FAQs

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: 1ml, 2ml, 6ml, 10ml, 20ml, 50ml.

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 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.

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

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

The Crystal^® 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 collaborate to 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™ handle weights exactly 884 grams and can be easily handled by any operator.

By using the AT-Connect™, you can easily and safely transfer your product from its bulk containment to the filling line.

You can connect and disconnect the AT-Connect™ to the AT-Port™ while maintaining aseptic conditions.

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

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

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

The AT-Filling Kit™ 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-Filling Kit™ is two years.

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™.

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. 

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