| 저자(한글) |
LI, Xi-lan,ZHOU, Gang,CHENG, Jun,WANG, Qiong,GU, Yu-ping |
| 초록 |
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. |
