Ampoule filling capacity increased
A second aseptic filling line has been qualified in the sterile block, increasing ampoule output and — equally important — giving the site redundancy for its most constrained operation.
A single aseptic line is a single point of failure. Planned maintenance, requalification and media fills all take a line out of service, and with one line those windows compete directly with supply. Two lines allow the assurance work to happen without it becoming a supply decision.
“With one line, every media fill is a supply decision. With two, it is just good practice.”
The new line was qualified through the full sequence — installation, operational and performance qualification, airflow visualisation, and three consecutive successful media fills per shift before any commercial product.
Both lines feed the same serialised packaging hall, so the pack a distributor receives is identical regardless of which line filled it.
Key facts
- Added
- Second aseptic filling line
- Benefit
- Capacity and redundancy for maintenance and requalification
- Qualification
- IQ/OQ/PQ, airflow visualisation, three media fills per shift
- Downstream
- Shared serialised packaging hall