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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。
The yield of the pharmaceutical products belongs to the composite yield: ■, for the vial potting, there are at least 3 processes (n = 3), the bottle mouth is about 1cm2, the potting process is about 30s, Process yield Pi was 0.999 97, the environment bacteria concentration is not more than 10 / m3; requirements ηΣ = 0.999 99, the yield per process Pi was 0.999 997, the environment is not more than 1 / m3. GMP (2010) to improve the cleanliness and thus reduce the bacteria concentration to 1/10, non-sterile sterile finished finished products will be one-tenth of a million down to 1/100000, that is, yield 10 times.