2010New EditionGMPCleanroom Classification Levels

AGrade:High-risk operation areas, such as filling zones, areas where buckets of rubber stoppers are placed, and open-top packaging containers that come into direct contact with sterile preparations, as well as areas for sterile assembly or connection operations, should maintain their environmental conditions using unidirectional airflow benches (shelters). The unidirectional airflow system must provide uniform air supply within its working area, with a wind speed of0.36-0.54m/sGuideline values should be supported by data proving the state of unidirectional flow and verified. Lower air velocities can be used within enclosed isolation chambers or glove boxes.

BGrade:sterile preparation and filling operationsAThe background area of the Grade A cleanroom.

CGrade andDGrade:A clean area of lower importance for operations in the production process of sterile products.