Bibliographic citations
Rodriguez, L., (2022). Calificación de instalación, operación y desempeño del equipo autoclave en el área de producción de un laboratorio farmacéutico nacional [Universidad Nacional de Trujillo]. https://hdl.handle.net/20.500.14414/19885
Rodriguez, L., Calificación de instalación, operación y desempeño del equipo autoclave en el área de producción de un laboratorio farmacéutico nacional []. PE: Universidad Nacional de Trujillo; 2022. https://hdl.handle.net/20.500.14414/19885
@misc{renati/1050979,
title = "Calificación de instalación, operación y desempeño del equipo autoclave en el área de producción de un laboratorio farmacéutico nacional",
author = "Rodriguez Pelaes, Luis Alberto Jesus",
publisher = "Universidad Nacional de Trujillo",
year = "2022"
}
ABSTRACT The objective of this work was to qualify the autoclave equipment in the production area of a national pharmaceutical laboratory located in Lima, year 2022, applying a descriptive, operational and experimental methodology. The qualification consisted of 3 stages: installation qualification (IQ), operation qualification (OQ) and performance qualification (PQ). The results of the installation qualification corresponding to the characteristics and conditions of the environment for the autoclave equipment to carry out its work were optimal. In the operation qualification, the results obtained were within the acceptance ranges according to the specifications of USP 42 (Pharmacopeia of the United States of America). Finally, in the performance qualification tests of the operation of the equipment with load were carried out to demonstrate the optimal sterilization of the equipment, the results obtained were satisfactory. It was concluded that the qualification of installation, operation and performance of the autoclave equipment in the production area is within the accepted range, complying with the specifications.
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