Quality requirements for compressed air in non steril pharmaceutical industry


Could you please help me with one problem about quality requirements for compressed air in pharmaceutical industry (non steril production).

I know that I have to use ISO 8573, but I did not find what quality requirements I have to satisfy for non steril production.

Maybe this quality requirements:

Parameter Unit Specification

Solid particles conc. 0.1-0.5μm/m³ 100

Solid particles conc. 0.5-1μm/m³ 1

Solid particles conc. 1-5μm/m³ 0

Pressure dewpoint ˚ C - 20

Total oil mg/m³ ≤ 0.01

Microbiological cont CFU / m³ 200

Thank you very much!

Slavica Pejak
Validation manager

ISO 8573.1 identifies three primary contaminant types as prevalent in a compressed air system. Solid particulates, water and oil (in both aerosol and vapor form) are recognized. Each is categorized and assigned a quality class ranging from class 0, the most stringent, to Class 9, the most relaxed. The end user-user is responsible for defining the air quality required for their particular application or process.

Air treatment manufacturers present technical data in reference to ISO 8573.1. An easy to understand ISO 8573.1: 2001 table defines the various air quality classes. The standard also determines that air quality shall be designated by the following nomenclature:

Compressed Air Purity Classes A, B, C:

A= solid particle class designation
B= humidity and liquid water class designation
C= oil class designation
Compressed Air Contamination

Contaminants originate from three general sources.
1.Contaminants in the surrounding ambient are drawn into the air system through the intake of the air compressor. Ingested contaminants appear in the form of water vapor, hydrocarbon vapors, natural particles and airborne particulates.
2. As result of the mechanical compression process, additional impurities may be introduced into the air system. Generated contaminants include compressor lubricant, wear particles and vaporized lubricant.
3.A compressed air system will contain in-built contamination. Piping distribution and air storage tanks, more prevalent in older systems, will have contaminant in the form of rust, pipe scale, mineral deposits and bacteria.

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Class 2 and or Class 3 are applicable in your case.

Thank you very much for your response Mr. Durga.

You want to tell that I have to decide on my one opinion what class my compressed air have to be?

I have to tell you that my compressed air is in directly contact with products.
I have liquid product, solid and semi solid. Can I have diffrent requirements for compressed air for diffrent typs of products.

Thank you

No need of different requirements. Chose highest grade that is applicable to your product and at the delivery point you always ensure you have proper filter. This will take care of all requirements.
Keep your distribution lines clean. It comes under preventive maintenance.

I suggest that you go with Class 2. Thats best as far as quality is concerned.


Thank you very much! You really help me.

Best regards