The complete guide CE 1639 · MDR Class IIb

PSA medical oxygen generators for hospitals: the complete guide.

How Pressure Swing Adsorption produces hospital-grade oxygen on site, why hospitals worldwide are switching from cylinders, and how to choose the right system for your facility. Engineered in Lisbon since 1981, deployed in 80+ countries.

ULTRAOX PSA medical oxygen generator by Ultra Controlo
Oxygen purity
95%
Oxygen 93 grade, EU + US Pharmacopoeia
Pipeline pressure
4–10bar
EN ISO 7396-1 hospital pipeline standard
Power per unit
7–10kW
Per 20 Nm³/h of oxygen output
Payback period
12–36mo
Typical capital recovery vs cylinders
Countries deployed
80+
Hospitals, ministries of health, NGOs
What is a PSA medical oxygen generator

Hospital oxygen, produced from the air at your facility.

For decades, hospitals depended on external oxygen supply chains: cylinders delivered by truck, liquid oxygen tanks refilled on schedule, and the constant anxiety of running out. Today, hospitals, ministries of health, and healthcare organisations worldwide are making a different choice. They produce their own medical oxygen on site, at the point of care, continuously and reliably, using Pressure Swing Adsorption technology.

PSA technology explained

From ambient air to medical-grade oxygen.

PSA stands for Pressure Swing Adsorption. It is a proven industrial and medical process that separates oxygen from the surrounding air. Unlike oxygen produced in a factory, bottled, and transported, a PSA system generates oxygen continuously from the air available at your location.

A PSA medical oxygen generator is a medical device that produces oxygen on site by passing compressed ambient air through twin-vessel zeolite molecular sieves. Nitrogen is selectively adsorbed; oxygen flows through and is delivered to the hospital pipeline at up to 95% purity.

Why this matters for hospitals

The entire process operates automatically, around the clock, without requiring the presence of an operator. Modern systems like the ULTRAOX include continuous gas monitoring, automated failover to a backup oxygen source if parameters drift outside specification, and remote diagnostics for real-time oversight. ULTRAOX was the first PSA oxygen production plant to be certified as a medical device under the European Directive.

Once installed, a PSA generator gives a hospital permanent supply chain independence. As long as the facility has electricity and air, it has oxygen.

PSA cycle · continuous oxygen output
Animated
N₂ +
O₂
Ambient air
Column A
Column B
O₂
95%
Adsorbing · producing oxygen
Regenerating · venting nitrogen
ULTRAOX PSA generator twin-tower configuration
Real ULTRAOX twin-tower PSA configuration
How PSA technology works

Four stages, one uninterrupted output.

The PSA process operates in continuous cycles measured in seconds. Two zeolite columns alternate between adsorption and regeneration so the supply to the hospital pipeline never stops.

WHO-recommended
01

Ambient air intake & oil-free compression

Filtered ambient air containing 21% oxygen, 78% nitrogen, and trace gases is drawn in and compressed by an oil-free compressor. The air is dried to remove moisture, oil vapour, and particulates. Oil-free compression is non-negotiable for medical oxygen.

Oil-free compression
02

Nitrogen adsorption in zeolite columns

Compressed air enters one of two columns filled with zeolite molecular sieve, a porous material that selectively adsorbs nitrogen molecules under pressure. Oxygen passes through to the buffer tank, reaching purity of up to 95%, exceeding pharmacopoeia minimums.

95% purity output
03

Regeneration cycle & continuous output

While one column produces oxygen, the other depressurises and vents nitrogen to atmosphere. The cycle alternates every few seconds, providing uninterrupted Oxygen 93 grade output to the EN ISO 7396-1 hospital pipeline. Output never stops, even during regeneration.

EN ISO 7396-1 ready
04

Continuous monitoring & auto-failover

Onboard sensors continuously track O₂ purity plus residual CO, CO₂, and water vapour levels. If any parameter drifts outside specification, the system automatically alarms and switches to the cylinder backup source. Zero operator intervention required for normal operation.

