摘要
对冷冻干燥粉针剂无菌灌装的验证方法进行了试验,确立了以硫乙醇酸盐液体培养基为模拟灌装液,对整个冻干生产线的全过程进行了验证。每次试验样本数均>3000瓶,当可信度为95％时,取得了污染率均<0．1％的良好效果。
The test for the method of aseptically filling lyophilized powder injection agent was carried out. With thioglycollate liquor medium as analogous filled liquid, the whole process of freezing and drying production line was tested, and the sample of every test was greater than 3000 bottles, thus, the reliability reached 90%. The result that the pollution rate was less than 0.1% was satisfactory.
出处
《医药工程设计》
2007年第2期29-31,共3页
Pharmaceutical Engineering Design
关键词
冻干粉针剂
无菌灌装
验证方法
液体培养基
模拟灌装
lyophilized powder injection agent
aseptic filling
verification method
liquor medium, analogous filling
