FAQs

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

• Enables safe cryogenic storage of the injectable drug product and its intermediate cGMP-grade products;
• Ensures container closure integrity (CCI) in cryogenic temperatures;
• Enables quick and safe fill & finish operations thanks to our Aseptic Technologies filling lines.
• Ensures a safer containment, with less particles than glass vials, as molded and assembled in a ISO5 environment: 
  
• Delivered sterile to customer (SAL 10^-6)

The AT-Closed Vial^® is produced in the following volume formats: 1 mL, 2 mL, 6 mL, 10 mL, 20 mL, 50 mL.

Three different packaging configurations exist to better fit your needs: the AT-CryoBox, the AT-Nest and the AT-Tray. The AT-CryoBox is suitable for cryogenic storage.

The AT-Closed Vial^® container is made from Cyclic Olefin Copolymer (COC). The AT-Closed Vial^® stopper is made from Thermoplastic Elastomer (TPE).

The AT-Closed Vial^® maintains a complete container closure integrity at very low temperatures, up to liquid nitrogen.

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.

All AT-Closed Vial^® orders are shipped from Aseptic Technologies in Belgium and can be shipped all over the world.

Yes, it is part of our VMP. It is provided with any equipment purchase, and you can also contact us to request a review of this data under CDA.

We can send you samples for compatibility study.

You can also rent our Crystal M1 Filling Line to test our vials and fill & finish solutions. Please get in touch with us for more information.

Depending on the chosen filling line, the AT-Closed Vial^® technology can be easily implemented at your site in as fast as two months.

The scalability of the technology is assured with our range of filing lines, from the manual Crystal M1 to the automated 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).

Our AT-Closed Vial^®, AT-Cap, AT-Filling Kit and AT-Connect, are all sterilized by gamma irradiation.

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.

Aseptic Technologies was founded in 2002 to revolutionize the fill & finish processes by making them safer, simpler, and cleaner.

From a small startup in 2002, the company has grown to become a strong actor in the industry, with customers worldwide.

The  M1 is a manual equipment that can fill up to 180 AT-Closed Vial^® per hour.

The  L1 is a semi-automated equipment that can fill up to 500 AT-Closed Vial^® per hour.

The  XL1 is an automated equipment, capable of 100% IPC, which can fill up to 675 AT-Closed Vial^® per hour.

The M1 Filling Line can be installed in a BSC or integrated in an isolator.

The L1 and XL1 Filling Lines are integrated in either a RABS or an isolator.

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.

All Filling Lines need electricity to operate. Depending on the chosen containment, some additional utility might be needed.

Yes, all our products are designed to be compatible with H₂O₂ decontamination and operations within isolators.

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-Port handle weights exactly 884 grams and can be easily handled by any operator.

By using the AT-Connector (or AT-Connect for smaller batches), you can easily and safely transfer your product from its bulk containment to the filling line.

You can connect and disconnect the AT-Connect (or AT-Connector) to the AT-Port while maintaining aseptic conditions.

A comprehensive Validation Master Plan (VMP) for the AT-Assembly is available upon request.

To avoid cross-contamination risks, it is recommended to discard the AT-Assembly after each use.

Yes, we can customize the AT-Assembly to fit your process needs. Please get in touch with us to know more.

The AT-Assembly can be used in all Aseptic Technologies equipment. We can also develop with you a solution that would fit your specific needs.

The shelf-life of the AT-Assembly is two years.

They are adaptable to all critical aseptic fluid transfer steps, including filling, sampling, filtration, storage, and distribution. Assemblies are designed to support applications from research and development to commercial manufacturing.

Assemblies are produced in ISO 7 cleanrooms, sterilized (SAL 10-6) or gamma-irradiated, and released by a qualified person (QP). Comprehensive validations – covering integrity, endotoxins, bioburden, and transport – ensure compliance and reliability.

Yes. Each assembly is tailored in collaboration with your team. We co-develop prototypes, align them with process feasibility, and scale up to manufacturing while maintaining sterility and regulatory compliance.

Yes. The packaging was tested after a full isolator decontamination cycle, and no trace of H2O2 was found inside the packaging.

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.

• Pharma: sterile connectors, vial adapters, fill & finish parts, etc.
• Biotech: single-use fluid transfer, sampling ports, etc.
• Diagnostics: cartridges, microfluidic housings, etc.
• Medical devices: closures, protective components, etc.

We provide the following services and expertise:

• ISO 8 to ISO 5 cleanrooms for sterility by design
• End-to-end in-house control of design, molding, and assembly
• Documentation and traceability for regulatory compliance

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.

The laser etching takes up less than 20 seconds per vial.

Yes, the AT-Etcher has been designed to engrave both room-temperature and frozen vials, allowing last-minute, pre-shipping etching of crucial information.

No, the AT-Etcher™ is only compatible with all sizes of Aseptic Technologies AT-Closed Vial^®.

Yes, all our products are shipped with the relevant certificate of conformity. Additional certificates can be released upon request.

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.

On-site audits are also possible.

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.

Drug Master Files (DMF) have been registered to the American FDA for the AT-Closed Vial^® and the AT- Cap™.

SKAN Life Cycle Support accompanies you throughout the full lifecycle of your system. After installation, our team provides qualification, preventive maintenance, operator training, troubleshooting assistance (remote or on-site), and access to spare parts and retrofit solutions.

Our support team aims to respond as quickly as possible; response time depends on location and the nature of the issue.

Absolutely. SKAN offers on-site, remote, and in-house (AT) training sessions for operators, supervisors, and maintenance staff. For more advanced technical training, customers can join the AT Academy.

Please get in touch with us via the contact form, one of our team members will get back to you as soon as possible.