一、血液制品的生产厂房应当为独立建筑物,不得与其它药品共用,并使用专用的生产设施和设备。

二、原料血浆、血液制品检验实验室应当符合国务院《病原微生物实验室生物安全管理条例》、国家标准《实验室生物安全通用要求》的有关规定。

三、原料血浆检验实验室应当独立设置,使用专用检验设备,并应当有原位灭活或消毒的设备。如有空调系统,应当独立设置。

四、原料血浆破袋、合并、分离、提取、分装前的巴氏灭活等工序至少在D级洁净区内进行。

五、血浆融浆区域、组分分离区域以及病毒灭活后生产区域应当彼此分开,生产设备应当专用,各区域应当有独立的空气净化系统。        https://www.sicola.com                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             

六、血液制品生产中,应当采取措施防止病毒去除和/或灭活前、后制品的交叉污染,病毒去除和/或灭活后的制品应当使用隔离的专用生产区域与设备,并使用独立的空气净化系统。