Peristaltic filling machine Cellana L1

fully-automaticrobotizedline-type

Overview
The Cellana L1 is an automated isolator fill‑finish line by SKAN for AT‑Closed Vial® primary packaging. It delivers a fully closed aseptic filling process with integrated H2O2 decontamination, nanox catalyst exhaust control and six‑axis robotic handling to ensure sterility control, GMP compliance and reproducible high‑accuracy filling.

Key features

• Automated robotic filling: fully automated operations minimizing manual interventions and contamination risks while ensuring repeatable dosing accuracy.
• Sterility assurance: AT‑Closed Vial® ecosystem combined with integrated skanfog H₂O₂ decontamination and nanox catalyst for validated decontamination and controlled exhaust.
• Minimized contamination risk: bulk product remains outside the isolator and connects aseptically via the AT‑Port aseptic liquid transfer system.
• Regulatory support: designed for cGMP and 21 CFR Part 11; supports Annex 1‑compliant process design.
• Single‑use fluid path: disposable filling kits and closures reduce cleaning validation scope and protect product integrity.
• Flexible vial sizes: compatible with AT‑Closed Vial® sizes 1–50 ml.
• Scalable modular platform: enables clinical‑to‑commercial transfer and replication for higher throughput.
• Fast turnaround: rapid decontamination cycles (<20 minutes) and shortened changeover due to minimal format parts.

Application

• Intended for biopharmaceutical manufacturers, CROs and C(D)MOs handling ATMPs.
• Designed for cell & gene therapy and other biologics including viral vectors, plasmid DNA and mRNA.
• Suitable for vaccines, personalized medicines and sterile biotech products requiring strict aseptic control.
• Facilitates scale‑up from clinical small batches to automated mid‑ and large‑scale production.

Process flow (primary steps)

• Material transfer: vials and consumables introduced via a rapid decontamination airlock into the isolator environment.
• Bulk connection: aseptic connection of bulk product outside the isolator using the AT‑Port System.
• Setup & fluid path preparation: fluid connections completed inside the decontaminated chamber via glove access.
• Filling: non‑coring needle fills through the stopper; peristaltic pump dosing provides high accuracy.
• Laser resealing: stopper resealed with a ~1‑second laser shot.
• Capping: snap‑fit AT‑Cap closure applied.
• Extraction: completed AT‑Nest units removed via the exit transfer system.

Product highlights

• Compact modular footprint optimized for minimal cleanroom space requirement.
• Six‑axis cleanroom robot performs filling, laser resealing and capping without manual handling.
• Enables installation in Grade C/D facilities due to isolator‑based sterility control; supports RABS option for Grade B.
• Modular design supports duplication for increased throughput and clinical‑to‑commercial scale‑up.

Regulatory & quality aspects

• Annex 1‑compatible process design minimizing interventions and contamination risk.
• Container closure integrity (CCI) validated by dye ingress, CT scan and headspace analysis as examples.
• Primary packaging materials meet relevant pharmacopoeial requirements (USP/EP).

Technical specifications

• Commercial name: Cellana L1
• Brand: SKAN
• Standard working chamber (W × D × H): 2000 × 1417 × 3000 mm
• Footprint: compact, modular design for minimal cleanroom space
• Containers: AT‑Closed Vial® (1–50 ml)
• Output / Throughput: up to 500 AT‑Closed Vial® per hour
• Filling volume range: 0.1–45 ml
• Filling line type: AT (AT‑Closed Vial® ecosystem)
• Consumables: single‑use filling kits and closures
• Robotics: six‑axis robotic handling with short changeover times
• Filling technology: peristaltic pump dosing; non‑coring needle filling through stopper
• Decontamination: integrated skanfog H₂O₂ system and nanox catalyst; rapid cycles <20 minutes
• Working chamber classification: Grade A (ISO 5)
• Recommended facility cleanroom: Grade C/D (isolator); RABS option for Grade B
• Automation & compliance: 21 CFR Part 11 and Annex 1 compatible
• Additional components: AT‑Port System, AT‑Cap, AT‑Assembly single‑use transfer system
• Laser resealing: ~1 second laser shot