The challenge
The client's new fill-finish suite had to meet EU GMP Annex 1 requirements for unidirectional airflow and recovery, and an earlier design had failed smoke studies at the filling zone.
Our approach
We modelled the room, isolator, filling machine and personnel positions in CFD, iterated the diffuser layout, return positions and air-change rates, then supported installation and performed airflow visualisation, particle counting, recovery and pressure-cascade qualification.
The outcome
The suite passed airflow visualisation and ISO 14644 classification at the first attempt, and the CFD models are now used for change control on the room.
Representative engagement. Client identity and certain project details are withheld or generalised under confidentiality agreements.