Standard Operating Procedure for IP Medical Oxygen

Introduction
Medical oxygen is used in treating patients with reduced tissue oxygen saturation levels and
reduced perfusion to the brain. By supplying oxygen from external source at high concentration,
saturation levels above 90% is maintained.

Industrial production of medical oxygen as per IP 2014 monograph requires oxygen not less than
90 per cent v/v, carbon dioxide not more than 300 ppm v/v, carbon monoxide not more than 5 ppm
v/v and water vapour not more than 67 ppm v/v.

Quality Adherence
manufacturing at our unit is done by air separation and compression process to achieve purities
greater than 99.5 plus/minus 0.2 per cent with pressure of around 145 pounds per square
inch.The analysis for purity is continuously done with the help of assay method which is one of the
methods specified as per Indian Pharmacopeia 2014 before batch sample testing, labelling and
dispatch.

Process
The air from atmosphere is suctioned through the filter which absorbs particulate matter in the air.
The air is then passed through a four stage compressor which is a horizontal tandem type. The
compressor has both inter and after cooler to cool the ambient atmospheric air. The air is then
passed through moisture separator chamber which is part of the compressor assembly. The
medium processed dry ambient air then is passed through a nitran cooler where the outgoing
nitrogen cools the incoming air. The medium pressure dry cooled air then passes through the
vaporisation cooler where moisture is absorbed. It then passes through filter where acetylene
impurities are absorbed, then it enters the chilling unit where the air is further chilled. Further it
passes through molecular sieve column where the carbon dioxide is adsorbed before entering the
column. The air then contains two major gases i.e. Oxygen, Nitrogen and rare gases.
The column has three levels the lower part where partial liquefaction takes place forming liquid rich
in oxygen at minus 183 degree centigrade.
The rising vapours in bottom column consisting mostly of Nitrogen are condensed by liquid oxygen
in the condenser of the rectification column.
The condensed liquid collects in the skirt bath at the bottom of the condenser and is called poor
liquid.

The rich and poor liquids thus formed are passed through an expansion engine where they are
expanded through valves and are taken to appropriate points of the top column.

Nitrogen being more volatile passes out as a gas from the tap of it in a vapour form . Nitrogen and
oxygen pass through heat exchangers 1 & 2 thus cooling the incoming air.

Thus high purity oxygen is formed which is then pumped under pressure into the filling points
where cylinders are connected.