低pH病毒灭活容器的验证与讨论  

Verification and Discussion of Containers for Low pH Viral Inactivation

作　　者：孟学科 尹云云 麻银林 郭雪松 杨晓东 MENG Xueke;YIN Yunyun;MA Yinlin;GUO Xuesong;YANG Xiaodong(Gansu Medical Products Administration,Lanzhou 730070;Sinopharm Lanzhou Biopharmaceuticals Co.,Ltd.,Lanzhou 730046)

机构地区：[1]甘肃省药品监督管理局,甘肃兰州730070 [2]国药集团兰州生物制药有限公司,甘肃兰州730046

出　　处：《中国医药工业杂志》2025年第1期109-112,135,共5页Chinese Journal of Pharmaceuticals

基　　金：甘肃省省级科技计划项目(2022GSMPA0029)。

摘　　要：该研究的目的是全面考察低pH病毒灭活容器的在线清洁效果、密封性、无菌性、热穿透性及热稳定性。通过检测在线清洁后淋洗水水样的各项指标,证明清洁效果;通过保压试验验证密封性;通过培养基模拟灌装以及过程温度控制试验证明无菌性、热穿透性和热稳定性。结果表明,清洁后检测淋洗水样,其可见异物、pH值、电导率、细菌内毒素、微生物限度、蛋白吸光度的检测结果均符合要求;低pH病毒灭活容器的保压测试合格;模拟除菌培养基于(24±1)℃下放置21 d,模拟病毒灭活,其间罐温稳定在(24.0±0.2)℃,无菌性、热穿透性及热稳定性良好。上述结果说明该低pH病毒灭活容器符合生产要求,可确保病毒灭活过程的可靠性。该研究为低pH病毒灭活容器的GMP和工艺要求验证提供了参考。The aim of this study was to comprehensively investigate the online cleaning effectiveness,integrity,sterility,thermal penetration,and thermal stability of the containers for low pH viral inactivation.The cleaning effectiveness was demonstrated by investigating the indicators of the rinsing water samples after online cleaning;the sealing performance was verified by pressure holding experiments;the sterility,thermal penetration and thermal stability were proved through simulated filling of the culture medium and the process temperature control tests.The results showed that after cleaning,the visible particles,pH value,conductivity,bacterial endotoxin,microbial limit and protein absorbance all met the requirements.The pressure-holding test of the low pH virus inactivation container was qualified.And the simulated sterilization culture medium was placed at(24±1)℃for 21 days for simulating the virus inactivation.During the examination period,the tank temperature was stable at(24.0±0.2)℃,indicating good sterility,thermal penetration and thermal stability.These results indicated that the containers for low pH viral inactivation met the production requirements and could ensure the reliability during the viral inactivation process.This study provided a reference for the validation of GMP and process requirements of the containers for low pH viral inactivation.

关 键 词：生物制品 低pH病毒灭活 容器 验证 风险管理 

分 类 号：Q93-334[生物学—微生物学] TQ464.56[化学工程—制药化工]