Highly potent active pharmaceutical ingredients pose a risk with regard to dustiness and spatial distribution of dust in the manufacture of pharmaceuticals. Traditional filter-based methods for dust investigations, for example based on IOM samplers have several disadvantages, such as the gravimetrical or wet chemical analysis of the collected samples, neither allowing the detection of airborne dust concentrations in real-time, nor time-resolved. Therefore, a recently developed chamber setup was equipped with low-cost particulate matter sensors to investigate their feasibility to detect and visualize the spatiotemporal distribution of pharmaceutical dusts in real-time. Experiments with the surrogate substance acetaminophen revealed that with a suitable adjustment of the atomization parameters, reproducible dust concentrations and the spatiotemporal dust distribution within the chamber setup were detectable with the sensors in real-time. Based on these results, lactose as a typical excipient in tableting blends for direct compression and a binary powder blend of acetaminophen and lactose were also investigated. The binary blend as well as plain lactose showed a reduced dustiness when compared to plain acetaminophen, indicating particle interactions between both substances which influence their tendency to become airborne. In conclusion, the particulate matter sensors allow investigations of spatiotemporal dust distributions in real-time.
Küllmar et al. (Sun,) studied this question.