Skip to content
Accessories & consumables, Filling consumables

AT-Closed Vial®

Vial system for closed filling processes

Compatibility
AT filling lines
Customization level
Standardized
AT-Closed Vial® at a glance

Innovative primary packaging for closed aseptic filling

  • Maximum product safety

    Closed filling process eliminates airborne contamination risks

  • Validated container closure integrity (CCI) down to -196 °C

    Reliable integrity even under cryogenic conditions

  • Reduced resource consumption

    No WFI consumption and reduced overfill requirements

  • Low validation effort

    High process reliability enables fast validation of filling processes

  • High process efficiency

    Fast filling cycles combined with a zero-error process approach

  • Scalable platform

    Compatible with AT filling solutions from development to commercial production

  • Flexible barrier systems

    Compatible with AT filling solutions in BSC, RABS, and isolators

  • Broad vial range

    Six sizes to cover various dosing requirements

Application

Closed vial technology for advanced biopharmaceutical processes

  • For ATMPs and cell and gene therapies

    Designed for the aseptic filling of autologous and allogeneic therapies, viral vectors, and cell banks. Supports critical requirements such as limited processing times and high product sensitivity.

  • For biotech companies, hospitals, and research institutions

    Applicable from research through clinical phases to commercial manufacturing – compatible with manual, semi-automated, and fully automated AT filling lines.

  • For cryogenic storage and intermediates

    Enables safe storage and transport of products and GMP intermediates at temperatures down to -196 °C without loss of integrity or functionality.

Fill Finish

The AT-Closed Vial® ecosystem

The AT-Closed Vial® system enables a fully closed aseptic filling process.

At its core is the AT-Closed Vial® as the primary packaging, combined with the AT-Cap as closure, complemented by suitable filling lines and the single-use system AT-Assembly for sterile liquid transfers.

All components are fully aligned, ensuring a consistent, contamination-controlled, and scalable process.

Process

Closed filling and storage process with AT-Closed Vial®

  • 1

    Vial provision

    Vials are delivered pre-closed, gamma-sterilized, and ready to fill. Manufacturing and assembly take place under ISO 5 conditions, including comprehensive quality control and CCI verification.

  • 2

    Aseptic filling

    The vial is punctured with a sterile needle through the stopper. Due to its elastic properties, the stopper reseals immediately. Airborne contamination is prevented as the system remains closed.

  • 3

    Laser re-sealing

    The stopper is resealed using a one-second laser shot, restoring container closure integrity after puncturing.

  • 4

    Capping

    A sterile snap cap is applied to secure the stopper until product use and protect against tampering.

  • 5

    Cryogenic storage

    After filling, inspection, and labeling, the vials can be frozen (typically at -80 °C) and, if required, stored in liquid nitrogen (LN₂) before delivery to the clinical site.

Product highlights

Comprehensive solution for aseptic filling

  • Close-up of an automated mechanical gripper placing a pink cap onto a small glass vial in a sterile production environment.

    Uncompromising container closure integrity (CCI)

    Validated CCI is ensured, which is critical for cryogenic storage. Robustness is achieved through vial design, polymer selection, ISO 5 assembly, and the closed filling method. The COC body and TPE stopper form a chemical bond, enhancing integrity at low temperatures. Validated methods such as dye ingress testing, CT scans, and laser-based headspace analysis confirm CCI.

  • A close-up of an automated filling needle piercing the blue stopper of a 1ml vial.

    Risk reduction in aseptic filling

    The functionally closed process eliminates airborne contamination risks. Unlike open vial methods, filling occurs through a resealable stopper, ensuring the vial remains closed at all times. This approach reduces product loss and significantly improves aseptic safety during filling and finishing.

  • Optimized for cryopreservation

    Validated for long-term cryogenic storage at temperatures down to -196 °C. Polymer components with similar deformation behavior and the chemical bond between stopper and vial body ensure reliable integrity even under extreme conditions.

Regulatory requirements

Highest regulatory standards

  • Annex 1-compliant process design

    The closed filling approach supports requirements for minimized interventions and reduced contamination risks.

  • Container Closure Integrity (CCI)

    Validated test methods (e.g., dye ingress, CT scan, headspace analysis) provide robust, regulatory- compliant proof of integrity.

  • Material compliance

    All materials for the vials meet relevant requirements (USP/EP) for primary packaging.

Technical specifications

  • Vial sizes

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

  • Filling volume

    0.1 ml to 45 ml

  • Materials

    COC (vial), TPE (stopper)

  • AT-CryoBox

    9-25 vials (cryogenic suitable)

  • AT-Nest

    25-88 vials

  • AT-Tray

    91-377 vials

  • AT-Adapt

    Needle-free extraction for 2–50 ml vials

FAQs

  • Reduction of contamination risks while maintaining validated container closure integrity – even under cryogenic conditions.

  • Through the combination of suitable polymer materials, chemical bonding between stopper and vial, and controlled ISO 5 manufacturing. Validated testing methods confirm tightness.

  • Yes. It is compatible with AT filling solutions across different automation levels and can be used from development to commercial production.

  • Unlike open glass vial processes, the system remains closed during filling, significantly reducing contamination risks and improving cryogenic performance.

Download

Related products

Related services

Get in touch!

Whether you have a question about our products, need technical support or would like to find out more about our solutions.

Back to top