Pharmaceutical-Grade
Contamination Control
Maintain cleanroom integrity with continuous footwear and equipment disinfection
Pharmaceutical Applications
Critical contamination control for every stage of pharmaceutical production
Airlock Clean Rooms
Prevent particulate and microbial contamination at ISO-rated cleanroom entry points
Compound Pharmacies
Ensure sterile compounding environments with automated disinfection protocols
Manufacturing Facilities
Protect production lines from cross-contamination in GMP-compliant facilities
Why Pharmaceutical Companies Trust UVZone
Validated contamination control for GMP-compliant pharmaceutical manufacturing
GMP Compliance
UVZone technology meets FDA Good Manufacturing Practice requirements for contamination control. Our systems provide documented, validated disinfection that supports regulatory compliance and audit readiness. Installation at cleanroom airlocks creates a critical control point that prevents environmental contamination from compromising sterile manufacturing processes.
Validated Efficacy
Independent laboratory testing confirms 99.9993% reduction of pharmaceutical-relevant organisms including Bacillus spores, Aspergillus, and Pseudomonas. Our validation protocols align with USP standards and provide the documentation needed for regulatory submissions. Each system includes performance qualification testing and ongoing monitoring capabilities.
Cleanroom Protection
Footwear is the primary vector for particulate and microbial contamination in cleanrooms. UVZone systems installed at gowning room exits provide a final barrier before personnel enter controlled environments. The technology eliminates the need for disposable shoe covers while providing superior contamination control and reducing operational costs.
Pharmaceutical Success Stories
Real results from pharmaceutical manufacturing and compounding facilities
Sterile Injectable Manufacturing Plant
Zero contamination events at cleanroom entry points since UVZone installation (24 months)
85% reduction in shoe cover consumption, saving $47,000 annually
Passed FDA inspection with commendation for innovative contamination control
"UVZone has become an integral part of our contamination control strategy. The validation data gives us confidence, and the automated operation ensures consistent performance across all shifts."
— Quality Assurance Director
Compounding Pharmacy Network
USP 797/800 compliance maintained across 12 locations with standardized UVZone protocol
Improved environmental monitoring results with 92% reduction in viable organisms
Staff satisfaction increased with simplified gowning procedures and faster room entry
"Implementing UVZone across our network has standardized our contamination control and simplified our compliance documentation. It's a technology that just works."
— VP of Operations
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 pharmaceutical specialists about validation, compliance, and implementation
Pharmaceutical Team: 1-800-UVZONE-2