Us Tech designs and builds ISO Class 5–8 cleanrooms for medical device, aerospace, and electronics OEMs operating maquiladoras in Tijuana. IQ/OQ/PQ validation and FDA 21 CFR 820 documentation included. 35+ years of binational cleanroom experience.
Every project starts with a process assessment to confirm the correct ISO class — avoiding over-engineering and its cost without compromising regulatory compliance.
Tijuana is not just cost-effective — it is the highest-density regulated manufacturing corridor in Mexico, with a 35-year track record of supplying FDA-regulated OEMs in the US market.
The San Ysidro and Otay Mesa crossings give your engineering team daily access to the facility. No overnight travel — Tijuana operates on Pacific Standard Time, same as your US office.
Fully-burdened direct labor in Tijuana runs 3–5× below comparable US markets. Under USMCA, qualifying medical device and electronics products ship to the US duty-free.
Tijuana has the deepest pool of trained cleanroom technicians and operators in Latin America — a direct result of 40+ years of medical device and electronics manufacturing concentration.
Us Tech has delivered cleanroom projects in Tijuana continuously since 1990. We understand dual-code compliance (NOM-001-SEDE + NEC 2023) and FDA audit documentation requirements.
Our IQ/OQ/PQ documentation package is structured to pass FDA 21 CFR Part 820 and ISO 13485 audits on first submission. Delivered as part of the project close-out package.
From engineering kickoff to final particle count certification for a standard 300–800 m² ISO Class 7 cleanroom — including IQ/OQ/PQ. Our Design-Build model compresses schedule by 20–30%.
Us Tech is a single-contract Design-Build firm. You deal with one engineering team, one project manager, and one accountability chain from kickoff to FDA documentation.
We review your product, process risk (ISO 14971), and URS before recommending a class. Preventing over-engineering saves $200K–$800K on a 500 m² project.
ISO 14971 · ISO 14644-1ACH calculation, pressure cascade design, Fan Filter Unit layout, AHU sizing with latent load compensation for Tijuana's coastal climate, and BMS integration for continuous ΔP monitoring.
ISO 14644-4 · ASHRAE 170Power for HVAC, FFUs, process equipment, clean lighting, GFI receptacles, and single-point grounding for ESD control. Dual-code: NOM-001-SEDE 2012 (Mexican regulatory) + NEC 2023 (US parent audits).
NOM-001-SEDE · NEC 2023Cleanroom panel systems, sealed penetrations, gowning room, airlocks, and clean utilities installation managed by our in-house construction team with full BIM coordination and daily progress reporting.
ISO 14644-4 · BIM ISO 19650Airflow and pressure balancing, HEPA filter integrity scan (aerosol photometer per IEST-RP-CC007), particle count certification per ISO 14644-1 Annex B in at-rest and in-operation states.
ISO 14644-1/2/3 · IEST-RP-CC007Complete Installation, Operational, and Performance Qualification protocols executed per FDA 21 CFR Part 820 and GAMP 5. Delivered as an FDA-audit-ready documentation package at project close-out.
FDA 21 CFR 820 · ISO 13485Our Design-Build model overlaps engineering and construction phases — cutting delivery time by 20–30% vs. the traditional sequential approach without compromising documentation quality.
Process review, ISO class confirmation, URS, preliminary layout and feasibility estimate.
HVAC, electrical, and structural engineering. BIM model, permit drawings for IMIP/STPS.
Panel systems, HVAC installation, electrical, clean utilities. Overlaps with engineering finalization.
Airflow balancing, HEPA integrity scan, pressure cascade verification, particle count certification.
Full validation protocol execution, FDA documentation package, preventive maintenance manual.
ISO Class 7 cleanroom for an orthopedic medical device OEM — including a dedicated ISO Class 8 gowning anteroom, HEPA plenum, DDC-controlled HVAC, dual NOM-001-SEDE + NEC 2023 electrical system, and full IQ/OQ/PQ documentation package. Zero observations at first FDA audit.
Send us an engineering brief — ISO class target, footprint, timeline, and regulatory requirements. A Senior Engineer will review and respond within 48 hours.
+52 664 666 8028 · +52 664 119 0814 · info@us-tech.com.mx