Boundy Maryanne, Leith David, Polton Thomas
Department of Environmental Sciences and Engineering, University of North Carolina at Chapel Hill Chapel Hill, NC 27599, USA.
Ann Occup Hyg. 2006 Jul;50(5):453-8. doi: 10.1093/annhyg/mel004. Epub 2006 Feb 16.
The trend among pharmaceutical companies to develop selective drugs of high potency has pushed the industry to consider the potential of each hazardous ingredient to become airborne. Dustiness issues are not unique to the pharmaceutical industry, but are relevant to any industry where powdered materials are mixed, transferred and handled. Interest in dustiness is also driven by concerns for worker health, the potential for plant explosions and the prevention of product loss. Unlike other industries, the pharmaceutical industry is limited by the milligram quantity of powdered material available for testing during product development. These needs have led to the development of a bench-top dustiness tester that requires only 10 mg of powder and fully contains the generated aerosol. The powder is dispersed within a 5.7 liter glass chamber that contains a respirable mass sampler and a closed-face sampler to quantify the respirable and total dust that are generated with a given energy input. The tester distinguished differences in dustiness levels of five different powders. Finer powders were dustier, and the respirable dust percentage was always less than that for total dust. Four testers have been built and evaluated using pharmaceutical grade lactose. Dustiness measurements determined using all four testers were comparable. The pharmaceutical industry uses surrogates such as lactose to represent active compounds in tests that estimate the dust concentration likely to occur in a new manufacturing operation. Differences between the dustiness of the active compound and its surrogate challenge the relevance of the surrogate tests to represent true exposures in the workplace. The tester can determine the dustiness of both the active compound and its surrogate, and the resultant ratio can help to interpret dust concentrations from surrogate tests. Further, dustiness information may allow the pharmaceutical researcher to select powder formulations that present low airborne concentrations in the workplace.
制药公司开发高效选择性药物的趋势促使该行业考虑每种有害成分变成空气传播物的可能性。粉尘问题并非制药行业所独有，而是与任何混合、转移和处理粉末状材料的行业相关。对粉尘问题的关注还受到对工人健康的担忧、工厂爆炸的可能性以及防止产品损失的驱动。与其他行业不同，制药行业在产品开发期间可用于测试的粉末状材料数量以毫克计，受到限制。这些需求促使开发出一种台式粉尘测试仪，该测试仪仅需10毫克粉末，并能完全容纳产生的气溶胶。粉末在一个5.7升的玻璃室内分散，该室内装有一个可吸入颗粒物采样器和一个封闭式采样器，以量化在给定能量输入下产生的可吸入粉尘和总粉尘。该测试仪区分了五种不同粉末的粉尘水平差异。粉末越细，粉尘越多，可吸入粉尘百分比始终低于总粉尘百分比。已经制造了四台测试仪，并使用药用级乳糖进行了评估。使用所有四台测试仪确定的粉尘测量结果具有可比性。制药行业在估计新制造操作中可能出现的粉尘浓度的测试中，使用乳糖等替代物来代表活性化合物。活性化合物与其替代物的粉尘iness差异对替代物测试代表工作场所真实暴露的相关性提出了挑战。该测试仪可以确定活性化合物及其替代物的粉尘iness，所得比率有助于解释替代物测试中的粉尘浓度。此外，粉尘iness信息可能使药物研究人员能够选择在工作场所空气中浓度较低的粉末配方。
