Industry 05 / 10
Medical Devices
Medical device facilities are shaped by the risk class of the product, its assembly steps, and its sterilization route. Cleanroom classification, electrostatic and particulate control, and packaging integrity are defined per process rather than applied uniformly across the building.
Engineering focus
- 01
Cleanroom classification matched to assembly and packaging steps
- 02
Interfaces with EtO, gamma, or steam sterilization routes
- 03
Electrostatic discharge (ESD) and particulate control at workstations
- 04
Segregated flows for components, work in progress, and finished goods
Relevant services
- 02Master Planning & Concept EngineeringZoning, flows and phasing fixed early, while changes are still inexpensive.
- 04Cleanroom DesignClassified spaces with defined pressure cascades, airlocks and gowning sequences.
- 05HVAC EngineeringAir systems designed for cleanliness, pressure, temperature and humidity control.
- 08Qualification & Validation (CQV)Documented evidence that facilities, utilities and equipment perform as intended.
Next step
Planning a pharmaceutical project?
Share the product type, the current stage and the main constraints. We will respond with a proposed scope and next steps.
+20 101 171 1700