Sartorius, FZB302498, Celsius® FFT Bag with Safecore™ Technology - MPC - MPC - SIT tested - 4 L

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.

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

Specifications
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

Connections (Physical):
Connector(s): MPC
Inlet Line: MPC Male + Sealing Cap + 3/8" ID TPE (C-Flex®) 0.43 m (17")
Outlet Line: MPC Male + Sealing Cap + 3/8" ID TPE (C-Flex®) 0.43 m (17")

Dimensions:
Dimensions: 440 mm × 453 mm × 129 mm

Features:
Integrity Tested: Yes
Stacking: 5

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
Freezer Technology: Conventional and Blast Freezers
Pack Size: 2

Sterility/Purity:
Delivery Condition: Sterile

Volume:
Volume: 4 L
Working Volume: 1 – 4 L