目的  评价一次性无菌转移系统（Allegro系统）用于人凝血因子Ⅷ（human coagulation factor Ⅷ，FⅧ）生产的可行性。方法  设计基于Allegro系统的一次性无菌转移系统，并对该系统进行各项验证。将该系统用于FⅧ生产并检测FⅧ的各项质量指标和稳定性。结果  Allegro系统的各项验证结果均符合规定的要求，且Allegro系统对制品的理化性质没有影响。Allegro系统的主要溶出物为叔丁醇和三甲基硅醇，溶出物含量分别为<3.0 mg/袋和<4.5 mg/袋，符合规定的安全性要求。采用Allegro系统生产的3批FⅧ的各项质量指标符合规定的标准，且FⅧ的稳定性良好。结论  一次性无菌转移系统（Allegro系统）可用于FⅧ生产。

Objective  To evaluate feasibility for application of a single-use sterile transfer system (Allegro system) in production process of human coagulation factor Ⅷ (FⅧ). Methods  A single-use sterile transfer system based on Allegro system was designed and validated. Allegro system was used for production process of FⅧ, and each of qualitative indexes and stability of FⅧ were detected. Results  Each of validation results of Allegro system met regulatory requirements. Allegro system had not an effect on physical and chemical properties of products. The main extractable substances were tert-butanol(<3.0 mg/package) and trimethylsilanol(<4.5 mg/package). Both extractable substances contents  met safety requirements. Each of qualitative indexes of 3 batches of FⅧ prepared by using Allegro system met regulatory standards. Stability of FⅧ products was good. Conclusion  The single-use sterile transfer system (Allegro system) can be applied to production process of FⅧ.