直立式聚丙烯输液袋装输液灭菌工艺研究

摘要

OBjective Todeterminethereliabilityofthesterilizationproceduresandloadingmethodsbyoptimizingthe sterilization process of infusion,and performance verification of infusion bath sterilizer;To determine the effect of sterilization sterilizationprocessbyheatpenetrationandbiologicalindicatortestofthreebatchesoftheproduct.Methods Usingahot water sterilizer,the whole process of sterilization was controlled by programmable automatic control system,and T32 -32 temperature verify system was used for performance verification. On this basis,the use of Bacillus stearothermophilus biologi-calindicatortoverifytheimplementationofthesterilizationprocess,todeterminethesterilizationeffect.Results Sterilized using 121℃ 12 min,F0 values﹥12,sterility assurance level( SAL)≤10-6 . Body bags had no rupture,no deformation,can be placed upright;Preparations tested to meet the quality standard of Chinese Pharmacopoeia 2010 edition. Conclusion Themethodwaspractical,accurateandreliable.%目的：通过输液灭菌工艺优选、大输液水浴灭菌器性能确认，确定灭菌程序及装载方式的可靠性；通过对产品进行3个批次的热穿透、生物指示剂试验，确定灭菌工艺的灭菌效果。方法使用大输液水浴灭菌器，采用可编程自动控制系统进行灭菌全过程控制，并采用 T32-32温度验证系统进行性能验证，在此基础上，使用嗜热脂肪杆菌芽孢生物指示剂实施灭菌工艺验证，确定灭菌效果。结果采用121℃灭菌12 min，F0值﹥12，无菌保证水平（ SAL）≤10-6。袋身无破裂、无变形，可直立放置；制剂质量按标准检测符合《中国药典》2010年版第二增补本标准。结论方法实用，结果准确可靠。