The European Directorate for the Quality of Medicine and Healthcare (EDQM) has revealed that it is launching an extraordinary public consultation on how best to include oxygen at 98% purity obtained via two-stage concentrators in European Pharmacopoeia.
The development is largely driven by the heightened need for medical oxygen during the current coronavirus pandemic, as widely reported by gasworld.
However, it is also as a result of the advances in technology since the last monograph was published, particularly the rise of double-stage pressure swing adsorption (PSA) oxygen generators.
European Pharmacopoeia currently includes two monographs on oxygen, firstly Oxygen (0417) and secondly, Oxygen (93%) or Oxygen 93 (2455).
Oxygen (0417) was drafted over 50 years ago and covers oxygen produced by cryogenic distillation, with an oxygen content specification of a minimum 99.5%. Oxygen 93 (2455) was first published in Europe in 2010 and covers oxygen produced by a concentrator that removes the nitrogen from ambient air using a PSA system.
At the time of the latter’s publication, the plants available on the market utilised a single-stage adsorption process which did not remove any argon from the air being processed. Advances have since been made in the design of PSA oxygen concentrators and companies like Novair and others are now producing double-stage PSA plants capable of producing oxygen with a nominal content of 98%.
This has prompted the decision to elaborate a new monograph, Oxygen (98%) (3098), especially as the ongoing Covid-19 pandemic has increased the demand for oxygen worldwide (by as much as a factor of 10).