PCI strives for a value-added focus to commissioning and qualification activities based on solid engineering principles. We assist client in program establishment and/or execution. In addition, we are among the first to have hands-on experience in paperless- execution of C&Q activities. We have a solid track record of successful completion of multiple projects both, small and large.

Our staff is highly experienced and familiarized with the requirements for performing:

  • Write-up and execution of Commissioning Test Scripts, as well as validation IQ, OQ and PQ protocols
  • Paper-less Execution of commissioning and qualification
  • Integrated commissioning and qualification approaches

 

We commission a majority of systems found in the Pharmaceutical, Biotech and Medical Device Industry. We have the hands-on experience and engineering knowledge to commission a variety of utilities, process equipment, and automation systems/software.

F.Y.I.

NORTH CAROLINA LAW IDENTIFIES COMMISSIONING AS AN ENGINEERING FUNCTION. THEREFORE, A PROFESSIONAL ENGINEER (P.E.) REGISTERED IN NORTH CAROLINA MUST BE RESPONSIBLE FOR ANY COMMISSIONING PROJECTS EXECUTED IN NORTH CAROLINA
 

Representative Systems from Biotechnology, Pharmaceutical and Medical Device Industries

FACILITIES AND UTILITIES

  • Clean Steam Generators
  • HVAC Systems
  • Emergency Power Systems
  • Clean Steam Systems
  • WPU / WFI water systems
  • Clean Gas Systems Clean-In-Place (CIP) skids
  • Steam In Place (SIP) skids - Clean Rooms

 

PROCESS EQUIPMENT: BIOTECHNOLOGY

  • Bioreactor / Fermentor skids
  • Buffer / Media Preparation Vessels
  • Process Tanks
  • Homogenizers
  • Centrifuges Chromatography skids
  • Ultrafiltration skids
  • Microfiltration skids

 

PROCESS EQUIPMENT: BIOTECHNOLOGY, PHARMACEUTICAL AND MEDICAL DEVICE

  • Lyophilizers
  • Depyrogenation
  • Fill / Finish Equipment
  • Packaging Lines
  • Diagnostic Equipment test beds
  • Diagnostic test bed procedures
  • Shakers

 

OTHER SYSTEMS

  • Environmental Chambers
  • Room Thermal Mapping
  • SIP / CIP Circuits
  • UV Pass
  • Stability Chambers
  • Sterilization Equipment
  • Cleaning Equipment