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直立式聚丙烯输液袋装输液灭菌工艺研究 被引量:1

Study on sterilization process of upright PP- bag for packing infusion
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摘要 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。 Objective To determine the reliability of the sterilization procedures and loading methods by optimizing the sterilization process of infusion,and performance verification of infusion bath sterilizer; To determine the effect of sterilization sterilization process by heat penetration and biological indicator test of three batches of the product. Methods Using a hot 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 biological indicator to verify the implementation of the sterilization process,to determine the sterilization effect. 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 The method was practical,accurate and reliable.
出处 《药学研究》 CAS 2015年第6期368-370,共3页 Journal of Pharmaceutical Research
关键词 直立式聚丙烯输液袋 大输液水浴灭菌器 灭菌工艺 Upright PP-bag Hot water sterilizer Sterilization process
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