目的 评估乙型脑炎减毒活疫苗半成品除菌过滤工艺的除菌效果。 方法 通过对乙型脑炎减毒活疫苗半成品除菌过滤工艺中的过滤器完整性、可提取物、细菌生存性、细菌挑战水平及化学兼容性进行测试，分析过滤器性能和除菌效果。 结果 生产工艺条件下，乙型脑炎减毒活疫苗半成品（模拟液）最大扩散流为11.6 mL/min，最低起泡点为3.200×10⁵ Pa，待测溶液在 2~8 ℃和室温条件下均无杀菌性。在最差条件下，可截留挑战水平为10⁷ CFU/cm²有效过滤面积的缺陷短波单胞菌，乙型脑炎减毒活疫苗半成品过滤后的病毒滴度和pH值吸附测量结果均在接受标准范围内，半成品与滤器之间无相互作用。 结论 过滤器与半成品接触后结构完整，其细菌生存性、细菌挑战及化学兼容性等良好，适用于乙型脑炎减毒活疫苗生产工艺过程。

Objective To evaluate the sterilization effectiveness of sterilization and filtration process of live attenuated Japanese encephalitis vaccine (JEV) final bulk. Methods Filter performance and sterilization effectiveness were analyzed by testing filter integrity, extractables, bacterial viability, bacterial challenge levels, and chemical compatibility in the sterilization and filtration process of JEV final bulk. Results Under the conditions of production process, the maximum diffusion flow of JEV final bulk (simulated solution) was 11.6 mL/min, the minimum foaming point was 3.200×10⁵ Pa, and the solution tested was not bactericidal at 2-8 ℃ and room temperature. Under the worst conditions, defective short-wave Aeromonas with a challenge level of 10⁷ CFU/cm² effective filtration area was retained, virus titers and pH adsorption measurements after filtration of JEV final bulk were within acceptable range, and there was no interaction between final bulk and filters. Conclusion The filters are structurally intact after contact with final bulk with good bacterial viability, bacterial challenge and chemical compatibility, and are suitable for the production process of JEV.