Exposure assessment of four pharmaceutical powders based on dustiness and evaluation of damaged HEPA filters

Tidsskriftartikel - 2014

Resume

In this study, we show the different dustiness characteristics of four molecular pharmaceutical powder candidates and evaluate the performance of HEPA-filters damaged with three different pin-hole sizes and exposed to dust using real industrial powders in a miniaturized EN15051 rotating drum dustiness tester. Finally we demonstrate the potential use of such data using first order exposure modeling to assess the potential worker exposure and transmission of active powder ingredients into ventilation systems. The four powders had highly variable inhalable dustiness indices (1,036-14,501 mg/kg). Dust particle size-distributions were characterized by three peaks; the first occurred around 60-80 nm, the second around 250 nm and the third at 2-3 µm. The second and third peaks are often observed in dustiness test studies, but peaks in the 60-80 nm range have not been reported previously. Exposure modeling in a 5 times 20 kg powder pouring scenario, suggests that excessive dust concentrations may be reached during use of powders with the highest dustiness levels. By number, filter-damage by three pinhole sizes resulted in damage-dependent penetration of 70-80 nm size particles, but by volume and mass the penetration is still dominated by particles larger than 100 nm. Whereas the exposure potential was evident, the potential dust concentrations in air-ducts following the pouring scenario above were at pg/m3levels. Hence filter penetration at these damage-levels was assumed to be only critical, if the active ingredients were associated with high hazard or unique product purity is required.

Reference

Levin DHM, Koponen IK, Jensen KA. Exposure assessment of four pharmaceutical powders based on dustiness and evaluation of damaged HEPA filters. Journal of Occupational and Environmental Hygiene 2014;11(2):165-177.
doi: 10.1080/15459624.2013.848038

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