Compressed Air for Pharma Plant

Health Canada Guideline

Air that comes into direct contact with primary contact surfaces and/or the product should be monitored to control the level of particulates, microbial contamination, and the absence of hydrocarbons. Limits used should take into consideration the stage of manufacture, product, etc. Additional tests might be required due to the nature of the product. Gas used in aseptic processes must be sterile and filters checked for integrity.

ICH Q7A

To verify the contents of the gas system at factories that comply with GMP, a complete gas analysis should be carried out at least once a year. This is particularly important in cases where the gas is in contact with the finished product. For example, in the GMP guide for APIs issued by the International Conference on Harmonization (ICH), Q7A -7.31 states that complete analysis should be carried out at suitable intervals (i.e. at least once a year).

What should the acceptable microbial count be in a non-sterile environment?
What guidance/regulation can you cite or recommend.

The safest thing to do is to match the air quality of the environment.in which you are operating. If it is ISO7, then test to ISO7, if it is grade C, then test to Grade C, etc.

Look up ISO14644 regarding ISO standards.(you have to buy it from ISO)

Look up http://ec.europa.eu/health/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf for the EU annex. (this is Free).

WHO reference http://apps.who.int/prequal/info_general/documents/TRS961/TRS961_Annex6.pdf (also Free)

ِDear Mr. Reddy,

Could you please give me reference/ guideline(s) about the limits you citied in your post?
Any assistance would be greatly appreciated.
Regards,

Dear Phyllis

I think Cs instrument have it measurement of the vaporous residual oil content
from 0.001 mg/m³ to 2.5 mg/m³.