Since 2002 at Aseptic Technologies we explore ways to make aseptic fill & finish process safer and easier, responding to new challenges of biopharmaceutical injectable developers and their CDMOs.
We fundamentally re-invented the entire process of fill & finish starting with its core element: the vial or more precisely the entire container closure system.
The AT-Closed Vial® and the AT-Closed Vial® Technology Filling Lines are a result of that reflection.
The AT-Closed Vial® is a vial that is closed before filling. The vial body and stopper are assembled together right after molding, in ISO 5 conditions. The vials are therefore closed before the start of the fill & finish process, eliminating contamination risks. Its unique material composition and manufacturing technique also enables the AT-Closed Vial® to secure Container Closure Integrity (CCI) during cryopreservation.
De-risking aseptic filling
Unique ready-to-fill polymer vials (COC)
Vial bodies and stoppers molded and assembled in ISO5
Ranging from < 1 ml to 50 ml
Closed throughout the filling process, eliminating contamination risks by design
The closed vial filling is performed in 3 steps with dedicated filling equipment in ISO 5 :
The vial is filled through the stopper with a special sterile needle. After the piercing, the stopper mechanically recloses thanks to its elasticity
The stopper is re-sealed with a one-second laser shot
The sterile snap-fit cap is placed on the vial to protect the stopper until the collection of the product
Cryopreservation
The AT-Closed Vial® technology enables safe cryogenic storage of the injectable drug product and its intermediate GMP-grade products.