Celsius® FFT|FFTp 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. 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.
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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 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
- 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 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|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.
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|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
- 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|FFTp 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