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目的了解无菌接管机在自然环境中高频连接能否达到预期的无菌效果,保证血液制品的安全。方法对成分制备环境、设备表面、使用和未使用的TSCD熔接片、工作人员手指连续抽查3次进行细菌培养,制备洗涤红细胞后的洗涤液抽检10份,通过一次性使用全封闭集菌培养器薄膜过滤收集细菌、进行细菌培养,观察细菌生长情况。结果成分制备环境、设备表面、使用和未使用的TSCD熔接片、工作人员手指细菌培养均符合Ⅲ类环境要求,菌数≤500 cfu/cm2。制备洗涤红细胞后的洗涤液进行细菌培养,无细菌生长。结论无菌接管机的无菌性能指标经确认,符合预期效果,可以正常使用。
Objective To understand whether aseptic pipettes can achieve the expected sterility in high frequency connection in the natural environment and ensure the safety of blood products. Methods The components preparation environment, the surface of the equipment, the used and unused TSCD fusing films were prepared. The staffs fingers were fingerprinted three times for bacterial culture. After washing the erythrocytes, 10 samples of the washing liquid were prepared. Through the disposable closed- Bacteria were collected by membrane filtration, cultured in bacteria and observed for bacterial growth. Results Components Preparation Environment, Equipment Surface, Used and Not Used TSCD Welds, Staff Finger Bacterial Cultures met Category III Environmental Requirements, Number of Strains ≤ 500 cfu / cm2. After the preparation of washing red blood cells for bacterial culture, bacterial growth. Conclusion The aseptic performance of aseptic pipette has been confirmed to meet the expected results and can be used normally.