Nitrogen Gas Validaton Specification

Dear Sir,

For Nitrogen Particulate Matter content criteria mentioned in our SOP as 5 mg/m3

How this criteria is defined? any guidelines for define the criteria for particulate matter in nitrogen

Please suggest

High-purity grades of nitrogen are composed of greater than 99.998 percent nitrogen. The common high-purity grade names include Research Purity and Ultra High Purity. All of the high-purity grades can also be considered Zero grade. This is because they meet the specification of having less than 0.5 parts per million of total hydrocarbons required of Zero grade nitrogen. Besides hydrocarbons, nitrogen contains other impurities like oxygen, carbon dioxide, carbon monoxide and water. None of the high-purity grades contain oxygen greater than 0.5 parts per million, carbon dioxide or carbon monoxide greater than one part per million, or water greater than three parts per million.
The pharmaceutical industry uses high-purity grades as a shield gas for some medications. The high-purity nitrogen protects the medicine from contacting and reacting with surrounding oxygen and moisture because it is a non-reactive gas, especially if it contains low levels of impurities.

Microbial limit- NMT 1CFU/ Cubic meter

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Nitrogen gas is generated from atmospheric air by elemination of impurities such as Oxygen, Carbon dioxide and other gases besides other impurities.
Contaminants in solid form originate from many different sources, e.g. dust particles from the surrounding atmosphere drawn in by the compressor air intake or by abrasion or corrosion within the compressed air system. They can range from very large, granular to extremely small submicron-sized particles. Furthermore, solid particles can be either inert particles or viable colony-forming units.
The three major contaminants in compressed air are solid particles, water and oil; these are categorized by compressed air purity classes.
These compressed air purity classes group the concentrations of each of the above contaminants into ranges, each range being given its own purity class index.
The international standard ISO 8573-1 is a compressed air quality specification that addresses these very same specific contaminants by providing a range of purity classes for particles, water and oil. It does not include classes for gases or microorganisms.
According to this ISO standard the Maximum number of particles per cubic metre are 5 mg/m3 for Class- 6 type of compressed air. There are 1 to 9 types of classes specified in this ISO standard for compressed air based on impurities levels of Particles, Oils, Humidity / Liquid water.
Therefore, same limit of particulate matter is applied for Nitrogen gas.

(Note:- Additional references will be shared if avaialble)

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Thank you sir

You are always welcome…!!

Dear Sir,
What it means of 0.1 CFU/Cubic foot in practice?

it is NMT 1 cfu/cubic meter.

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