Pharmaceutical Research Lab Phoenix
Complete pharmaceutical research facility coating including 12 ISO Class 7 cleanrooms, GMP-compliant laboratory areas, and sterile processing zones across 220,000 square feet.
Project Overview
A leading biopharmaceutical company required a complete facility upgrade for their Phoenix research laboratory, including 12 ISO Class 7 cleanrooms for sterile compounding and formulation development. The project demanded strict adherence to FDA cGMP regulations and USP 797/800 standards for pharmaceutical compounding.
Our pharmaceutical coatings team implemented cleanroom-certified systems with validated cleaning procedures and independent air quality testing. All work was performed using HEPA-filtered equipment with continuous particle monitoring. The facility achieved ISO Class 7 certification on first inspection and passed FDA audit with zero observations.
Challenges & Solutions
Pharmaceutical cleanrooms require the highest standards of cleanliness and regulatory compliance in the coatings industry.
Key Challenges
- ISO Class 7 cleanroom certification requirements
- FDA cGMP (current Good Manufacturing Practice) compliance
- Active pharmaceutical research operations
- Particle count validation and air quality testing
- Sterile processing areas and biosafety level 2 labs
Our Solutions
- USP 797/800 compliant coating systems
- HEPA-filtered application with particle monitoring
- Phased execution with validated cleaning procedures
- Independent third-party air quality certification
- Antimicrobial epoxy for sterile areas
GMP-Compliant Cleanroom Coating Systems
Specialized pharmaceutical-grade coating systems designed for sterile manufacturing and research environments.
ISO Class 7 Cleanrooms
- • USP 797/800 compliant
- • Particle count validated
- • Seamless cove base systems
- • Non-shedding surfaces
Sterile Processing Areas
- • Antimicrobial epoxy systems
- • Chemical disinfectant resistant
- • Seamless, cleanable surfaces
- • FDA Title 21 compliant
cGMP Documentation
- • Material traceability records
- • Installation qualification (IQ)
- • Operational qualification (OQ)
- • Performance qualification (PQ)
Project Results
ISO Class 7 certification achieved on first inspection with FDA audit compliance and zero observations.
Client Testimonial
"Moorhouse Coating's expertise in pharmaceutical cleanroom environments was evident from day one. Their understanding of cGMP requirements, USP 797/800 standards, and FDA expectations exceeded our stringent quality standards. The coating systems they installed achieved ISO Class 7 certification on the first inspection, and we passed our FDA pre-approval inspection with zero observations related to facility conditions. Their documentation was impeccable — every material lot number, application parameter, and environmental reading was tracked and recorded. This level of quality and compliance assurance is exactly what pharmaceutical manufacturing requires."
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Learn MoreFrequently Asked Questions
Common questions about pharmaceutical laboratory and cleanroom coating projects
What are USP 797 and USP 800 requirements for cleanroom coatings?
USP 797 (sterile compounding) and USP 800 (hazardous drug handling) require cleanroom surfaces that are smooth, impervious, free from cracks and crevices, and able to withstand repeated cleaning and disinfection. Coatings must not shed particles, harbor microorganisms, or react with cleaning agents. We use epoxy systems specifically formulated for pharmaceutical environments with documented low particle emission and validated cleaning procedures. All materials include certificates of analysis and lot traceability documentation.
How do you achieve ISO Class 7 cleanroom certification?
ISO Class 7 (formerly Class 10,000) allows maximum 352,000 particles ≥0.5μm per cubic meter. We achieve this through HEPA-filtered application equipment, continuous particle monitoring during work, validated cleaning procedures between coats, and strict gowning/entry protocols. After coating completion, we perform pre-certification cleaning and coordinate with independent third-party certification companies for particle count testing, air velocity measurements, and HEPA filter integrity testing. Our systems consistently achieve certification on first inspection.
What cGMP documentation is required for FDA compliance?
Current Good Manufacturing Practice (cGMP) regulations require extensive documentation including: Installation Qualification (IQ) with material certifications, lot numbers, and environmental conditions; Operational Qualification (OQ) demonstrating proper application procedures and cure verification; Performance Qualification (PQ) showing the coating system meets all functional requirements; and complete batch records with material traceability. We provide turnkey documentation packages that satisfy FDA inspectors and support your quality management system.
Can you work in active pharmaceutical research laboratories?
Yes, we specialize in phased execution that isolates work areas while maintaining laboratory operations. Critical equipment and research materials are protected using validated cleaning and containment procedures. Our teams are trained in GMP requirements, contamination control, and laboratory safety protocols. All personnel undergo background checks and facility-specific training. We coordinate closely with quality assurance, EHS, and research management to ensure zero impact to ongoing studies and compound development work.
What makes coatings suitable for sterile processing areas?
Sterile processing coatings must resist chemical disinfectants (bleach, IPA, hydrogen peroxide, quaternary ammonium compounds), provide seamless, crevice-free surfaces that prevent microbial harbor, contain EPA-registered antimicrobial additives for continuous protection, and withstand rigorous daily cleaning protocols. We use pharmaceutical-grade epoxy systems with integrated cove base details that eliminate floor-to-wall transitions. These systems are tested for microbial resistance per ASTM standards and validated for use in aseptic manufacturing environments.
Need GMP-Compliant Pharmaceutical Coatings?
Our pharmaceutical coatings team specializes in cleanroom certification, cGMP compliance, and FDA-ready documentation.