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Celsius® FFT with SafecoreTM Technology

Celsius® FFT with SafecoreTM 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 any type of commercially available equipment (conventional and blast freeze and thaw methods).

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Products (2)

12L Celsius® FFT with SafecoreTM Technology (OPTA/OPTA)
Connector Inlet
MPC Male + sealing cap
Connector Outlet
MPC Male + sealing cap
12L Celsius® FFT with SafecoreTM Technology (MPC/MPC)

Celsius® FFT with SafecoreTM 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 any type of commercially available equipment (conventional and blast freeze and thaw methods).

Celsius® FFT with SafecoreTM 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 that is scalable from small to large-size single-use container. 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 Operation

  • 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 SafecoreTM Technology provide single-use freeze & thaw solutions for every process step when frozen storage and frozen shipment are required. Celsius® FFT with SafecoreTM Technology are configured with the features needed to decouple downstream process steps and securely transport drug substances to drug product sites.

Celsius® FFT with SafecoreTM Technology is qualified against extensive biological, chemical,physical, extractable and functional testing.

The performance and assurance of supply of Celsius® FFT with SafecoreTM 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 SafecoreTM Technology is available in size of 12 L nominal fill volume 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®

All fluid-contact components of Celsius® FFT Celsius® FFT with SafecoreTM 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-Safecore-Technology-Datasheet-en-B-2562994-Sartorius.pdf
en 728.9 kB
Celsius® FFT Accessory

Optional accessories are available for use with Celsius® FFT with Safecore™ Technology:

  • A sample bag cover to place and attach a sample bag to remain with the main container throughout lifecycle.
  • A label placard offering a dedicated labelling space.

Celsius® FFT Box Shipper

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.

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