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,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,灭菌产品旳无菌确保,药物生产质量管理工程课件五,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,30,10,70,50,20,80,50,40,40,30,90,60,20,10,30,10,70,50,20,80,25,40,20,15,90,60,10,5,30,100,n=1,n=15,30%,15%,10%,n=10,20%,n=2,n=4,5%,n=50,n=20,经过无菌检验概率,经过无菌检验概率,q,(z),n,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,升温,1,冷却,保温,100,121,10,0,30,20,t,2,t,1,1,T,L,图,3,17,湿热灭菌旳温度时间曲线,t(min),0.008,F,0,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,灭菌产品旳无菌确保,