Oxygen and PSA
What is checked in a PSA plant factory acceptance test?
What should a buyer check during a witnessed factory acceptance test of a PSA oxygen plant before it is shipped?
Short answer
WHO's technical specifications for health facility oxygen systems (December 2024) ask the supplier of an oxygen generator plant for a pre-shipment inspection report with certificates of analysis of the product output, technical tests and calibration, and documentation proving the safety and efficacy of all components, later cross-checked against the tests on site.
The EU good manufacturing practice guidelines, Annex 15 on qualification and validation (30 March 2015), place the factory acceptance test (FAT) before installation: where applicable, equipment, especially with novel or complex technology, may be evaluated at the vendor before delivery, and should be confirmed there to comply with the user requirements or functional specification. See factory acceptance test.
What WHO (2024) asks for before shipment
- Oxygen generator plant: a pre-shipment inspection report including all certificates of analysis of the product output, technical tests and calibration, and other documentation proving the safety and efficacy of all components of the plant.
- Cylinder filling station: certificates for calibration and inspection prior to shipment.
WHO then asks for tests on site to be conducted and documented according to the manufacturer's established protocols, with the results cross-checked against the pre-shipment inspection. Before commissioning, it asks for a minimum of 72 hours of continuous operation to test the entire system, a check of all analysers and alarms, including power failure, and a check of the automatic switch-over to the secondary or reserve oxygen supply.
Factory tests and site tests
Under Annex 15, where appropriate and justified, a documentation review or test done at the FAT need not be repeated on site during installation or operational qualification, provided it is shown that transport and installation leave the functionality unaffected. UNDP's technical and regulatory requirements for oxygen plants (effective 1 January 2025) list pre-shipment inspection among the required items, together with performance tests of at least three days of continuous operation, alarm tests and commissioning reports. See DQ, IQ, OQ and PQ for an oxygen plant and how a PSA plant is commissioned.
ULTRAOX plants
The ULTRAOX SC datasheet states that the equipment is parameterised and tested in the factory and ready to start on site; on large plants, installation, initial start-up and staff training are supervised by factory technicians.
More questions
Does a factory test replace the tests on site?
Not entirely. Annex 15 (2015) lets some tests done at the FAT go unrepeated on site if transport and installation do not affect functionality, and WHO (2024) asks for the site results to be cross-checked against the pre-shipment inspection.
How long should the plant run before commissioning?
WHO (2024) asks for a minimum of 72 hours of continuous operation to test the entire system before commissioning, with all analysers and alarms checked.
Sources
- WHO, Technical specifications for health facility based medical oxygen systems (31 December 2024), section 1.1, lines 37 and 52, and section 1.2, line 52
- European Commission, EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice, Annex 15: Qualification and Validation (30 March 2015), sections 3.4 to 3.7
- UNDP, REQ-OXY-001 v01, Technical and regulatory requirements for oxygen plants (effective 1 January 2025), section 6.2
- ULTRAOX SC datasheet, p. 3
Ultra Controlo figures come from its technical datasheets. Third-party facts were read at the source on the date shown.
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