New approach to fill&finish
The AT-Closed Vial® Technology is an aseptic fill&finish solution aiming to minimize the contamination risks while simplifying the process. The Technology was initially designed for biopharmaceuticals, potent and cryostored injectable products. It consists in 2 parts:
AT-Closed Vial®
Ready-to-fill closed polymer vials: molded and directly assembled (closed) in ISO5, gamma-sterilized.
Crystal® Filling Lines
Scaling-up solutions from manual filling to commercial batches (up to 180 vials/minute) adapted to specific processing of AT-Closed Vial®.
Advantages
> Contamination by exposure to the environment is completely eliminated by keeping the vial always closed.
> The vial ensures drug product protection: its polymer-made body is resistant to shocks and to very low temperature storage. That also maximizes operators and healthcare professionals safety when dealing with potent drugs.
EASIER
> Lean manufacturing: no washing, no sterilization, no cooling, no stoppering and no crimping.
> No wet utilities: electricity only.
> Small footprint, less cleanroom space.
> Quick validation.
Process
1. Filling of the vial with a needle puncturing the elastomeric stopper.
2. Immediate laser re-sealing to restore the closure integrity of the filled vial.
3. Capping with a tight snap-fit cap protecting the piercing area.
