Controlled Environments
4–6 month deployment · Certified · Autonomous
GMP-certified autonomous capacity in 4 to 6 months, deployed without interrupting existing production.
In detail
GMP-certified capacity in 4 to 6 months. While conventional construction takes 14 to 18 months, a Biomodule is already producing. It deploys on an adjacent plot, operates autonomously and does not interrupt existing production lines. No construction impact on batches in progress. No regulatory downtime. No friction with the main facility.
The Biomodule is also an investment risk management tool: it validates the new line before committing permanent space. If the programme succeeds, the module is integrated as permanent capacity. If direction changes, the asset retains its value. For facilities with no room for physical expansion, it is the only route to greater certified capacity without halting production.
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.
See more →Sectores aplicables
EV components, ADAS sensors, power electronics — electrification created cleanroom requirements that conventional automotive facilities cannot meet.
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
EV components, ADAS sensors, power electronics — electrification created cleanroom requirements that conventional automotive facilities cannot meet.
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
EV components, ADAS sensors, power electronics — electrification created cleanroom requirements that conventional automotive facilities cannot meet.
See more →Sectores aplicables
