ABSTRACT
OBJECTIVE To prove the batch monitoring system to be effective and practicable.METHODS The sterilization process of each batch with the batch monitoring system was monitored.RESULTS Among monitored 7057 6 batches failed,the failure rate was 0.09%.CONCLUSIONS By analyzing the failure causes,we should enhance the maintenance of the sterilizator and limit the using times of the monitor device.It proves that the batch monitoring system is effective and practicable to monitor the pulse-vacuum-pressure-steaming sterilizator.
ABSTRACT
OBJECTIVE To verify the effect of batch monitoring system insteod of the indicator in the package.METHODS From Apr 17,2007 to Jul 29,2008,the batch monitoring system was used to monitor the sterilization effect of each batch,at the same time,inside each package we placed the indicator as control.RESULTS A total of 7057 batches were monitored,in which 7051 were eligible,and among 166870 packages in all,the indicators were all eligible,which included 56600 dressing packages and 110270 instrument packages.There was no difference between batch monitoring system and indicators.CONCLUSIONS The effect of batch monitoring system is credible,and the indicator inside package can be replaced.
ABSTRACT
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 8min,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.