Controlled Environments
ISO 14644-1 · Class 1–9 · Turnkey
We design and build ISO 14644-1 cleanrooms (Class 1 to Class 9) as turnkey solutions.
In detail
The particle is the enemy. Classification is the answer. We design and build ISO 14644-1 cleanrooms — Class 1 to Class 9 — as turnkey solutions: structural envelope, HVAC design, HEPA/ULPA filtration, environmental monitoring and commissioning documentation aligned with ISO 14644-1:2015 (classification), -2:2015 (monitoring) and -4:2022 (design, construction and start-up).
Our projects range from single manufacturing cells to multipurpose facilities of over 5,000 m². We design for the operational life cycle, not just for initial certification. A classified room that loses its classification two years later is not a deliverable — it is a liability. Every Enforced room is built to stay classified.
Grade D to Grade A — every GMP class, every regulatory framework, one single project owner.
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MDR 2017/745, FDA QMSR, ISO 13485 — classified environments built to pass both the Notified Body and the FDA with the same documentation package.
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Live pathogens. Pharmaceutical GMP. Both in the same facility — solved by a single engineering team.
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Precision fermentation and cellular agriculture demand pharmaceutical-grade environmental controls. Most food-sector builders cannot deliver them.
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Manufacturing yield is a direct function of environmental control. Every design decision carries a production cost.
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EV components, ADAS sensors, power electronics — electrification created cleanroom requirements that conventional automotive facilities cannot meet.
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Flight-critical components. AS9100 quality system. The environment is where compliance takes physical form.
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Since 2022, surgical antiseptics fall under pharmaceutical GMP — not biocides. The facility requirement changed without many manufacturers getting adequate notice.
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Grade D to Grade A — every GMP class, every regulatory framework, one single project owner.
See more →Sectores aplicables
MDR 2017/745, FDA QMSR, ISO 13485 — classified environments built to pass both the Notified Body and the FDA with the same documentation package.
See more →Sectores aplicables
Live pathogens. Pharmaceutical GMP. Both in the same facility — solved by a single engineering team.
See more →Sectores aplicables
Precision fermentation and cellular agriculture demand pharmaceutical-grade environmental controls. Most food-sector builders cannot deliver them.
See more →Sectores aplicables
Manufacturing yield is a direct function of environmental control. Every design decision carries a production cost.
See more →Sectores aplicables
EV components, ADAS sensors, power electronics — electrification created cleanroom requirements that conventional automotive facilities cannot meet.
See more →Sectores aplicables
Flight-critical components. AS9100 quality system. The environment is where compliance takes physical form.
See more →Sectores aplicables
Since 2022, surgical antiseptics fall under pharmaceutical GMP — not biocides. The facility requirement changed without many manufacturers getting adequate notice.
See more →Sectores aplicables
Grade D to Grade A — every GMP class, every regulatory framework, one single project owner.
See more →Sectores aplicables
MDR 2017/745, FDA QMSR, ISO 13485 — classified environments built to pass both the Notified Body and the FDA with the same documentation package.
See more →Sectores aplicables
Live pathogens. Pharmaceutical GMP. Both in the same facility — solved by a single engineering team.
See more →Sectores aplicables
Precision fermentation and cellular agriculture demand pharmaceutical-grade environmental controls. Most food-sector builders cannot deliver them.
See more →Sectores aplicables
Manufacturing yield is a direct function of environmental control. Every design decision carries a production cost.
See more →Sectores aplicables
EV components, ADAS sensors, power electronics — electrification created cleanroom requirements that conventional automotive facilities cannot meet.
See more →Sectores aplicables
Flight-critical components. AS9100 quality system. The environment is where compliance takes physical form.
See more →Sectores aplicables
