Automated filling machine Cellana L1

modularliquidaseptic

Overview
The Cellana L1 is an automated, isolated robotic fill finish line for ATMPs designed for aseptic(-toxic) applications. It integrates AT-Closed Vial® technology with SKAN isolator technology to ensure sterility control, reproducible filling accuracy and GMP alignment. The system is modular and configurable for scale-up from clinical to commercial production.

Capacity and core data

• Containers: AT-Closed Vial®
• Objects per hour: Up to 500
• Filling volume: 0.1–45 ml
• Filling line type: AT (AT-Closed Vial® ecosystem)

Key features at a glance

• Automated robot filling: automated filling process minimizing contamination risks and ensuring reproducible dosing accuracy.
• Sterility assurance: AT-Closed Vial® technology with integrated skanfog H₂O₂ decontamination.
• Reduced contamination risk: bulk product containers remain outside the isolator and connect aseptically via the AT-Port system.
• Regulatory compliance: designed to meet cGMP and 21 CFR Part 11 requirements.
• Single-use filling path: disposable filling kits and closures reduce cleaning validation needs.
• Versatility: adaptable to all AT-Closed Vial® sizes (1–50 ml).
• Efficiency: rapid decontamination cycles (<20 minutes) and fast changeover with minimal format parts.

Application

• For biopharmaceutical manufacturers, CROs and C(D)MOs.
• Suitable for biotech products, vaccines, personalized medicines, cell and gene therapy production (viral vectors, plasmid DNA, mRNA) and cell banks.
• Facilitates scale-up from clinical small-batch systems to automated mid- and large-scale production via modular duplication.

AT-Closed Vial® ecosystem
The ecosystem enables a fully closed aseptic filling process: primary packaging AT-Closed Vial® combined with the AT-Cap closure, AT-Assembly single-use system for sterile liquid transfers and AT-Port for aseptic bulk connections. All components are aligned to maintain contamination control and process scalability.

Process (integrated steps)

• 1 Material transfer: vials and consumables transferred via a rapid decontamination airlock.
• 2 Bulk product connection: aseptic connection outside the isolator via AT-Port System.
• 3 Setup and fluid path preparation: fluid connection inside the decontaminated chamber using glove access.
• 4 Filling: vials filled through the stopper using a non-coring needle to preserve closure integrity.
• 5 Laser resealing: stopper resealed with a one-second laser shot.
• 6 Capping: snap-fit AT-Cap applied.
• 7 Extraction: completed AT-Nest transferred out through the exit transfer system.

Product highlights

• Compact, modular design with small footprint for minimal cleanroom space requirements.
• Fully automated operations using a six-axis cleanroom robot performing filling, laser resealing and capping; peristaltic pump used for high dosing accuracy.
• Suitable for installation in Grade C or D environments due to isolator-based sterility control, lowering facility requirements and costs.
• Designed for smooth clinical-to-commercial scale-up; can be replicated or expanded for higher throughput.

Regulatory and quality aspects

• Annex 1-compliant process design supporting minimized interventions and reduced contamination risks.
• Container Closure Integrity (CCI) validated using methods such as dye ingress, CT scan and headspace analysis.
• Materials comply with relevant pharmacopoeial requirements (USP/EP) for primary packaging.

FAQs (selected)

• What products can the Cellana L1 process? It supports aseptic filling of ATMPs including cell and gene therapies, viral vectors, plasmid DNA, vaccines and cell banks.
• What throughput and vial sizes are supported? Up to 500 vials per hour; compatible with AT-Closed Vial® sizes 1–50 ml.
• How is sterility maintained? Via isolator technology providing a Grade A environment, automated H₂O₂ decontamination and robotic operation to minimize operator interaction; AT-Closed Vial® technology preserves closure integrity.

Caractéristiques / spécifications techniques

• Model: Cellana L1
• Manufacturer / Brand: SKAN
• Standard working chamber (W × D × H): 2000 × 1417 × 3000 mm
• Footprint: compact, modular design — minimal cleanroom space required
• Containers supported: AT-Closed Vial® (1–50 ml)
• Output / Throughput: Up to 500 AT-Closed Vial® per hour
• Filling volume range: 0.1 ml to 45 ml
• Filling path: single-use disposable filling kits and closures
• Cleanroom installation requirement: Grade C or D (isolator provides Grade A / ISO 5 working chamber)
• Working chamber class: Grade A (ISO 5)
• Decontamination: integrated skanfog H₂O₂ system with nanox catalyst for validated decontamination and exhaust management
• Alternative barrier: RABS available for Grade B installations
• Transfer / connection: AT-Port System for aseptic liquid transfer
• Robotics: six-axis robotic handling with short changeover times
• Automation & dosing: peristaltic pump dosing for high accuracy; full automation minimizes manual handling
• Laser resealing: one-second laser shot for stopper reseal
• Capping: snap-fit AT-Cap application
• Compliance: cGMP and 21 CFR Part 11 aligned; Annex 1 supportive design
• Decontamination cycle time: rapid cycles, typically <20 minutes