MetalCore operates fully integrated ISO 14644-compliant cleanrooms engineered for sterile assembly, precision machining, and contamination-controlled manufacturing across medical, aerospace, and electronics sectors.
Modern medical devices, aerospace components, and advanced electronics require manufacturing environments where airborne particulates, microbial counts, and static discharge are strictly controlled. MetalCore's cleanroom facility is designed to meet these rigorous demands without compromising throughput or precision.
Our controlled environments feature HEPA/ULPA filtration, positive pressure cascades, strict gowning protocols, and continuous environmental monitoring. Every component produced undergoes documented traceability from raw material to final inspection. This ensures compliance with FDA, ISO, and AS standards while delivering defect-free assemblies.
Our modular cleanroom infrastructure supports multiple ISO classifications, allowing us to match environmental controls to your specific application requirements.
| ISO Class | Max Particles ≥0.5μm | Max Particles ≥5μm | Typical Applications |
|---|---|---|---|
| ISO 5 (Class 100) | 3,520 / m³ | 29 / m³ | Sterile device assembly, implant packaging, optical lenses |
| ISO 6 (Class 1,000) | 35,200 / m³ | 293 / m³ | Electronics assembly, precision sensor calibration |
| ISO 7 (Class 10,000) | 352,000 / m³ | 2,930 / m³ | Medical component machining, aerospace sub-assemblies |
| ISO 8 (Class 100,000) | 3,520,000 / m³ | 29,300 / m³ | Raw material prep, general clean packaging, final QA |
From precision machining to final sterile packaging, our controlled environments support the complete lifecycle of contamination-sensitive components.
5-axis machining within ISO 7 environments for titanium, stainless steel, and medical-grade polymers with zero particulate cross-contamination.
Manual and automated assembly in ISO 5 workstations with ESD controls, torque documentation, and serialized batch tracking.
Non-contact optical inspection, CMM verification, and functional testing performed in particle-controlled zones to prevent post-process contamination.
Blister packing, pouch sealing, and vacuum packaging using ISO Class 5 laminar flow hoods. Full gamma/EO compatibility available.
Continuous HVAC monitoring, positive pressure differentials, humidity regulation (40-60% RH), and temperature stabilization ±1°C.
Complete lot traceability, environmental monitoring reports, material certs, and batch records aligned with FDA 21 CFR Part 11 standards.
Our quality management systems and facility certifications ensure every cleanroom process meets or exceeds global regulatory requirements.
Quality Management Systems
Medical Device Quality Standards
Aerospace Manufacturing Compliance
Cleanroom Classification & Testing
Quality System Regulation
Electrostatic Discharge Protection
Sterile Manufacturing Guidelines
Defense & Aerospace Export Controls
Share your technical specifications, cleanroom class requirements, and production volumes. Our engineering team will respond within 24 hours with a detailed capability assessment and competitive quote.