Medical-grade HEPA filtration, engineered to a sub-detectable threshold.
EcoMedPollutec designs, certifies and maintains hospital and cleanroom pollution-control systems built to ISO 14644-1, ISO 13485 and EN 1822-1:2019 — backed by 4.7 billion sensor readings logged across 312 live facilities in 2024.
Response within 4 business hours · NDA available on first contact · No-obligation site assessment.
- ISO 14644-1
- ISO 13485
- EN 1822-1:2019
- ISPE Member
Eighteen years of installed evidence, in six numbers.
Every figure below is taken from active EcoMedPollutec deployments — production telemetry, audit logs or rolling 5-year retention cohorts. No projections.
- 01 1,412 healthcare facilities commissioned across 34 countries since 2007
- 02 96.4% client retention rolling 5-year cohort, audited annually
- 03 98.6% avg. particulate reduction across 1,400+ commissioned healthcare sites
- 04 11 days to certification average on-site turnaround · 4.3× EMEA median
- 05 4.7B sensor readings / 2024 across 312 PollutecSense™-monitored hospitals
- 06 42 consecutive months zero Class-A cleanroom breach events — pharma accounts
The only EU-headquartered firm holding this triple certification, active simultaneously.
Three ISO and EN frameworks, independently audited, valid across hospital, pharmaceutical and biomedical tender submissions in the EU, MENA and Latin America.
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01
ISO 14644-1
Cleanroom & Associated Controlled Environments
Class 1 through Class 9 air cleanliness classification by particle concentration. The governing standard for operating-theatre, ICU and compounding-pharmacy air handling.
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02
ISO 13485
Medical Devices — Quality Management Systems
Mandatory Quality Management System for designers and installers of medical-device-adjacent environment control systems. Required for EU MDR-aligned tender submissions.
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03
EN 1822-1:2019
High-Efficiency Air Filters (EPA, HEPA & ULPA)
European classification and testing methodology for HEPA-grade filter media — from H10 through U17 — with full in-situ scan-test record for every commissioned installation.
Four systems a hospital or pharma site can audit against.
Each module ships with a documented commissioning protocol, a PollutecSense™ monitoring point registry, and an independent third-party validation report. Pick the module that maps to your facility gap.
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01
Air
Operating-theatre & isolation-ward HEPA air handling
Negative / positive pressure cascades, H14 in-line filtration, room-to-room particulate mapping. Sized for ISO Class 5 compartments with full BMS integration.
- Typical lead time · 9–14 weeks
- Re-cert cadence · every 12 months
- Reference class · 312 live sites
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02
Water
Hemodialysis, endoscope & compounding water purification
Multi-barrier RO + UV + sub-micron loops for renal, sterile-services and pharmacy-grade water, with online TOC and endotoxin telemetry at the point of use.
- Output spec · Ph. Eur. & AAMI
- Loop telemetry · 4-second poll
- Validation · EP / USP aligned
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03
Cleanroom
Pharmaceutical & biomedical Class-A cleanroom envelopes
Aseptic-suite build, retrofitted envelope upgrades, and 42-month breach-free operation across every active Class-A pharmaceutical account on our books.
- Cleanliness · ISO Class 5 / GMP A
- Breach record · 42 mo. at zero
- Engineers on staff · 42 licensed
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04
Telemetry
PollutecSense™ contamination monitoring & alerting
Continuous, audit-grade telemetry for particulate, differential pressure, microbial air and water-quality signals — surfaced to facilities and infection-control teams.
- Sites monitored · 312 hospitals
- Readings · 4.7B / 2024
- Uptime · 99.94% (12 mo)
What real-time contamination telemetry looks like inside a 312-hospital deployment.
PollutecSense™ is the proprietary monitoring fabric underneath every EcoMedPollutec installation. Every HEPA-filtered room, every water-loop point-of-use, every cleanroom envelope ships with a hardened sensor node and a documented integration into the facility's BMS.
- Particulate · PM0.3 & PM10 4-second poll, 60-second buffer
- Differential pressure · room cascades 5-second poll, alert on ±2 Pa deviation
- Microbial air · active & passive sampling Hourly settle plates, daily active impinger
- Water TOC & endotoxin at point of use Continuous, alert on USP & EP thresholds
- Filter ΔP · HEPA load curve 1-minute poll, predictive replacement at 80%
- Door / pass-box events & access audit Event-driven, full OPC-UA log
Six facility types where medical-grade pollution control is non-negotiable.
If your site handles immunocompromised patients, aseptic compounding, sterile processing, or live biological research — sub-detectable thresholds are the operating requirement, not the aspiration.
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A
Hospitals & tertiary care
Operating theatres, ICUs, neonatal units, transplant wards and isolation suites. Cascade-pressure air handling, H14 HEPA, negative-pressure isolation rooms.
638 active installations -
B
Pharmaceutical manufacturing
GMP-aligned Class-A aseptic suites, BSL-2 / BSL-3 enclosures, fill-finish lines and 42-month breach-free operation across every active pharma account.
241 active accounts -
C
Outpatient clinics & dental surgical centres
Procedure-room HEPA retrofits, instrument-sterilisation airflow, dental aerosol containment and per-chair commissioning with documented validation reports.
312 active sites -
D
Veterinary & biomedical research
Vivarium air handling, BSL-3 vivarium envelopes, necropsy suites and animal-holding cascade pressure with full telemetry integration to institutional IACUC systems.
117 active facilities -
E
Medical-device manufacturing
ISO Class 7 / 8 cleanroom buildouts, sterilisation-room envelopes and packaging-line contamination control for Class IIa through Class III device manufacturers.
68 active sites -
F
Municipal & public-health laboratories
Diagnostic-air handling for national reference labs, BSL-3 containment envelopes, and WHO Eastern Mediterranean Regional Office airborne-infection-prevention project sites.
36 active sites · since 2019
Don't see your facility type? Most complex hospital and research environments are unusual by design. We'll audit against your local regulatory framework.
Request a Compliance Audit