Japanese–English glossary
Cleanroom
クリーンルームkurīn rūmu
A room in which airborne particles and microorganisms are kept below specified levels, with filtered air, pressure differentials, controlled entry for people and materials, and routine monitoring. Pharmaceutical cleanrooms are classified by grade (A to D in EU GMP Annex 1 and PIC/S, which Japanese aseptic manufacturing follows) and, for particles, by ISO 14644-1 class. A Japanese facility description may give the grade, the ISO class or both, and the two are not interchangeable because grades also set microbial limits and the in-operation state.