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Pharmaceutical Overview

For drug manufacturers, speed-to-market is everything. Timelines are short, regulatory thresholds are high, and profits thrive on consistency and compliance. We help you stay competitive in a fast-paced global market by planning, designing, and delivering sustainable pharmaceutical operations that keep you on track for profitability, current Good Manufacturing Practices, and environmental stewardship. Gannett Fleming provides a comprehensive integrated approach to delivering your project on time and within budget.

Our Experience

Gannett Fleming’s pharmaceutical industry experience includes a comprehensive range of applications. We offer facility master planning, architectural and engineering design, construction management, and full turnkey project delivery services for pharmaceutical manufacturing, R&D, process support, facilities, and utilities. In addition to our design and construction management capabilities, we bring a wealth of validation experience with FDA and EU regulations. Gannett Fleming provides a complete, integrated solution.

Innovative Design Solutions 

  • Aseptic and sterile filing operations
  • BSL 2, 3, and 3+
  • Bulk manufacturing
  • cGLP and cGMP facilities
  • Fermentation
  • Liquid processing
  • Medical devices
  • Parental processing and packaging
  • Pharmaceutical drying, blending, granulation, and coating
  • Potent compounds
  • Regulated utility systems
  • Renewable energy
  • Solvent storage and handling
  • WFI and USP water systems.
  • Clean rooms
  • Laboratories
  • Research and development facilities
  • Pilot plants
  • General offices and related facilities
  • Vivariums
  • Warehouses.

Our staff of highly skilled design and automation engineers has designed more than 200 control systems for the pharmaceutical and biotechnology industries.

Pharmaceutical Services

Process

  • Fermentation and bioreactors
  • Chromatography
  • Ultrafiltration
  • Buffer prep
  • High purity water/steam
  • Solvent storage and handling
  • Process waste decontamination
  • Drying, blending, granulation, coating
  • Liquid/Liquid extraction
  • Centrifuging
  • Neutralization
  • Milling
  • Cryogenics
  • Isolation and containment
  • Vessels/Mixers
  • Aseptic and sterile filling
  • Process controls
  • Material conveying
  • Process safety
  • Cold storage
  • High purity water systems.

Process Automation

  • Continuous Polymerization (CP)
  • Solid State Polymerization (SSP)
  • Polymer transfer
  • Extrusion processes
  • Material handling
  • Dust collection systems
  • Batch reactors
  • Continuous processes
  • Pelletizing
  • Drying
  • Chemical distribution
  • Separation systems
  • Thermal fluid systems
  • Heat transfer
  • Scrubbers/Incinerators/RTO’s
  • Hazardous material
  • Process safety.

Architecture

  • Building condition assessment
  • Architectural design
  • Building code analysis
  • Master planning
  • Programming
  • Interior design
  • 3D modeling
  • Site planning.

Commissioning, Qualification, & Validation (CQV)

  • CFR Part 11 compliance
  • Change control management
  • Cleaning validation program development
  • Data interpretation, comparison, and report generation
  • Development of system procedures (use/operation, administration, PM)
  • Factory and site acceptance testing
  • Installation qualifications
  • Operation qualifications
  • Performance qualifications
  • Protocol developments and execution
  • Startup assistance
  • System documentation development, revision, and verification (walk-down), including engineering turn-over packages, drawing, and manuals
  • Trouble shooting and resolution
  • Validation master planning.

Mechanical Engineering

  • Studies, assessments, and evaluations
  • cGMP & energy audits
  • HVAC system design
  • Piping design and layout
  • Building and process piping
  • Plumbing systems design
  • Utility systems design
  • Fire protection systems.

Electrical Engineering

  • Central utility plants
  • Cogeneration
  • Emergency/standby power
  • Energy management systems
  • Lighting systems
  • Power distribution systems
  • Security and communication systems
  • Short circuit/coordination/arc flash studies
  • Substation upgrades. 

Environmental

  • Compliance
  • Permit acquisition
  • Sustainability and long-term planning
  • Property acquisition/divestiture
  • Site development
  • Remedial actions.

Construction Services

  • Construction management
  • Construction inspection
  • Program management
  • Engineering, procurement, and construction (EPC)
  • Construction management at-risk (CMAR).