Aseptic vial filling system for gene therapy products
Elevate the sterility of your fill-and-finish process with a high-speed system designed for precision filling of advanced biotherapeutics, ensuring consistent product integrity in aseptic environments.
Fills and Seals Liquid Vials Aseptically
The Cellana XL1 from SKAN Group is an automated aseptic filling line designed for the stringent demands of pharmaceutical and biotech industries. It excels in filling and sealing liquid vials, specifically targeting applications in cell and gene therapy, next-generation biologics, and aseptic compounding. Operating with a process that includes weighing, decontamination, sealing, and capping, the Cellana XL1 ensures precise filling from 0.1 ml to 50 ml, achieving a throughput of up to 700 vials per hour with high accuracy.
Utilizing isolator technology, it integrates seamlessly into production lines, offering full GMP compliance and minimal changeover time due to its single-use materials. This line is particularly flexible, allowing for easy scalability from the Crystal® Pure M1 to larger batch processing. It features rapid decontamination airlocks for swift and clean transfer, along with 100% in-process control of vial weight.
Constructed for Grade C installations, the Cellana XL1 supports pharmaceutical manufacturers in maintaining sterility and product integrity, reducing the risk of contamination. It complies with CFR 21 Part 11 standards, offering reliable automation tailored for complex therapeutic formulations. The equipment is designed for efficient operations, with an aseptic bulk connector facilitating the streamlined introduction of bulk products.
Benefits
- Enhances product sterility and safety with isolator technology and rapid decontamination.
- Increases operational efficiency by filling up to 700 vials per hour with high accuracy.
- Minimizes production downtime with rapid changeovers using single-use materials.
- Ensures regulatory compliance with full GMP standards and CFR 21 Part 11 certification.
- Streamlines integration into existing production lines, facilitating scalable manufacturing processes.
- Applications
- Cell,Next generation biologics,Compounding,Gene therapy,Aseptic filling
- End products
- Car-t cell therapies,Viral vectors,Vaccines,Monoclonal antibodies,Mrna therapeutics,Sterile ophthalmic solutions,Injectable antibiotics,Personalized medicine vials,Cell banks,Plasmid dna
- Steps before
- Purification,Preparation of bulk product,Aseptic connection setup
- Steps after
- Laser re-sealing,Capping,Sterilization,Packing
- Input ingredients
- novel pharmaceutical products,biotech products,cell therapy products,gene therapy products,viral vectors,plasmid DNA,cell banks,bulk product,closed vials
- Output ingredients
- filled vials,capped vials,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 700 vials/hour
- Filling accuracy
- 100% weight IPC
- Automation
- Automated Filling Line
- Decontamination airlock time
- Less than 20 min
- Compliance
- CFR 21 part 11 compliant
- Material usage
- Single-use material only
- Installation Grade
- Grade C
- Automation level
- Automated
- Batch vs. continuous operation
- Batch
- Changeover time
- Minimal
- Cleaning method
- Rapid decontamination
- Filling range
- 0.1 ml to 50 ml
- Filling speed
- Up to 700 vials/hour
- Homogenization and cooling
- Bulk product homogenized and cooled
- Smooth transition
- From Crystal® Pure M1
- Weight inspection
- 100% IPC of weight
- Single-use material
- Yes
- Compatibility with viral vectors and plasmid DNA
- Yes
- GMP Compliance
- Full GMP compliance
- CFR 21 part 11
- Compliant
- Automation integration
- Compatible with isolated modules
- Changeover flexibility
- Minimal change over
- Batch size flexibility
- Filling from 0.1 ml to 50 ml
- Single-use materials
- Only single-use material
- Aseptic connector for bulk
- Yes
- Robotic integration
- Integrated robotic vial handling