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Celsius® FFT 2L (Opta®/Opta®)

Celsius® FFT (Flexible Freeze & Thaw) and Celsius® FFTp (Flexible Freeze & Thaw for Plate Freezer) is a unique bag-in-shell system that replaces traditional freezing and thawing methods.

The single-use containers are sterile, pre-assembled and ready-to-use for freezing and thawing biopharmaceutical solutions in commercially available equipment with the intent to leverage your existing freeze & thaw infrastructure.

Item no.:  FZB129267

 

Celsius® FFT can be used with any type of conventional and blast freezers while Celsius® FFTp is specifically designed to be frozen in horizontal type plate freezers. Celsius® FFT | FFTp provides exceptional robustness and confidence when handling the frozen container. Celsius® FFT along with it's purpose-designed single-use shippers (Celsius® FFT Box Shipper) offers enhanced process capabilities to create a versatile approach to safeguarding your product in conventional manufacturing.

Maximum Product Security:

  • Extensive functional qualification in real process conditions
  • Confident handling protecting the complete assembly
  • Pre-qualified shipper (ASTM D4169 AL1 mechanical and ISTA7D extreme summer thermal performances)

Simple, Easy to Use Solution:

  • Closed system processing for successful aseptic processes
  • Container design promotes easy handling for operator
  • Shell design provides consistent heat transfer to each unit

Improved Process Efficiency:

  • Stackable for efficient use of freezer space
  • One-way logistics using single-use Celsius® FFT Box Shippers
  • Single-use point accountability and process expertise (bag, shell & shipper from one supplier)

Create Process Flexibility:

  • Replace bottles and carboys using existing freezers and thawing methods
  • Configurable to fit process needs, Multi-fill with design into manifold
  • Common film for efficient process development and samples in lab-scale Celsius® Paks

Celsius® FFT|FFTp provides single-use freeze & thaw solutions for every process step when frozen storage and frozen shipment are required. These containers are configured with the features needed to decouple downstream process steps and securely transport drug substances to drug product sites.

Celsius® FFT|FFTp PDS are qualified against extensive biological, chemical,physical, extractable and functional testing.

The performance and assurance of supply of our Celsius® products are based on the complete control of our manufacturing process for the resins, the film, the bags, the filters and the assemblies. Other fluid-contact components are secured by strategic partnerships, long term contracts and quality agreements.

Brochure

Celsius® Product Lines - Discover our Freezing Capabilities
en 1.6 MB

Datasheet

Celsius® FFT Single-Use Container for Flexible Freeze-Thaw Processes
en 1.7 MB

Flyer

Celsius FFT: safeguarding your drug substances in conventional FT manufacturing
en 616.0 kB

Publication

Freeze-Thaw Performance and Robustness Assessment of Celsius FFT 6 L
en 826.4 kB

Applications

  • Application Area
    Frozen Storage & Shipping
  • Process Step
    • Cell Harvest & Downstream Processing Intermediates
    • Drug Substance Purification
    • Drug Product Formulation
    • Bulk drug substance freezing and thawing
    • Process intermediates freezing and thawing

Compliance Information

  • Biocompatibility (USP Class VI)
    USP and ISO 10993-5; USP
  • Extractables
    Extractable data readily available
  • Physico-chemical Compatibility
    USP and EP 3.1.7
  • Quality Standards
    ISO 9001 and ISO 13485 for medical devices

Connections (Physical)

  • Inlet Line
    3/8" Opta® SFT Male + 3/8" ID TPE (C-Flex®) 0.38 m (15")
  • Outlet Line
    3/8" Opta® SFT Male + 3/8" ID TPE (C-Flex®) 0.38 m (15")
  • Sampling Lines
    1/8" Luer Female + Plug + 1/8" ID TPE (C-Flex®) 0.5 m (20")

Dimensions

  • Dimensions
    38.6 × 32.8 × 12.4 cm

Features

  • Sampling Option
    Yes
  • Stacking
    5

General Specifications

  • Design
    bag in shell
  • Temperature Range
    -70°C – +45°C (for use at lower temperatures contact Sartorius)

Materials of Construction

  • Film Material
    Film S71: Ethylene-vinyl acetate (EVA)

Product Information

  • Brand
    Celsius® FFT
  • Freezer Technology
    Conventional and Blast Freezers
  • Pack Size
    1

Sterility

  • Delivery Condition
    Sterile

Volumes

  • Volume
    2 L
  • Working Volume
    0.5 L – 2L
Celsius® FFT 2L 4-Unit Shipper
Item no.
FTH-SM00103-0007

The Celsius® FFT Box Shipper is a robust, qualified solution allowing safe shipment of frozen Celsius® FFT to remote locations. Celsius® FFT Box shipper is a single-use shipper refrigerated by dry-ice pellets which significantly simplifies biopharmaceuticals supply chain through one-way logistics and the transport of frozen Celsius® FFT to its destination site for thawing.

Celsius® FFT 2L 1-Unit Shipper
Item no.
FTH-SM00103-0006

The Celsius® FFT Box Shipper is a robust, qualified solution allowing safe shipment of frozen Celsius® FFT to remote locations. Celsius® FFT Box shipper is a single-use shipper refrigerated by dry-ice pellets which significantly simplifies biopharmaceuticals supply chain through one-way logistics and the transport of frozen Celsius® FFT to its destination site for thawing.