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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 apply bacterial endotoxin test to pyrogen quality control in infusion production. Methods: Through the interference test of sampling points of samples, the pyrogen monitoring points of important processes in the production process were established, and the bacterial endotoxin test was conducted in time to assist the production department to find out the factors that affect the product quality. Results: Analysis of the reasons for the impact of product quality, improve the product after the passing rate. Conclusion: Bacterial endotoxin test method used in the production process can indeed play a preventive role in advance, help to improve product quality.