Sartorius, Flexsafe-FF, Flexsafe® 2D Advanced for Fill & Finish

Flexsafe® 2D Advanced for Fill & Finish is a single-use system for small batch volumes replacing the traditional stainless steel surge tank containing the drug product in the filling area. Flexsafe® enables single-use bioprocessing throughout all process steps and all applications all using just one film.

Small Premium Flexsafe® 2D Advanced bags to Secure your Drug Product
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
With a unique material, Flexsafe® significantly reduces the validation effort and costs
Extractables and leachable studies
Toxicological assessment and stability studies

Specifications
Applications:
Application Area: Final filling
Process Step: Drug Product Final Filling

Compliance Information:
Lot Release Testing: Yes

Connections (Physical):
Connector(s): Opta® SFT Connector; KPC; Tri-clamp; MPC
Line LeakTest: 100% Leak tested in line
Port Diameter: 110 mm if RAFT configuration

Dimensions:
Dimensions: Depending on volume range
Tube Length: Upon request

Features:
Integrity Tested: No
Number of Lines: 2 - 6

General Specifications:
Tubing: Silicone (Tuflux® SIL); Silicone (Accusil™); Silicone (Liveo® Pharma Advanced Pump Tubing); TPE (Tuflux® TPE); Other platinum-cured silicone available upon request

Materials of Construction:
Film Material: Film S80: Polyethylene (PE)
Tubing Material: Synthetic Thermoplastic Elastomer; Platinum-Cured Silicone

Product Information:
Brand: Flexsafe® 2D

Sterility/Purity:
Delivery Condition: Sterile

Volume:
Volume Range: 3 L - 20 L