Oxygen is an essential medicine required at all levels of the health care system; only high quality, medical-grade oxygen should be given to patients. Pressure swing adsorption (PSA) oxygen generating plants are a source of medical-grade oxygen. This document provides technical specifications as the minimum requirements that a PSA Oxygen Plant must meet for use for the administration of medical-grade oxygen.
Medical grade oxygen is defined as follows:
PhEur: Contains between 90.0%V/V and 96% V/V of O2. Remainder mainly consists of argon and nitrogen. This monograph applies to oxygen used on site where it is produced. It does not apply to individual concentrators.
USP: Oxygen produced from air by molecular sieve process. Contains not less than 90.0 % V/V and not more than 96 % O2 V/V, the remainder consists of mostly argon and nitrogen.
Pressure swing adsorption (PSA) is the process by which ambient air passes through an internal filtration system (e.g. a molecular sieve [zeolite granules or membranes]), which has a large enough total surface area to separate nitrogen (N2) from the air, concentrating the remaining oxygen (O2) to a known purity. It typically consists of an air compressor, dryer, filters, dual separation chambers, a reservoir, and controls. PSA oxygen generator plant is a unit designed to concentrate oxygen from ambient air at scale, with output capacity varying according to calculated oxygen demand, typically ranging from 2 Nm3 /hr to 200 Nm3 /hr. For distribution of oxygen produced from PSA plants, oxygen can either be piped directly from the oxygen tank to wards, or further compressed to fill cylinders via a supplemental booster compressor and a cylinder filling ramp/manifold.
All medical PSA oxygen generator plants are sources of oxygen that can produce medical-grade oxygen, at scale, 24 hours a day, 7 days a week. PSA plants themselves can be turn-key units complete with all the necessary equipment and supplies; however, the staff operating and maintaining them require specialized training. Strict maintenance schedules are needed to prevent malfunctions. Adequate supplies and spare.
parts are needed to allow operations for 5 years in resource-limited settings. A reliable supply chain is needed to meet any additional needs.