Calificación de una envasadora automática en el área de envasado en un laboratorio farmacéutico, Piura - 2021
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Date
2021
Journal Title
Journal ISSN
Volume Title
Publisher
Universidad Nacional de Trujillo
Abstract
El presente informe tiene como objetivo la calificación de 3 distintas etapas del modelo en V de calificación de equipos de la envasadora automática en un laboratorio del farmacéutico, para lo cual se desarrolló una metodología descriptiva, observacional y experimental. En la calificación de instalación (IQ) se verificó las características y condiciones en las cuales el equipo desempeñará sus funciones de la manera más óptima. Por otro lado, en la calificación de operación (OQ) se verifica el correcto funcionamiento de cada una de las partes del equipo, realizando las medidas, el material de construcción y el estado en el que se encuentra cada una de las partes que conforman el equipo, contrastándose con la documentación proporcionada por el fabricante. En la calificación de desempeño (PQ) se evalúa el trabajo del equipo simulando el proceso para el cual está diseñado pudiéndose obtener los resultados esperados para cumplir con los requerimientos del proceso.
ABSTRACT The objective of this report is to qualify 3 different stages of the V-model for qualification of automatic packaging machine equipment in a pharmaceutical laboratory, for which a descriptive, observational and experimental methodology was developed. In the installation qualification (IQ) the characteristics and conditions in which the equipment will perform its functions in the most optimal way were verified. On the other hand, in the operation qualification (OQ) the correct functioning of each of the parts of the equipment is verified, carrying out the measurements, the construction material and the state in which each of the parts that make up the equipment is found. , contrasted with the documentation provided by the manufacturer. In the performance qualification (PQ), the team's work is evaluated by simulating the process for which it is designed, being able to obtain the expected results to meet the process requirements
ABSTRACT The objective of this report is to qualify 3 different stages of the V-model for qualification of automatic packaging machine equipment in a pharmaceutical laboratory, for which a descriptive, observational and experimental methodology was developed. In the installation qualification (IQ) the characteristics and conditions in which the equipment will perform its functions in the most optimal way were verified. On the other hand, in the operation qualification (OQ) the correct functioning of each of the parts of the equipment is verified, carrying out the measurements, the construction material and the state in which each of the parts that make up the equipment is found. , contrasted with the documentation provided by the manufacturer. In the performance qualification (PQ), the team's work is evaluated by simulating the process for which it is designed, being able to obtain the expected results to meet the process requirements
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Keywords
calificación, equipo, instalación, operación, desempeño.