Sterile block construction completed
Construction of Ergopharm's sterile block has been completed and the facility handed over for qualification, ahead of the media-fill programme that will decide whether it can make injectable medicines.
The block is built around a classified core: a Grade A filling zone under unidirectional airflow, within a Grade B background, entered through Grade C preparation areas and Grade D support. Personnel and materials reach the core through separate airlock chains, and the pressure cascade between grades is monitored continuously with alarms.
“Handover was not the finish line. It was the point at which we started having to prove things.”
Handover began qualification rather than ending construction. Airflow visualisation studies, cleanroom classification to ISO 14644-1, HVAC performance qualification, and cleanroom recovery testing all precede any product contact — and all precede the media fills that will simulate the aseptic process itself.
The design decisions taken here were revisited a decade later against the 2022 revision of EU GMP Annex 1 and its contamination control strategy.
Key facts
- Zones
- Grade A core, Grade B background, C and D support
- Airflow
- Unidirectional at the filling zone, visualised and recorded
- Classification
- ISO 14644-1
- Next step
- Media fills before any commercial batch