We do have RLAF for sampling of final API . ISO Class 8 (100000 ) is maintained for facility by AHU. RLAF has 0.3 micron HEPA for supply, 10 micron pre filterat return and 3 micron intermediate filter then RLAF should be qualified as ISO 5 or ISO 8. (manufacturer of RLAF claims iso class 5)
LAF always creates ISO 5 area hence Qualification shall be done as ISO 5. No matter what the surrounding area is.
Is there any Guideline for ISO 5 ACPH limit…