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AT-Closed Vial®

Product catalog summary

Overview of AT-Closed Vial® Technology
The AT-Closed Vial® technology offers a ready-to-fill closed vial system designed to minimize contamination risks during the filling process. It is characterized by its cleanliness, closure, and sterility, achieved through molding in an ISO5 cleanroom and gamma irradiation.

Applications
Since 2009, this technology has been widely adopted for cell and gene therapies, viral vectors, and cell banks, trusted by various biotech and pharmaceutical entities globally.

Container Closure Integrity
The technology ensures robust container closure integrity (CCI) even at cryogenic temperatures, validated through its design, materials, and manufacturing process.

Materials and Design
The vial body is made from Cyclo-Olefin Copolymer (COC) and the stopper from Thermoplastic Elastomer (TPE), meeting USP and EP standards. The vials are available in six sizes, ranging from 1 ml to 50 ml.

Filling Lines
A range of filling lines, from manual to fully automated, are available to suit different stages of product development and commercialization. These lines can be used in BSC/RABS or SKAN isolators for enhanced safety.

Filling Process
The filling process involves three steps: filling through the stopper with a sterile needle, laser re-sealing of the stopper, and capping with a sterile snap-fit cap.

Packaging Options
The vials are available in three packaging configurations: AT-CryoBox™, AT-Nest™, and AT-Tray™, accommodating different vial sizes and storage needs.

Additional Features
The AT-Adapt™ is a needleless collection device compatible with vials from 2ml to 50ml. A full Validation Master Plan is provided, along with certifications including ISO 9001:2015 and ISO 15378:2017.

Contact Information
Contact details for Aseptic Technologies and SKAN offices in Belgium, Switzerland, Germany, USA, and Japan are provided for further inquiries.

Catalog excerpts

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

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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...

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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.

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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...

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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...

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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...

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All Aseptic Technologies catalogs and technical brochures

*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.

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