空气阻断的法规景常见缺陷及工程解决方案邓海根21ppt课件.pptVIP

欧盟无菌药品指南-2008 26. 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 back-flow. 26. 无菌生产的A/B级区内禁止设置水池和地漏。在其它洁净区内，生产设备或水池与地漏不应直接相连。在洁净要求较低级别区，地面排水设施应设隔离装置或水封，防止倒灌。 WHO 无菌药品-2010 11.6 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 maint