 g/pill and for packaged products the specification is 7.4 - 9.6 g/pill; and appearance was also evaluated. In addition, a watertightness test was performed on the product in the primary packaging, in which we must obtain 100% of the envelopes evaluated as compliant; the appearance and contents of the primary packaging were also analyzed. The data obtained from the manufacturing process in its different stages were analyzed and compared according to the acceptance criteria for each stage. It is concluded that the process met the specified specifications.
ABSTRACT The purpose of this report of pre-professional practices aimed to describe the development of control during the manufacturing process of analgesic-anti-inflammatory pills: benzidamine hydrochloride 3 mg in a national laboratory. The controlled manufacturing process from the dispensing of raw materials and inputs, manufacturing and conditioning. Product tests were performed such as weight, which for bulk tablets the specification is 1.6 - 2.0 g/pill and for packaged products the specification is 7.4 - 9.6 g/pill; and appearance was also evaluated. In addition, a watertightness test was performed on the product in the primary packaging, in which we must obtain 100% of the envelopes evaluated as compliant; the appearance and contents of the primary packaging were also analyzed. The data obtained from the manufacturing process in its different stages were analyzed and compared according to the acceptance criteria for each stage. It is concluded that the process met the specified specifications.
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Keywords
Control de Proceso, fabricación, acondicionado.