Particle count for compressed air

GOOD ENGINEERING PRACTICE (cGEP)
#1

I am working for the qualification of compressed air system in a pharma industry,
can any one give me their inputs regarding non-viable particle count of compressed air and the people who are able to perform this test.
pls mail me the details to npavanraju@gmail.com

Regards,
Pavan

#2

Good day

It is recommend that you develop an air quality program for validation that is repeatable for verification and compliance for FDA enforced cGMP. Compressed or process air lines should be tested on a routine or regular basis. A thorough evaluation of the application and manufacturing process is required to ensure the appropriate solution, both technically and financially.

Direct Product Contact
Oil mist/particulate (matter): Grade D 1 mg/m3 0.1 mg/m3
Moisture/Dew Point: Grade D 1267ppmv/0 degF
Gaseous Hydrocarbons (minus methane): Grade D 5ppm 2ppm
Halogenated Hydrocarbons: Grade D 5ppm 1ppm.

Alex Kennedy

#3

Dear Pavan,

specifically regarding particle count in compressed air, as a general rule the compressed air with product contact should have the same or better particle count as the environment. The particles are measured with an accessory for a particle counter called high pressure diffuser, (which is quite expensive, around 40% of the particle counter), where the compressed air is decompressed and expanded previous to entering the particle counter to avoid damaging the counter.

Best regards

Alfred

#4

Hi alex

please give me reference guideline or references for test and acceptance criteria.

Thanks
Vipul Jain
09016429108

#5

Dear Vipul,

The reference guideline is ISO 8573