Celsius® CFT: Controlled and Scalable Freeze and Thaw
Celsius® CFT (Controlled Freeze and Thaw) is a complete system for proven freeze-thaw performance, providing a fully integrated, end-to-end solution designed to minimize manual handling of drug substance and mitigate the associated risks, while the controlled-rate plate freezing and thawing system minimizes cryoconcentration.
With this integrated approach, biomanufacturers can safely and confidently manage the entire cold chain from filling and freezing to shipping, thawing and dispensing.
Fast and reproducible thermal cycling promotes consistent operations, allowing critical process parameters to be controlled and monitored.
Controlled-rate freeze/thaw platform minimizes cryoconcentration and prevents product degradation
Pre-qualified shipping solutions streamline process logistics from filling to dispensing, including frozen transport
Scalability from 1L to 100L with consistent freeze/thaw performances across the industrial scale
A Robust and Reliable Platform for cGMP Manufacturing
The Celsius® CFT technology from Sartorius is a controlled-rate freezing and thawing system designed to minimize cryoconcentration. It provides a fast and reproducible thermal cycle, ensuring product security from fill through drain. It also delivers flexibility by processing from 1 L up to 100 L of solution in presterilized single-use Celsius® Paks.
Celsius® FT33/66/100 Vertical Plate Freezer
Celsius® FT33/66/100 is a controlled-rate freeze and thaw system designed to minimize the adverse effects of the cryoconcentration in your biopharmaceutical products. This modular equipment uses a patented heat transfer technology in vertical plates that provide unprecedented freeze and thaw performance and flexibility.
The Celsius® FT33/66/100 is a modular system with up to three freeze/thaw chambers to offer load capacity per thermal cycle of 33L, 66L, and 100L. It is designed for the freezing and thawing of 1 L, 2 L, 8.3 L, and 16.6 L Celsius® Paks and comes equipped with:
Freeze/thaw chambers (from one to three)
A temperature control unit (TCU)
A control cabinet with HMI and process-relevant sensors
Celsius® Pak 1 L, 2 L, 8.3 L, 16.6 L Bags
Celsius® CFT features Celsius® Paks that are sterile, pre-assembled, single-use bags purposely engineered to fit into reusable structural frames. The unique design of the bag helps to prevent cryoconcentration during freeze and thaw cycles, which prevents product degradation. Plus, filled Celsius® Paks are never carried or directly handled throughout the lifecycle of the product.
Celsius® Paks offer the following benefits:
- Durable construction
- Certified leak protection on the bag, tubing and connectors
- Proven performance in multiple commercial drug manufacturing processes
- Completely integrated platform from filling through draining
Celsius® FS16 Filling Station
The Celsius® Filling Station streamlines the filling and pressurization of commercial-scale Celsius® Paks with minimal operator intervention. The elevated mounting platform includes a docking system that allows for ideal alignment of the transfer cart with other components of the Celsius® CFT system, ensuring smooth transfers and protecting drug substance.
The Celsius® FS16 Filling Station:
- Accommodates all Celsius® Paks sizes
- Reproduces the container shape in the freezer to optimize liquid distribution and heat transfer
- Allows for automatic filling and pressurizing via the scale terminal controller
Sartorius offers various shipping options for the Celsius® CFT platform. All solutions are qualified according to the ASTM D4169 Assurance Level 1 and the ISTA 7D extreme summer temperature profiles.
Celsius® Shippable Storage Module (SSM)
The Celsius® Shippable Storage Module (SSM) is used to ship multiple frozen Celsius® Paks to remote locations, allowing for storage of up to 100 L of product. Shippable as a standalone item in refrigerated trucks, it can be placed in the SSM thermal insulated reusable shipper for aircraft transportation.
Celsius® SSM Shipper
The Celsius® SSM shipper provides adequate insulation and refrigeration to maintain all frozen Celsius® Pak at the desired temperatures while stored in Celsius® SSM. This is a reusable shipping system which can transport up to 100L of product to its destination site for thawing.
End-to-End Platform Solution
Celsius® CFT is the only fully integrated platform to transfer frozen drug substance worldwide with a single source for plate freezers and freezable storage containers. With excellent reproducibility from bag to bag, batch to batch and unit to unit and strong process control for cGMP manufacturing, you can protect and secure bulk drug substance across the entire cold chain.
- Proven platform — over a hundred production systems installed worldwide
- Integrated accessories minimize manual handling
- Complete end-to-end functionality, from filling and freezing to shipping, thawing and dispensing
- Pre-qualified shippers (mechanical and thermal) maximize product safety
Fast and Reproducible Thermal Cycling
The Celsius® CFT system provides controlled-rate freezing and thawing of biopharmaceutical products. Taking advantage of optimized container geometry, minimum freeze path length and maximized heat transfer, the system can deliver 100 L freeze/thaw cycles in less than five hours. This prevents cryoconcentration and reduces overall process time.
- Reproducible freeze and thaw cycles from Celsius® Pak to Celsius® Pak, batch to batch, and device to device
- Reduced bulk-scale concentration to ensure less variation and degradation of proteins
- Robust bag construction to prevent breakage and loss of valuable drug substance
- Proven performance — hundreds of thousands of Celsius® Paks sold in commercial drug manufacturing processes