Single-use transfer and filling solutions in barrier isolated filling lines

Ensure sterile, high-volume liquid transfer and final filling in pharmaceutical production with solutions designed to prevent microbial contamination and optimize process efficiency.

Facilitates Sterile Liquid and Component Transfers

Biosafe® and SART System™ from Sartorius offer a cutting-edge solution for aseptic transfer processes in pharmaceutical and biotech production lines. These systems provide unique capabilities for securely facilitating sterile transfers of liquid formulations, components, and drug products through isolators, minimizing contamination risks. Ideal for applications like vaccine production and cell and gene therapies, they maintain high-integrity transfers essential for injectable biologics and mRNA lipid nanoparticles. The Biosafe® system’s magnetic connection ensures a seamless and contamination-free process, while the SART System™ minimizes footprint and optimizes ergonomic efficiency in transfer operations. Capable of modular configuration, these systems integrate seamlessly with existing operations, simplifying setup and reducing downtime. Featuring single-use options, they eliminate the need for cleaning and sterilization, conforming to GMP and FDA standards for regulatory compliance.

Benefits

  • Enhances patient safety by minimizing microbial contamination risks.
  • Streamlines operations with quick, contamination-free setup through single-use components.
  • Integrates effortlessly into existing systems, optimizing space and ergonomics.
  • Meets strict regulatory standards, ensuring GMP and FDA compliance.
  • Reduces operational costs with simplified maintenance from single-use design.

General


Applications
Liquid formulations,Vaccines,Pharmaceutical tablets,Nutraceuticals,Monoclonal antibodies,Mrna production,Regenerative medicine,Bioconjugation,Biopharmaceuticals,Cell and gene therapy,Pharmaceutical powders
End products
Mrna lipid nanoparticles,Monoclonal antibody vials,Car-t cell therapies,Stem cell therapy solutions,Lyophilized injectable compounds,Injectable biologics,Covid-19 vaccines,Nutraceutical pills,Soft gel capsules,Ophthalmic solutions,Bispecific antibodies,Liquid oral syrups,Tablet blisters,Influenza vaccines
Steps before
Aseptic preparation,Component transfer,Sterilization,Assembly of sterile fluid path
Steps after
Sealing,Final inspection,Labeling,Packaging
Input ingredients
stoppers,plungers,aluminum seals,primary packaging components,sterile fluid
Output ingredients
filled syringes,filled vials,final drug product
Market info
Sartorius AG is renowned for manufacturing high-precision laboratory and bioprocess equipment. They specialize in filtration, fermentation, and cell cultivation systems, known for their innovation and reliability in the pharmaceutical and biotech industries.

Technical Specifications


Automation
Single-use technology
Capacity
Varies based on batch volume
Filling method
Single-use and ready to use transfer
Filling volume
Customizable to application
Filling accuracy
High assurance of supply
Filtration system
Sterile filter transfer set
Material transfer efficiency
Improved with Biosafe® bottle-shaped bags
Port size
Biosafe®110
Design
SART System™ for reduced footprint

Operating Characteristics


Automation level
Manual / PLC / SCADA
Batch vs. continuous operation
Batch / Inline Continuous
CIP/SIP
CIP 121°C / SIP 135°C
Cleaning method
CIP / Manual
Energy efficiency
0.5–2 kWh/kg moisture

Material Compatibility


Density/particle size
0.5–2.5 g/cm³ / 50–1000 µm

Product type Characteristics


Aseptic transfer
Secured by the Biosafe® RAFT system
Final filling setup
Simplified by Octoplus FF®

Physical Characteristics


Footprint
Compact / Smaller footprint
Bag shape
Bottle-shaped
Bag type
Single-use / Ready to Use / Ready to Sterilize / Ready to Fill
Bag size
Customizable
Discharge method
Tubing transfer through a port
Automation level
Reduces human intervention

Custom Options


Port Types
Biosafe®110,SART System™
Bag Options
RTU,RTS,RTF
Configuration
Bottle-shaped bags,Flexsafe®2D bags
Connector Types
Gammasart ATD™ connector
Systems and Components
Octoplus FF® configurations
Material Transfer Efficiency
Bottle-shape 2G design