预灌封注射器密封系统完整性研究

目的:通过微生物侵入挑战性试验,确认采用预灌封注射器包装的小容量注射剂产品的密封完整性.方法:按无菌生产要求在预灌封注射器内灌装胰胨大豆肉汤培养基,培养14 d后,置于大肠埃希菌菌悬液中浸泡4 h.浸泡后样品继续培养7 d,观察细菌侵入情况.结果:培养7 d后,注射器内培养基均无细菌生长.结论:预灌封注射器密封系统能满足密封完好性的要求,可保证产品不受细菌侵入.

Study on the integrity of the prefilled syringes with sealing system

Objective:Seal integrity of the prefilled syringes containing small volume of injection product was confirmed by the bacterial challenging test.Methods:According to production requirements,the pre-casting sterile syringe filling trypticase soy broth was incubated for 14 days,soaked in a suspension containing Escherichia coli for 4 hours.Bacterial contamination was observed after samples were incubated for 7 days.Results:The syringes were not contaminated by the tested E.coli.Conclusion:Prefilled syringes with sealing system can meet the requirements of integrity and protect the products from bacterial invasion.