반응형 제약 및 의료기기, GMP/국내외 규정 및 가이드라인42 클린룸 환기횟수 관련 가이드라인(2) EU GMP, ISPE EU GMP Volume 4, EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 1, Manufacture of Sterile Medicinal Products(corrected version) 14. The particle limits given in the table for the “at rest” state should be achieved after a short “clean up” period of 15-20 minutes (guidance value) in an unmanned state after completion of operations. ISPE Good Pra.. 2020. 2. 11. 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 2 3 4 5 다음 반응형