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Flexsafe® 2D Validation Bag 500 mL

Standard Flexsafe® 2D validation bags made of the new polyethylene S80 film are specially designed for small-scale studies and for validation of our Flexsafe® bag family. They are excellently suited to process development and validation testing, such as interaction studies and stability testing in a variety of process steps and applications.

Item no.:  FYB120974

Availability:  On Request

Standard Flexsafe® 2D validation bags made of the new polyethylene S80 film are designed for small-scale studies and for validation of the Flexsafe® bag family. They are available in 150 mL and 500 mL volumes to support end users’ process development and validation testing. Flexsafe® bags have been designed by combining material science and a Quality by Design approach to provide outstanding cell growth, robustness and assurance of supply for all biomanufacturing process steps.

Standard Flexsafe® 2D validation bags have been designed for process development and validation testing, such as interaction studies and stability testing in a variety of process steps and applications:

  • Buffers and media storage
  • Cell cultures
  • Downstream purification steps, such as fraction collection
  • Storage of process intermediates
  • Storage of bulk drug substances
  • Drug product storage
  • Sampling
  • Optimized additive package -> Excellent cell growth performance
  • Pharmacopeia-listed antioxidants -> Simplified toxicological assessment
  • Combined strength and flexibility of the film and the welds -> Robust, safe and easy-to-use bag suitable for all applications
  • Contracts with suppliers for back-up resin and extrusion equipment and safety stocks -> Long-term assurance of supply and business continuity plan
  • Control of resin, extrusion and bag-making process -> Reliable quality, assurance of supply and change control

Brochure

Flexsafe® — Nuevo Film de PE – Su Nuevo Punto de Referencia
es 3.0 MB
Flexsafe® - A nova pelicula de Pe - Sua nova referencia
pt 3.1 MB
Flexsafe® — New PE film. New Benchmark.
en 3.0 MB
Flexsafe® — Nouveau film en PE. Nouvelle référence.
fr 3.1 MB
Flexsafe® — Новая пленка. Новый стандарт качества.
ru 3.1 MB

Datasheet

Flexsafe 2D Validation Bags — 150 mL and 500 mL
en 285.4 kB

Product properties

  • Volume
    500 mL
  • Pack Size
    10

Technical attributes

  • Sterilization Method
    Gamma irradiation
  • Gas Barrier Layer Material
    Ethylene vinyl alcohol (EVOH)
  • Product Contact Layer Material
    Linear low-density polyethylene (LLDPE)
  • Fittings
    Female Luer Lock & Needle free sampling port, MPC Male Coupling
  • Bag Port 1
    ¼” x 7/16” x 300 mm, ¼" MPC Male Coupling, + ¼" MPC Female Cap, clamp
  • Bag Port 2
    1/4" x 7/16" x 100mm, Female Luer lock + needle-less sampling, clamp