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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;
- Oxygen 93 manufactured on-site within healthcare facility, using 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).
EIGA 2015
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