Auto-failover · zero operator
Why hospitals switch

Four reasons the world's hospitals are moving to on-site oxygen.

The shift toward on-site PSA oxygen generation is not a trend. It is a structural change in how healthcare systems think about critical medical infrastructure.

Reason 01

Supply chain independence

Every hospital relying on delivered oxygen is exposed to the same risks: supplier delays, transport disruptions, fuel volatility, and road infrastructure failures. During the COVID-19 pandemic, hospitals in dozens of countries ran out of oxygen. The cause was not lack of oxygen in the atmosphere. It was inability of supply chains to scale fast enough. Facilities with PSA generators kept operating.

100%
independence from external supply chains
Reason 02

Substantial long-term cost reduction

Cylinder and liquid oxygen carry high recurring costs: the gas itself, delivery charges, cylinder rental fees, handling, and labour. A PSA generator replaces almost all recurring costs with a single input: electricity. Capital investment is typically recovered within 12 to 36 months. Over a 10-year operational lifespan, savings often exceed 70 percent of equivalent cylinder supply cost.

12–36 mo
payback · up to 70% TCO savings over 10 years
Reason 03

Continuous, reliable supply

A well-designed PSA system operates 24 hours a day, 7 days a week, 365 days a year. Oxygen is produced on demand, matched to actual consumption. There is no risk of running low at the end of a delivery cycle, no weekend shortfalls, no emergency orders. Duplexed systems with two parallel production lines provide additional redundancy if one line requires maintenance.

24/7/365
on-demand oxygen production with auto-failover
Reason 04

WHO and international standards

The World Health Organisation recognises on-site PSA oxygen generation as appropriate for medical oxygen production in healthcare facilities. Certified systems holding ISO 13485, CE 1639, and MDR Class IIb satisfy requirements of most international procurement processes, including UN agency tenders and bilateral health programmes. ULTRAOX was the first PSA plant certified as a medical device under European Directive.

CE 1639
MDR Class IIb · ISO 13485 · WHO recommended
PSA vs LOX vs cylinders

Three ways to supply hospital oxygen, compared.

No single oxygen supply method is right for every facility. The correct choice depends on hospital size, supply chain reliability, electricity availability, and oxygen consumption volume.

Method 1
Cylinders
Bottled gas, delivered by truck
Method 2
Liquid Oxygen (LOX)
Cryogenic tank, refilled regularly
Supply chain dependency
High · daily/weekly deliveries
Medium · monthly deliveries
Capital cost (CAPEX)
Lowest · manifold only
Medium · tank + civil works
Running cost (OPEX)
Highest per Nm³
Medium-high
10-year TCO vs cylinders
Baseline (100%)
~50–70%
Continuity risk
High · depends on logistics
Medium · depends on supplier
Oxygen purity
99.5% medical grade
99.5% medical grade
Clinical equivalence
All clinical applications
All clinical applications
Best for
Small clinics, backup supply
Large urban hospitals with reliable suppliers
PSA economic threshold: Above 10 to 15 Nm³/hour of continuous demand, the running cost of PSA is substantially lower than either cylinder or LOX supply. Below this threshold, cylinders may remain more cost-effective. Ultra Controlo provides free pre-project sizing assessments for all enquiries.
ULTRAOX PSA medical oxygen generator
ULTRAOX® First medical-device PSA
The reference PSA generator

ULTRAOX. The PSA generator that set the medical-device standard.

ULTRAOX was the first PSA oxygen production plant certified as a medical device under the European Directive. Engineered and manufactured in Lisbon since 1981, deployed in hospitals, ministries of health, UN agencies, and NGO programmes across more than 80 countries.

