SMOKE STUDIES

Smoke Studies are fundamental tests for correctly evaluating the trend of the air flows in the controlled areas and the related operations employed in these areas. The main purpose is to document unidirectionality of flows, particularly within areas classified as grade A and in grade transition zones. In fact, any turbulence or inadequate operations could pose the risk of contamination within the processes sterile. We have a lot of experience in Smoke Studies, starting from the end of 90s when they were still in an almost experimental phase. Over time the activity has evolved in conjunction with improvements in GMP practices, of the indications of Annex 1, and regulatory agency controls. In parallel our video shooting and set construction techniques also have undergone an evolution that allows us to evaluate both in the best possible way the flow trend from the various perspectives and the aseptic operations.

CONSULTANCY

Our Smoke Studies allow us to evaluate the correct airflow pattern in various situations: clean rooms, airlocks, glove boxes, pass boxes, RABS lines, isolators, robotic systems, vertical and horizontal LAF hoods. We work closely with production, engineering, and QA to identify and resolve any critical issues that may be encountered. To obtain the best video recordings, all cameras are placed at the best visibility points of both airflow and operations, taking into account distance, FOV (field of view), height above the camera plane, tilt, lighting, etc.

EQUIPMENT

During the execution of the Smoke studies you can see all the camera shots in real time on special tablets connected remotely, for an instant evaluation of air flows and operator behaviour. For this reason, a special scenography is set up using sheets and backgrounds able to bring out the air flow to the maximum through the smoke tracer. Smoke tracers are also placed exactly at the points of interest, using specific cables, suction cups and specific mounting systems.