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Celsius® FFTp

Celsius® FFTp is designed for use in horizontal type plate freezers only. While similar to the Celsius® FFT concept, the shell design of Celsius® FFTp is compact and flat compared to the one in Celsius® FFT. It fits perfectly to the surface of the plate freezer to maximize heat transfer for uniform, fast and reproducible freeze and thaw processes. Two sizes of Celsius® FFTp are available, 6 L and 12 L nominal fill volume.

Item no.:  FZB115784

Availability:  On Request

Celsius® FFT can be used with any type of convential 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 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 ISTA7D extreme summer thermal performance)

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 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

The versatile range of Celsius® FFT|FFTp Pre-Designed Solutions (PDS) provide single-use freeze & thaw solutions for every process step when frozen storage and frozen shipment are required. Celsius® FFT|FFTp PDS 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. You can use our intuitive digital brochure to select your Celsius® FFT|FFTp PDS in a few seconds. PDS help speed up process design, reduce the numbers of stock keeping units (SKU’s) and hence reduce inventory management complexity and costs.

The performance and assurance of supply of PDS 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 are available in sizes of 2 L, 4 L, 6 L and 12 L nominal fill volume (6 L and 12 L nominal fill volume only for Celsius® FFTp) and feature a variety of connections to allow fluid transfer across the entire drug manufacturing process.

Inlet, sampling and outlet connectors

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

Tubes

  • Clear C-Flex® tubing allows for sterile weld connection with BioWelder® TC and sterile seal disconnection with BioSealer®
  • EVA tubing enables sterile seal disconnection with Vante™ sealer

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

  • Best quality, change control and business continuity with at least 24 months change notification
  • Best delivery reliability with available stocks
  • Compliance to quality standards such as USP <87> and USP <88>, TSE-BSE, REACH

Brochure

Discover our freezeing capabilities Celsius product lines
en 1.2 MB

Flyer

Celsius FFT: safeguarding your drug substances in conventional FT manufacturing
en 391.9 kB

Publication

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

Product properties

  • 100% Bag Chamber Leak Testing
    Yes
  • 100% Visual Inspection
    Yes
  • Bioburden (ISO11737), Endotoxin (USP 85 and EP 2.6.14), Sub-visible particulates (USP 788 and EP 2.9.19)
    Lot release testing on representative finished product
  • Biocompatibility (USP Class VI)
    USP<87> and ISO 10993-5; USP<88>
  • Change control and business continuity
    48 months notification period on Celsius® bags and 24 months on critical fluid-contact components
  • Physico-chemical Compatibility
    USP<661> and EP 3.1.7
  • TSE-BSE Status
    EMA/410/01 and EP 5.2.8
  • Primary Product Type
    2D Freezing Bags
  • System Type
    Horizontal Plate Freezers
  • Connector Inlet
    MPC Male + sealing cap
  • Connector Outlet
    MPC female + sealing cap
  • Line Inlet
    3/8" ID 15/32" OD EVA 0.3m
  • Line Outlet
    3/8" ID 15/32" OD EVA 0.3m
  • Sampling Option
    Yes
  • Thermowell
    No
  • Tubing
    EVA
  • Dimensions
    67.8 × 51.3 × 6.9 cm
  • Sterility
    Gamma irradiated
  • Pack Size
    1
  • Temperature Range
    -70°C to +45°C (for use at lower temperatures contact Sartorius)
  • Volume
    12 L
  • Working Volume
    3 L – 12L

Technical attributes

  • Quality Standards
    ISO 9001 and ISO 13485 for medical devices
  • Inlet
    Sanitary or Aseptic Connection under LAF with quick coupler
  • Outlet
    Sanitary or Aseptic Connection under LAF with quick coupler
  • Extractables
    Extractable data readily available
  • Gas Barrier Layer Material
    Ethylene vinyl alcohol (EVOH)
  • Materials of Construction
    Shell: HDPE; Screw: isoplast 101 40% LGF, natural; Nut: nylon 6/6, natural
  • Product Contact Layer Material
    EVAM®
  • Film Material
    S71
  • Pressure Range
    Max. 1 barg in transfer lines
  • Area of Application
    Frozen Storage & Shipping
  • Process Step
    • Cell Harvest & Downstream Processing Intermediates
    • Drug Substance Purification
    • Drug Product Formulation

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