目的:评价基于二氧化碳检测原理的BacT/ALERT 3D Dual-T?快速微生物检测系统作为药典无菌检查法的替代用于创新生物制品的可行性。方法:以细胞制品作为应用对象,参考各国药典及国外指导原则,研究快速方法在专属性、检测限、非劣效性方...目的:评价基于二氧化碳检测原理的BacT/ALERT 3D Dual-T?快速微生物检测系统作为药典无菌检查法的替代用于创新生物制品的可行性。方法:以细胞制品作为应用对象,参考各国药典及国外指导原则,研究快速方法在专属性、检测限、非劣效性方面是否可替代药典方法。结果:评价结果表明快速方法在专属性和检测限参数上达到了药典方法性能相当,大部分情况下可比药典方法更快地报告阳性结果,快速方法对产品质量的决策不劣于药典方法,且在数据完整性方面具备优势。结论:在风险管理的前提下,经验证的快速方法可作为药典无菌检查的替代方法用于创新生物制品的快速放行。展开更多
VOCs play an increasingly important role in affecting air quality and threatening human health in China in recent years,where industry activities show a significant contribution to VOCs emission.In this article we rep...VOCs play an increasingly important role in affecting air quality and threatening human health in China in recent years,where industry activities show a significant contribution to VOCs emission.In this article we report our long term study of industrial VOCs emissions of six major industries (vehicle manufacturing,printing,equipment coating,electronic manufacturing,furniture manufacturing and bio-pharming) on the aspects of emission characteristics,environmental impact and health risk assessment,and control challenge analysis with the purpose to obtain in-depth understanding of industry VOCs emissions and offer some original basements for national control and management of industry VOCs emissions.This study shows that all these industries give middle or low emission with total VOCs concentration less than 1000 mg/m3 at each exhaust pipe.Benzenes,esters,alcohols,ketones,alkanes,chloroalkanes and alkenes were detected as the major emission components and the most frequently monitored VOCs were benzenes,which varied obviously with different processes and industries.The environmental impact assessments indicate that vehicle manufacturing and benzenes should be prior controlled with the purpose to reduce air pollution.While,health risk assessments suggest that furniture manufacturing and chloroalkanes should be firstly controlled.Control analysis indicates that developing technologies with low cost and high efficiency and establishing and completing specific industry emission standards/regulations are the two key issues in VOCs emission management at present stage.展开更多
文摘目的:评价基于二氧化碳检测原理的BacT/ALERT 3D Dual-T?快速微生物检测系统作为药典无菌检查法的替代用于创新生物制品的可行性。方法:以细胞制品作为应用对象,参考各国药典及国外指导原则,研究快速方法在专属性、检测限、非劣效性方面是否可替代药典方法。结果:评价结果表明快速方法在专属性和检测限参数上达到了药典方法性能相当,大部分情况下可比药典方法更快地报告阳性结果,快速方法对产品质量的决策不劣于药典方法,且在数据完整性方面具备优势。结论:在风险管理的前提下,经验证的快速方法可作为药典无菌检查的替代方法用于创新生物制品的快速放行。
基金supported by the Team Interaction and Cooperation of the Science and Technology Program of the Chinese Academy of Sciencesthe Knowledge Innovation Program of the Chinese Academy of Sciences(KZCX2-YW-JS402)+4 种基金the National Basic Research Program of China(2010CB732300)the Strategic Priority Research Program of the Chinese Academy of Science(XDB05050200)the National High Technology Research and Development Program of China(2012AA063101)the Program of Chinese Academy for Environmental Planning(2012A014)Beijing Municipal Natural Science Foundation(8112015)
文摘VOCs play an increasingly important role in affecting air quality and threatening human health in China in recent years,where industry activities show a significant contribution to VOCs emission.In this article we report our long term study of industrial VOCs emissions of six major industries (vehicle manufacturing,printing,equipment coating,electronic manufacturing,furniture manufacturing and bio-pharming) on the aspects of emission characteristics,environmental impact and health risk assessment,and control challenge analysis with the purpose to obtain in-depth understanding of industry VOCs emissions and offer some original basements for national control and management of industry VOCs emissions.This study shows that all these industries give middle or low emission with total VOCs concentration less than 1000 mg/m3 at each exhaust pipe.Benzenes,esters,alcohols,ketones,alkanes,chloroalkanes and alkenes were detected as the major emission components and the most frequently monitored VOCs were benzenes,which varied obviously with different processes and industries.The environmental impact assessments indicate that vehicle manufacturing and benzenes should be prior controlled with the purpose to reduce air pollution.While,health risk assessments suggest that furniture manufacturing and chloroalkanes should be firstly controlled.Control analysis indicates that developing technologies with low cost and high efficiency and establishing and completing specific industry emission standards/regulations are the two key issues in VOCs emission management at present stage.
