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).
A statement on the EDQM website explains, “…the main issue appears to be the distribution systems in place within healthcare facilities rather than the actual availability of oxygen supplies. Recourse to a PSA plant provides healthcare facilities that do not have access to oxygen produced from cryogenic distillation of air, for example field hospitals, with an alternative source of oxygen.”
“In view of the urgency of the situation, the European Pharmacopeia Commission is launching an extraordinary public consultation on how best to include oxygen 98% obtained via two-stage concentrators…”
Source: NOVAIR
Novair was among the very first companies to introduce the oxygen generator as a source of medical oxygen supply to hospitals in Europe in 1994, and claims to be the manufacturer offering the most extended range of oxygen generators for hospital use to the market. As a result, the company is particularly busy during the current pandemic, responding to the high demand for oxygen and generator systems.
In an upcoming exclusive interview to be published on the gasworld website later this week, Founder and President Bernard Zenou said of the prospect of a new monograph, “This new Monograph, when published, will provide to healthcare facilities a framework for the production of oxygen in-situ with almost equivalent quality to oxygen produced by cryo- distillation.”
He cites this development as the biggest opportunity for Novair in the next five years and said of the importance of onsite oxygen generation, “The new MDR (Medical Device Regulation) replacing the current Medical Device Directive (93/42/EEC) is a big challenge and opportunity for NOVAIR.”
“Oxygen produced in-situ by PSA or DS-PSA process are becoming mature and fully reliable solutions. They must definitely have an increasing place in the industrial landscape and in the health sector of today and tomorrow.”
Hot topic: Opening the door to onsite oxygen generation
EDQM notes that feedback on its proposed consultation is requested by 3rd May 2020, though is clear that responses must be accompanied by concrete supporting data to be considered by the European Pharmacopeia Commission.
Responses and data can be sent to epd@edqm.eu