Pharmaceutical Biopharmaceutical Nutraceuticals R&D / Labs Medical Devices
Commissioning & Validation      

 

 

 

PHARMACEUTICAL DESIGN PROCESS:


 • Identify Business goals
 • Data Collection process
 • Responsibility Matrix
 • Process Flows
 • Civil Site/ Landscape
 • Environmental
 • Site-vehicular/pedestrian flows
 • Material/Personnel/Waste flows
 • Program Statement
 • Floor Plans/Elevations
 • Identify ECL, TS, cGMP zone
 • Preliminary code review
 • Interior Finish Matrix 21CFR, Part

    210/211
 • General locations of MEPP systems
 • General MEPP system sizing, and

    criteria
 • Project Schedule
 • Commissioning Master Plan- CMP
 • Validation Master Plan- VMP
 • FDA submission Package

 

 

 

 

 

Conceptual Design

Proposed Building

 

BUSINESS GOALS:

 

 • Accessibility
 • Minimal cost/ Best value
 • Specific product Output
 • 24x7 facility reliability

 • Adaptability

 • Building pressurization control

 • Energy efficiency goals

 • Flexibility in audio visual systems     

 • Functionality

 • Maintainability

 • Redundant and resilient HVAC

   systems
 • Compliance excellence

 • Sustainability

 • Survivability
 • Reliability

 • Scalability

 • Security/Safety

 • Serviceability

 • Sophisticated detection and fire 

   suppression systems

 • Space and organizational
    process functionality

 • Structured raceways for flexible

    cabling
 • Redundant electrical services

 

 

 

Material/personnel flows. process engineering, validatable design solutions, and efficient layouts is critical to manufacturing success.

 

 

 

 

 

 

 

 

Comparison of Airborne Environmental Cleanliness Requirements

 

 

"...ARCHITECTURE  that is responsive to its' surroundings and  to its' users needs..."

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