Single-use Transfer and Filling Solutions in Barrier Isolated Filling Lines
Improve Your Patient Safety
With our range of single-use technologies for final filling, you can reduce the risk of microbial ingress, product cross contamination and improve your patient safety. The main sources of contamination are the human interventions, the transfer of primary packaging components and the assembly of the sterile fluid path for final filling. The use of isolators combined with single-use and ready to use transfer and filling solutions reduce these sources and significantly increase the safety of your final filling process.
Biosafe® Simplifies Your Aseptic Transfer of Closure Components
Biosafe® is a unique magnetic connexion without any rotation available in inside or outside opening configuration according to Annex 1 regulation. Biosafe® bags exits in RTU (Ready to Use) and RTS (Ready to Sterilize) options that already contain your stoppers, plungers, and aluminum seals from your supplier for vials and syringes filling lines. In addition, the RTF (ready to fill) option is also available for processing your stoppers at your facility.
Biosafe® Bottle-shape 2G New Design improved Material Transfer Efficiency
Biosafe® 110 bottle-shaped bags combined with the small-foot print of the Biosafe® 110 port is a step change improvement toward enhanced aseptic processing.
Biosafe® 110 bottle-shaped bags benefits:
- Superior robustness of the beta bag
- Elevated cleanliness thanks to an automated manufacturing process
- Efficient transfer of high volumes of components
- Flexible portfolio to meet various needs in aseptic material transfer
The bottle-shaped bags are compatible with all Biosafe® 110 ports.
SART System™ Enables a Sterile Liquid Transfer
Secure Your Drug Product Transfer
The SART System™, a smaller footprint RTP system (Rapid Transfer Port), preserves the integrity of your isolator and creates a sterile transfer of your drug product. The reduced footprint of the SART System™ meets the challenge of ergonomic optimization around your formulation or filling isolator from clinical to commercial-scale operations.
Small Premium Flexsafe® 2D bags to Secure your Drug Product
Flexsafe® 2D single-use bags in custom filling sets for various final filling applications :
- Fits Small Batch Volume for personalized medicines
- Ensures Premium film quality with high assurance of supply and extensive characterization and qualification
- Maximizes product recovery and ease draining thanks to its optimized bag design
- Fast tracks validation work with highly characterized materials
- Provides a complete aseptic processing platform in combination with Biosafe® and SART™ port
Octoplus FF® Simplifies The Setup of Your Filling Line
Secure Your Final Filling:
Octoplus FF® provides a completely single-use alternative to traditional stainless steel “break tank “or “buffer tank” systems in a wide range of applications. Octoplus FF® can be configured with a large variety of components and connectors. 3 configurations are available, filling bag triple-packed, bag inside the isolator transferred through a Biosafe® port, or bag outside with a tubing transfer through a Biosafe® port.
Biosafe® RAFT System
The combination of Biosafe® RAFT bags with Biosafe® Ports enhances the sterility assurance in Aseptic Processing for Drug Product Transfer into isolators as well as transfer from different classified manufacturing USP/DSP areas at Drug Substance site. Biosafe® RAFT support modularity and flexibility and optimizes facility footprint.
Biosafe® a Safe and Easy to Use Solution
For Fast Aseptic Transfer of Closure Components
With the robust design and proven performance of the Biosafe® RTP system you can secure and simplify the transfer of your components. The multiple configurations available will match your need and overcome your contamination concerns associated to such a critical application.
One Fully Integrated Solution for Drug Product Repartition
The collaboration between two expert companies, Syntegon an expert in final filling machine and Sartorius a leader in single-use, makes you simplify the set up of your filling lines. Octoplus eliminates cleaning, sterilization and assembling of final filling parts and can be installed on your filling line in less than 10 minutes.
Biosafe® RAFT for zone-to-zone liquid transfer
The Biosafe® Rapid Aseptic Fluid Transfer (RAFT) system provides easy-to-use and reliable through-the wall aseptic transfer of liquid between clean rooms of different environmental classification while ensuring a total confinement.