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 ...

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 ...

The heart of cleanroom technology is the High Efficiency Particulate Air (HEPA) and Ultra Low Particulate Air (ULPA) filters that trap particles as small as 0.3 microns with an efficiency of 99.99%.

Cleanrooms are built to consider air flow, air pressure, temperature, and other important points, but sometimes errors occur and maintaining a noncontaminated environment can be a challenge when ...