Celsius® FFT|FFTp Bags with Safecore™ Technology

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.

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With its innovative bag-in-plate design, the Safecore™ Technology provides exceptional protection to Celsius® FFT|FFTp in a proven design format that is scalable from small to large-size single-use container. Celsius® FFT|FFTp along with its purpose-designed shippers (Celsius® FFT|FFTp Box and Celsius® FFT Bulk Shipper) offers enhanced process capabilities to create a versatile approach to to protect 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 high robustness and more uniform freeze/thaw, plates compress the bag to reduce ice bulging formation
  • Container assembly is tool-free and intuitive for minimum risk during production assembly

Maximum Robustness down to -80°C

  • Material selection based on characterization of physical and thermal properties across wide temperature range to ensure suitable use for the intended application
  • Handling and shipping qualifications built on deep understanding of mechanical stresses occurring during lifecycle for reliable performance in real-world environments
  • 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 stringent regulations for shipping containers

Celsius® FFT|FFTp with Safecore™ Technology provides single-use freeze & thaw solutions for every process step when frozen storage and frozen shipment are required. Celsius® FFT|FFTp 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|FFTp with Safecore™ Technology is qualified against extensive biological, chemical, physical, extractable and functional testing.

Our assurance of supply and performance for Celsius® FFT with Safecore™ Technology is based on the fact that we retain complete control over 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 exceptional delivery reliability.

Celsius® FFT|FFTp 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
  • MPC quick couplers are used for either sanitary connection or aseptic connection under ISO5 laminar air flow to single-use systems

Tubes

  • Clear C-Flex® tubing allows for sterile weld connection with Biowelder® TC and sterile seal disconnection with Biosealer® TC

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

  • Exceptional quality, change control and business continuity
  • Exceptional delivery reliability with available stocks
  • Compliance to quality standards such as USP <87> and USP <88>, TSE-BSE, REACH

Applications

  • Application Area
    Frozen Storage & Shipping  
  • Process Step
    • Cell Harvest & Downstream Processing Intermediates  
    • Drug Substance Purification  
    • Drug Product Formulation  
    • Bulk drug substance freezing and thawing  
    • Process intermediates freezing and thawing  

General Specifications

  • Design
    bag-in-plates cassette  
  • Temperature Range
    -80 °C - + 45 °C  

Materials of Construction

  • Film Material
    Film S71: Ethylene-vinyl acetate (EVA)  

Product Information

  • Brand
    • Celsius® FFT with Safecore™ Technology  
    • Celsius® FFTp with Safecore™ Technology  

Sterility/Purity

  • Delivery Condition
    Sterile  
Celsius® FFT|FFTp Shipper
Item no.
M_Celsius_FFT_Shipper

Celsius® FFT|FFTp Box Shippers are robust, qualified solutions which enable the reliable shipment of frozen Celsius® FFT|FFTp to remote locations. These single-use shippers, refrigerated by dry-ice pellets, significantly simplify the biopharmaceuticals supply chain through one-way logistics.

Celsius® FFT|FFTp Accessory
Item no.
M_Celsius_FFT_accessory

Optional accessories available for use with Celsius® FFT|FFTp with Safecore™ Technology include:

  • A sample bag cover to place and attach a sample bag to the main container so that it remains with it throughout its lifecycle
  • A label placard offering a dedicated labelling space for the Celsius® FFT.

Celsius® FFT Bulk Shipper
Item no.
M_Celsius_FFT_Bulk_Shipper

Celsius® FFT Bulk Shipper simplify frozen transfers by enabling bulk processing during frozen storage and shipping of Celsius® FFT with Safecore™ Technology. Multiple Celsius® FFT with Safecore™ Technology can be loaded per Bulk Shipper when using spacers.

Celsius® FFTp freezer
Item no.
M_Celsius_FFTp_freezer

The Celsius® FFTp freezer is a horizontal plate freezer which allows for controlled and adjustable freezing of biological products in Celsius® FFTp with Safecore™ Technology containers.