Medicine filling and sealing machine Cellana XL1

for the pharmaceutical industryfor vialsfully-automatic

Overview
The Cellana XL1 is a robotic fill-finish line engineered for the AT-Closed Vial® system to enable a fully automated, closed aseptic filling workflow for ATMPs and other biotech products. It integrates 100% in-process control (IPC) by weight and supports modular scale-up from clinical to commercial throughput.

Capacity & key figures

• Containers: AT-Closed Vial®
• Throughput: Up to 700 vials/hour
• Filling volume: 0.1–45 ml (validated)
• Filling line type: AT

Primary benefits

• 100% IPC by weight for every vial with automated calibration to ensure dosing consistency
• Closed aseptic processing with robotic handling, AT-Closed Vial® technology and integrated skanfog H₂O₂ decontamination
• Reduced contamination risk: bulk product remains outside the isolator and connects via the AT-Port aseptic transfer
• Regulatory readiness: designed for GMP, 21 CFR Part 11 and Annex 1 alignment; delivered with validation documentation
• Single-use consumables: disposable filling kits and closures to protect product integrity and reduce cleaning validation
• Versatile: supports AT-Closed Vial® sizes from 1 to 50 ml
• Modular scale-up: platform architecture enables duplication for higher throughput
• Fast changeovers and short decontamination cycles (typically under 20 minutes)

Application

• Target users: biopharmaceutical manufacturers, CROs, C(D)MOs
• Suitable for: vaccines, personalised medicines, cell and gene therapies (viral vectors, plasmid DNA, mRNA) and scale-up from clinical to commercial production

AT-Closed Vial® system
The AT-Closed Vial® combines primary vials, snap-fit AT-Cap closures and single-use AT-Assembly for sterile liquid transfer to provide a contamination-controlled, closed primary packaging system suitable for scalable aseptic production.

Process (high level sequence)

• Material transfer: vials and consumables introduced via rapid decontamination airlock
• Bulk product connection: aseptic connection made outside the isolator using the AT-Port System
• Vial handling: robotic arm retrieves AT-Nest and picks individual vials
• Empty weighing: initial vial weight recorded
• Filling: non-coring needle fills through the stopper
• Laser resealing: stopper resealed with a one-second laser shot
• Final weighing: final weight recorded to provide 100% IPC
• Capping and return: snap-fit AT-Cap applied and vial returned to nest; completed nests transferred out

Product highlights

• Dual-robot configuration for parallel handling of multiple AT-Nest units without manual intervention
• Commercial scale-up capability while maintaining dosing accuracy and process consistency
• Integrated skanfog H₂O₂ decontamination with nanox catalyst for validated decontamination and controlled exhaust
• Short validated workflows and rapid changeovers enabled by single-use assemblies and minimal format parts

Regulatory & validation

• Process design aligned with Annex 1 to minimise interventions and contamination risk
• Container Closure Integrity (CCI): validated test methods available (dye ingress, CT scan, headspace analysis)
• Delivered with a validation master plan and complete test package for the AT-Closed Vial® process

Technical specifications (summary)

• Working chamber (W×D×H): 2000 × 1417 × 3000 mm
• Footprint: compact, modular design with minimal cleanroom space requirement
• Output: up to 700 AT-Closed Vial® per hour
• Filling range: 0.1–45 ml (validated)
• Consumables: single-use only
• Cleanroom requirement: designed for Grade C installation; working chamber Grade A (ISO 5)
• Decontamination: integrated skanfog H₂O₂ system with nanox catalyst
• Transfer systems: AT-Port aseptic liquid transfer; rapid airlock with integrated H₂O₂ decontamination
• Robotics: six-axis handling; dual-robot option
• In-Process Control: automated 100% IPC by weight
• Compliance: GMP, 21 CFR Part 11 and Annex 1 aligned

Model & product data

• Model: Cellana XL1
• Brand: SKAN
• Primary packaging: AT-Closed Vial® (supported sizes 1–50 ml)
• Validated filling range: 0.1–45 ml
• Maximum throughput: up to 700 vials/hour
• Standard working chamber dimensions: 2000 × 1417 × 3000 mm (W × D × H)
• Cleanroom/isolator: designed for Grade C installation with Grade A (ISO 5) working chamber
• Decontamination: skanfog H₂O₂ + nanox catalyst (validated)
• Transfer: AT-Port aseptic liquid transfer; rapid decontamination airlock
• Automation: six-axis robots, dual-robot option, modular platform
• IPC: 100% in-process weight control with automated calibration
• Consumables: single-use filling kits and closures
• Regulatory: delivered with validation master plan; GMP, 21 CFR Part 11 and Annex 1 aligned