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 ...

Revised versions of ISO 14644 adopt changes to sampling procedures and monitoring plans for cleanrooms. The International Organization for Standardization (ISO) published the long-awaited revisions to ...

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 ...