Slide background
Slide background




Safe design and operation of on site generation of oxygen 93% for medical use

ID 1668 | | Visite: 6603 | Documenti Chemicals EntiPermalink: https://www.certifico.com/id/1668



Safe design and operation of on site generation of oxygen 93% for medical use

Oxygen for medicinal use is a prime requirement for all healthcare facilities for both the treatment of patients with respiratory disease and for providing additional oxygen to patients being treated within the facility.

For those hospitals and clinics, where the demand is higher, oxygen is normally distributed throughout the facility using a medical gas pipeline system.

The design requirements for the supply source used to supply medical oxygen to the pipeline system are detailed in the standard, EN ISO 7396-1 Medical gas pipeline systems; Pipeline systems for compressed medical gases and vacuum.

Two different products are included in the standard:

- Medicinal oxygen supplied from liquid oxygen vessels and/or gaseous oxygen cylinders; and
- Oxygen 93 manufactured on-site within the healthcare facility, using an oxygen concentrator unit.

Medicinal oxygen supplied either in cylinders or as a cryogenic liquid, is required to be manufactured by an approved supplier with a manufacturers licence (to demonstrate compliance with guidelines detailed in the European Commission’s Guide to Good Manufacturing Practice (GMP))

Within the European Union, the supplier of medical oxygen is required to hold a marketing authorisation in accordance with Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, detailing the clinical indications and contraindications and specific warnings for the safe use of the product.

The specification of this medical oxygen is detailed in the European Pharmacopoeia monograph for medical oxygen, which specifies a minimum purity of 99.5% oxygen.

The quality, safety and efficacy of the medical oxygen are ensured by the medical gas supplier through a quality management system under the responsibility of a qualified person.

Oxygen 93 can be manufactured on-site within the healthcare facility, under the responsibility of the healthcare facility pharmacist, using an oxygen 93 supply system and meeting the appropriate and specific quality and safety criteria for medicinal products prepared in Pharmacies (see Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme Guide PE010-4 Guideline to good practices for the preparation of medicinal products in healthcare establishment).

Oxygen 93 is not being ‘put on the market’, so it currently falls outside the regulation for the manufacture and supply of medicinal product Directive 2001/83/EC.

Oxygen 93 concentrator units are covered by the requirements for CE marking in accordance with the Medical Device Directive, (Council Directive 93/42/EEC of 14 June 1993 concerning medical devices).

The specification of the oxygen manufactured using an oxygen 93 supply system is detailed in the European Pharmacopoeia monograph for oxygen 93, which specifies the oxygen content to be between 90% and 96% and gives appropriate limits and analysis methods of other possible contaminants during the production.

As the oxygen 93 is produced by adsorbing the nitrogen from ambient air, the major contaminant in oxygen 93 is argon, which can be present up to 5%.

When the oxygen 93% monograph was introduced it was stated that the benefits of PSA oxygen (oxygen 93 per cent) are to allow production and supply of oxygen at sites where access for cylinder and liquid oxygen supply is difficult or impossible. PSA concentrators are in use in a number of fields particularly by the military (field hospitals).

The quality of the gas is very much dependent upon the performance of the equipment that produces it.

At the time of preparation of this publication, oxygen 93 is not licensed under a marketing authorisation, thus it is not evaluated by regulatory authorities and thus it cannot be considered as “equivalent medicine” for the oxygen.

EIGA 2015

Descrizione Livello Dimensione Downloads
Allegato riservato Safe Design and Operation On Site Generation Oxygen 93 for Medical Use.pdf
EIGA 2015
291 kB 14

Tags: Chemicals EIGA

Articoli correlati

Ultimi archiviati Chemicals

Piano di controllo nazionale pluriennale Sicurezza alimentare 2020 2022   Relazione 2021
Mar 27, 2024 87

PCNP pluriennale Sicurezza alimentare 2020-2022 | Relazione 2021

Piano di controllo nazionale pluriennale Sicurezza alimentare 2020-2022 | Relazione 2021 ID 21585 | 27.03.2024 / In allegato Il Ministero della Salute, in qualità di punto di contatto nazionale per la Commissione europea per il Piano di controllo nazionale pluriennale (PCNP) ha predisposto la… Leggi tutto
Mar 25, 2024 104

Direttiva 2001/58/CE

Direttiva 2001/58/CE ID 21574 | 25.03.2024 Direttiva 2001/58/CE della Commissione, del 27 luglio 2001, che modifica per la seconda volta la direttiva 91/155/CEE che definisce e fissa le modalità del sistema di informazione specifica concernente i preparati pericolosi ai sensi dell'articolo 14 della… Leggi tutto
Mar 25, 2024 91

Decreto 7 settembre 2002

Decreto 7 settembre 2002 ID 21573 | 25.03.2024 Decreto 7 settembre 2002 - Recepimento della direttiva 2001/58/CE riguardante le modalita' della informazione su sostanze e preparati pericolosi immessi in commercio. (GU n.252 del 26.10.2002) Collegati
Direttiva 2001/58/CE
Leggi tutto
PNAA Ministero della Salute 2024 2026
Mar 11, 2024 218

PNAA Ministero della Salute 2024-2026

Piano Nazionale di controllo ufficiale sull’Alimentazione degli Animali 2024-2026 ID 21478 | 11.03.2024 La programmazione dei controlli ufficiali nella filiera dei mangimi prevede un’attività di verifica ispettiva e un’attività di campionamento a sua volta distinta in MONITORAGGIO e in… Leggi tutto
Feb 28, 2024 783

Decreto 15 febbraio 2024

Decreto 15 febbraio 2024 / Elenco officine autorizzate produzione PMC al 14.02.2024 Approvazione dell'elenco delle officine che alla data del 14 febbraio 2024 risultano autorizzate alla produzione di presidi medico chirurgici. (GU n.49 del 28.02.2024) Collegati[box-note]I Presidi Medico Chirurgici… Leggi tutto

Più letti Chemicals

Regolamento  CE  n  178 2002
Ott 24, 2022 103155

Regolamento (CE) N. 178/2002

Regolamento (CE) n. 178/2002 Regolamento (CE) n. 178/2002 del Parlamento europeo e del Consiglio del 28 gennaio 2002 che stabilisce i principi e i requisiti generali della legislazione alimentare, istituisce l'Autorità europea per la sicurezza alimentare e fissa procedure nel campo della sicurezza… Leggi tutto
Notifica HACCP
Apr 05, 2022 70429

Notifica ai fini registrazione Regolamento CE n. 852/2004

Notifica ai fini della registrazione (Reg. CE n. 852/2004) - Ex notifica sanitaria alimentare ID 7901 | 06.03.2019 / Modello notifica allegato [panel]Regolamento (CE) 852/2004...Articolo 6 Controlli ufficiali, registrazione e riconoscimento 1. Gli operatori del settore alimentare collaborano con le… Leggi tutto