应用3M化学PCD标准包的研究

3M Standardized CI PCD:Its Application and Evaluation

目的应用3M公司提供的标准包PCD对挑战装置对灭菌批量过程监控,从而保障灭菌效果。方法将标准包CI PCD、BI PCD挑战包分别应用于1号锅(132℃,3.5、8 min),2号锅(134℃,3.5、8 min)。结果310锅次CI PCD挑战包移动指示卡均合格或达到终点,240个BI PCD挑战包生物培养均为阴性,移动指示卡均达到终点。结论标准包CI PCD挑战装置对灭菌物品进行批量监测时,准确度更精确,使灭菌质量进一步得到保障。

OBJECTIVE To apply 3M standardized chemical indicator （CI） process challenge device （PCD） to the practice of batch monitoring to guarantee sterility assurance. METHODS The standardized CI PCD and biological indicator （BI） PCD to two different sterilizers were applied with the test parameters of 132℃ , 3.5min and 8min, and 134℃, 3.5min and 8rain, respectively. RESULTS A total of 310 trials of CI PCD were obtained as negative results, with the ink moved into the accept area of the moving-front style indicator, and 240 trials of BI PCD were obtained as negative results. CONCLUSIONS Standardized CI PCD can provide further sterility assurance with more accurate monitoring and batch release capabilities.