Celsius® FFT|FFTp Bags

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|FFTp with Safecore™ Technology provides single-use freeze & thaw solutions for every process step when frozen storage and frozen shipment are required, and are configured with the features needed to decouple downstream process steps and securely transport drug substances to drug product sites. It addition, they are qualified against extensive biological, chemical, physical, extractable and functional testing.

Key Features:

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

• 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.

Specifications:

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