Sterile block construction begins
Construction has begun on Ergopharm's sterile block, a dedicated aseptic facility with its own air handling, water system, airlocks and personnel routes, separate from the existing manufacturing building.
Sterile manufacture is not an activity that can be added to a general facility. It requires classified areas with a maintained pressure cascade, a Water-for-Injection system, gowning sequences that take longer than most people expect, and a physical separation from operations that generate dust or handle unclassified materials. Building it separately is the only arrangement that does not compromise both.
“You do not add aseptic manufacturing to a building. You build a building around it.”
The design places the filling operation in a Grade A environment within a Grade B background, with material and personnel entering through their own airlock sequences and no route that allows either to shortcut the cascade. Utilities serving the block — air, water, steam and process gases — are dedicated rather than shared.
Construction is followed by commissioning and a full qualification programme; nothing is filled for supply until that programme is complete.
Key facts
- Separation
- Dedicated building, dedicated utilities
- Environment
- Grade A filling within a Grade B background
- Access
- Separate personnel and material airlock sequences
- Before supply
- Full commissioning and qualification programme