Abstract: Objective　To test and evaluate the sterilization efficacy of a self-developed formaldehyde generating terminal sterilization equipment for biosafety laboratories, and to provide scientific support for its application and promotion.Methods　Using Geobacillus stearothermophilus or Bacillus subtilis var. niger spores as biological indicators, the single-factor variable method was applied to systematically investigate the effects of three key parameters—paraformaldehyde dosage, sterilization duration, and ambient relative humidity—on the sterilization efficacy of isolators in biosafety laboratories. Results Complete sterilization was achieved with paraformaldehyde dosages of 3, 1.5, and 0.75 g/m3 for 6 h of sterilization. With a fixed dosage of 0.75 g/m3, valid sterilization was attained after 2, 4, and 6 h of exposure. Under the fixed dosage and duration, qualified sterilization efficacy was obtained at relative humidity levels of 70%, 75%, and 80%.Conclusion　The self-developed formaldehyde generating terminal sterilization equipment exhibits excellent and reliable sterilization efficacy for isolators in biosafety laboratories under optimized parameters, and can be used for terminal disinfection and sterilization in biosafety laboratories. 

Key words: biosafety, terminal sterilization, formaldehydegeneration;sterilizationefficacy

摘要： 目的　测试并评价自主研发的甲醛发生型生物安全实验室终末灭菌设备的灭菌效果,为设备应用与推广提 供科学依据。方法　以嗜热脂肪地芽孢杆菌或枯草杆菌黑色变种芽孢为生物指示剂,采用单因素变量法系统测试 多聚甲醛用量、灭菌作用时间、环境相对湿度3个关键参数对生物安全实验室隔离器灭菌效果的影响。结果　在 每立方米空间投加3、1.5、0.75 g多聚甲醛且灭菌 6 h,均可实现完全灭菌效果;固定多聚甲醛投加量 0.75 g/m3,作 用2、4、6 h均灭菌合格;固定投加量与灭菌时间,环境相对湿度70%、75%、80%条件下灭菌效果合格。结论　自主 研发的甲醛发生型终末灭菌设备在优化参数下对生物安全实验室隔离器具有优良、可靠的灭菌效果,可以用于生 物安全实验室终末消毒灭菌。

关键词: 生物安全, 终末灭菌, 甲醛发生, 灭菌效果