【摘要】 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。更多还原

【Abstract】 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 change rate of 40h-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 30h-1,when the clean-down capability from class 7to class 5is within 20minutes.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.更多还原