Celsius® FFT: Robust Freeze Containers for a More Reliable Cold Chain
Ready-to-Use Solutions for Commercially Available Equipment
Implementing a reliable cold chain operation requires a robust container system for storage and transport of bulk drug substance. Celsius® FFT (Flexible Freeze and Thaw) is a unique bag-in-shell system that replaces traditional freezing and thawing methods. The single-use containers are sterile, pre-assembled and ready-to-use for freezing and thawing biopharmaceutical solutions in commercially available equipment — so you can leverage your existing freeze and thaw infrastructure.
Meet the New Generation of Celsius® FFT and FFTp
In this webinar, Sartorius product experts introduce the newest generation of Celsius® single-use freeze and thaw containers for protecting bulk drug substances in the cold chain and explain how the new solutions were tested and validated.
Purpose-designed single-use containers pass rigorous robustness testing and provide excellent thermal performance down to -80°C
Container design and tubing configurations promote easy, confident operations; container is delivered pre-assembled, ready to be filled
Standardized design is compatible with conventional freeze/thaw methods and leverages existing infrastructure
Stackable containers, designed according to standard international pallet dimensions, maximize storage and shipping density and reduce associated risks during handling
A Complete Container Assembly for Conventional and Blast Freezers
Celsius® FFT is engineered for reliable performance in conventional cold chain environments. As a container, the unique bag-in-shell system provides superior protection for frozen drug substance, yet is easy to fill, handle and transport. When used with its purpose-designed single-use shippers, Celsius® FFT provides biomanufacturers with a versatile solution for conventional freeze-thaw workflows.
Celsius® FFT with Safecore™ Technology
Celsius® FFT with Safecore™ Technology freezing containers feature an innovative cassette design, bringing together a semi-rigid bag composed of two polyester plates and a bag assembly protected by a surrounding shell. The plates secure the bag and lines by adding impact resistance, suppressing wrinkles and restricting degrees of freedom. The excellent bag-to-plate contact provides higher robustness and more uniform freeze and thaw.
Manufacturers that use Celsius® FFT with Safecore™ Technology benefit from:
- A flexible solution that can be used with any type of conventional and blast freezers
- Proven performance down to -80°C
- Simplified operation, with stackable freezing containers and an integrated line management system for secured tubing, pinch-clamp and connector stowage
- Bulk processing, with versatile multi-modal shipping solutions
Both solutions are qualified according to the ASTM D4169 Assurance Level 1 and the ISTA 7D extreme summer temperature profiles.
Celsius® FFT Box Shipper
The Celsius® FFT Box Shipper is a robust, qualified solution allowing safe shipment of frozen Celsius® FFT containers to remote locations. Celsius® FFT Box shipper is a single-use shipper refrigerated by dry-ice pellets, which simplifies cold chain operations through one-way logistics and the transport of frozen Celsius® FFT to its destination site for thawing.
Celsius® FFT Bulk Shipper
The Celsius® FFT Bulk Shipper is designed according to standard European pallet dimensions. It maximizes storage and shipping density and reduces associated risks during handling. Up to 10 frozen 12 L Celsius® FFT with Safecore™ Technology freezing containers can be loaded on a single bulk shipper.
Celsius® FFT Accessories
Optional accessories are available for use with Celsius® FFT with Safecore™ Technology freezing containers
- A sample bag cover , which allows the end-user to position an ID sample bag with the drug substance container so that both can be stored and shipped together
- A freeze-resistant label placard offering dedicated labelling space
Simple, Scalable, Configurable
The Celsius® FFT platform brings versatility and flexibility to biomanufacturers. It can be used throughout all processes, from harvest to downstream process intermediates and bulk drug substances. Leveraging the existing equipment infrastructure, these containers can be easily deployed in clinical drug development, as well as in commercial manufacturing. Celsius® FFT containers can be used with any type of conventional and blast freezers and are completely scalable, accommodating up to 12 L fill volumes.
- Freezing containers are pre-assembled
- Cleaning and inspection capabilities built-in container design
- Configurable with various connector/disconnector technologies
- Integrated line management system for secured tubing, pinch-clamp, and connector stowage
Fully Qualified and Validated
Celsius® FFT freezing bags provide single-use freeze and thaw solutions for every process step when frozen storage and frozen shipment are required. They are configured with the features needed to decouple downstream process steps and securely transport drug substances to drug product sites. Plus, they are qualified against extensive biological, chemical, physical, extractable and functional testing.
- Replace bottles and carboys using existing freezers and thawing methods
- Configurable to fit a range of process needs
- Full compliance with ISO 11137 allows sterility assurance level validation of 10–6 over the entire shelf life of the product
- Shipping solutions qualified according to ASTM D4169 at Assurance Level 1 and ISTA 7D extreme summer/winter temperature profiles
The Story of Robust and Consistent Frozen Storage and Shipment
Learn how a reliable cold chain operation requires the right commercial scale solution, from controlled bag film production to a unified process including reliable control mechanisms.