Purity
Up to 95%
Oxygen 93 grade, EU + US Pharmacopoeia
Certification
CE 1639
MDR Class IIb · ISO 13485:2016
Flow range
5 to 1000 Nm³/h
Across SC, ST, and CO configurations
Pipeline
EN ISO 7396-1
4 to 10 bar outlet pressure
ULTRAOX containerised PSA generator deployed in cold-climate environment
ULTRAOX CO Containerised
Built for any environment

From Saharan deserts to Arctic snowfields.

The containerised ULTRAOX CO system is engineered for deployment in extreme operating conditions: high-altitude clinics, desert hospitals, tropical humidity, and below-freezing latitudes. Pre-assembled, factory-tested, and ready in 24 to 72 hours.

Operating range
−20°C to +50°C
Deploy time
24 to 72 hours
Infrastructure
Self-contained
Form factor
20 ft / 40 ft container
Inside the system

Engineered to medical-device standards. Built to last.

Every ULTRAOX is assembled in our Lisbon facility under ISO 13485:2016 quality control. Oil-free compressors, premium zeolite molecular sieves, redundant gas analysers, and continuous monitoring systems all integrated into a single CE 1639 certified medical device.

  • Oil-free compression Mandatory for medical oxygen. No hydrocarbon contamination at any stage of production.
  • Premium zeolite molecular sieves Long-life adsorbent material engineered for continuous duty cycles and high purity output.
  • Redundant gas analysers Continuous monitoring of O₂ purity, residual moisture, CO and CO₂. Auto-failover on out-of-spec.
  • Remote diagnostics ready Optional remote telemetry for predictive maintenance and 24/7 oversight by Ultra Controlo engineers.
ULTRAOX PSA medical oxygen generator close-up detail
Real-world deployments

ULTRAOX in service. Hospitals on five continents.

Real PSA oxygen plants delivered, commissioned, and supported by Ultra Controlo. Ministries of health, UN agencies, the Global Fund, and NGO partners across Africa, the Middle East, and Latin America.

CV
2024
Cabo Verde · Praia

Hospital Agostinho Neto regional referral hospital

A ULTRAOX ST PSA generator with redundant compression and dual-tower production serves a 220-bed regional referral hospital across the Sotavento islands. Twin-tower configuration ensures continuous supply during maintenance windows.

Beds
220
Configuration
ULTRAOX ST
Ministry of Health partnership
ML
2026
Mali · Bamako + Kayes

Two ULTRAOX duplex plants commissioned by the Minister of Health

A ULTRAOX duplex PSA system at Hôpital Dermatologie de Bamako and a Ministerial inauguration of an ULTRAOX in Kayes by Colonel Major Dr Assa Badiallo Touré. National oxygen production capacity strengthened across two regions.

Plants
2 duplex
Inauguration
Ministerial
Ministry of Health Mali
YE
2025
Yemen · Zabeed

Zabeed General Hospital ULTRAOX 180D ST

A high-capacity ULTRAOX 180D ST with 2×ULTRASCREW 37 VSD PM oil-free compressors and 2×ULTRACON 10 PSA modules. Designed for high-demand regional hospital operations under challenging supply conditions.

Capacity
180 Nm³/h
Compressors
2×37 kW VSD
Humanitarian deployment
AO
2026
Angola · Benguela

UNDP and Global Fund national programme

Inauguration of ULTRAOX at Hospital de Benguela under a national UNDP and Global Fund programme covering up to 8 hospitals nationwide. Complete supply, installation, training, and lifecycle support across regional facilities.

Hospitals
Up to 8
Donor
UNDP + GF
UNDP · Global Fund
PE
Active
Peru · High-altitude Andes

Andean clinic high-altitude PSA installation

An ULTRAOX system operating at high altitude in the Peruvian Andes, supplying critical care services to remote mountain populations. Demonstrates ULTRAOX viability across extreme operating environments and altitudes.

