AT-Closed Vial® Ready-to-fill closed vial

Closed vial for aseptic fill & finish The AT-Closed Vial® technology is based on the concept of a ready-to-fill closed vial, reducing the risk of contamination of the filling process. The AT-Closed Vial® is Clean: low level of particles as a result of molding in ISO5 cleanroom Closed: vial body and stopper assembled right after molding, in ISO5 Sterile: ready to use after gamma irradiation Container Closure Integrity 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...

The product contact parts are made of the following materials: —» Vial body: Cyclo-Olefin Copolymer (COC) —> Stopper: Thermoplastic Elastomer (TPE) The AT-Closed Vial® meets USP and EP requirements for pharmaceutical primary containers. The AT-Closed Vial® is suitable for very small to large filling volumes. The vial is available in six formats ranging from 1 ml up to 50 ml.

The AT-Closed Vial® is filled in three simple steps: 1. Filling: the vial is filled through the stopper with a specific sterile needle. After the piercing, the stopper mechanically recloses due to its elasticity. 2. Laser re-sealing: the stopper is resealed with a one second laser shot. 3. Capping: the sterile snap-fit cap is placed on the vial to protect the stopper until the collection of the product. Filling Lines To adapt to your specific needs, we have developed a complete range of Filling Lines. From manual to fully automated systems, our Filling Lines can be used at any stage of the product...

Packaging The AT-Closed Vial® is available in three packaging configurations in order to satisfy your specific needs: —> AT-CryoBox™: 9 to 25 vials per package depending on the vial size —> AT-Nest™: 25 to 88 vials —> AT-Tray™: 91 to 377 vials The AT-CryoBox™ (pictured) is adapted to cryogenic storage . Collection device The AT-Adapt™ is a needleless collection device that has been developed to fit the AT-Closed Vial® (from 2ml to 50ml) and facilitate your process. Validation Master Plan A full Validation Master Plan and all tests are supplied with the AT-Closed Vial®. Aseptic Technologies certifications...

SKAN AG Kreuzstrasse 5 4123 Allschwil, Switzerland +41 61 485 44 44, [email protected] SKAN Stein AG Industriestrasse 3 4332 Stein, Switzerland +41 62 885 03 00, [email protected] SKAN Deutschland GmbH Nickrischer Straße 2 02827 Görlitz/Hagenwerder, Germany +49 358 223 789 0, [email protected] SKAN US, Inc. 7409 ACC Blvd., Suite 200 Raleigh, NC 27617, USA +1 919 354 6380, [email protected] SKAN Japan 5194-61 Katsuren-Haebaru Uruma-shi Okinawa 沖縄県 904-2311, Japan 日本 +81 98 934 9922, [email protected] © 2023 – Aseptic Technologies S.A. – Brochure AT-Closed Vial® – V2.0 Aseptic Technologies S.A. reserves...