高压静电检漏法对口服轮状病毒活疫苗包装无损密封性检查  

Non-destructive sealing inspection for packaging of oral rotavirus vaccine(live) by high voltage electrostatic leak detection method

作　　者：朱衍志[1] 杨淼[1] 丁志慧[1] 石岩[1] 徐永浩[1] 赵一欢[1] 蒋井明[1] 张静 朱莉萍[1] 

机构地区：[1]兰州生物制品研究所有限责任公司质量保证部,甘肃省疫苗工程技术研究中心,甘肃兰州730046

出　　处：《微生物学免疫学进展》2017年第1期42-45,共4页Progress In Microbiology and Immunology

摘　　要：目的探索高压静电检漏法对口服轮状病毒活疫苗包装无损密封性检查的可行性。方法采用高压静电检漏法对口服轮状病毒活疫苗包装密封性进行检查,并观察此方法对疫苗有效成分的影响。结果口服轮状病毒活疫苗经18 000 V和14 000 V高压静电检测显示,导电电流值均极低;病毒滴度结果均在6.0~6.5 lg CCID_(50)/mL之间,热稳定性试验病毒滴度下降值在0.5~1.0 lg之间,均符合质量标准,且与对照组(A组和B组)检测结果差异无统计学意义(P>0.05)。结论高压静电检漏法用于口服轮状病毒活疫苗包装无损密封性检查是可行的。Objective To investgate non-destructive sealing inspection for packaging of oral rotavirus vaccine, live by a high voltage electrostatic leak detection method. Methods The sealing of containers which were filled with oral rotavirus vaccine, live was examined by the high voltage electrostatic leak detection, and the related influnce on the effective components in the vaccine was evaluated. Results The vaccine containers were detected at a high voltage electrostatic of 18 000 V and 14 000 V, and the tests showed that the value of conductive current was very low, the virus titer was between 6.0 and 6.5 lgCCID50/mL and the titer reduced 0.5-1.0 lg by the thermal stability test, in comparison with the detected resuits from control groups there were no a statistical meaning （P〉0.05）, which were in accordance with the related quality standards. Conclusion The investigation showed that the high voltage electrostatic leak detection can be used to check the non-destructive sealing of the packaging of oral rotavirus vaccine, live.

关 键 词：高压静电检漏 口服轮状病毒活疫苗 无损密封性 病毒滴度 

分 类 号：TQ460.69[化学工程—制药化工]