Grade A

The cleanroom grade for high-risk operations such as aseptic filling, stoppering, open ampoules and aseptic connections, usually under unidirectional airflow within a RABS or isolator. It must meet ISO 5 particle limits at rest and in operation, and under EU GMP Annex 1 no microbial growth is expected in any sample. Any recovery is investigated and identified to species. Grade A must be monitored continuously during critical processing.