非PVC软包装输液灭菌工艺研究

目的通过对非PVC软包装输液灭菌的温度、压力、时间、F0值考察研究,制定灭菌标准。通过进行灭菌器的性能验证确定灭菌效果。方法使用PSMVR-RC-8T型大输液水浴灭菌器,采用可编程自动控制系统进行控制灭菌的全过程。采用XZP-16型16路巡检仪与16支Pt100温度探头,按照预先制定的验证方案进行灭菌器的性能验证。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,无变形现象;制剂质量按标准检测符合2005年版中国药典增补本标准。灭菌器性能验证符合要求,可以保证灭菌效果。结论方法实用,结果准确可靠。

Non-PVC soft packaging sterilization process of infusion

OBJECTIVE To establish the sterile standard by the research of temperature,pressure,time and the value of F0 on the sterilization of non-PVC soft-packing transfusion,and the sterile effect was ensured through the performance verification of the sterilizer.METHODS The PSMVR-RC-8T type water immersing sterilization cabinet of transfusion was utilized,the programmed and auto-controlling system of sterilization was adopted,and moreover the XZP-16 type of 16 channels inspecting instrument and 16 pieces of Pt100 temperature probes were used.To carry out the performance verification following the pre-programmed verification plans.RESULTS The sterile parameter is used with 121℃ for 12min,F012,and the sterile assurance level（SAL）10-6.No fracture and deformation of soft-package were found.Furthermore the quality of injection dosage was up to the standard of ChP2005 supplement,the performance verification of sterilizer met the requirements,and the effect of sterilization can be ensured.CONCLUSION The method was practical and the result was accurate and reliable.