Japanese–English glossary
Cleanroom grade classification
グレード分類gurēdo bunrui
Dividing manufacturing areas into grades, A to D, according to the cleanliness the operations there require, with limits for airborne particles and microorganisms at rest and in operation. The grade sets monitoring locations, frequencies and limits, and the gowning and transfer rules. Japanese aseptic manufacturing documents follow the A to D scheme of EU GMP Annex 1 and PIC/S; facility documents may also give ISO 14644-1 classes for particles. When a Japanese CPC or CDMO quotes its cleanroom capacity, ask for the grade of the room where open steps take place.