AT-Closed Vial® and Container Closure Integrity during Cryogenic Storage
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AT-Closed Vial®
The AT-Closed Vial®
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.
The robustness of the container closure integrity (CCI) in cryogenic temperatures is validated and holistically covered by the vial materials and design, its manufacturing process, and the closed vial filling process.
Combined with the rapidity of operation for minimizing of the contact with the cryoprotectant, the AT-Closed Vial® technology is, since 2009, the solution of choice for autologous and allogeneic cell and gene therapies, vectors, cell banks and trusted by pharmaceutical companies, academic institutions, CDMOs and hospitals globally.
Cost of Goods
Together with our users on a journey of making the novel injectable treatments a commodity, at Aseptic Technologies, we provide the following features for the cost of goods reduction, while operating with AT-Closed Vial® technology:
- No water for injection use
- Zero-defect approach
- Minimization of product loss
- Reduction of validation effort
- Reduction of overfill
- Smaller footprint of the aseptic filling lines
In addition, the AT-Closed Vial® is available in three formats in order to satisfy your specific needs: AT-CryoBox™ (9 to 25 vials depending on the vial volume), AT-Nest™ (25 to 88 vials) and AT-Tray™ (91 to 377 vials).