Aseptic filling solution for small cgmp batches
Ensure sterile and efficient filling of small-volume parenterals while maintaining product integrity and compliance with cGMP standards in critical environments.
Fills, Caps, and Seals Aseptic Products
The Spectra M1 from SKAN is a semi-automated isolated fill & finish unit designed for the precise and sterile production of small batches in pharmaceutical and biotech settings. Combining SKAN’s advanced isolator technology with Aseptic Technologies’ AT-Closed Vial® system, it ensures consistent cGMP-compliant operations. The unit features a peristaltic pump that accurately doses liquid products such as viral vectors, monoclonal antibodies, and injectable drugs, while minimizing contamination risks through its closed filling process. Its rapid decontamination cycle, facilitated by the integrated skanfog® system, allows for fast and safe operations, maintaining sterility without HVAC connections. The Spectra M1 supports a range of filling volumes from 0.1 ml to 50 ml, with the flexibility to connect to bulk materials via the AT-Port™. It is specifically designed for ease of use with an intuitive batch status tracking system, ensuring real-time monitoring of operations. This unit complies with CFR21 part 11 standards, making it a reliable choice for regulated environments focusing on personalized medicine and small-volume parenterals.
Benefits
- Enhances sterility assurance with a closed filling process, reducing contamination risks.
- Minimizes cycle times with fast decontamination, boosting operational efficiency.
- Ensures precise dosing with a high-accuracy peristaltic pump, improving product consistency.
- Streamlines small-batch operations with semi-automation, reducing manual intervention.
- Complies with regulatory standards like CFR21 part 11, ensuring seamless integration into compliant production lines.
- Applications
- Cell,Next generation biologics,Compounding,Gene therapy,Aseptic filling
- End products
- Personalized medicine doses,Viral vectors,Vaccines,Small volume parenterals,Monoclonal antibodies,Parenteral nutrition solutions,Injectable drugs
- Steps before
- Material Preparation,Homogenization,Cooling,Decontamination
- Steps after
- Capping,Resealing,Batch Status Tracking,Sterilization
- Input ingredients
- AT-Closed Vial®,AT-CryoBox™,AT-Cap™,AT-Filling Kit™,bulk product,aseptic liquid connector,AT-Port™ System
- Output ingredients
- filled vials in AT-CryoBox™,sealed and capped 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.
- Compliance
- cGMP compliant
- Filling volume
- 0.1 ml to 50 ml
- Connection type
- Aseptic connection to bulk with AT-Port™
- Cycle time
- Fast decontamination cycle with skanfog®
- Batch status tracking
- Live status on screen
- Automation
- Semi-automated
- Filling method
- Semi-automated AT-Closed Vial® process
- Decontamination time
- Fast cycle
- Pump type
- Peristaltic pump
- Accuracy
- High accuracy with integrated weighting cell
- Working Mechanism
- Semi-automated AT-Closed Vial® filling
- Integrated Steps
- Filling,laser-resealing,capping
- Batch Size
- Small cGMP batches
- Aseptic Connection
- AT-Port™ System
- Decontamination Cycle
- Fast with skanfog®
- Batch Status Tracking
- Live on built-in screen
- Automation Level
- Semi-automated
- Cycle Time
- Fast
- Density/particle size
- 0.5–2.5 g/cm³ / 50–1000 µm
- Container type
- AT-Closed Vial®
- Machine Footprint
- Compact
- Discharge Method
- Mousehole and exit laminar airflow
- Control Panel Type
- Integrated screen in isolator chamber
- Filling Volume
- 0.1 ml to 50 ml
- Closed Filling Process
- AT-Closed Vial®
- Control panel type
- Integrated HMI
- Decontamination option
- skanfog® rapid cycle
- Connection type
- Aseptic liquid connection with AT-Port™
- Filling volume range
- 0.1 ml to 50 ml
- Process integration
- AT-Closed Vial® technology
- Automation level
- Semi-automated