Challenge and approach
The cold room had to prove it could hold temperature for a preclinical biologics cell culture.
PE ZD worked as subcontractor: the validation structure, deviation reports, calibration records, functional qualification, and empty-load, full-load, and recovery tests. The site is in Taipei. The recorded stage is validation and qualification, not construction. The target is PIC/S GMP, marked as global.
Scope
- HVAC
- Cleanroom