text.skipToContent text.skipToNavigation

Celsius® FFT

Celsius® FFT can be used with any type of equipment for freezing and thawing such as laboratory freezer, cold room, temperature controlled cabinet or water bath. Four sizes of Celsius® FFT are available, 2 L, 4 L, 6 L, and 12 L nominal fill volume. Pre-qualified shippers for world-wide shipment of Celsius® FFT is offered as part of the complete logistics solution.

Order Number:  FZB212435

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

  • Dimensions
    69.8 × 53.4 × 13.1 cm
  • Temperature range
    -70°C to +45°C (for use at lower temperatures contact Sartorius)
  • Volume
    12 L
  • Working volume
    3 L – 12L
  • Tubing
    Clear C-Flex® 374
  • Thermowell
    No
  • Stacking
    5-high
  • Connector Outlet
    ⅜" OPTA® SFT Male
  • Connector Inlet
    ⅜" OPTA® SFT Male
  • Sampling Lines
    1/8" ID 1/4" OD Clear C-Flex® 0.5m
  • 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
  • Connector Sampling
    1/8" ID Luer Female + luer lock plug
  • Primary Product Type
    2D Freezing Bags
  • System Type
    Conventional Freezers
  • Biocompatibility (USP Class VI)
    USP<87> and ISO 10993-5; USP<88>
  • Physico-chemical compatibility
    USP<661> and EP 3.1.7
  • TSE-BSE Status
    EMA/410/01 and EP 5.2.8
  • Bioburden (ISO11737), Endotoxin (USP 85 and EP 2.6.14), Sub-visible particulates (USP 788 and EP 2.9.19)
    Weekly testing on representative finished product
  • Change control and business continuity
    48 months notification period on Celsius® bags and 24 months on critical fluid-contact components
  • 100% Bag Chamber Leak testing
    Yes
  • 100% Visual Inspection
    Yes
  • Sterility
    Gamma irradiated

Technical attributes

  • Inlet
    Sanitary or Aseptic Connection under LAF with quick coupler; Sterile Weld with Biowelder® TC
  • Outlet
    Sanitary or Aseptic Connection under LAF with quick coupler; Sterile Weld with Biowelder® TC
  • Extractables
    Extractable data readily available
  • Materials of Construction
    Shell=== HDPE; Screw=== isoplast 101 40% LGF, natural; Nut=== nylon 6/6, natural
  • Gas barrier layer material
    Ethylene vinyl alcohol (EVOH)
  • Product contact layer material
    EVAM®
  • Stackability
    Yes
  • 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
  • Quality standards
    ISO 9001 and ISO 13485 for medical devices