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Celsius® FFT Bag with Safecore™ Technology 12 L (MPC/MPC)

Celsius® FFT|FFTp with Safecore™ Technology is a single-use sterile and pre-assembled container with an innovative bag-in-plate design (cassette) for exceptional protection during frozen storage and shipping of biopharmaceutical products.

Item no.:  FZB302503

 

* 72 Hours Turnaround Time

With its innovative bag-in-plate design, the Safecore™ Technology provides exceptional protection to Celsius® FFT|FFTp in a proven design format that is scalable from small to large-size single-use container. Celsius® FFT|FFTp along with its purpose-designed shippers (Celsius® FFT|FFTp Box and Celsius® FFT Bulk Shipper) offers enhanced process capabilities to create a versatile approach to safeguarding your product in conventional manufacturing.

Safecore™, bag-in-plate (cassette) design

  • Plates protect the bag and lines by adding impact resistance, suppressing wrinkles and restricting degrees of freedom
  • Excellent bag-to-plate contact provides higher robustness and more uniform freeze/thaw, plates compress the bag reducing ice bulging formation
  • Container assembly is tool-free and intuitive for minimum risk during production assembly

Maximum Robustness down to -80°C

  • Materials selection based on characterization of physical and thermal properties across wide temperature range to ensure suitable use for the intended application
  • Handling and shipping qualification built on deep understanding of mechanical stresses occurring during lifecycle for high confident performances against real-world environment
  • Storage and shipping operations down to -80°C, multiple freeze-thaw cycles, shipping qualification according to ASTM D4169 at Assurance Level 1 method

Simplified Operation

  • Plates are transparent with bag chamber fully visible for product inspection
  • Configurable with various connector/disconnector technologies, easy wipe down
  • Sample bag compartment to store/ship sample bag, label adhered to the shell for full product traceability, label placard for end-user labelling

Bulk Processing

  • Bulk Shipper minimizes storage and shipping density and reduces associated risks during handling with multiple frozen containers per pallet
  • Compatible for truck and ocean transportation in refrigerated environment as is, compatible with any type of thermal insulated shipper for air transportation
  • 2 shipping solutions: Box and Bulk Shippers, qualified according to the most restrictive regulations for shipping containers

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

Celsius® FFT|FFTp with Safecore™ Technology is qualified against extensive biological, chemical, physical, extractable and functional testing.

The performance and assurance of supply of Celsius® FFT with Safecore™ Technology 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 and are available off-the-shelf to provide best delivery reliability.

Celsius® FFT|FFTp with Safecore™ Technology is available in a variety of connections to allow fluid transfer across the entire drug manufacturing process.

Inlet and outlet connectors

  • Opta® SFT Male enables sterile connections to other single-use systems
  • MPC quick couplers are used for either sanitary connection or aseptic connection under ISO5 laminar air flow to single-use systems
  • Tubes

  • Clear C-Flex® tubing allows for sterile weld connection with Biowelder® TC and sterile seal disconnection with Biosealer® TC

All fluid-contact components of Celsius® FFT|FFTp with Safecore™ Technology are secured by supply contracts and quality agreements to provide:

  • Best quality, change control and business continuity
  • Best delivery reliability with available stocks
  • Compliance to quality standards such as USP <87> and USP <88>, TSE-BSE, REACH

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

Connections (Physical)

  • Inlet Line
    MPC Male + Sealing Cap + 3/8" ID TPE (C-Flex®) 0.75 m (30")
  • Outlet Line
    MPC Male + Sealing Cap + 3/8" ID TPE (C-Flex®) 0.75 m (30")

Dimensions

  • Dimensions
    69.8 × 55.4 × 12.8 cm

Features

  • Integrity Tested
    No
  • Stacking
    5

General Specifications

  • Design
    bag-in-plates cassette
  • Temperature Range
    -80°C – +45°C

Materials of Construction

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

Product Information

  • Brand
    Celsius® FFT
  • Freezer Technology
    Conventional and Blast Freezers
  • Pack Size
    2

Volumes

  • Volume
    12 L
  • Working Volume
    3 L – 12L
Label Placard Celsius® FFT
Item no.
FZA307267 Discontinued

Label Placard Celsius® FFT is an optional accessory which allows to securely place a label to the main container which can then remain attached throughout lifecyle.

Celsius® FFT 12L 1-Unit Shipper
Item no.
FTH-SM00103-0005

Celsius® FFT|FFTp Box Shippers are robust, qualified solutions allowing safe shipment of frozen Celsius® FFT|FFTp to remote locations. This single-use shippers refrigerated by dry-ice pellets significantly simplifies biopharmaceuticals supply chain through one-way logistics.

Spacers for 12L Celsius® FFT
Item no.
FTH-SM00101-0083 Discontinued

Celsius® FFT Bulk Shipper simplifies frozen transfers by enabling bulk processing during frozen storage and shipping of Celsius® FFT with Safecore™ Technology. Multiple Celsius® FFT with Safecore™ Technology can be loaded per Bulk Shipper when using spacers.

Sample Bag Cover Celsius® FFT|FFTp 12L

Sample Bag Cover Celsius® FFT|FFTp 12L is an optional accessory which allows to securely place a sample bag to the main container which can then remain attached to it throughout lifecyle.

Celsius® FFT Bulk Shipper
Item no.
FTH-SM00101-0082

Celsius® FFT Bulk Shipper simplifies frozen transfers by enabling bulk processing during frozen storage and shipping of Celsius® FFT with Safecore™ Technology. Multiple Celsius® FFT with Safecore™ Technology can be loaded per Bulk Shipper when using spacers.