Cleanroom design frozen for the first manufacturing block
The cleanroom design for Ergopharm's first manufacturing block has been frozen, fixing airflow, pressure cascade, personnel and material routes before construction begins rather than adjusting them once walls are standing.
Contamination control is decided on a drawing board. Once a building exists, the cheap fixes are procedural — more gowning steps, more cleaning, more monitoring — and procedures are the weakest form of control because they depend on people doing the right thing every time. Design that separates flows physically does not.
“A procedure asks people to get it right every time. A wall does not ask.”
The design fixes a pressure cascade from the cleanest areas outward, unidirectional personnel routes through gowning airlocks that cannot be bypassed, and separate material airlocks so that people and goods never share a door. Air handling is specified for the recovery and change rates the intended classification requires, with terminal filtration at the point of supply.
Room classification and the monitoring that will demonstrate it are defined at design stage against ISO 14644-1, so that qualification later measures what the design promised rather than describing what was built.
Key facts
- Fixed at design
- Pressure cascade, personnel and material routes, air changes
- Separation
- Gowning airlocks for people; separate airlocks for materials
- Filtration
- Terminal filters at the point of supply
- Classification
- Defined against ISO 14644-1 before construction