Aseptic filling line for biopharmaceuticals
Streamline your aseptic filling process with precision dosing and minimal space requirements, ensuring sterility and efficiency in high-speed operations for advanced therapies and biopharmaceuticals.
Fills and Seals Sterile Injectable Vials
The Crystal™ L1 Robot Line in RABS, developed by SKAN, is a cutting-edge aseptic filling line tailored for the pharmaceutical and biotech industries. It excels in the precise filling of sterile injectable drugs, including monoclonal antibodies, viral vectors, and CAR-T cell therapies. Utilizing a high-class cleanroom 6-axis robotic arm, the system fills, seals, and caps vials with up to 500 unit throughput per hour. Its operation is managed via a Human Machine Interface, ensuring exceptional dosing accuracy. Designed to integrate into existing production lines, it features a Restricted-Access Barrier System (RABS) that maintains a controlled environment for sensitive biotherapeutics. The Crystal™ L1’s minimal footprint and single-use materials allow for rapid deployment and reduced cross-contamination risks. Furthermore, it meets cGMP and CFR 21 Part 11 compliance, ensuring adherence to industry standards while supporting scalability from pilot operations to full-scale production.
Benefits
- Enhances production efficiency with high-speed, precise vial filling.
- Simplifies compliance with cGMP and CFR 21 Part 11 standards.
- Minimizes contamination risk through single-use material utilization.
- Accelerates production scale-up with rapid, on-site installation.
- Optimizes workspace with a compact footprint and integrated RABS.
- Applications
- Next generation biologics,Compounding,Biopharmaceuticals,Cell and gene therapy,Aseptic filling
- End products
- Car-t cell therapies,Customized compounded medications,Viral vectors,Monoclonal antibodies,Sterile ophthalmic solutions,Rna vaccines,Freeze-dried biotherapeutics,Injectable drugs,Lipid nanoparticles
- Steps before
- Bulk product container preparation,Aseptic liquid connection setup,AT-Closed Vial® preparation
- Steps after
- Sterilization,Container closure integrity verification,Packing
- Input ingredients
- bulk product container,single-use material,AT-Closed Vial®,aseptic liquid connector
- Output ingredients
- filled AT-Closed Vial®,capped and re-sealed vials,processed AT-Nest™
- Market info
- Aseptic Technologies is known for its innovative solutions in the field of aseptic filling and finishing systems. They specialize in advanced equipment designed for sterile manufacturing processes, particularly in the pharmaceutical and biotech industries.
- Filling volume
- 0.1 ml to 50 ml
- Filling speed
- Up to 500 vials/hour
- Automation
- Robotic / HMI-Controlled
- Accuracy
- High dosing accuracy
- Footprint
- Minimal
- Installation time
- Installed and qualified in 1 week
- Compliant Standard
- CFR 21 part 11
- Single-use material
- Yes
- Operating environment
- Grade B
- Connection type
- Aseptic liquid connector
- Automation level
- Robotic arm / HMI controlled
- Batch vs. continuous operation
- Batch
- Changeover time
- Minimum
- CIP/SIP
- N/A (Single-use material)
- Cleaning method
- Single-use materials
- Integrated Steps
- Filling,laser re-sealing,capping
- Operating Environment
- Grade B (RABS)
- Working Mechanism
- 6-axis robotic arm
- Biological compatibility
- Aseptic filling process
- Cleanability
- Minimal footprint
- Corrosive resistance (e.g. acids)
- cGMP materials
- Single-use materials
- Yes
- Container type
- AT-Closed Vial®
- Compact footprint
- Minimal
- Machine footprint
- Small
- Filling volume
- 0.1 ml to 50 ml
- Filling speed
- Up to 500 vials/hour
- Single-use material
- Yes
- Control panel type
- HMI (Human Machine Interface)
- Discharge method
- Mousehole mechanism
- Control panel type
- Human Machine Interface (HMI)
- Integration possibilities
- AT-Port™ System for Aseptic Liquid Connection
- Robotic Arm
- 6-axis Cleanroom Robotic Arm
- Footprint
- Minimal
- Material Usage
- Single-use materials
- Filling Volumes
- 0.1 ml to 50 ml
- Vial Processing Capability
- Up to 500 AT-Closed Vial® per hour