Clean Room
Controlled assembly for medical devices with contamination-sensitive requirements and compliant documentation.
Our cleanroom capabilities support assembly and packaging of components that require low particulate environments. We align gowning, handling, and inspection procedures with your device risk profile.
Material flow, dedicated tooling, and disciplined training maintain batch integrity while protecting sensitive surfaces. You receive clear records that simplify submissions and customer audits.
Cleanroom essentials
Practices that protect sensitive device builds
Environmental controls
Air quality monitoring and logs
Gowning discipline
Trained teams and audited routines
Material flow
Segregated zones to avoid cross-contamination
Inspection plans
Magnification and surface checks
Batch records
Full traceability per lot
Validated cleaning
Documented procedures and intervals
