Challenge and approach
The line had to make a sterile injectable, a small-molecule drug already on the market, so airflow and room pressure could not be approximate.
The site is in Hsinchu County. PE ZD’s turnkey scope was concept design, risk assessment, design review, construction, air balance and pressure adjustment, and test qualification, through detail design, construction, validation, and qualification. The target is PIC/S GMP.
Scope
- HVAC
- Cleanroom
