A Novel Two-Chamber Setup for Containment Investigations with Special Focus on the Dustiness of Pharmaceutical Powders Depending on the Airflow.

In the present study, it was shown that a newly developed two-chamber setup (TCS) for containment investigations consisting of an emission and a detection chamber may serve to predict the dustiness of HPAPIs in a sealed system at different flow conditions. These flow conditions include the plain diffusive transport and the diffusive transport with the oppositely directed convective flow of airborne particles of the safe surrogate substance acetaminophen (ACAM). A linear correlation was found between an atomized amount of up to 400 mg of ACAM and the resulting dust emissions. The dust emission was reduced significantly by an oppositely directed convective flow. The results from the examinations, using either atomized ACAM or smoke for the determination of the evacuation time of the detection chamber, indicated that both methods are comparable. Furthermore, computational fluid dynamics (CFD) simulations were performed to determine the evacuation time. A time period of 9 min was sufficient for a reproducible evacuation and a reliable detection of most airborne ACAM particles within the detection chamber. CFD simulations were also carried out to simulate the air velocity resulting from various pressure differences and to visualize the flow of the airborne particles within the detection chamber.