ISO 14644: Airborne Particulate Cleanliness in Cleanrooms and Clean Zones
Over time, cleanrooms around the world have grown more sophisticated, underscoring the need for a single international standard to address cleanroom classification and testing. In response, the ISO 209 Technical Committee formed ISO 14644:2015.
GMP cleanroom operators and users are faced with making changes in their cleanroom classification and/or re-qualification SOPs. In some cases, a risk assessment may be required to retrospectively investigate the potential impact on product quality leading to potential changes to their cleanroom and air handling systems to comply with the required Class/Grade.