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分装过程中尘粒变化的影响因素探讨
引用本文:周园,魏嵬,徐斌,王弢,陈文晔.分装过程中尘粒变化的影响因素探讨[J].微生物学免疫学进展,2010,38(4):42-45.
作者姓名:周园  魏嵬  徐斌  王弢  陈文晔
作者单位:兰州生物制品研究所,兰州730046
摘    要:通过对在线粒子实时监测系统采集的尘粒变化数据进行分析,探讨影响分装过程中尘粒变化的因素。对同批次分装时四个监测点和不同批次分装时同一监测点尘粒变化的数据进行分析,结果表明,在分装的前期准备、后期清场以及排除故障期间,粒子数变化明显。可见洁净间人员的数量及人员的行为是影响分装过程中尘粒变化的主要因素。

关 键 词:在线尘埃粒子监测系统  无菌分装

Discussions on the impact factors of data change of dust particle number during filling process
Institution:ZHOU Yuan,WEI Wei,Xu Bin,et al.(Lanzhou Institute of Biological Products,Lanzhou 730046,China)
Abstract:To analyze the factors which can influence the data change of dust particle number during filling process.The data of dust particle number were collected and analyzed by on-line real monitoring system from four monitoring point of the same batch and the same monitoring point of different batches during filling process.The results showed that during the pre-filling preparation,post-clearance and the fault clearing,the changing of particle number is significant,so the main factor of influencing the data chang of dust particle number is the person's quantity in cleaning room and behavior of operator.
Keywords:On-line monitoring system for dust particles  Sterile-filling
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