I have searched the internet for the requirement on microbial load in compressed air…
My manufacturing plant is supplying compressed air for non-sterile liquid production, and we would like to accept Grade D for our cleanroom, since there is no guideline for cleanroom standard for non-sterile production…
However, there is somewhat contradictory information in ISPE guideline…
It states that for sterile application, the microbial load of the cleanroom should follow the class of cleanroom (i.e. grade D in my case, and it should be non more than 200 cfu/m3)
But for non-sterile application, the typical microbial load should be NMT 5 cfu/m3…
Which level should i adopt? And why is the microbial load in non-sterile application smaller than that of class D cleanroom which is for sterile application?