摘要
通过对2008年流感裂解疫苗生产中的监控,结果显示,流感病毒接种鸡胚尿囊液中未检出沙门菌,除菌过滤前微生物限度均小于10CFU/ml、细菌内毒素均小于25EU/ml,纯化过程去除了99%的杂蛋白。表明生产中使用的健康鸡胚尿囊液是符合生物制品规程的要求,现行生产工艺对微生物限度和细菌内毒素的控制是有效的,现行纯化过程对病毒液的纯化是有效的。
The Salmonella and microbial limits of the influenza vaccine semipreduct were monitored in 2008. The results showed that allantoic fluid inoculated by influenza virus is free of Salmonella, the microbial limit is below to 10 CFU/ml and the endotoxin is below to 25EU/ml before aseptic filtration, 99% hyteroprotein is removed by purification technique. The allantoic fluid of chick embryo used for production is in keeping with the GMP demands. The actual manufacture technique is effective to control the bacteria and endotoxin.
出处
《微生物学免疫学进展》
2009年第3期16-20,共5页
Progress In Microbiology and Immunology
关键词
流感裂解疫苗
沙门菌
微生物限度
监控
Influenza vaccine（ split virion）
Salmonella
Microbial limit
Monitoring
