文献类型：期刊文献

英文题名：Field test of pharmaceutical cleanroom cleanliness subject to multiple disturbance factors

作者：Yang, Zixu[1,2];Hao, Yunfeng[3];Shi, Wenxing[1,2];Shao, Xiaoliang[3];Dong, Xiufang[4];Cheng, Xuanrui[5];Li, Xianting[1,2];Ma, Xiaojun[6]

第一作者：Yang, Zixu

通讯作者：Shi, WX[1]

机构：[1]Tsinghua Univ, Sch Architecture, Dept Bldg Sci, Beijing 100084, Peoples R China;[2]Tsinghua Univ, Sch Environm, Beijing Key Lab Indoor Air Qual Evaluat & Control, Beijing 100084, Peoples R China;[3]Univ Sci & Technol Beijing, Sch Civil & Resource Engn, Beijing 100083, Peoples R China;[4]China Aviat Planning & Design Inst Grp Co Ltd, Beijing 100083, Peoples R China;[5]Beijing Union Univ, Coll Urban Rail Transit & Logist, Beijing 100101, Peoples R China;[6]Beijing Union Univ, Coll Biochem Engn, Beijing 100023, Peoples R China

第一机构：Tsinghua Univ, Sch Architecture, Dept Bldg Sci, Beijing 100084, Peoples R China

通讯机构：[1]corresponding author), Tsinghua Univ, Sch Architecture, Dept Bldg Sci, Beijing 100084, Peoples R China.

年份：2021

卷号：42

外文期刊名：JOURNAL OF BUILDING ENGINEERING

收录：;EI(收录号：20213410809557);Scopus(收录号：2-s2.0-85113235071);WOS:【SCI-EXPANDED(收录号:WOS:000689731700004)】；

基金：This study was supported by the National Key Research and Devel-opment Program of China (Grant No. 2018YFC0705204) and (Grant No. 2018YFC0705201) .

语种：英文

外文关键词：Pharmaceutical clean room; Field measurement; Differential pressure; Entry of personnel

摘要：Biopharmaceutical cleanrooms have high cleanliness requirements to supervise and manage processes and ensure the quality of production. However, on-site data, including real-time particle concentrations and differential pressure in biopharmaceutical cleanrooms, are scarce for both operational and at-rest conditions. In this study, a field experimental investigation of multiple disturbance factors in a cleanroom environment was performed in a newly built cleanroom. The impact of the number of personnel, entry of personnel, and air change rate on the cleanliness level was measured and analyzed. It was concluded that: (1) a notable over-specification of cleanliness was observed in the operational state. The particle concentrations with size larger than 0.5 mu m were 1041 pc/m3 and 2901 pc/m3 in the temporary storage room and configuration room, respectively, which was considerably lower than the required Class B specification; (2) An increase in the number of people entering the room and extension of the door opening time may cause the invasion of more particles to the cleanroom with higher cleanliness. The particle concentrations increased by approximately 2000 pc/m3 with the addition of one person. (3) In the at-rest state, the particle concentration was two orders of magnitude lower than the standards. Therefore, the supply air volume in the at-rest state can be reduced when other disturbance factors are under control. The active power of the supply air fan was reduced by 41.7% in this stage, indicating great potential for energy saving. The field measurement provides evidence of the effect of disturbance factors on the cleanliness.