疫苗生产中基于风险评估的清洗剂变更

Cleaning agent change in vaccine production based on risk assessment

目的在白喉-破伤风-无细胞百日咳疫苗生产车间玻璃瓶清洗剂的变更中,引入质量风险管理,对新清洗剂进行风险分析与评估,以确保更换清洗剂对产品质量无影响。方法运用风险评估工具对新清洗剂进行风险评估,根据风险级别制定相应风险控制措施,对新清洗剂进行验证,确认其清洗效果以及对产品的影响。结果清洗后玻璃瓶淋洗水中细菌内毒素含量≤0.25内毒素单位/ml、总好氧微生物计数≤100菌落形成单位/ml、总霉菌酵母菌计数≤10菌落形成单位/ml、总有机碳≤1.5μg/cm2(淋洗水和擦拭取样)、电导率≤1.3μS/cm,结果均符合要求。结论在变更控制中运用质量风险管理,指导变更控制措施的制定和变更内容的实施,保证了更新新清洗剂的风险可接受,且产品质量不受变更影响。

Objective To introduce quality risk management during the change of glass bottle cleaner in the DTaP production workshop to analyze and evaluate the risk of new cleaner and ensure that the replacement of cleaner has no impact on product quality.Methods Risk assessment tools were used to evaluate the risk of new cleaning agent and risk control measures were formulated according to the risk level.The new cleaner was verified to confirm its cleaning effect and impact on the product.Results After cleaning with new cleaner,the bacterial endotoxin content in glass bottle leaching water was≤0.25 endotoxin unit/ml,total aerobic microbial count was≤100 colony-forming unit(CFU)/ml,total yeast and mould count was≤10 CFU/ml,total organic carbon was≤1.5μg/cm2(both leaching water and wiping),and the conductivity was≤1.3μS/cm.All results met requirements.Conclusion The application of quality risk management in change control guides the formulation of change control measures and the implementation of change,and confirms that the risk caused by new cleaner is acceptable and the replacement does not impact product quality.