Pharmaceutical Manufacturing Wall Systems
Cincinnati Pharmaceutical Manufacturing Facility
- Industries: Pharmaceutical
- Services: Hygienic Epoxy Wall Systems, Urethane Concrete
Solving Cleanroom Wall Compliance Issues in FDA cGMP Facilities
When a pharmaceutical manufacturing facility in Cincinnati needed to upgrade approximately 1,200 SF of manufacturing suite walls that were failing cleanroom certification requirements, they faced a critical challenge: the existing concrete block construction with grout lines created sanitation issues and prevented the facility from meeting FDA cGMP standards for pharmaceutical production environments.
The Challenge
The pharmaceutical facility operates manufacturing suites requiring strict cleanliness standards and regulatory compliance for drug production. The manufacturing spaces featured concrete block walls with visible grout lines. These grout lines caused significant issues with both cleaning protocols and room certification for pharmaceutical manufacturing. The existing block walls with grout lines prevented the facility from achieving or maintaining these certifications, putting production operations at risk. In pharmaceutical production environments, every surface detail matters:
Regulatory & Certification Requirements
Pharmaceutical manufacturing facilities must meet stringent FDA requirements under 21 CFR Parts 210 & 211 (Current Good Manufacturing Practices):
- 21 CFR 211.42 – Design and Construction Features: Drug manufacturing facilities must be suitably designed, spacious, and maintainable, with smooth, hard, easily cleanable interior surfaces free of cracks and open joints to ensure proper operation.
- 21 CFR 211.58 – Maintenance: Buildings must be kept clean and sanitary, and any surface that cannot be adequately cleaned or sanitized must be removed and replaced.
Hardig's Approach
Rather than installing a weak drywall overlay system, Hardig proposed and executed a high-performance solution: resurfacing the existing concrete block walls using a specialized epoxy paste system with integrated fiberglass reinforcement, creating seamless, pharmaceutical-grade wall surfaces.
Fiberglass Reinforced Panel (FRP) System with Epoxy Paste
Hardig's solution involved resurfacing approximately 1,200 SF of concrete block using high-performance epoxy paste with an integrated fiberglass reinforcement system.
Pharmaceutical-Grade Surface Characteristics
The material chosen prevents particulate contamination, offers easy residue and contaminant removal due to its smooth, non-porous surface which facilitates FDA-required cleaning validation, and boasts a 20+ year lifespan under strict pharmaceutical cleaning protocols.
Integrated Urethane Floor Finishes
In addition to the wall system, Hardig installed urethane floor finishes in the manufacturing suites. This approach ensured the entire room envelope met pharmaceutical cleanroom standards with coordinated, compatible systems designed to work together.
Compliance with Pharmaceutical Standards
The completed wall system met: FDA 21 CFR 211.42 (smooth, hard, easily cleanable walls). FDA 21 CFR 211.58 (cleanable and sanitary condition). ISO 14644 cleanroom standards (non-shedding surfaces). ISPE (International Society for Pharmaceutical Engineering) baseline guides for facility design
The Results
The plant staff praised the cleanability and smoothness of the new wall finish. The FRP system made their sanitation processes significantly easier.
The wall upgrade brought the manufacturing suites up to pharmaceutical industry standards for cleanroom construction. The facility could now:
- Achieve and maintain ISO cleanroom certification
- Pass FDA inspections without wall-related 483 observations
- Validate cleaning procedures as required by cGMP
- Manufacture products requiring stringent environmental controls
- Demonstrate commitment to quality and compliance
The seamless epoxy/fiberglass system completely eliminated the grout lines that previously harbored contaminants, prevented effective cleaning, and compromised cleanroom certification.
Project Specifications
- Industry: Pharmaceutical Manufacturing
- Client: Pharmaceutical Manufacturing Facility (confidential)
- Location: Cincinnati, Ohio
- Total Square Footage: ~1,200 SF per suite (4 suites total)
- Facility Type: cGMP Manufacturing Suites/Cleanroom Environments
- Solution Provided: Fiberglass Reinforced Panel (FRP) Wall Systems
- Systems Installed: High-performance epoxy paste with integrated fiberglass reinforcement, urethane floor finishes
- Problem Addressed: Concrete block walls with grout lines causing cleaning/certification issues
- Special Requirements: FDA cGMP compliance (21 CFR 210/211), ISO cleanroom standards, seamless construction, chemical resistance, easy cleanability, validation-friendly surfaces
- Performance Standards: Smooth/hard surface per FDA 211.42, chemical resistance to pharmaceutical disinfectants, impact resistance, non-particle-shedding, moisture impervious
- Business Impact: Success led to 3 additional manufacturing suite projectsReady to Upgrade Your Pharmaceutical Manufacturing Spaces?
Ready to Address Your Food & Beverage Facility Flooring Issues?
Dealing with grout-lined walls preventing cleanroom certification? Struggling to validate cleaning procedures on porous surfaces? Need to bring manufacturing suites up to FDA cGMP standards? Hardig’s fiberglass-reinforced epoxy wall systems create seamless, pharmaceutical-grade surfaces that eliminate contamination concerns and streamline sanitation processes.