Case · Industrial
Planta de manufactura — dispositivos médicos
Class-II medical-device manufacturing plant with ISO 7 and ISO 8 cleanrooms, FDA-ready validation, and a critical go-live deadline.
Location
Coyol Free Zone, Alajuela
Area
9,500 m²
Duration
12 months
Delivered
2023
The challenge
Class-II medical-device manufacturing plant with ISO 7 and ISO 8 cleanrooms, FDA-ready validation, and a critical go-live deadline.
The solution
Cleanroom validation coordinated in parallel with civil works. Dedicated team for IQ/OQ/PQ qualification documentation.
Results
- Cleanroom qualification on time.
- Client internal audit approved on first attempt.
- Commercial production 30 days after handover.