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6L Celsius<sup>®</sup> FFTp (MPC/MPC)

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 11 L nominal fill volume.

Item no.:  FZB114079

Availability (ex works):  On Request

   

Celsius® FFT can be used with any type of conventional and blast 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 Box 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 and ISTA7D extreme summer thermal performances)

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 Box 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

Celsius® FFT|FFTp provides single-use freeze & thaw solutions for every process step when frozen storage and frozen shipment are required. These containers 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.

The performance and assurance of supply of our Celsius® products 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.

Brochure

Celsius® Product Lines - Discover our Freezing Capabilities
en 1.6 MB

Datasheet

Celsius® FFT Single-Use Container for Flexible Freeze-Thaw Processes
en 1.7 MB

Flyer

Celsius FFT: safeguarding your drug substances in conventional FT manufacturing
en 616.0 kB

Publication

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

Applications

  • Application Area
    Frozen Storage & Shipping
  • Process Step
    • Cell Harvest & Downstream Processing Intermediates
    • Drug Substance Purification
    • Drug Product Formulation

Compliance Information

  • 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 and ISO 10993-5; USP
  • Extractables
    Extractable data readily available
  • Physico-chemical Compatibility
    USP and EP 3.1.7
  • Quality Standards
    ISO 9001 and ISO 13485 for medical devices

Connections (Physical)

  • Connector Inlet
    MPC Male + sealing cap
  • Connector Outlet
    MPC Male + sealing cap
  • Inlet
    Sanitary or Aseptic Connection under LAF with quick coupler
  • Line Inlet
    3/8" ID 15/32" OD EVA 0.15m
  • Line Outlet
    3/8" ID 15/32" OD EVA 0.15m
  • Outlet
    Sanitary or Aseptic Connection under LAF with quick coupler

Dimensions

  • Dimensions
    56.6 × 40.4 × 5.1 cm

Features

  • Thermowell
    No

General Specifications

  • Temperature Range
    -70°C – +45°C (for use at lower temperatures contact Sartorius)
  • Tubing
    EVA

Materials of Construction

  • Film Material
    S71
  • 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®

Physicochemical Information

  • Pressure Range
    Max. 1 barg in transfer lines

Product Information

  • Pack Size
    6
  • Primary Product Type
    2D Freezing Bags
  • Sterilization Method
    Gamma irradiation
  • System Type
    Horizontal Plate Freezers

Volumes

  • Volume
    6 L
  • Working Volume
    6L

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