Environment
Andean
Altitude
High
Latin America deployment
BD
2024
Bangladesh

ULTRAAR ME 2.60/1000 medical air plant

Companion ULTRAAR ME 2.60/1000 UD DS 4G PO medical air plant with 2×ULTRASCREW 7 FSD compressors, 1000L receiver, and full ULTRADRY treatment chain. Demonstrates Ultra Controlo's complete medical gas pipeline capability.

Capacity
2×52 Nm³/h
Pressure
10 bar max
Hospital procurement
Sizing & specification

How to size a PSA oxygen system for your hospital.

Choosing the right PSA system requires understanding your facility's actual and projected oxygen demand. Five factors determine the appropriate system size.

Ultra Controlo's engineering team provides free pre-project site assessments and system sizing consultations as part of every project enquiry.

Request free sizing assessment
01

Peak flow rate, not average

Medical oxygen systems must be sized for peak demand, not average demand. Peak typically occurs in the ICU, operating theatres, and emergency departments simultaneously. A system sized only for average consumption will be insufficient during high-demand events.

02

Active beds and clinical specialisms

General ward beds typically consume less oxygen per hour than ICU or surgical beds. A hospital with 10 ICU beds may consume more oxygen than one with 50 general ward beds. Specialty mix affects total demand significantly.

03

Pipeline pressure requirements

Hospital pipeline systems typically operate at 4 bar. The PSA system must maintain this pressure at peak flow continuously. ULTRAOX outlet pressure spans 4 to 10 bar across all configurations to suit varied pipeline standards.

04

Backup and redundancy requirements

Regulatory requirements and clinical risk assessments often mandate a backup oxygen source: either a cylinder manifold or a second PSA production line, to cover maintenance periods and system faults. Duplex configurations provide built-in redundancy.

05

Growth projections

A system sized only for current demand may be insufficient within 3 to 5 years. Modular systems, where additional production capacity can be added as demand grows, are preferable for facilities undergoing expansion. ULTRAOX modular design supports incremental capacity growth.

Standards & certification

The compliance stack required for hospital oxygen.

A hospital PSA oxygen generator must satisfy multiple international standards. ULTRAOX holds the complete medical-device compliance stack.

CE 1639

MDR (EU) 2017/745 Class IIb

Medical device certification under the European Medical Device Regulation. Required for hospital oxygen generators sold or operated in the EU and aligned markets.

ISO 13485:2016

Manufacturer quality system

Quality management system certification for medical device manufacturers. Governs design, production, and post-market surveillance processes throughout the device lifecycle.

EN ISO 7396-1

Medical gas pipeline systems

European standard for medical gas pipeline systems. Specifies design, installation, function, performance, documentation, testing, and commissioning of compressed medical gas pipelines.

Oxygen 93

EU + US Pharmacopoeia

Pharmacopoeia grade designation for medical oxygen produced by PSA. Both European Pharmacopoeia and US Pharmacopeia specify minimum 93% purity (±3%) for clinical use.

Frequently asked questions

Common questions about PSA oxygen for hospitals.

Answers from our engineering team to the questions hospital procurement, biomedical engineers, and ministries of health most often ask.

What is a PSA medical oxygen generator?

A PSA (Pressure Swing Adsorption) medical oxygen generator is a medical device that produces oxygen continuously from ambient air at the point of care. It separates oxygen from nitrogen using zeolite molecular sieves under alternating pressure cycles, delivering up to 95% pure oxygen directly to the hospital pipeline.

ULTRAOX was the first PSA oxygen plant certified as a medical device under the European Directive.

Can PSA oxygen be used for all clinical applications, including intensive care and surgery?

Yes. PSA-generated oxygen meeting pharmacopoeia purity standards (Oxygen 93, minimum 93% O₂) is clinically equivalent to cylinder or liquid oxygen and is appropriate for all hospital applications, including:

Mechanical ventilation, anaesthesia, neonatal care, hyperbaric oxygen therapy, surgical theatres, ICU bedside delivery, and emergency resuscitation.

How long does it take to install a PSA oxygen system?

