Commissioning and Qualification

PCI strives for a value-added focus to commissioning and qualification activities based on solid engineering principles. We assist clients 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.

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