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