冻干粉针剂产品可见异物的影响因素及其控制

Influence Factors and Control of Visible Foreign Matter in Freeze-dried Powder for Injection

目的通过分析影响冻干粉针剂产品可见异物的因素,制定减少可见异物的方法,提高冻干粉针剂产品的质量。方法从影响可见异物的工艺用水、原辅材料、西林瓶胶塞、料液过滤系统、空气净化系统等方面进行分析。结果与结论在生产中按以上方面加以解决以控制可见异物,提高了产品质量。

Objective By analyzing the influence factors of visible foreign matter in freeze-dried powder for injection,to develop improved methods and improve the quality of freeze-dried powder for injection.Methods Process water,bulk and excipients,vial stopper,liquid filtration systems,air purification systems and so on were analyzed.Results and Conclusion The products quality can be improved by controlling influence factors of visible foreign matter in freeze-dried powder for injection.