BPF 1989 – Pharmaceutical Industry Guide

Controlled Room Classification Standards

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 toMax. Nº of microorganisms per m3 of air (in activity)
0.5 µm5 µm0.5 µm5 µm
In non-activity (b)In activity
A3500035000<1
B35000350000200010
C3500002000350000020000100
D350000020000not defined (c)not defined (c)200