无热原蒸汽灭菌在疫苗生产中的应用与效果验证  

Effect validation and application of sterilizing fluid-products with pyrogenfree steam during biological products production

作　　者：马延明[1] 杨勇[1] 王涛[1] 李国晏[1] 

机构地区：[1]兰州生物制品研究所,兰州730046

出　　处：《微生物学免疫学进展》2009年第1期26-29,共4页Progress In Microbiology and Immunology

摘　　要：为保证生物制剂生产的安全性,采用空载热分布试验,满载热穿透试验和微生物挑战试验对无热原蒸汽灭菌柜进行验证。另取疫苗生产中常用的Earle's液、PBS液及0.2%水解乳蛋白各5批,均采用无热原注射用水配制,无热原蒸汽灭菌。选用"Fluids121℃"15分钟循环程序和"Fluids115℃"20分钟循环程序检测热原质与灭菌效果。灭菌试验验证结果显示,无热原蒸汽灭菌符合现行GMP的要求。In order to ensure the safety of biological products production, the sterilizing effect of autoclave sterilizer was validated with the hot-distribution experiment, the Bowin-Dick test and the micro-organism sign test. The four media products in production, including 10 batch of Earle＇s solulotion, PBS dilutent, SPGG solution, 0.2% hydrolysis lacto-protein were prepared with water for injection and sterilizated with the pyrogenfree steam. After the ＂Fluids121 ℃＂ 15 minute cycle and ＂Fluids115℃＂ 20 minute cycle procedures, the pyrogen and sterilizing effect was tested. The results showed that the effect of sterilizing with pyrogenfree steam achieves the GMP standard requrirement.

关 键 词：脉动式真空高压蒸汽灭菌器 无热原蒸汽 灭菌效果 验证 热原 

分 类 号：TQ464[化学工程—制药化工]