As per my experience, we need to do the following activities:
It should meet the room respective Grade (A / B /C / D) requirements.
It should be free from Oil content / traces.
Perform this study by using Filter paper.
It should be as per the Dew point.
If the Dew point is -40°C, moisture content shall be 127ppm - This limit is for
It should be -40
Microbial load shall be checked at generation point & user point (if the filter is 0.45 micron).
If the finlal filter is 0.2 micron, and it is in Grade “A”, sterility test shall be performed.
If the final filter is 0.2 micron, and it is in Grade “D”, the limit of Microbial load should be: NMT 100 cfu / cu.m (USP 30)
- Filter Integrity Test:
For 0.2 micron filter, filter integrity should be done, as per the defined frequency of your PQ protocol / VMP / Policy
Thanks & Regards,
I need a clarification in this.
Which grade has to be followed to Compressed air (which will be used for the jet milling of an API).
Any seasonal variation has to be taken into account?
What are all the parameters which has to be monitored after validation?
Any specific quideline is available?
Thanks & regards