Do we need to follow the Medical air specification given in USP or EP for Compreesed air Qualification or some other guideline. Anyone having any guidance document.
Regards
Anup Sharma
The typical compressed air system consists of an oil-free air compressor that compresses the ambient air and an air dryer connected to an air receiver surge tank that supplies air throughout the distribution system. Where a non-oilfree air compressor is used, the compressed air passes through a coalescing filter and oil vapor absorber filter where the hydrocarbons are removed then passes into the surge tank and distribution system.
- All use points will be sampled for a minimum of seven consecutive days including the compressed air exit point from the air compressor.
- Testing will be in accordance with documented procedures.
- Environmental tests (microbiological and nonviable particulate) will be taken for information only for non-sterile use.
- Environmental tests for sterile use must meet the criteria for the area of use.
Water and oil None detected
Oil 0.1 mg/m3
Odor No smell
Atmospheric dew point 508F (20 mg/m3)
Microbiology for total count Reference only (no growth for aerobic organisms for sterile)
Particulate (nonviable) (total count of particles 0.5 mm per cubic foot)
Reference only (meet area quality standards)
Carbon monoxide NMT 10 ppm; 5 ppm
Carbon dioxide NMT 50 ppm ; 500 ppm
Nitric oxide/nitrogen dioxide NMT 2.5 ppm; 2 ppm
Sulfur dioxide NMT 5 ppm ; 1 ppm
Dear Durga
From where these limits are derived. Can you please provide me the guidance documents for the same.
Regards
Anup Sharma
You can refer EP/USP and any manufacturer of air compressors. You can even look medical gasses manufacturer sites. A popular company for such compressor is Ingersol Rand and FESTO too.
USP/EP are mentioning only medical air. Compressed air are not mentioned in any pharmacopoeia.
Regards
Anup Sharma
[COLOR=“black”]A medical gas is a gaseous substance that meets medical purity standards and has application in a medical environment. Medical gas manufacturing is governed by the FDA’s current Good Manufacturing Practices (cGMP). The quality of medical gases must also meet the official standards of the United States Pharmacopoeia (USP). USP provides a listing of drugs licensed for use in the United States & Europe with the analytical standards necessary to establish purity suitable for human use applied to each of the listed drugs. Drugs sold for human consumption in the U.S. must meet or exceed the purity standards listed in the USP. Drugs meeting these requirements must include a designation on their label that demonstrates compliance with standards listed within the USP.
These standards are the legal requirements enforced by the U.S. Government under the cGMP (current Good Manufacturing Procedures) regulations. Under these standards, medical gases are categorized as prescription drugs.
Medical gases that must meet these requirements include:
Oxygen USP
Nitrogen NF (National Formulary)
Helium USP
Air USP -> THIS IS WHERE COMPRESSED AIR COMES-IT IS CONTACT SUBSTANCE
Carbon Dioxide USP
Nitrous Oxide USP
Mixtures [/color]
Anup, I think what you’re looking for is the International Standard for Compressed Air Quality (ISO8573.1: 2010), which specifies various grades of compressed air quality.
For product contact compressed air then the relevant tests would be particulates, oil and moisture (water). You would also need to carry out microbiological testing. Carbon monoxide etc would only be required for breathing air, e.g. air supplied for operators during high containment processing, or for patient use (which I think is where Durga is coming from with his posts).
I hope that helps.