Flexsafe® 2D Advanced PVC - Type 1 - 5 L

Tech Support Documents
Flexsafe® 2D Advanced PVC - Type 1 - 5 L
 

The Sartorius Flexsafe® 2D Advanced PVC bags are designed for fluid handling in cell and gene therapy production. They ensure excellent biocompatibility and regulatory compliance, making them ideal for media transfer, harvest, and final filling applications.

Volume
Item No.: 
FLS314258
Availability: 
Piece
1

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

Sartorius Flexsafe® 2D Advanced PVC Bags for Cell and Gene Therapy Production

The Sartorius Flexsafe® 2D Advanced PVC bags are the ultimate solution for fluid handling in cell and gene therapy (CGT) production. These bags are meticulously designed for media transfer, harvest, and final filling, ensuring excellent biocompatibility and regulatory compliance. Constructed using our S80 PE film, and high-quality tubing in polyvinyl chloride (PVC) and thermoplastic elastomer (TPE) for welding, they offer robust performance and flexibility for critical applications.

Key Features:

  • Versatile Design: Available in five pre-designed solutions with volumes ranging from 20 mL to 20 L, these bags are perfect for various fluid handling processes, including transfer, harvest, and media handling.
  • Biocompatibility: Flexsafe® film supports excellent biocompatibility, ensuring safe interaction with biological materials.
  • Robustness: High robustness of Flexsafe® film provides durability and reliability throughout the production process.
  • Reproducible Extractables and Leachables (E&L) Profile: Ensures a consistent and reproducible E&L profile, maintaining product purity and safety.
  • ASTM Tested and Validated: Compatible with ASTM validated shell for safe handling of high-value critical products.

Additional Benefits:

  • Confidence® Validation Services: Sartorius offers extensive validation services for extractables and leachables testing, ensuring a holistic solution for integrating single-use systems or conventional equipment into bioprocesses.
  • Regulatory Expertise: With a deep understanding of the regulatory landscape, Sartorius provides a consultative approach to address validation-related challenges.

The Flexsafe® 2D Advanced PVC bags are designed to cover all CGT fluid handling production steps, from upstream to final filling, ensuring a reliable and efficient process.

Optimize your cell and gene therapy production with Sartorius Flexsafe® 2D Advanced PVC bags – where innovation meets compliance.

Datasheet

Flexsafe® 2D Advanced
en 1.0 MB

Applications

  • Application Area
    Liquid storage & shipping
  • Process Step
    Media Preparation

Connections (Physical)

  • Connector Inlet
    Luer Lock
  • Connector Outlet
    Luer Lock
  • Connector(s)
    Luer lock
  • Inlet Line
    • Luer Lock + ¼" ID TPE (Tuflux® TPE) 0.5 m
    • Addition line: Luer Lock + 3⁄32" ID PVC (DEHP-free) 0.3 m
  • Outlet Line
    Y line: Luer Lock + ⅛" ID TPE (Tuflux® TPE) 0.3 m and Luer Lock + 3⁄32" ID PVC (DEHP-free) 0.3 m
  • Sampling Lines
    Luer Lock + ¼" ID TPE (Tuflux® TPE) 0.15 m

Dimensions

  • Tube Length
    • 0.3 m (12")
    • 0.5 m (20")
  • Tube Size (ID – OD)
    • 1/4" × 3/8" (6.4 mm × 9.6 mm)
    • 1/8" × 1/4" (3.2 mm × 6.4 mm)
    • 3/32" × 5/32" (2.4 mm × 4.0 mm)

Features

  • Number of Lines
    3

General Specifications

  • Tubing
    • TPE (Tuflux® TPE)
    • PVC (DEHP-free)

Materials of Construction

  • Film Material
    Film S80: Polyethylene (PE)

Product Information

  • Bag Type
    2D storage & shipping bag
  • Brand
    Flexsafe® 2D
  • Filter Type
    No Filter
  • Pack Size
    16

Sterility/Purity

  • Delivery Condition
    Sterile

Volume

  • Volume
    5 L