生产无菌药品的背景环境——B级区换气次数实测分析

Field tests and analyses for air change rate needed for GMP Grade B area——the background area for manufacturing sterile medicinal products

对3处用于无菌药品生产的无菌室进行了实测。通过调整房间换气次数及系统运行状态,测试分析了换气次数与洁净度和自净时间等的关系,并与理论分析结果进行了比较。结果表明,实测结果与理论分析结果相当接近。当不考虑A级区贡献时,40h-1的换气次数即可保证B级区对于自净时间的要求。若考察7级至5级的自净时间,则所需的最小换气次数可降至约30h-1。当A级区占房间面积比例较大时,仅靠A级区的循环净化就可以保证B级区对于洁净度和自净时间的要求。

Tests three facilities in-situ used for sterile medicine manufacture. Through changing air change rates and system operating status, tests and analyses the relationship between air change rate, air cleanliness and clean-down capability. Compares the test results with the theoretical analysis, which show good agreement. The air chang6 rate of 40 h-1 would be sufficient for the requirement of the clean-down capability for Grade B area, if the contribution from Grade A area is not taken into consideration. The minimum air change rate can be reduced to be about 30 h-1, when the clean-down capability from class 7 to class 5 is within 20 minutes. When the ratio of Grade A area to the room area is larger, the requirement of both the air cleanliness and the clean-down capability could be met by the contribution of the circulation and cleaning of air from Grade A area only.