Flexsafe® 2D Advanced for Fill & Finish

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Flexsafe® 2D Advanced for Fill & Finish Flexsafe® 2D Advanced for Fill & Finish Flexsafe® 2D Advanced for Fill & Finish 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.

Item No.: 
Flexsafe-FF
Availability: 
Piece
1

*Custom/bulk order quotes are provided within 72 hours of request.

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

Datasheet

Flexsafe® 2D Advanced
en 1.0 MB

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
  • SART System™ Port
    SART System™ Port
    Item no.
    M_SART_Aseptic_Transfer_Eqip

    The SART System™ is designed to secure the aseptic transfer of sterile liquid into a sterile final filling environment. With its small dimensions, the SART System™ Port can easily be installed on Isolator or RABS (Restricted Access Barrier System) panels.

  • Biosafe® Aseptic Transfer Port
    Biosafe® Aseptic Transfer Port
    Item no.
    M_Biosafe_Aseptic_Transfer_Equipment

    The Biosafe® range of Aseptic Transfer Ports offers reliable and easy-to-use solutions for the secure transfer of components and fluids. Biosafe® Aseptic Transfer Ports also effectively maintain the integrity of critical areas, including isolators, RABS and cleanrooms.