鱼宝生都成益辛亚军

    (1.西安利君制药有限责任公司，西安 710077；2.西安秦巴药业有限公司，高陵 710201)

    冻干粉针剂可见异物控制实践的探讨

    鱼宝生1都成益1辛亚军2

    (1.西安利君制药有限责任公司，西安 710077；2.西安秦巴药业有限公司，高陵 710201)

    针对冻干粉针剂可见异物的控制问题，按照污染现象，污染贡献，原因分析和对应之策的思路，系统地探讨了：①管道系统，冻干机和洗瓶机零部件，焊接接头内表面的自由状态产生的问题。②不锈钢钝化的有关问题。③注射用水使用点过滤器之后的检测数据的置信度问题。④纯蒸汽使用点不设防的相关问题。⑤纯蒸汽管道系统，对工器具脉动真空灭菌柜的污染问题。⑥洗瓶机压缩空气使用点过滤器，脉冲放散过载的特殊工况。⑦隧道烘箱洁净度，网带链传动护罩上的积尘，网带轨道金属磨屑和振动的问题。⑧其他相关问题。

    冻干粉针剂；可见异物；焊接接头；钝化；工艺用水；纯蒸汽；压缩空气；过滤器；隧道烘箱

    Abstract:With respect to the control of visible foreign matter in frozen dry powder infusion, and based on contamination phenomenon, causes analysis and counter measures, the followings were discussed in this article: 1) the problems occurred in the piping system, the components of freezing and drying machine and bottle washing machine and the inner surface at welds; 2) problem related to making stainless steel inactive; 3) reliability of test data from infusion water by using fi lter; 4) problem related to use of pure steam; 5) contamination occurred in vacuum sterilizing cabinet in view of using pure steam piping system; 6) speci fi c working condition of overload in pulse divergence when fi lter is used in bottle washing machine with compressed air; 7) problems about cleanness of tunnel oven, dust appeared in the cover for transmission belt and the vibration of track; 8) other problems. ......