关键词: 生物安全, 终末灭菌, 甲醛发生, 灭菌效果

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