空气洁净度和无菌药品成品率的关系

Relationship between Air Cleanness and Qualified Product Rate of Sterile Medicine

药品成品率属于复合成品率:■,对于西林瓶灌封,最少有3道工序(n=3),瓶口约1cm2,灌封历程约经过30s,则算出要求ηΣ=0.999 9时,每道工序成品率Pi为0.999 97,环境菌浓不大于10个/m3;要求ηΣ=0.999 99时,每道工序成品率Pi为0.999 997,环境菌浓不大于1个/m3。GMP(2010)提高洁净度从而降低菌浓到1/10后,非最终灭菌无菌药品成品的不合格率将万分之一下降到10万分之一,即成品率提高10倍。

Qualified product rate for medicine is compound product rate： η∑=n＋1∏i=1Pi For the fill process for penicillin bottle, if it isrequired to obtain η∑=0.9999, the finished product rate for every process shall be reached as Pi=0.99997 and the environmental bacterial concentration shall be not greater than 10 CFU/m3; if η∑=0.99999 is required, then the finished product rate for every process shall be reached as Pi=0.999997 and the environmental bacterial concentration shall be not greater than 1 CFU/m3. That is in the latest version of GMP （2010）, when the cleanness increases so that the bacterial concentration reduces to 1/10, then the unqualified rate of sterile medicine will be reduced from 1/10000 to 1/100000, that is the qualified product rate is increased for 10 times.