[ oxygen ] production technique for medicinal oxygen was introduced safely, the Oxygen( 98 %) Monograph( 07 / 2024:3098) came into force on the 1 July 2024.
This followed an extensive consultation by the European Directorate for the Quality of Medicines( EDQM) with representatives of the oxygen supply industry and medical experts.
Medicinal oxygen cylinder preparation. Image courtesy of APCI
The Oxygen( 98 per cent) Monograph allows for oxygen with a minimum purity of 96 % by volume, generated on two-stage adsorption plants using different zeolites or molecular sieves.
Monographs are public standards that form part of the European Pharmacopeia.
The ASU is not a medical device, and the oxygen supplied to the hospital requires a marketing authorisation, as it is the oxygen gas – not the oxygen generation equipment – that is subject to regulatory control.
If an electrolyser is located off-site, the oxygen it produces must either be liquefied or compressed into cylinders for distribution to the hospital. In this centralised production case, the medicinal oxygen gas would need to be packaged in accordance with GMP and supplied under a marketing authorisation.
Medicinal oxygen from on-site PSA concentrators
The EU Oxygen( 93 per cent) Monograph( 04 / 2011:2455) refers to oxygen produced by single-stage concentrators through adsorption purification of ambient air using zeolites, with an oxygen content in the range of 90 – 96 %.
Modern two-stage medicinal oxygen PSA equipment is capable of producing oxygen at 98 % purity, which is not covered by the Oxygen( 93 per cent) and Oxygen Monographs. To ensure that the adoption of this new two-stage PSA
Neither the Oxygen( 93 per cent) Monograph nor the new Oxygen( 98 per cent) Monograph covers gas produced by individual concentrators for domiciliary applications.
Publication of the new Oxygen( 98 per cent)
Monograph demonstrates that the EDQM has been willing to review emerging oxygen production techniques that support responsible patient care. Hopefully, they will continue to have the capacity to introduce new Monographs in response to industrial innovation, such as the co-production of oxygen on hydrogen electrolysers.
About the author
Stephen B. Harrison is the managing director of sbh4 consulting. A major focus of his work is strategic and techno-economic evaluation of electrolyser projects and technologies on behalf of investors and banks. His expertise in market, commercial, and technical due diligence is based on a foundation of many years in industry, where he operated at a senior executive level. In the past seven years, his insights have matured, and his skill have been sharpened by supporting investors with more than 30 buy-side due diligence cases through sbh4.
42 Hydrogen Tech World | Issue 22 | June 2025