Our Pharmaceutical client at their suburban Chicago site needed to close the gap between construction activities and fully validated and operational pilot plants.
Hot and Cold WFI loops for Pilot Plant use were installed and controlled by an Allen-Bradley ControLogix PLC with an Intellution iFix graphical interface.
Dynamic Engineering Design provided onsite technical assistance and project management including Construction Punch-listing and supervision of 3rd Party System Integration.
Commissioning began with Factory Acceptance Testing (FAT). Procedures were reviewed, executed and documented.
Instrument calibration technical support was provided. Site Acceptance Testing – Dry Testing (SAT) procedures were reviewed, executed, and documented. System passivation technical support was provided. A sampling and water quality study procedure was prepared. Site Acceptance Testing – Wet Testing (SAT) procedures were reviewed, executed, and documented. A Commissioning Summary report was prepared including the resolution of all discrepancies.
Following a successful and well documented commissioning, Validation documents were prepared, approved and executed.
- Installation Qualification (IQ) for equipment, controls & utilities.
- IQ Summary report and discrepancy report resolution
- Operational Qualification (OQ) equipment, controls & utilities.
- OQ Summary report and discrepancy report resolution
- Performance Qualification (PQ) Protocol preparation & review.