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1、洁净室换气次数标准（一）在各国的洁净室标准中，相同级别的非单向流洁净室的经验换气次数并不相同。我国洁净厂房设计规范（GB 50073-2001 ）中明确规定了不同级别的非单向流洁净室洁净送风量计算所需的经验换气次数，见下表：空气洁净度等级GB 50073-2001ISO/DIS 146444医药洁净厂房设计规范6 级（ 1000 级）5060次2556次-7 级（ 10000 级）1525次1125次定5次8 级（ 100000 级）1015次3.57次15次9 级(1000000 级)1015次3.57次12次备注：换气次数适用于层高小于 4.0m的洁净室。室内人数少、热源小时，宜采用下限值
2、。 大于100000级的洁净室换气次数不小于12次另外：实验动物环境及设施国家标准GB 14925 2001规定普通环境 810次/h屏障环境1020隔离环境 2050(二)温度和相对湿度洁净室(区)的温度和相对湿度应与药品生产工艺相适应。无特殊要求时，温度应控制在1826 C,相对温度应才$制在45%65% 。(三)压差(1)洁净室必须维持一定的正压，可通过使送风量大于排风量的办法达到，并应有指示压差的装置。(2)空气洁净度等级不同的相邻房间之间的静压差应大于5Pa,洁净室(区)与室外大气的静压差应大于10Pa ,并应有批示压差的装置。(3)工艺过程产生大量粉尘、有害物质、易烯易爆物质及生产
3、青霉素类强致敏性药物，某些爸体药物，任何认为有致病作用的微生物的生产工序，其操作室与其相邻房间或区域应保持相对负压。(四)新鲜空气量洁净室内应保持一定的新鲜空气量，其数值应取下列风量中的最大值：(1)非单向流洁净室总送风量的10%30% ,单向流洁净室总送风量的 2%4% ;(2)补偿室内排风和保持正压值所需的新鲜空气量；(3)保证室内每人每小时的新鲜空气量不小于40 m3。(五)其他标准说明：1、无菌医疗器械管理规范(YY 0033 2000):十万级洁净区换气次数：丁 15次/h万级洁净区 换气次数：丁 20次/h.2、体外诊断试剂实施细则：没有具体规定，只规定了压差范围。3、药品生产质量
4、管理规范：没有规定，只规定了压差范围。4、洁净厂房设计规范(GB50073-2001 ):十万级洁净区换气次数：10次/h 15次/h万级洁净区换气次数：15次/h25次/h。5、GMP验证指南(2000版)建议：十万级洁净区换气次数：丁 15次/h万级洁净区换气次数：丁 25次/h.文字6、生物污染控制(ISO14644 )国际标准第一章洁净等级划分：十万级洁净区换气次数：10次/h 15次/h万级洁净区换气次数：15次/h 25次/h。也就是说，换气次数问题可以商榷。(六)一般的洁净区换气次数说明：编号房间名称风口长(m)宽(m)房间面积M2房间高度m风口风速(m/s)换气次数1男一更10
5、.4840.4846.93252.60.5224.332男二更10.4840.4844.922.60.003女一更10.4840.4846.93252.60.004女二更10.4840.4844.922.60.005缓冲间10.4840.4846.14252.60.00610.4840.4842.620.4840.4842.6走道310.0030.4840.4842.640.4840.4842.67万级洗衣10.630.6311.68752.60.008万级洗衣灭菌10.630.6315.51252.60.00万9万级整衣间10.4840.4848.52.60.00级1010.4840.484
6、2.6区20.4840.4842.6轧盖间34.720.0030.4840.4842.640.4840.4842.61 110.9850.5252.620.9850.5252.6灌装传递3.45831.2350.722.641.2350.722.612脱皮10.320.321.5812.60.0013更衣10.320.322.4752.60.0014缓冲10.320.324.062.60.001510.630.632.6配药间140.0020.630.632.616容器灭菌间10.4840.48415.82.60.001 7洁具清洗间10.4840.4848.22.60.0018配药辅助间10
7、.4840.4847.82.60.0019万级传递间10.4840.4844.6752.60.00编号房间名称风口长(m)宽(m)房间面积m2房间高度m风口风速(m/s)换气次数1精制更衣间10.4840.4842.4752.60.3444.562精制缓冲间10.4840.4844.062.60.3830.363过滤间10.4840.48416.952.60.3817.8020.4840.4842.60.55超4浓缩间10.4840.48415.812.60.520.11滤20.4840.4842.60.485超滤间10.4840.48413.62.60.4821.4620.4840.4842
8、.60.426称量间10.4840.4848.12.60.0020.4840.4842.67容器清洗间10.4840.4844.062.60.00编号房间名称风口长(m)宽(m)房间面积m2房间高度m风口风速(m/s)换气次数1洗瓶更衣间10.4840.4846.292.60.3216.502洗瓶缓冲间10.4840.4844.2552.60.322.87洗3洗瓶内走道10.4840.4846.38252.60.4221.34瓶410.4840.4842.60.7间20.4840.4842.60.7洗瓶间30.4840.484522.60.717.4740.4840.4842.60.750.4
9、840.4842.60.7510.630.632.60.6洗胶塞间20.630.63282.60.5523.5530.630.632.60.66洁具清洗间10.4840.4843.52.60.00编号房间名称风口长(m)宽(m)房间面积m2房间高度m风口风速(m/s)换气次数1一更衣间10.320.322.72.60.631.512二更衣间10.320.322.452.60.634.723缓冲间10.320.322.452.60.5732.99410.4840.4842.61.1走道20.5433.1620.4840.4842.615气闸110.320.322.72.60.9549.896气闸
10、210.320.322.42.60.423.637周转间10.320.3216.642.61.117.89纯20.320.322.61化810.320.322.61粉碎间13.220.41车20.320.322.60.9间910.320.322.61.05烘干间18.1818.3320.320.322.61.31010.4840.4842.61.2洗酸间23.7631.4020.4840.4842.61.11 1前室10.320.322.882.61.259.081210.630.6343.353.51.1纯化间20.630.632.6129.1930.630.632.611310.630.6337.1130.75操作间20.630.632.60.728.2430.630.632.60.7514称量间10.320.328.362.61.220.3515容器清洗间10.4840.48411.982.60.9525.7216洁具存放间10.320.323.3
