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Celsius® FFT with Safecore™ Technology 4L (MPC/MPC)

Celsius® FFT|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.

Celsius® FFT is compatible with any types of commercially available equipment (conventional and blast freeze and thaw methods). Celsius® FFTp is compatible with horizontal plate freezers.

Item no.:  FZB302498

 

* 72 Hours Turnaround Time

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 1.5 MB

Features

  • Sampling Option
    No
Celsius® FFT 4L 4-Unit Shipper
Item no.
FTH-SM00103-0018

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.

Celsius® FFT 4L 1-Unit Shipper
Item no.
FTH-SM00103-0017

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.