Challenge and approach
The product was in the clinic, a biologics cell culture. The job was to lock concept and detail design. Construction is not in this record.
PE ZD worked as consultant: concept design, URS, risk assessment, commissioning review, and qualification planning. Systems covered utilities (HVAC, N2, O2, CDA), cleanroom HVAC, a walk-in refrigerator, and fire services. The site is in New Taipei. The targets are PIC/S GMP and US FDA.
Scope
- HVAC
- Cleanroom
