CLEAN ROOM MONITORING – REGULATORY STANDARDS Ø Air Classification as per Schedule M Grade Maximum permitted number of particles / m3 equal or above at rest in operation 0.5µm 5.0µm 0.5µm 5.0µm A 3,520 29 3,500 29 B 35,200 293 3,52,000 2,930 C 3,52,000 2,930 35,20,000 29,300 D 35,20,000 29,300 not defined not defined Note:- Grade A and B correspond to with class 100, M 3.5, ISO 5 Grade C correspond to with class 10000, M 5.5, ISO 7 Grade D correspond to with class 100000, M 6.5, ISO 8 Ø Air Classifications by US FDA guideline on Sterile Drug Products Clean Area Classification <0.5 µm Particles/ft3 <0.5 µm Particles/mt3 Microbiological Limit cfu/ft3 cfu/m3 100 100 3,500 <1 <3 1000 1000