Where the medicine is made
Sterile & aseptic fill-finish
Cleanroom suites, airlocks and pressure cascades for aseptic processing, designed to EU GMP Annex 1 and ISO 14644, with clean utilities engineered for sterile service.
Pharmaceutical manufacturing
What we design
- Annex 1 contamination control strategy
- Grade A/B with RABS or isolator integration
- WFI, clean steam & depyrogenation
Nothing is less forgiving than an aseptic suite. The product is exposed, so the design has to hold a Grade A environment over it, keep a clean-to-less-clean pressure cascade in every direction, and move people, components and waste without ever crossing those paths. The contamination control strategy drives the layout, not the other way round.
Typical zones
| Area | Designed for |
|---|---|
| Grade A — critical zone | Unidirectional airflow over the exposed product, inside an isolator or RABS |
| Grade B — aseptic core | Background to Grade A: high air changes, terminal HEPA, strict gowning |
| Grade C — preparation | Solution and component preparation, positive to Grade D |
| Grade D — support | Washing, equipment preparation and the airlocks that step people in |
| Controlled, unclassified | Packing, warehousing and technical areas, comfort-conditioned |
Decisions we settle early
Barrier technology
Isolator or RABS. It sets the room grade around the line, the gowning regime and much of the footprint.
Airlock & gowning strategy
How people, components and waste step between grades without ever sharing a route.
Clean utility generation
WFI and pure steam capacity, loop sizing, drainability and the sampling points designed in from the start.
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.
- Clean & black utilitiesPW, WFI, clean steam and gases on the clean side; chilled water, chillers and compressed air on the black side.
- Process & equipmentPFDs, fully annotated P&IDs, equipment specification, sizing and layout.
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.