Smoke Studies pharmaceuticals

High-quality videos, technical assistance and support for pharmaceutical Smoke Studies

Best practices in Pharmaceutical Smoke Studies

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.

OUR SKILLS

We are specialized in the creation of video documentation suitable to satisfy regulatory requirements (FDA, AIFA, EMA, etc.) for studies analyzing air flows and operations in sterile environments. Using the “Tracer Particle Visualization” obtained with water generators and with the appropriate contrast structures, we record the direction and trend of the flows. In summary:

Use of the best constantly updated equipment, and water-based smoke generators (WFI or PW)

Tracer particles of correct buoyancy and durability, appropriate contrast tools to precisely visualize the actual air flows

Use of multiple cameras to ensure a complete assessment of airflow from different simultaneous perspectives

Diagnosis of airflow effects of air flows over the areas criticism through activities “as built”, “at rest”, “dynamic” and “in operation”.

Documentation and test analysis of airflow patterns in constant synergy with production, engineering, and QA experts.

Simulations of set up, operation, component and product transfer, environmental monitoring interventions

BUSINESS SECTORS

Smoke Studies are one of the most important tests for the qualification of a pharmaceutical production department, but not only. Our many years of experience allows us to work in different environments and to evaluate the correct trend of air flows in the most varied situations, offering very high level instrumentation with transversal applications for every need.