Levin Marcus, Koponen Ismo K, Jensen Keld A
a Department of Micro- and Nanotechnology, Technical University of Denmark , Lyngby , Denmark.
J Occup Environ Hyg. 2014;11(3):165-77. doi: 10.1080/15459624.2013.848038.
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 pinhole sizes and exposed to dust using real industrial powders in a miniaturized EN15051 rotating drum dustiness tester. We then 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 previously reported. 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/m(3) levels. 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. [Supplementary materials are available for this article. Go to the publisher's online edition of Journal of Occupational and Environmental Hygiene for the following free supplemental resource: An example of a typical particle number time-series of a complete dustiness test. It provides information on the HEPA-filter used including a scanning electron microscopy image of it. It also provides APS-measurements of particles penetrating the damaged HEPA-filter.].
在本研究中，我们展示了四种分子药物粉末候选物的不同粉尘特性，并在小型化的EN15051转鼓式粉尘测试仪中，使用实际工业粉末评估了被三种不同针孔尺寸损坏并暴露于粉尘中的高效空气过滤器（HEPA）的性能。然后，我们利用一阶暴露模型来评估工人潜在暴露以及活性粉末成分向通风系统的传播，以此证明这些数据的潜在用途。这四种粉末的可吸入粉尘指数变化很大（1,036 - 14,501毫克/千克）。粉尘粒径分布有三个峰值；第一个峰值出现在60 - 80纳米左右，第二个峰值出现在250纳米左右，第三个峰值出现在2 - 3微米处。在粉尘测试研究中经常观察到第二和第三个峰值，但之前尚未报道过60 - 80纳米范围内的峰值。在一个5×20千克粉末倾倒场景中的暴露模型表明，在使用粉尘含量最高的粉末时，可能会达到过高的粉尘浓度。从数量上看，三种针孔尺寸造成的过滤器损坏导致70 - 80纳米尺寸颗粒的穿透率与损坏程度相关，但从体积和质量上看，穿透率仍以大于100纳米的颗粒为主。虽然暴露潜力很明显，但在上述倾倒场景后，风道中的潜在粉尘浓度处于皮克/立方米水平。因此，只有当活性成分具有高危害性或需要独特的产品纯度时，才认为在这些损坏水平下的过滤器穿透是关键的。[本文提供了补充材料。请访问《职业与环境卫生杂志》出版商的在线版本，获取以下免费补充资源：完整粉尘测试的典型颗粒数时间序列示例。它提供了所使用的高效空气过滤器的信息，包括其扫描电子显微镜图像。它还提供了穿透损坏的高效空气过滤器的颗粒的气动力学粒径谱仪测量结果。]
