Investigations on the Spatial Dust Distribution for Emission Site Localization in Containment

Area of Science:

• Pharmaceutical Engineering
• Occupational Health and Safety
• Aerosol Science

Background:

• Dustiness and spatial dust distribution pose significant challenges in handling highly active pharmaceutical ingredients (HPAPIs).
• Accurate detection and localization of airborne dust at low concentrations are critical for contained manufacturing environments.
• Existing methods may lack the sensitivity or spatial resolution required for extremely low concentrations.

Purpose of the Study:

• To develop a reproducible chamber setup for atomizing small powder quantities.
• To detect and map the spatial distribution of airborne dust at very low concentrations.
• To demonstrate the localization of dust emission sites using stationary sampling within a confined space.

Main Methods:

• Chamber setup development and characterization using fuming sulfuric acid for evacuation time determination.
• Atomization of acetaminophen surrogate powder and spatial distribution detection using Institute of Occupational Medicine (IOM) samplers.
• Quantification of airborne acetaminophen via High-Performance Liquid Chromatography (HPLC) and Computational Fluid Dynamics (CFD) simulation of airflow.

Main Results:

• A linear relationship was observed between sample mass and aerosol quantity formed.
• Significant spatial variations in dust detection were observed, indicating convective mass transport.
• CFD simulations confirmed the convective mass transport and spatial distribution patterns of airborne dust.

Conclusions:

• The developed chamber setup allows reproducible atomization and sensitive detection of airborne dust.
• Emission sites can be localized using stationary sampling data, even at extremely low concentrations.
• This methodology is applicable to ensuring safety in the contained manufacture of HPAPI-containing pharmaceuticals.