摘要
目的确认T800/H2/C3型层流式隧道消毒灭菌的性能,供生产使用。方法在层流式隧道满载运行时,测定其热渗透及消毒灭菌、除热原效力。结果热渗透测定时灭菌段各测试点温度≥300℃,保持时间≥5min；灭菌效力实测F值超过60min；除热原效力实测灭菌温度为250℃,时间≥40．1min；生物指示剂ACE test经隧道干热灭菌后培养7d,结果均为阴性；含细菌内毒素(25,250 EU/mL)的10个样品经隧道干热灭菌后细菌内毒素检测结果均为阴性。以上各项性能参数均符合《T800/H2/C3型层流式隧道验证方案》要求。结论确定T800/H2/C3型层流式隧道验证合格,可以发证使用。
Objective To confirm the sterilization property of model T800/H2/C3 laminar flow tunnel for prodnction. Methods Measure the efficiency of removing pyrngen by heat permeation throngh sterilizalion with model T800/H2/C3 laminar flow tunnel while it was fully loaded. Results The heal permeation measurement： the temperature at measurement point of sterilization segment was higher than 300℃ lasting for more than 5 min. Sterilization efficiency： the tested F valte was above 60 min. The effieieney of removing pyrogen： the tested sterilization temperature was 250℃ for more than 40. 1 rain. The bioindieaator ACE tost was negative for 7 d of culture after the tunnel sterilization. Each of the 10 samples of 25 EU/mL and 250 EL/mL of endotoxin was tested uegative after sterilization by tunnel dry heat sterilization. All the above parameters conformed to the requirenwnts of the test arid verification scheme for model T800/H2/C3 laminar flow tnnnel. Conclusion Model T800/H2/C3 laminar flow tunnel passes the test and verification so it can get the approval to be used.
出处
《中国药业》
CAS
2006年第17期43-44,共2页
China Pharmaceuticals
关键词
层流式隧道
消毒灭菌
CMP验证
细菌
热原
细菌内毒素
laminar flow tunnel
sterilization
GMP verification
bacteria
pyrogcu bacteria endotoxin
