SELECTING PORTABLE AND AUTOMATED AIR SAMPLER DEVICES TO MEET CGMP

摘要

PIC/S Annex 1 was recently updated in January 2017 and, under the Clean Room and Clean Air Device Monitoring section, the recommended limits for microbial monitoring of clean areas during operation have remained intact since 2003. A one cubic meter sample volume is still required using an air sampling instrument for active air sampling (see Table 1).