| 空气洁净度和无菌药品成品率的关系 |
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| 引用本文： | 许钟麟,周斌. 空气洁净度和无菌药品成品率的关系[J]. 医药工程设计, 2013, 0(6): 28-30 |
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| 作者姓名： | 许钟麟 周斌 |
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| 作者单位： | [1]中国建筑科学研究院建筑环境与节能研究院许钟麟工作室,北京100013 [2]南京工业大学城市建设与安全工程学院,江苏南京210009 |
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| 摘 要： | 药品成品率属于复合成品率：η∑=n＋1∏i=1Pi,对于西林瓶灌封,最少有3道工序（n=3）,瓶口约1cm^2,灌封历程约经过30s,则算出要求η∑=0．9999时,每道工序成品率Pi为0．99997,环境茵浓不大于10个／m3;要求η∑=0．99999时,每道工序成品率Pi为0．999997,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。
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| 关 键 词： | 无菌药品 成品率 空气洁净度 |
Relationship between Air Cleanness and Qualified Product Rate of Sterile Medicine |
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| Xu Zhonglin,Zhou Bin. Relationship between Air Cleanness and Qualified Product Rate of Sterile Medicine[J]. Pharmaceutical Engineering Design, 2013, 0(6): 28-30 |
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| Authors: | Xu Zhonglin Zhou Bin |
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| Affiliation: | 1. Xu Zhonglin Studio, Institute of Building Environment and Energy Efficiency, China Academy of Building Research, Beijing, 100013; 2. College of Urban Construction and Safety Engineering, Nanjing University of Technology, Nanjing, 210009) |
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| Abstract: | 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. |
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| Keywords: | sterile medicine qualified product rate air cleanness level |
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