输液生产过程的细菌内毒素检查

Bacterial Endotoxin Test Used in Producing Process of Transfusion

目的:将细菌内毒素检查法应用于输液生产过程的热原质量控制。方法:通过监测点样品的干扰试验,建立生产过程重要工序的热原监测点,及时进行各监测点的细菌内毒素检测,协助生产部门查找影响产品质量的因素。结果:分析出影响产品质量的原因,改进后提高了产品的合格率。结论:细菌内毒素检查法应用于生产过程,确实可起到事前预防的作用,有助于提高产品质量。

Objective: To inspect the feasibility of bacterial endotoxin test used in producing process of transfusion. Methods: py-rogen test point of produce process was established and the interference factor of bacterial endotoxin test was studied. Results: The influential factors to production quality have been found. Acceptable end rate of production has been raised. Conclusions: Bacterial endotoxin test could be used for pyrogen test in producing process of transfusion, raising quality of production.