Both the USA cGMP 1 and EU GMP 2 dictate that cleanroom classification must be carried out according to ISO 14644-1. The version of this ISO standard released in 1999 4 was rewritten by a group of ...

A one-size-fits-all approach to monitoring practices and results is never appropriate, given the diversity of practice within the pharmaceutical industry. Cleanroom monitoring and classification are ...

A Clean Room, or cleanroom, is a laboratory environment that ensures that airborne particles are maintained at a very low concentration. This room is isolated, actively cleansed, and prevented from ...

Today’s standards define airborne particle monitoring in units of particles per cubic meter (particles/m 3). These standards tend to require sampling an entire cubic meter (1 m 3) to establish an ...