CONTROLLED ROOM CLASSIFICATION STANDARDS

BPF 1989 (Pharmaceutical Industry Guide)

CLEAN ROOMS

Classification of the different air qualities required to manufacture sterile products:

  Maximum Nº of particles per m3 of air, with a dimension equal or superior to Max. Nº of microorganisms per m3 of air (in activity)
0.5 µm 5 µm 0.5 µm 5 µm
In non-activity (b) In activity
A 3500 0 3500 0 <1
B 3500 0 350000 2000 10
C 350000 2000 3500000 20000 100
D 3500000 20000 not defined (c) not defined (c) 200