工程密闭风险评估在高活性药物生产中的应用

Application of Engineering Sealing Risk Assessment in the Production of Highly Active Drugs

通过工程密闭风险评估的方法评估高活性药物生产中粉尘暴露操作环节对操作人员的危害以及采取的密闭防护措施。首先通过危害评估确定物质的危害,再通过暴露评估识别出潜在的暴露环节,进而评价出系统的密闭性能目标,并据此制定密闭控制措施。工程密闭风险评估的方法对含高活性物质药物生产设备或系统的选择,厂房设施设计具有指导意义。

In this paper,the hazards of dust exposure to operators in the production of high active drugs was evaluated by the risk assessment method of engineering sealing,and the protective measures of sealing was taken.Firstly,the harm of the substance was determined through the hazard assessment,and then the potential exposure link was identified through the exposure assessment,and then the sealing performance target of the system was evaluated,and the sealing control measures were formulated accordingly.The method of engineering sealing risk assessment was of guiding significance to the selection of equipment or system and the design of plant facilities for the production of drugs containing high active substances.