自动化系统在水痘疫苗半成品配制中的应用

目的 应用自动化系统进行水痘疫苗的半成品配制,以降低劳动强度,提高产品均一性.方法 采用自动化系统完成水痘疫苗的原液稀释和半成品分装,并与人工操作方法进行比较,比较两种方法的清洁、灭菌和保温效果以及疫苗半成品、成品的检定结果.结果 自动化操作可使工作人员减少60％,工时缩短80％.两种方法对容器或罐体的清洗和灭菌效果均达到工艺要求.采用自动化方法保温时温度可控.用自动化操作系统制备的半成品疫苗,其滴度差异小于人工操作方法,变异系数分别为0.00％和2.17％.两种方法生产的成品疫苗的稳定性试验结果均达到标准病毒滴度不低于3.3 lg蚀斑形成单位(plaque-forming unit,PFU)/0.5 ml].自动化和人工方法生产的成品疫苗于37℃放置7d,病毒滴度分别为3.7和3.6 lgPFU/0.5 ml;于2～8℃放置18个月分别为3.5和3.4 lgPFU/0.5 ml.结论 将自动化系统应用于水痘疫苗的原液稀释、半成品分装,可降低劳动强度,提高产品的均一性.

Application of automatic system in preparation of semi-finished varicella vaccine products

Objective To reduce labor intensity and increase homogeneity of varicella vaccine by application of automatic system for preparation of semi-finished products.Methods The dilution of varicella vaccine bulk and filling of semi finished product were conducted by either the automatic system or a manual method.The cleaning,sterilizing and insulating effects of containers and verification results of semi-finished and final products were compared between the two methods.Results Automatic operation reduced 60％ labor and 80％ work time.The cleaning and sterilizing effects of container or tank by both methods complied with process requirements.The temperature maintenance was well controlled by the automatic method.Difference among the virus titers of semi-finished products produced by automatic system was much smaller as compared with manual method,with coefficient of variation at 0.00％ and 2.17％,respectively.The stability test results of final products met the titer requirementno less than 3.3 lg plaque-forming unit (PFU)/0.5 ml.The virus titers of final products produced by automatic and manual methods were 3.7 and 3.6 lgPFU/0.5 ml at 37 ℃ for 7 d,and 3.5 and 3.4 lgPFU/0.5 ml at 2-8 ℃ for 18 months.Conclusion The use of automatic system for bulk dilution and semi-filling can reduce labor intensity and improve homogeneity of the product.