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 ...
Cleanrooms are designated as controlled environments where the levels of airborne particles are carefully regulated. Their construction and utilization are meticulously planned to minimize the ingress ...
The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advice, leading to confusion and sometimes incorrect interpretation.