Plasma Fractionation Capital Expansion Project


In Illinois, a pharmaceutical manufacturer undertook a capital expansion project for a second plasma fractionation area at their facility. This project consisted of three pooling, two adsorptions, six fractionation bays, associated utilities, computerized systems, and storage to utilize the Kistler-Nitschmann-Cohn (KNC) three-step process.


At the onset of the project, Performance Validation (PV) played a significant role in updating procedures used to develop the following documents to utilize the Integrated Commissioning & Qualification (ICQ) approach to qualification the new utilities and process equipment.

  1. User Requirement Specifications (URS)
  2. Requirements Traceability Matrices (RTM)
  3. Design Reviews (DR)
  4. Design Qualifications (DQ)
  5. Factory Acceptance Testing (FAT)
  6. Site Acceptance Testing (SAT)
  7. Receipt Verification (RV)
  8. Commissioning Test Plan (CTP)
  9. Installation and Operational Qualifications (IOQ)
  10. Performance Qualifications (PQ)

Ultimately, the client elected to halt the construction of the facility. However, the process and utility skid systems were tested through FAT to ensure properly constructed and operational systems were delivered to the site. PV was responsible for developing and executing items one through five listed above for several systems. In addition, PV resources were responsible for the execution of the following FATs:

  • Adsorption Filter Presses in St. Gallen, Switzerland
  • Adsorption Vessels and Skids in Stratford, WI
  • Chilled Glycol Pump Skids in Greensboro, NC
  • Clean-In-Place (CIP) Skids in Sun Prairie, WI
  • Fractionation Buffer Vessels in Springfield, MO
  • Fractionation Filter Press Plate Handling System in Uetendorf, Switzerland
  • Fractionation Filter Press Wash System in Aesch, Switzerland
  • Fractionation (Glycol) and Centrifuge (Ethanol) Temperature Control Modules in Fort Atkinson, Wisconsin
  • Pure Steam Generator, Vapor Compression Distillation Units, Water Pretreatment Skids, Booster Pump Skid, Triplex Softener Skids in Knoxville, TN
  • Solids Handling System in Osterburken, Germany
  • Thaw Tanks in Syracuse, NY
  • Thaw Tank Temperature Control Modules in Oakville, Ontario, Canada
  • Water Bath and Bottle Cutter in Lohra, Germany (remote execution)
  • Water Cooled Glycol Chillers in Cleveland, OH

PV created FAT punch lists and followed up with vendors to close items before shipment of the equipment to the client’s facility.

In addition to document development and execution, PV performed equipment inspections, reviewed turnover packages (TOPs), created a physical library at the facility and developed an online library which contained 3D models, executed FATs, equipment inspections, P&IDs, specifications, and TOPs.

The Results

Performance Validation successfully developed documents and executed FATs to ensure the Illinois pharmaceutical company received the utilities and process equipment specified to meet their needs. In addition, after receipt of the equipment, Performance Validation created an organized library to store all documentation packages associated with the expansion project.