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Celsius® FFT 12L (2T, OPTA, TPE)

Celsius® FFT 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.

It is compatible with any type of commercially available equipment (conventional and blast freeze and thaw methods).

Item no.:  FZB302504

   

Celsius® FFT with Safecore™ Technology can be used with any type of conventional and blast freezers. . With its innovative bag-in-plate design, the Safecore™ Technology provides exceptional protection to Celsius® FFT in a proven design format. Celsius® FFT along with its purpose-designed shippers (Celsius® FFT Box and 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 Operations

  • 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 with Safecore™ Technology provides single-use freeze & thaw solutions for every process step when frozen storage and frozen shipment are required. Celsius® FFT 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 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 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

Tubes

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

All fluid-contact components of Celsius® FFT 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

Datasheet

Celsius® FFT | FFTp with Safecore™ Technology
en 946.2 kB

General Specifications

  • Temperature Range
    -80°C – +45°C
  • Tubing
    Clear C-Flex® 374

Volumes

  • Volume
    12 L
  • Working Volume
    3 L – 12L

eShop Dynamic Attributes

  • Application Area
    Frozen Storage & Shipping
  • Connector Inlet
    ⅜" Opta® SFT male
  • Connector Outlet
    ⅜" Opta® SFT male
  • Film Material
    S71
  • Gas Barrier Layer Material
    Ethylene vinyl alcohol (EVOH)
  • Inlet Line
    3/8" ID 5/8" OD Clear C-Flex® 0.75m
  • Materials of Construction
    • Shell: HDPE, Screw: isoplast 101 40% LGF, natural, Nut: nylon 6/6, natural
    • natural; Nut: nylon 6/6
    • natural
  • Outlet Line
    3/8" ID 5/8" OD Clear C-Flex® 0.75m
  • Pressure Range
    Max. 1 barg in transfer lines
  • Process Step
    • Cell Harvest & Downstream Processing Intermediates
    • Drug Substance Purification
    • Drug Product Formulation
  • Product Contact Layer Material
    EVAM®
  • Sampling Option
    No
  • Stacking
    5
  • Sterilization Method
    Gamma irradiation
  • Thermowell
    No
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.

Label Placard Celsius® FFT
Label Placard Celsius® FFT
Item no.: FZA307267

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 Bulk Shipper
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. The Bulk Shipper minimizes storage and shipping density and reduces associated risks during handling. Multiple Celsius® FFT with Safecore™ Technology can be loaded per Bulk Shipper which is compatible for truck and ocean transportation as is and with any type of thermal insulated shipper with the suitable dimensions for air transportation (cargo and passenger air-craft).

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

Celsius® FFT Bulk Shipper simplifies frozen transfers by enabling bulk processing during frozen storage and shipping of Celsius® FFT with Safecore™ Technology. The Bulk Shipper minimizes storage and shipping density and reduces associated risks during handling. Multiple Celsius® FFT with Safecore™ Technology can be loaded per Bulk Shipper which is compatible for truck and ocean transportation as is and with any type of thermal insulated shipper with the suitable dimensions for air transportation (cargo and passenger air-craft).

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

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.

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