New GMP Facility Construction
Ground-up plants built to FDA cGMP from day one.
FDA/GMP design-build
W SUN Construction is a Southern California design-build general contractor specializing in FDA/GMP-compliant manufacturing facilities. We take your plant from concept to a commissioned, certified, audit-ready building — on time and on budget.
Capabilities
One team coordinates the building, cleanroom, mechanical systems, and turnover package.
Ground-up plants built to FDA cGMP from day one.
ISO Class 5–8 controlled environments, engineered and built by one team.
Grow inside your operating plant without shutting it down.
In-house mechanical: the air system your classification depends on.
IQ/OQ/PQ documentation and certification, ready for inspectors.
We fix the 483 findings — and build so the next one never happens.
Why W SUN
A general contractor built around regulated manufacturing, with the disciplines that determine whether the facility performs.
Built for production. Engineered for inspection. Ready for what comes next.
Industries served
Each project starts with the process, the governing standard, and the inspection path.
Sanitary, washdown-ready plants built to 21 CFR Part 117.
Facilities that meet 21 CFR Part 111 from slab to ceiling.
ISO-classified cGMP environments, sterile to non-sterile.
Animal-food plants built to 21 CFR Part 507 and state feed standards.
Hygienic GMP facilities aligned with ISO 22716.
ISO Class 8 controlled environments with ASHRAE-grade contamination control.
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How we deliver
The same team carries the operating requirements from first concept through validated turnover.
We map your product, process, and regulations to a facility concept and a real budget.
GMP zoning, classifications, and airflow engineered before construction starts.
Cleanroom and MEP construction with contamination-controlled sequencing.
IQ/OQ/PQ, certification, and an audit-ready turnover package.
Requalification and maintenance that protect your validated state.
The W SUN approach
We start with product flow, people flow, sanitation, utilities, pressure relationships, and the inspection path. Then we coordinate the facility around those requirements.
Tell us what you make, where you are, and what the facility must achieve.
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