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目的通过对灭菌过程验证装置(PCD)在灭菌过程中的效果验证,验证灭菌程序设计的有效性,寻求更好地高压灭菌监测方法。方法将设计好的PCD放入灭菌条件最差的位置,同时将指示物放入灭菌包的中央位置,对比二者合格率。结果经过7台灭菌器16 554批次,合格16 538批次;PCD合格率达到99.90%,合格的16 538批次中,294 141个灭菌包内指示物均合格;生物监测224批次均合格,二者化学监测结果一致。结论通过大批量的对比试验数据验证,证实了PCD在灭菌过程中的使用方便、环保,敏感性更高、更安全可靠,更优于包内指示物的使用。
Objective To validate the effectiveness of the sterilization program design by validating the effectiveness of the sterilization process validation device (PCD) in the sterilization process and to find a better method of autoclave monitoring. Methods The designed PCD was placed in the worst sterilization conditions, while the indicator placed in the center of the sterilization package, compared with the two pass rate. The results passed 16 554 batches of 7 sterilizers and passed 16 538 batches. The pass rate of PCD reached 99.90%. Of the 16 538 qualified batches, 294 141 sterilization packs were qualified; 224 batches of biological monitoring All qualified, both the same chemical monitoring results. Conclusions The data of large amount of comparative experiments proved that PCD is convenient to use in the process of sterilization. It has higher environmental protection, higher sensitivity, more safety and reliability, and is superior to the use of indicator in the package.