Installation timelines vary by facility:

Indoor installation (ULTRAOX SC or ST) in a prepared technical room can be commissioned within 2 to 4 weeks of equipment arrival.

Containerised installation (ULTRAOX CO) can be operational in 24 to 72 hours, as systems arrive pre-assembled and require only utility connections.

What are the electricity requirements for a PSA oxygen generator?

Power consumption depends on production capacity. As a general reference, a system producing 20 Nm³/hour of oxygen typically consumes approximately 7 to 10 kW.

Ultra Controlo provides precise power specifications during the site assessment phase and offers UltraGreen renewable-energy compatibility for solar-powered or hybrid installations.

What maintenance does a PSA system require?

A well-designed PSA system requires periodic preventive maintenance every 6 to 12 months. This covers filter replacement, zeolite sieve inspection, compressor servicing, and calibration of the monitoring system.

Ultra Controlo's UltraCare programme provides scheduled preventive maintenance, corrective maintenance on demand, 24/7 international technical support, and a genuine spare parts service.

Is PSA oxygen generation approved by the WHO?

Yes. The World Health Organisation recommends on-site PSA oxygen generation as an appropriate method for producing medical oxygen in healthcare facilities, particularly in low- and middle-income countries.

WHO technical specifications for PSA oxygen generators are publicly available and consistent with the design parameters of certified systems like ULTRAOX.

What certifications should a hospital PSA oxygen generator have?

A hospital PSA oxygen generator must hold:

CE marking under MDR (EU) 2017/745 as a Class IIb medical device. ISO 13485:2016 quality system certification for the manufacturer. Oxygen output compliant with EN ISO 7396-1 pipeline standards. Pharmacopoeia (Oxygen 93) purity grade.

ULTRAOX is certified CE 1639 under MDR Class IIb.

How does PSA compare to liquid oxygen (LOX) for hospitals?

PSA generation produces oxygen on-site continuously from ambient air, eliminating delivery dependencies. LOX requires regular tanker deliveries from specialist suppliers and cold storage infrastructure.

PSA is typically more cost-effective above 10 to 15 Nm³/hour continuous demand and provides supply chain independence. LOX may suit very large urban hospitals with reliable supplier access and high daily oxygen consumption.

Can the system operate in hot climates or remote locations?

Yes. The containerised ULTRAOX CO system is specifically designed for deployment in extreme environments, including:

Deserts, tropical climates, high-altitude locations, coastal humidity, and sites with no existing technical infrastructure. ULTRAOX systems are operating in environments ranging from the Sahara to coastal Cabo Verde to high-altitude Andean clinics.

What is the typical payback period for a PSA oxygen generator?

The capital investment in a PSA system is typically recovered within 12 to 36 months, depending on the facility's oxygen consumption and the local cost of cylinder supply.

Over a 10-year operational lifespan, savings often exceed 70 percent of the equivalent cylinder supply cost.

What oxygen purity does ULTRAOX produce?

ULTRAOX consistently delivers oxygen at up to 95% purity, exceeding the minimum 93% purity required by both European Pharmacopoeia and United States Pharmacopeia for medical oxygen produced by PSA methods (Oxygen 93 grade).

Where is ULTRAOX manufactured and deployed?

ULTRAOX is engineered and manufactured in Lisbon, Portugal by Ultra Controlo since 1981.

The systems are deployed in hospitals, ministries of health, UN agencies, and NGO programmes across more than 80 countries, including Cabo Verde, Mali, Angola, Yemen, Peru, Bangladesh, and many others across Africa, the Middle East, Latin America, and Southeast Asia.

Request a project assessment

Ready to discuss oxygen for your hospital?

Ultra Controlo provides free project assessments, system sizing consultations, and technical support throughout the procurement and installation process. Our engineering team in Lisbon is available to discuss your facility, your timeline, and your compliance requirements.

CE 1639
MDR Class IIb
ISO 13485:2016
80+ countries
Since 1981