PHARMACOPEIA COMPLAINCE/ CERTIFICATION
|Gas Type||US PHARMACOPEIA USP XXII OXYGEN 93% MONOGRAPH||INDIAN PHARMACOPEIA OXYGÈN 93%||EUROPEAN PHARMACOPEIA OXYGÈN 93%||ABSSTEM TECHNOLOGIES( MedO)|
|Oxygen||O2||90-96%||more than 90%||90-96%||93% ± 3%|
|Carbonmonoxide||CO||‹ 0.001%||‹ 5 ppm||‹ 3ppm|
|Carbondioxide||CO2||‹ 0.03%||‹ 300 ppm||‹ 168 ppm|
|Sulphur Dioxide||SO2||‹ 1 ppm||0 ppm|
|Nitrogen Oxides||NOX||‹ 2 ppm||0 ppm|
|Water||H2O||-500 C ( ‹ 67 ppm)||‹ 35ppm|
|Oil||-||‹ 0.1mg/m3||‹ 0.1mg/m3||‹ 0.08mg/m3|
Manufacturing of MedO is organized according to a quality management system certified by ISO 9001:2015
WHY DO WE NEED OXYGEN COMPLIANCE VIA PHARMACOPEIA
Pharmacopeia means an official publication containing a list of medicinal drugs with their effects and directions for their use. In past there had been a lot of discussions based upon level of medical oxygen purity. Different countries had various understandings about oxygen purity delivers via bottled Cylinders (having gas), Liquid oxygen (via cryogenic process) and Onsite Generators (via PSA process). So, to standardize the oxygen purity on global level, US | EUROPEAN | INDIAN | UK countries prepared and released their standards for supply of medical oxygen. Now the medical oxygen purity percentages declared by these countries/continents has to be complied in order to be able to supply medical grade oxygen.
In short the medical oxygen purity based upon global acceptable limit must range between 90%-96%.
MINIMUM OXYGEN PURITY
Per the European pharmacopeia the level of purity required is between 90 - 96% to be called as Medical Grade Oxygen. Such purity can be seen using Oxygen analyzer that is equipped on the machine and in any manner if the machine is unable to provide the purity per the standards, then it stops and switches automatically to the other (machine or cylinder manifold). Hence, the hospital is always having a continuous supply of Medical grade oxygen.
USP XXII OXYGEN 93% MONOGRAPHOxygen 93% is oxygen produced from atmosphere using PSA (Pressure Swing Adsorption) process. It provides oxygen not less than 90.00% and not more than 96.00%, oxygen by volume
MONOGRAPH: 2455 Oxygen 93%Group 9G Medicinal gases Oxygen 93%. It provides oxygen not less than 90.00% and not more than 96.00%, oxygen by volume
IP ADDENDUM 2005
More than 90%Mentions oxygen more than 90% when produced using PSA (Pressure Swing Adsorption) process