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.
The AT-Closed Vial® technology is designed in Belgium, at Aseptic Technologies, and then manufactured at dedicated third-party production sites in France and Germany.
The scalability of the technology is assured with our range of filing lines, from the manual Crystal® M1 to the automated Crystal® L1 and XL1 Robot Lines.
The shelf-life of the AT-Closed Vial® depends on the packaging configuration, with a minimum shelf life of 2 years. Please get in touch with us for more details.
The AT-Closed Vial® should be stored in a dry environment at room temperature, anywhere between 15°C to 25°C (59°F to 77°F).
We have three different packaging configurations to better fit your needs: the AT-CryoBox™, the AT-Nest™ and the AT-Tray™. The AT-CryoBox™ is suitable for cryogenic storage.
Since 2011, Aseptic Technologies is a member of SKAN Group. Leveraging each other’s technological excellence, we provide integrated solutions for fill & finish projects together.
The operator does not need any specific equipment to operate the Aseptic Technologies Filling Lines.
Attention, a specific site policy might require the operator to wear safety equipment, even if it is not required by Aseptic Technologies to operate the Filling Line. Please refer to your site Health & Safety measures for any specific requirement.
Yes, as member of SKAN Group, we can offer you the best integrated solutions by combining our advanced expertise with Aseptic Technologies Filling Lines and SKAN isolators.
The AT-Port is compatible with all Aseptic Technologies equipment and can easily be installed on your isolator/RABS/cleanroom to transfer your product in aseptic conditions.
The AT-Port is also compatible with any process that requires fluid transfer between areas with different containment levels.
The AT-Cellyx is designed to streamline the final processing of cell therapy manufacturing by combining controlled mixing and cooling into one integrated device, ensuring optimal product homogeneity and thermal stability before the filling step.
The AT-Cellyx can handle bulk sizes ranging from 0.25 liters to 5 liters, with 0.5-liter bags being the most commonly used. It is compatible with bag ranges of 0.25L, 0.5L, 1L, 2L, and 5L.
An optional in-line cell counter can be added to provide real-time cell concentration monitoring before filling. While the cell counter is a standalone Windows device, it is physically encapsulated by the AT-Cellyx unit.
The AT-Cellyx is designed to ensure no shear stress to cell and no foaming/splashing during mixing. It also maintains precise thermal control, keeping the bulk product at 4°C +/- 2°C, with capability down to 2°C (39.2°F, with capacity down to 35.6°F) to preserve cell viability and stability.
Yes, the AT-Cellyx is compatible with Aseptic Technologies’ existing closed filling systems, and the connection to existing AT systems (AT-Filling Kit, AT-Port system...) is easy, ensuring seamless integration and maintenance of sterility.
The AT-Cellyx offers a compact and easy-to-integrate solution, reducing manual handling and ensuring consistency throughout the batch. Its integrated design improves efficiency, reproducibility, and thermal control, fulfilling an industry requirement where precision, reproducibility, and process integration are critical.
Yes, the AT-Etcher has been designed to engrave both room-temperature and frozen vials, allowing last-minute, pre-shipping etching of crucial information.
It is the production of plastic components in ISO-certified cleanrooms (ISO 8 to ISO 5). This guarantees sterility, precision, and low bioburden for critical pharma, biotech, diagnostic, and medical applications.
We manage everything in-house: mold design, validation, production, cleanroom assembly, packaging, and documentation. This provides traceability, regulatory readiness, and consistent product quality. We provide you with end-to-end project management, process engineering and clear expertise to help you get the parts you need.
We handle all scales, from small pilot or prototype runs to full industrial production. Whether hundreds or millions of parts, our processes ensure reproducibility and compliance.
We can send you preparatory documentation (e.g., Quality Agreement, Site Master File, etc.) upfront, and give you access to the latest third-party licensable audit report from Rx-360.
Our Quality Team can provide a Letter of Authorization to our DMF for your IND or BLA submission, or we can guide you through our VMP to support your registration process.
We have a dedicated Aseptic Technologies Service Team in charge of installation, preventive maintenance, and troubleshooting. For the complete Service portfolio, please get in touch with us.