Aseptic filling station for small batch processes
Streamline small batch manufacturing with a tabletop filling station that reduces contamination risks and enhances precision in filling and capping operations, ideal for cell therapies and next-gen biologics.
Fills, Seals, and Caps Aseptic Vials
The Crystal™ M1 Filling Station by SKAN Group is a tabletop solution tailored for precise aseptic filling tasks in the pharmaceutical and biotech sectors. Its standout feature is utilizing the AT-Closed Vial® system to maintain functional closure throughout the process, thereby minimizing contamination risks. Ideal for operations such as engineered T-cells, mRNA vaccines, and monoclonal antibodies, this station supports up to 200 vials per hour with filling volumes ranging from 0.1 ml to 50 ml. The manually operated system seamlessly integrates into a biosafety cabinet or isolator, offering flexibility and ease of use for small, personalized batch production.
The process involves individual vial filling through a secure stopper, followed by laser re-sealing and snap-fit capping, ensuring a sterile environment for sensitive products. The equipment is ready for on-site setup in just six weeks and can be installed and qualified within a day, facilitating swift adoption. Fabricated to comply with cGMP standards, it caters to R&D, process development, and production scale-ups, with single-use, tool-less format changes guaranteeing a reproducible and scalable process.
Benefits
- Reduces contamination risks with closed vial technology for safer aseptic processing.
- Enables rapid deployment with quick setup and qualification, minimizing production interruptions.
- Adapts to varied production needs through flexible batch processing from 0.1 ml to 50 ml.
- Simplifies changeovers and maintenance with single-use, toolless format options.
- Enhances compliance and safety with cGMP-aligned processes suitable for pharmaceutical and biotech applications.
- Applications
- Cell,Next generation biologics,Compounding,Gene therapy,Aseptic filling
- End products
- Sterile syringes,Personalized medicine doses,Monoclonal antibodies,Ophthalmic solutions,Custom medicinal compounds,Mrna vaccines,Engineered t-cells,Parenteral nutrition bags
- Steps before
- Bulk product preparation,Dosing system calibration,Laser control unit calibration,AT-Filling Kit connection
- Steps after
- Laser re-sealing,Capping,Processed vial extraction,Batch validation
- Input ingredients
- bulk product,AT-Filling Kit
- Output ingredients
- filled AT-Closed Vial,snap fit AT-Cap,processed vials
- 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 speed
- Up to 200 AT-Closed Vial®/hr
- Filling volume
- 0.1 ml to 50 ml
- Installation time
- Installed and qualified in 1 day
- Validation
- Easy validation
- Material Type
- Single-use material only
- Changeover
- Toolless format change
- Delivery time
- At your site in 6 weeks
- Filling accuracy
- High filling accuracy
- Batch vs. continuous operation
- Batch
- Cleaning method
- Manual
- Installation time
- 1 day
- Validation process
- Easy validation
- Filling volume range
- 0.1 ml to 50 ml
- Filling speed
- Up to 200 vials per hour
- Automation level
- Manual
- Re-sealing technology
- Laser re-sealing
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Footprint
- Tabletop
- Vial Size
- 0.1 ml to 50 ml
- Filling Speed
- Up to 200 vials per hour
- Installation
- For standard biosafety cabinet
- Flexibility
- Installed in Biosafety Cabinet or Isolator
- Changeover Time
- Toolless format change
- Weight
- Not specified
- Dimensions
- Not specified
- Material
- Single-use material only
- Control panel type
- Manual
- Integration with Biosafety Cabinet or Isolator
- Yes
- Toolless format change
- Yes
- Flexibility for AT-Closed Vial® technology
- Yes