Fill finish solutions

Cellana L1

Robotic fill finish line for the AT-Closed Vial®

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

Containers

AT-Closed Vial®
Objects per hour

Up to 500
Filling volume

0.1-45 ml
Filling line

AT

Cellana L1 at a glance

Automated filling of ATMPs

Automated robot filling

Automated filling process, minimizing contamination risks and ensuring reproducible filling accuracy
Sterility assurance

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 cGMP and 21 CFR Part 11 requirements
Single-use filling path

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

Scaling of aseptic filling applications for ATMPs

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

Suitable for biotech products, vaccines, and personalized medicines requiring stringent sterility.
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® 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

Cellana L1 integrates the AT-Closed Vial® technology within a modular SKAN isolator

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

Setup and fluid path preparation

Fluid connection inside the decontaminated chamber using glove access.
4

Filling

Vials are filled through the stopper using a non-coring needle to preserve closure integrity.
5

Laser resealing

The stopper is resealed with a one second laser shot.
6

Capping

A snap-fit AT-Cap is applied.
7

Extraction

Completed AT-Nest are transferred out through the exit transfer system.

Product highlights

Compact, modular design with small footprint

Fully automated operations

A six-axis cleanroom robot performs filling, laser resealing, and capping without manual handling. The process achieves high dosing accuracy with a peristaltic pump. Automation minimizes human error, enhances reproducibility, and ensures product quality.
Clinical to commercial scale-up

The modular design enables smooth transition from manual systems such as pure² M1 to automated mid- and large-scale production. This enables manufacturers to scale production while maintaining process consistency and meeting regulatory requirements.
Lower cleanroom requirements

Cellana L1 can operate in Grade C or D environments due to its isolator-based sterility control. This reduces the need for higher-grade cleanrooms, lowering construction and operational costs while ensuring GMP compliance and sterility.

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.
Material compliance

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

Cellana L1 - Automation for safe ATMP filling processes.

Technical specifications

Standard working chamber

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

Compact, modular design, minimal cleanroom space requirement

Output

Up to 500 AT-Closed Vial® per hour
Filling volume

0,1 ml to 45 ml
Consumables

Single-use materials only

Cleanroom requirement

Grade C/D
Working chamber

Grade A (ISO 5)
Decontamination

Integrated skanfog decontamination system and nanox catalyst for validated decontamination and exhaust management
Alternative barrier option

Also available in RABS for installation in Grade B environment

Aseptic liquid transfer

AT-Port System
Material transfer

Rapid airlock with integrated H₂O₂ decontamination

Robotics

Six-axis robotic handling with short changeover times
Compliance

21 CFR Part 11 und Annex 1 compliant

FAQs

It supports aseptic filling of ATMPs such as cell and gene therapies, viral vectors, plasmid DNA, vaccines, and cell banks.
Cellana L1 can process up to 500 vials per hour. Compatible with all AT-Closed Vial® sizes (1 to 50 ml).
Sterility is ensured by SKAN’s isolator technology providing a Grade A environment, automated H₂O₂ decontamination, and robotic operation minimizing operator interaction. The AT-Closed Vial® technology further safeguards closure integrity.
Thanks to its integrated isolator and decontamination technology, the Cellana L1 is designed for installation in Grade C or D cleanrooms. This reduces facility costs compared to systems requiring higher-grade environments.
It bridges semi-automated filling (pure² M1) to automated, higher-throughput operations. Its modular design enables replication for commercial production, ensuring reproducibility and regulatory compliance.