Air filtration, water pollution control, cleanroom certification, and remote monitoring — each scoped to a governing ISO or EN reference, delivered by 42 in-house clinical engineers, and mapped to the measurable output a procurement officer can evaluate.
Response within 4 business hours · Audit scoped against ISO 14644-1, ISO 13485, and EN 1822-1:2019
Engineered clean-air envelopes for surgical suites, isolation rooms, compounding pharmacies, and ICU isolation bays. Each installation is commissioned against a class declared in the scope document, not estimated post-hoc.
H13 / H14 ceiling-mounted and inline housings for operating theatres, transplant units, and negative-pressure isolation. Sealed gasket assemblies, in-situ scan-tested per EN 1822-1:2019 Annex A.
U15 / U16 terminal stages for pharmaceutical compounding and BMT cleanroom envelopes. Aluminium separators, polyurethane gaskets, scan-certificate per filter.
Single-pass cascade pressure architecture for airborne infection isolation. Cascaded magnehelic gauges, sealed-room pressure verification, and 12-Pa differential benchmarked to NF S90-351 zone 4.
Operating-theatre envelope, 11 m × 7 m × 3.2 m clear height. Three-stage filtration retrofit with H14 terminal stage and sealed housing conversion.
| Parameter | Pre-retrofit | Post-retrofit |
|---|---|---|
| ISO 14644-1 class | ISO 7 | ISO 5 |
| Particulate @ ≥0.5 µm | 352,000 / m³ | 1,890 / m³ |
| Airborne CFU / m³ | 18 | < 1 |
| ACH | 15 | 28 |
Closed-loop distribution, real-time conductivity monitoring, and microbiological control loops for pharmacy, dialysis, CSSD, and laboratory service lines. Each loop is sized to the demand profile and validated against the relevant pharmacopeial monograph.
RO + EDI skid assemblies, sanitary 316L ring-main distribution, continuous conductivity / TOC telemetry integrated to PollutecSense™.
Double-pass RO + ultrafiltration for compounding and final-rinse applications. Continuous microbiological trending with growth-based and rapid methods in parallel.
36-bed haemodialysis suite, ISO 23500-compliant feed water retrofit, two-stage RO + ultrafilters.
| Parameter | Pre | Post |
|---|---|---|
| Conductivity | 8.4 µS/cm | 0.9 µS/cm |
| Total chlorine | 0.42 mg/L | < 0.02 mg/L |
| HPC / 100 mL | 340 | 7 |
| Endotoxin EU/mL | 0.86 | < 0.03 |
GMP and clinical-environment validation delivered on-site in an average of 11 days — 4.3× faster than the EMEA industry median, per our internal 2024 cohort. Documentation is issued against ISO 14644-3 and the relevant annexes, not internal proprietary templates.
Particle count, air pressure differential, airflow velocity, temperature / RH mapping, and recovery testing across full classified zones. Reports bound and indexed for audit reuse.
Building-management hookup for differential pressure, particle counters, and damper actuators. Sequence-of-operation reviewed and signed off by a licensed clinical engineer before handover.
Across every pharmaceutical compounding account under management, no class-A cleanroom breach event has been recorded since February 2022. The figure is reported in our quarterly compliance brief, not in marketing collateral, and is independently auditable.
Cross-reference table for procurement, QA, and infection-control leads evaluating scope against internal regulatory binders. EcoMedPollutec is the only EU-headquartered firm simultaneously holding ISO 14644-1, ISO 13485, and EN 1822-1:2019 triple certification for medical filtration installations.
| Module | Primary standard | Companion reference | Typical timeline | Recertification |
|---|---|---|---|---|
| Air Filtration · HEPA | EN 1822-1:2019 | ISO 14644-1 · NF S90-351 | 6 – 9 weeks | Annual in-situ scan |
| Air Filtration · ULPA | EN 1822-1:2019 (U15/U16) | ISO 14644-4 · GMP Annex 1 | 8 – 12 weeks | 6-month integrity test |
| Water · Purified | Ph. Eur. · USP <1230> | ISO 22519 · EP 4.1.4 | 8 – 11 weeks | Quarterly sanitisation |
| Water · Highly purified | Ph. Eur. · USP <1230> | EP 4.1.4 · ISO 23500 | 10 – 14 weeks | Monthly microbiological |
| Cleanroom Certification | ISO 14644-3:2005 | GMP Annex 1 · WHO TRS 961 | 11 days on-site | Annual (Class ≥5) |
| PollutecSense™ Monitoring | ISO 14644-2 · ISO 16000 | EN 16798 · IEC 62443 | Live · 99.94% uptime | Continuous, audited |
Send your current ISO/EN scope document and we will return a compliance gap matrix within four business hours, free of charge and without obligation.
