반응형 클린룸1 클린룸 환기횟수 관련 가이드라인(1) FDA, WHO TRS.961 [FDA Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice (2004)] C. Clean Area Separation Air change rate is another important cleanroom design parameter. For Class 100,000 (ISO 8) supporting rooms, airflow sufficient to achieve at least 20 air changes per hour is typically acceptable. Significantly higher air change rates are normally needed for Class 10,0.. 2020. 2. 6. 이전 1 다음 반응형