Cleanroom and GMP Setup
Cleanroom and GMP environment setup means building the controlled spaces where supplements are made: air handling, particle control, finishes, gowning, and flow that meet EU GMP and ISO cleanroom standards. This is what keeps product safe and consistent, and it is built to the zoning agreed during facility design.
What the setup includes
A compliant clean environment is more than walls and a filter:
- Air handling (HVAC): filtration, pressure cascades, temperature and humidity control sized to the process.
- Classification: the right cleanroom grade for each step, set by the facility design and layout.
- Finishes and fixtures: cleanable, durable surfaces that suit GMP and stand up to regular sanitation.
- Gowning and flow: entry, gowning, and material routes that protect the clean zones.
Built to be proven
A cleanroom only counts once it is verified, so the environment is built to be validated. Air, pressures, and performance are checked through validation (IQ/OQ/PQ) and documented to support GMP certification.
How it fits the project
The cleanroom is built during the build-and-equip stage of a turnkey factory setup, alongside utilities and the equipment it houses.
Request a quote to discuss the cleanroom your products require.
Frequently asked questions
A cleanroom is a controlled space where airborne particles, temperature, and humidity are managed to limit contamination. Supplement and nutraceutical production needs controlled environments so products are safe, consistent, and GMP-compliant.
The right classification depends on the process and product. Different steps may need different grades, which is why zoning and classification are set during facility design and built into the cleanroom and HVAC.
Yes. Cleanrooms are built to recognised standards such as EU GMP and ISO cleanroom classifications, with the documentation needed to support validation and certification.
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