FAQ - Conteo de partículas en producción farmacéutica y ciencias de la vida

Pregunta
During revalidation, is it mandatory to carry out particle monitoring for 3 consequitive days in laminar air flow unit & as well as in area qualification ?

Respuesta

No. It is required that you certify the area in accordance with ISO 14644-1. You may also chose to perform additional testing to satisfy your monitoring program requirements, but that would be based on a site-by-site issue and not one forced from regulations.