塑料袋装血液抗凝液灭菌方法的研究

Steriligation of anticoagulants in plastic bags

塑料袋装抗凝液的灭菌方法报道很少,过去其灭菌温度和时间多随经验而定。我们根据热杀菌动力学,以F_0值做为灭菌主要参数,从理论上对实践摸索出的灭菌方法可靠性进行验证,经D值、Z值、F_0值运算证明:107℃45min蒸气灭菌,F_0值等于8.08,符合中国《药品生产管理规范》有关规定,灭菌效果可靠。并对质量控制作了论述。

Sterilization method for anticoagulants in plasticbag is rarely reported. The temperature and timesfor sterilization in the past depended upon operator'sexperience. According to heat bactericidal dynamicsand the parameter F_0, the reliability of sterilizationwas comfirmed theoretically. It was proved that F_(0)value was 8.08 at 107℃ for 45 minutes. Steam ster-ilization. The results are in consistnt with the rulesof drug production and management in China.