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Celsius® FFTp 12L (OPTA/OPTA)

Celsius® 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.

It is compatible with horizontal plate freezers.

Item no.:  FZB302500

   

Celsius® FFTp with Safecore™ Technology can be used with horizontal plate freezers. With its innovative bag-in-plate design, the Safecore™ Technology provides exceptional protection to Celsius® FFTp in a proven design format. Celsius® FFTp along with its purpose-designed box 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
Shipping Solution
  • Celsius® Box Shipper, qualified according to the most restrictive regulations for shipping containers

Celsius® FFTp with Safecore™ Technology provides single-use freeze & thaw solutions for every process step when frozen storage and frozen shipment are required. Celsius® 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® FFTp with Safecore™ Technology is qualified against extensive biological, chemical, physical, extractable and functional testing.

The performance and assurance of supply of Celsius® FFTp 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® 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
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® 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

Datasheet

Celsius® FFT | FFTp with Safecore™ Technology
en 1.5 MB

  • Application Area
    Frozen Storage & Shipping
  • Biocompatibility (USP Class VI)
    USP and ISO 10993-5; USP
  • Connector Inlet
    3/8" Opta® SFT Male
  • Connector Outlet
    3/8" Opta® SFT Male
  • Dimensions
    69.8 × 55.4 × 6.4 cm
  • Extractables
    Extractable data readily available
  • Film Material
    S71
  • Gas Barrier Layer Material
    Ethylene vinyl alcohol (EVOH)
  • Line Inlet
    3/8" ID 5/8" OD Clear C-Flex® 0.75m
  • Line Outlet
    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
  • Pack Size
    2
  • Physico-chemical Compatibility
    USP and EP 3.1.7
  • 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®
  • Quality Standards
    ISO 9001 and ISO 13485 for medical devices
  • Sampling Option
    No
  • Stacking
    5
  • Sterilization Method
    Gamma irradiation
  • Temperature Range
    -80°C – +45°C
  • Thermowell
    No
  • Tubing
    Clear C-Flex® 374
  • Volume
    12 L
  • Working Volume
    9.6 L – 11L
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® FFTp 12L 2-Unit Shipper
Celsius® FFTp 12L 2-Unit Shipper
Item no.: FTH-SM00103-0010

The Celsius® FFTp Box Shipper is a robust, qualified solution allowing safe shipment of frozen Celsius® FFTp to remote locations. Celsius® FFTp 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® FFTp to its destination site for thawing.

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