Fill finish solutions

Cellana XL1

Robotic fill finish line for the AT-Closed Vial® with 100 % IPC

Application type: Aseptic(-toxic)
Customization level: Modular configuration

Containers

AT-Closed Vial®
Objects per hour

Up to 700
Filling volume

0.1-45 ml
Filling line

AT

Cellana XL1 at a glance

100 % IPC for maximum safety for ATMP filling

Filling accuracy

100% IPC of weight for each vial, supported by automated calibration for consistent dosing accuracy
Sterility assurance

Fully automated robotic filling process, AT-Closed Vial® technology and integrated skanfog H₂O₂ decontamination
Reduced contamination risk

Bulk product containers remain outside the isolator and connect via the AT-Port aseptic liquid transfer system
Regulatory compliance

Fully aligned with GMP and 21 CFR Part 11 requirements with comprehensive validation package
Single-use pathways

Disposable filling kits and closures ensure product integrity and reduce cleaning validation needs
Versatility

Adaptable to all sizes of the AT-Closed Vial® (1–50 ml)
Ideal for scale-up

Built on modular technology platform for smooth scaling-up strategies
Efficiency

Rapid decontamination cycles (<20 minutes) and fast changeover due to minimal format parts

Application

Scale-up of filling capacity for ATMPs

For biopharmaceutical manufacturers, CROs, and C(D)MOs

Suitable for biotech products like vaccines, or personalized medicines in small batch sizes.
For cell and gene therapy production

Designed for handling intermediates such as viral vectors, plasmid DNA, and mRNA within an aseptic environment.
For scale-up from clinical to commercial

Facilitates regulatory compliance and smooth transfer from small-scale (e.g. pure² M1) to automated production through modular duplication.

Fill Finish

The AT-Closed Vial® system

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

Fully automated fill and finish process within a Grade A isolator environment

1

Material transfer

Vials and consumables are transferred via the rapid decontamination airlock.
2

Bulk product connection

Outside of the isolator, connected aseptically via the AT-Port System.
3

Vial handling

A robotic arm collects the AT-Nest from storage and picks individual vials.
4

Empty weighing

The initial vial weight is recorded.
5

Filling

Vials are filled through the stopper using a non-coring needle to preserve closure integrity.
6

Laser resealing

The stopper is resealed with a one second laser shot.
7

Final weighing

Final weight is recorded for 100% IPC.
8

Capping and return to nest

A snap-fit AT-Cap is applied. The processed vial is placed back into its nest.
9

Repetition and extraction

The cycle continues until all vials in the nest are processed. Completed AT-Nest are transferred out through the exit transfer system.

Product highlights

Advanced filling line for ATMPs

Filling accuracy and automated process

100 % in-process weight control combined with automated calibration ensures consistent dose accuracy for every vial. The dual robot equipment fills up to ten AT-Nest with the highest accuracy, without any manual intervention.
Commercial scale-up

Cellana XL1 is built for commercial-scale production, offering fully automated vial handling, high throughput, and advanced IPC. It enables seamless scale-up from semi-automated systems while preserving dosing accuracy and process consistency.
Rapid, validated workflows

Integrated skanfog H₂O₂ decontamination technology and the nanox catalyst ensure validated decontamination and safe exhaust in under 20 minutes. Combined with single-use assemblies and minimal format parts, the system enables fast changeovers between products or batches.

Regulatory requirements

Highest regulatory standards with the AT-Closed Vial® Technology

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.
Reliable validation

Delivered with a validation master plan and a complete test package for the AT-Closed Vial® process.

Cellana XL1 - 100 % IPC for maximum safety for ATMP filling.

Technical specifications

Standard working chamber

2000 × 1417 × 3000 mm (W × D × H)
Footprint

Compact, modular design, minimal cleanroom space requirement

Output

Up to 700 AT-Closed Vial® per hour
Filling volume

0,1 ml to 45 ml
Consumables

Single-use materials only

Cleanroom requirement

Operation in Grade C
Working chamber

Grade A (ISO 5)
Decontamination

Integrated skanfog decontamination system and nanox catalyst for validated decontamination and exhaust management

Aseptic liquid transfer

AT-Port System
Material transfer

Rapid airlock with integrated H₂O₂ decontamination

Robotics

Six-axis robotic handling with short changeover times
In Process Control

Automated 100 % IPC of weight
Compliance

21 CFR Part 11- and Annex 1-compliant

FAQ

Cellana XL1 is an automated fill-and-finish line for AT-Closed Vial®. It combines robotic handling, 100% in-process weight control, and SKAN isolator technology to ensure sterility, accuracy, and efficiency in pharmaceutical and biotechnology manufacturing.
Yes. The Cellana XL1 is modular and compatible with other Cellana isolator modules, enabling manufacturers to scale up production and adapt workflows as demand increases.
Sterility is maintained through closed vial technology, an integrated Grade A isolator, and automated H₂O₂ decontamination. Material transfer is secured via rapid airlocks and the AT-Port liquid connector. Automation minimizes operator involvement, reducing contamination risks
The system is compatible with all AT-Closed Vial® formats from 1 ml to 50 ml. The validated filling range covers 0.1 ml to 45 ml, making it suitable for both small clinical batches and large-scale production.
Thanks to its integrated isolator and decontamination technology, the Cellana XL1 is designed for installation in Grade C cleanrooms. This reduces facility costs compared to systems requiring higher-grade environments.