We provided commissioning & qualification services for this cGMP manufacturing project which won the ISPE Facility of the Year award for Project Execution. The facility features ISO-7/ISO-8 cleanrooms, QA/QC laboratories, GMP warehouse, office area, and support spaces.
Implementing an ASTM E2500 approach, we flagged critical quality-impacting systems early using a risk-based approach which improved the project timeline by removing redundant repeat tests, and simplified turnover by leveraging commissioning documentation for qualification.
Commissioned Systems: Chilled Water | Heating Hot Water | Air Distribution | BSL-3/General Exhaust | Space Pressure Monitoring | RO/DI | LN2 | Process Gases | Standby/Emergency Power | Electrical Distribution | Lighting/Lighting Controls | Building Automation System
