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Cleanroom Design & Installation for
503A / 503B Compounding Pharmacies

Turnkey USP <797> & <800> Compliant Cleanroom Solutions

At Team 4 Products LLC, we provide end-to-end cleanroom design, engineering, and installation specifically
tailored for 503A and 503B compounding pharmacies across the United States. Our solutions meet USP <797>,
USP <800>, FDA cGMP guidelines, and state board requirements.

Why Cleanroom Compliance Matters

Sterile compounding requires strict control over contamination, airflow, pressure, and microbial levels. Non-compliance can result in:

  • FDA warning letters or shutdowns
  • Loss of 503B registration
  • Patient safety risks
  • Operational inefficiencies

Our Capabilities

  • ISO 5, ISO 7, ISO 8 environments
  • Optimized workflow and contamination control
  • HEPA filtration systems
  • Pressure cascade design
  • Air change compliance
  • Temperature and humidity control
  • Prefabricated cleanroom panels
  • GMP-compliant materials
  • Scalable and fast installation
  • Installation & commissioning
  • IQ/OQ support
  • Smoke studies
  • Particle testing
  • Full documentation package

Designed for 503A & 503B Pharmacies

  • Sterile consumables (vials, stoppers, caps)
  • Autofilling and packaging systems
  • Production workflow optimization
  • Regulatory-driven design
  • Turnkey delivery
  • Fast deployment
  • Scalable infrastructure
  • Single vendor solution
  • Compounding pharmacies
  • Telehealth networks
  • GLP-1 providers
  • Longevity clinics
  • Pharma startups

Start Your Cleanroom Project

Contact Team 4 Products LLC to begin your cleanroom project from concept to validation.

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