Calificación de diseño, instalación, operación y desempeño del sistema de generación, almacenamiento y distribución de aire comprimido en el laboratorio Neorfármaco del Ecuador Neorfármaco Cía. Ltda.

Abstract

In this study the compressed the qualification of the compressed air system was carried out from its generation, storage and distribution in the Neorfármaco Laboratory in Ambato city. Air system was qualified starting from its generation, storage and distribution in the Neofármaco Laboratory. Compressed air is widely used in various drug production processes. Impurities in compressed air may jeopardize products. Therefore, it is mandatory to satisfy the quality criteria that govern this type of critical support systems. For the qualification, the protocols and reports of design qualification (DQ), installation qualification (IQ), operation qualification (OQ) and performance qualification (PQ) were implemented. For DQ protocols, it was supports that the design satisfies the user requirements, in the same way the IQ was verified the physical conditions of the air, characteristics and components of the system. In the operation qualification, the correct operation of the system was verified and the results of the operational tests show that the compressed air system accomplish the quality attributes as established the ISPE and ISO 8573 standards, Thus, class 2 in particle content, class 4 for dew point and class 2 for oil content and without the presence of microbial growth. Finally, in the performance qualification, the same parameters were evaluated for 3 days, showing that the system is continuous, reproducible and distributes quality compressed air.