高压蒸汽灭菌柜性能验证方法的研究

高压蒸汽灭菌柜在使用之前和运行一定时间后，必须进行性能验证，采用热分布，热穿透和微生物挑战试验法对GE，GEV型脉冲式蒸汽灭菌柜的性能进行验证，多孔物质及流体物质灭菌循环中，灭菌腔内不存在冷点，具备有效的热穿透力，嗜热脂肪芽孢杆菌（ATCC7953）在规定灭菌时间内被完全杀死。因而确认高压灭菌柜的各项性能均达到生产要求，由此建立的一套验证方案及试验方法和结果得到了国家GMP认证中心的认可。

Study of validation methods of performance qualification for autoclaves

Autoclaves must be validated for their performance quality before starting to be used or be revalidated after using periodically.The heat distribution test?Bowin Dick test and ACE test have to be used for performance validation of GE and GEV type autoclaves.In proous load cycle and fluids load cycle,the cold point did not be found.After sterilizing cycle all of Bacillus stearothermophilus(ATCC 7953)were killed.The results showed that all performance parameters were in confirmation with the production standard,so a serials of validation protocols were created and test methods were established.All results and validation methods were approved by the national GMP certification center.