2014 Category Winner for Project Execution

Grifols is the winner of the 2014 ISPE Facility of the Year Award for Project Execution for their North Fractionation Facility, located in Clayton, North Carolina. The $340 Million project is a 150,000 SF expansion on their existing campus for Human Blood Fractionation.


Grifoils Imagine 1


Grifoils Imagine 4

Product Quality

  • Validated a closed process to eliminate contamination risk and reduce clean room space
  • Developed a robotic bottle opening system to eliminate potential plasma contact with operators
  • Employed automation systems reducing human error and increasing process repeatability

 Manufacturing Efficiency

  • Expanded site output by 100% to 6MML of plasma
  • Lowered labor per liter fractionated by 40%
  • Increased process yield between 8 and 15% across fractions produced by leveraging
  • Grifols advanced understanding of processing human plasma
  • Achieved a 31% reduction in energy per liter with closed process in ambient space

 Equipment and Technology

  • Built a fully automated processing train reducing cycle times, improving yield, and minimizing human intervention
  • Developed in-house process utilizing horizontal thaw vessels, ABO, and precipitation reactors
  • Implemented the industry’s first disc-stack centrifuge for fractionation, featuring closed processing, CIP systems operating in ambient conditions
  • Achieved a 90% reduction in medical waste generated per liter fractionated

 Facility Integration

  • Produced a modern, sustainable facility that eliminated harsh cold work environments while achieving excellent functional arrangements resulting in a minimization of material movement
  • Contained manufacturing operations on a single level
  • Minimized clean room footprint to 12% of gross space

Project Execution

  • Fully integrated, co-located project team consisting of both owner and EPCM(V) contractor staff allowing for the concurrent design and construction schedule to work
  • Used onsite fabrication shop and super skid approach; saving 4 months and 15% of cost
  • Assembled pilot centrifuge installation to develop and debug software
  • Leveraged RV/IV commissioning data for use in final qualification package