Gene Therapy Manufacturing Cleanroom Flooring
Cincinnati Children's Hospital
- Industries: Healthcare, Pharmaceutical
- Services: Industrial Epoxy Flooring, Joint Filling & Repair, Urethane Concrete
Healthcare Facility Industrial Flooring
When Cincinnati Children’s Hospital needed to retrofit their gene therapy manufacturing facility with new mechanical systems, they faced a critical challenge: installing 28,000 SF of GMP-compliant flooring that would create a seamless, monolithic surface over extensively cut and patched concrete slabs, all while maintaining ISO Class 7 cleanroom standards essential for pharmaceutical manufacturing.
The Challenge
The project involved a facility with existing structural conditions requiring extensive concrete slab cutting to accommodate new underground mechanical systems. The primary requirement was a monolithic, seamless floor that would not “telegraph” — meaning the cuts, patches, and transitions between new and old concrete sections could not be visible or create surface irregularities.
Regulatory Requirements
The flooring system needed to support ISO Class 7 cleanroom certification. This certification requires surfaces that are:
- Non-porous
- Non-particle-shedding
- Capable of withstanding aggressive cleaning protocols, including disinfectants and sanitizing agents used in pharmaceutical production.
Hardig's Approach
Hardig provided a 28,000 SF resinous flooring solution engineered specifically for pharmaceutical manufacturing requirements:
Clean Rooms: 12,000 SF of Urethane Concrete
Urethane concrete was selected for the cleanroom areas because of its superior chemical resistance, impact durability, and ability to withstand thermal shock from cleaning protocols.
Support Spaces: 10,000 SF of Epoxy Slurry
Support areas received broadcast epoxy slurry systems. This solution provides the seamless, easily sanitizable surface required for controlled environments while offering excellent abrasion resistance for high-traffic zones.
Mechanical Equipment Rooms: 6,000 SF of Waterproofing
Mechanical spaces received specialized waterproofing systems to protect against condensation, chemical spills, and equipment leaks that could compromise the structural slab and migrate contaminants into cleanroom areas.
Crack Bridging Technology
To directly address the telegraphing challenge, Hardig's installation incorporated crack and joint bridging membranes reinforced with fiberglass matting at every cut line and transition point. The result is a truly monolithic appearance that conceals all substrate irregularities while preventing future crack propagation.
The Results
The flooring system successfully met all project goals and regulatory requirements for Cincinnati Children’s gene therapy facility. It achieved:
- ISO Class 7 Certification with a flawless cleanroom certification, requiring no remediation.
- Despite continuous 24/7 operations, aggressive daily pharmaceutical cleaning, and thermal cycling, the floor shows zero cracking or telegraphing, maintaining a seamless, monolithic appearance.
- Hardig completed the installation on time, allowing the facility to meet its accelerated schedule for equipment validation and FDA inspections
- Ultimately led to FDA approval to begin manufacturing gene therapies for pediatric patients.
Project Specifications
- Industry: Pharmaceutical Manufacturing/Gene Therapy
- Client: Cincinnati Children's Hospital Medical Center
- Location: Cincinnati, Ohio
- Total Square Footage: 28,000 SF
- ISO Classification: Class 7 Cleanrooms
- Project Timeline: 8-week accelerated schedule
- Systems Installed: Urethane Concrete (12,000 SF), Epoxy Slurry (10,000 SF), Waterproofing Membranes (6,000 SF)
- Special Requirements: GMP compliance, crack bridging over cut sections, multi-trade coordination, occupied facility constraints
- Performance Standards: Chemical resistance, thermal shock resistance, non-particle-shedding, seamless/monolithic appearance
Ready to Discuss Your Pharmaceutical Flooring Project?
Planning a pharmaceutical manufacturing facility, research laboratory, or hospital cleanroom? Hardig’s specialized resinous flooring systems meet the most stringent regulatory requirements while delivering the durability and performance your operations demand.