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首页> 外文期刊>Chemical Weekly >Dishman Group's Swiss subsidiary announces containment performance validation at high potent API facility
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Dishman Group's Swiss subsidiary announces containment performance validation at high potent API facility

机译:Dishman集团的瑞士子公司宣布在高效API设施中进行密闭性能验证

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摘要

Switzerland-based Carbogen Amcis AG - owned by Dishman Pharmaceuticals and Chemicals Ltd. has announced that its commercial facility for multipurpose production of highly potent active pharmaceutical ingredients (APIs) has fully met all design specifications for the containment of highly active APIs. The facility, located on the site of Dishman Pharmaceuticals, in Ahmedabad, limits worker exposures to <1 μ g/m3 and is thus capable of manufacturing compounds of the highest occupational exposure band (Category IV), which includes carcinogens. "Performance within the design specification was verified through application of industry standard surrogate testing designed to evaluate the safe handling of highly potent APIs," the company informed in a press note.
机译:总部位于瑞士的Carbogen Amcis AG(由Dishman Pharmaceuticals and Chemicals Ltd.拥有)宣布,其用于多用途生产强效活性药物成分(API)的商业设施已完全满足所有包含高活性API的设计规范。该设施位于艾哈迈达巴德(Ahmedab​​ad)的迪什曼制药(Dishman Pharmaceuticals)现场,可将工人的暴露量限制在<1μg / m3,因此能够生产具有最高职业暴露范围的化合物(类别IV),其中包括致癌物。该公司在一份新闻简报中表示:“通过应用行业标准的替代测试来验证设计规范内的性能,该替代测试旨在评估高效API的安全处理。”

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