Supports Good Manufacturing Practices
Entryway Protection
Independently validated contamination control for biotech, pharmaceutical and clean manufacturing. UV-C + Ozone delivers documented pathogen mitigation to key transition zones and critical areas.
Clean Manufacturing Applications
Critical contamination control for every stage of production
Airlock & Cleanroom Entry
Pharmaceutical Manufacturing
Manufacturing Facilities
Biosafety Labs (BSL 1-3)
Why Clean Manufacturing Companies Trust UVZone
Validated contamination control for clean manufacturing
Enhanced Audit and Contamination Control Programs
By targeting shoe-borne contamination, UVZone supports Current Good Manufacturing Practices (cGMP) and requirements for contamination control. UVZone provides a measurable, repeatable disinfection step that strengthens audit readiness and minimizes risk of non-compliance
Validated Efficacy
Independent laboratory testing confirms 3-5Log reduction of industry-relevant organisms.
Seamless Integration
UVZone is easily integrated into existing protocols, requires no additional staff or training and can be customized to fit your facility's needs.
Regulatory Compliance & Validation
Comprehensive documentation and support for pharmaceutical regulatory requirements
FDA Registration & Compliance
Patho3Gen UVZone systems are FDA-registered medical devices (Class II) and meet all requirements for use in pharmaceutical manufacturing environments. Our technology supports compliance with 21 CFR Part 211 (cGMP) and provides the documentation needed for regulatory submissions and inspections.
USP Standards Alignment
For compounding pharmacies, UVZone technology supports compliance with USP 797 (Sterile Compounding) and USP 800 (Hazardous Drugs) by providing validated contamination control at critical entry points. Our systems integrate seamlessly with existing cleanroom protocols and environmental monitoring programs.
Validation Support
Each UVZone installation includes comprehensive validation documentation: Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. We provide ongoing technical support for revalidation, change control, and regulatory audit preparation.
Enhance Your Contamination Control Strategy
Speak with our specialists about validation, compliance, and implementation