Scientific field testing
PLASMAIR validated under real operating conditions
From the first prototyping phase in a pharmaceutical cleanroom to TRL9 operational validation in a operating theatre. Results certified by third‑party bodies and presented at the CLIMA 2025 World Congress.
94%
Reduction in bacterial load — TRL7 (pharmaceutical)
87,7%
Reduction in bacterial load — TRL9 (surgical theatre)
50,3%
Reduction in particles ≥ 0.5 µm — TRL7
ISO 8→7
Improved environmental classification stability in Ce.Me.Di. operating theatre
Continuous environmental decontamination
The validation project
The 8 objectives of the technical protocol
The validation process was designed to demonstrate the effectiveness of PLASMAIR according to UNI EN ISO 14644 Annex 1, 2022, under real operating conditions.
1
Reduction of airborne bacterial and viral load
Deep reduction of bacterial and viral load, in accordance with ISO 14644 cleanroom classification criteria and EU GMP Annex 1 environmental-control requirements, with a strong decrease in suspended particles ≥ 0.5 µm.
2
Mixing efficiency and energy saving
Optimized recirculation and airflow mixing. The plasma process allows ventilation rates to be reduced while maintaining ISO 14644 class, achieving significant energy savings.
3
Air quality control in daily operations
Continuous air-quality monitoring during routine operation via networked digital sensors.
4
Monitoring of critical parameters in classified environments
Continuous monitoring of air quality, differential pressure and environmental parameters in ISO-classified environments using CO₂, ozone, pressure, humidity and temperature sensors.
5
Verification of material compatibility
Assessment of plasma compatibility with common materials used in controlled environments, accPre-commercial validation activities supporting CE marking compliance, according to the types of operations carried out in the environment.
6
Testing of the pre‑series prototype
Pre-commercial validation activities supporting CE marking compliance.
7
Verification of software and integrated control systems
Validation of software integration with environmental sensors, AHU dampers, presence detectors and access-control systems.
8
Comparison of parameters before and after
Comparison between baseline environmental parameters and measurements collected after 7 days of continuous plasma operation.
Validations
From TRL7 prototype to TRL9 field validation
A progressive validation pathway lasting over 6 years, with tests in real environments and independently verified results.
| Location | Before plasma | With plasma | ISO 8 limit |
|---|---|---|---|
| Point 1 | 15 cfu/4h | 3 cfu/4h | 50 cfu/4h |
| Point 2 | 1 cfu/4h | 1 cfu/4h | 50 cfu/4h |
| Point 3 | 16 cfu/4h | 1 cfu/4h | 50 cfu/4h |
| Point 4 | 16 cfu/4h | 0 cfu/4h | 50 cfu/4h |
| Point 6 | 25 cfu/4h | 1 cfu/4h | 50 cfu/4h |
| Average | 16 cfu/4h | 1 cfu/4h | -- |
First validation — Prototype level TRL 7
La Vetro Bergantino (MN) — ISO 8 pharmaceutical industrial cleanroom
Verification of biological stability
Geobacillus stearothermophilus
Biological spores (10²–10⁴) used as standard indicators in pharmaceutical production. No growth detected; biological stability confirmed in every session.
Latest validation — Prototype level TRL 9
Ce.Me.Di. Turin (Lifenet Group) — ISO 7 surgical theatre
Key result
Ce.Me.Di. Turin (Lifenet Group) — a standard surgical theatre — achieved ISO 8 environmental classification during continuous plasma operation under real operating conditions, alongside a significant reduction in airborne microbiological contamination. The improvement in environmental cleanliness classification was independently verified by a third-party laboratory.
| Point | CFU/m³ | EN17141 Class |
|---|---|---|
| 1 | 240 | ISO 10 |
| 2 | 280 | |
| 3 | 400 | |
| 4 | 240 | |
| 5 | 293 |
| Point | CFU/m³ | EN17141 Class |
|---|---|---|
| 1 | 40 | ISO 8 |
| 2 | 27 | |
| 3 | 13 | |
| 4 | 75 | |
| 5 | 24 |
1.
Up to 99.9% microbiological inactivation efficacy against bacteria, viruses and fungi in air and on exposed surfaces.
2.
Particulate reduction: aggregation and removal of ultrafine particles (PM0.5, PM1, PM2.5, PM5 and PM10) through plasma–particle interaction.
3.
4.
Ventilation optimisation: energy savings versus traditional systems while maintaining the same ISO classification.
5.
Duct decontamination: plasma reduces contamination within ducts and filters.
International recognition
CLIMA 2025 World Congress — REHVA 15th HVAC World Congress
“Cold plasma technology is a safe and effective solution for indoor air disinfection. The technology is suitable for integration into HVAC infrastructures of hospitals, laboratories and controlled environments.”
— Conclusions, CLIMA 2025 Poster ID 250301
TRL7 — Pharmaceutical
94%
Reduction of airborne bacterial load in ISO 8 industrial cleanroom. La Vetro Bergantino (MN)
TRL9 — Surgical theatre
87,7%
Reduction of bacterial load. Achieved ISO 8 airborne microbiological classification during plasma operatio.
Ce.Me.D. Turin. Third-party verified.
CLIMA 2025 — International
99,9%
Demonstrated efficacy against bacteria, viruses and fungi. Presented at CLIMA 2025 REHVA World Congress