CAJ | 학술논문

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。
목적：통과수액멸균공예우선、대수액수욕멸균기성능학인，학정멸균정서급장재방식적가고성；통과대산품진행3개비차적열천투、생물지시제시험，학정멸균공예적멸균효과。방법사용대수액수욕멸균기，채용가편정자동공제계통진행멸균전과정공제，병채용 T32-32온도험증계통진행성능험증，재차기출상，사용기열지방간균아포생물지시제실시멸균공예험증，학정멸균효과。결과채용121℃멸균12 min，F0치﹥12，무균보증수평（ SAL）≤10-6。대신무파렬、무변형，가직립방치；제제질량안표준검측부합《중국약전》2010년판제이증보본표준。결론방법실용，결과준학가고。
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.