1.1    欧盟GMP

附录1无菌药品生产第五十条：

Sinks and drains should be prohibited in grade A/B areas used for aseptic manufacture. In other areas air breaks should be fitted between the machine or sink and the drains. Floor drains in lower grade clean rooms should be fitted with traps or water seals to prevent backflow.

1.2    WHO GMP

第六卷无菌生产产品第11.6章节：

Sinks and drains should be avoided wherever possible and should be excluded from Grade A and B areas where aseptic operations are carried out. Where installed they should be designed, located and maintained so as to minimize the risks of microbial contamination; they should be fitted with effective, easily cleanable traps and with air breaks to prevent backflow. Any floor channels should be open and easily cleanable and be connected to drains outside the area in a manner that prevents the ingress of microbial contaminants.

1.3    FDA cGMP

CFR 21, Part 211(制剂行业cGMP)第211.48章节(b):

 Drains shall be of adequate size and, where connected directly to a sewer, shall be provided with an air break or other mechanical device to prevent back-siphonage.

1.4    中国GMP

无菌药品第七章——厂房，第二十九条：

无菌生产的A/B级洁净区内禁止设置水池和地漏。在其它洁净区内，水池或地漏应当有适当的设计、布局和维护，并安装易于清洁且带有空气阻断功能的装置以防倒灌。同外部排水系统的连接方式应当能够防止微生物的侵入。

其中的空气阻断功能就是欧盟、WHO和FDA GMP中提到的air break.