Where devices are made
Medical devices
ISO 14644 cleanrooms for assembly, process-specific environmental control, and flexible, reconfigurable production cells, classified for the markets the product must serve.
Medical device manufacturing
What we design
- ISO 14644 cleanrooms for assembly
- Process-specific environmental control
- Flexible, reconfigurable production cells
Device manufacture changes faster than pharma. Lines are reconfigured, products are added and cell layouts move, so the cleanroom has to be classified correctly for each process step while staying easy to rearrange. Services are brought down to the cell rather than buried in the fabric.
Typical zones
| Area | Designed for |
|---|---|
| Assembly cleanrooms | Classified to the process step and the market the device serves |
| Production cells | Reconfigurable bays with services dropped from above |
| Cleaning & packaging | Controlled environment through to the sealed pack |
| Gowning & airlocks | Stepped entry sized for the headcount on the line |
| Component & finished storage | Controlled conditions where the product requires it |
Decisions we settle early
Classification per step
Which steps need a classified environment, and to what class, rather than over-classifying the whole hall.
Reconfigurability
How far the cells must move over the building’s life, which drives the services and ceiling strategy.
Target markets
The regulators the device must satisfy, agreed before classification is fixed.
The disciplines behind it
Every discipline this facility type depends on is designed and coordinated in-house, by one team.
- Architecture & GMP layoutSpace planning, cleanroom construction, wall/ceiling/floor systems, doors and pass-throughs, and the flows that keep contamination out.
- HVAC & air handlingAHU-wise ducting, supply and return balancing, pressure cascades and area classification.
- Electrical & automationPower distribution, cable trays, lighting to lux targets, control panels and monitoring.
Let’s design it right.
From the first concept sketch to an issued-for-construction package, Agon designs pharmaceutical facilities that meet the highest international standards. We would welcome the conversation.