A proven 5-stage turnkey methodology powered by 3D Building Information Modeling (BIM Level 2), aerodynamic CFD simulations, and rigorous GAMP 5 qualification.
Ensuring zero ambiguity, strict adherence to budget, and guaranteed compliance at first-pass validation.
Every successful cleanroom starts with a rigorous assessment of process requirements, contamination risks, personnel flows, and regulatory boundaries. We formulate an auditable User Requirement Specification (URS) and establish the architectural baseline.
Using cutting-edge Building Information Modeling (BIM Level 2) and Computational Fluid Dynamics (CFD), we design the architectural envelope, HVAC ductwork, ceiling grids, and piping in millimeter precision before fabrication.
Cleanroom components are precision-manufactured under factory-controlled conditions. On-site installation is carried out by certified cleanroom assemblers using non-particulate methods, slashing on-site construction time by up to 50%.
With the physical envelope sealed, our mechanical engineers install terminal HEPA/ULPA filters, calibrate airflow velocities, balance room pressure cascades, and tune precision climate controls to achieve stable steady-state conditions.
Our certified validation engineers conduct comprehensive qualification testing following GAMP 5 and ISO 14644 standards. We provide an audit-ready qualification dossier and hands-on staff training before final operational handover.