Service and projects
SAT (site acceptance test)
A site acceptance test (SAT) is, in the EU good manufacturing practice guidelines for medicinal products (EudraLex Volume 4, Annex 15, 2015), a test of equipment once it is received on site: Annex 15 says a factory acceptance test may be supplemented by a SAT following receipt of the equipment at the manufacturing site.
In Annex 15, FAT and SAT are listed before installation qualification (IQ), which includes verifying the correct installation of components, instrumentation, equipment, pipework and services against the engineering drawings and specifications, and operational qualification (OQ), which normally follows IQ and tests that the system operates as designed.
For PSA oxygen plants, UNDP's requirements (effective 1 January 2025) describe verification and acceptance tests under installation and commissioning: the supplier is responsible for testing the complete plant, including oxygen purity, flow rate, pressure, functionality and safety checks for alarms, emergency systems and operational parameters, with the results documented. The 2020 WHO interim specification for PSA plants (superseded by WHO's technical specifications of 31 December 2024) stated that conformity of the installation shall be verified by a certified third party, and the Global Fund commissioning guideline (28 August 2024) sets a minimum of 24 hours of uninterrupted running at the rated maximum flow, with purity above 90% at all times. See commissioning.
Sources
- European Commission, EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice, Annex 15: Qualification and Validation (30 March 2015), sections 3.7 to 3.11
- UNDP, REQ-OXY-001 v01, Technical and regulatory requirements for oxygen plants (effective 1 January 2025), section 7.4
- WHO, Technical specifications for PSA oxygen plants, interim guidance (8 June 2020)
- Global Fund / Build Health International, Overview: PSA Oxygen Plant Commissioning Guidelines (28 August 2024)
- WHO, Technical specifications for health facility based medical oxygen systems (31 December 2024), note on the oxygen generator plant specification (supersedes the 2020 interim PSA specifications)
Ultra Controlo figures come from its technical datasheets. Third-party facts were read at the source on the date shown.