Celsius® FFTp: Compact SU Containers Perfect for Horizontal Plate Freezers
Designed for horizontal plate freezers, Celsius® FFTp (Flexible Freeze and Thaw for Plate Freezer) offers all the advantages of the Celsius® FFT with the unique bag-in-shell system, but with a flatter, more compact design to fit perfectly to the surface of the plate freezer, maximizing the heat transfer for uniform, fast and reproducible freeze and thaw processes, alleviating the concern of cryoconcentration. With Celsius® FFTp, you can bring the Sartorius standard of quality to your existing freeze and thaw infrastructure.
Product quality can be undermined without properly protecting sensitive biological products during freeze and thaw. Sartorius experts explain how advanced plate freezing technology and compatible single-use containers can simplify cold chain security.
Unique bag design, with secured tubing stowage, protects high-value BDS and ensures uniform freezing and thawing
Pre-assembled containers are designed with the end-user in mind, facilitating filling operations
Fast and reproducible thermal cycling combined with the monitoring and control of critical process parameters removes the risk of cryoconcentration
Celsius® FFTp can be shipped in pre-qualified single-use box shippers for simple frozen transfer
A Complete Container Assembly for Horizontal Plate Freezers
Celsius® FFTp is purpose-designed for horizontal plate freezers and engineered for reliable performance in conventional cold chain environments. The container system effectively protects bulk drug substance without compromising versatility. It’s easy to fill and, with its purpose-designed box and bulk shippers, it’s easy to transport.
Freezer
Celsius® FFTp Freezer
The horizontal plate freezer enables controlled and adjustable freezing and thawing of bulk drug substances. Engineered to work with Celsius® FFTp containers, the freezer ensures a uniform heat transfer to and from the containers by using moveable shelves for compressing the Celsius® FFTp containers between the product shelves.
In collaboration with HOF Sonderanlagenbau GmbH, Sartorius offers two standard freezers optimized for applications with Celsius® FFTp.
- Compact and small footprint design
- Online monitoring of critical process parameters
- Optimized contact between moveable shelves and bag providing uniform heat transfer
- Vertical integration of the refrigeration system
Freezing Containers
Celsius® FFTp with Safecore™ Technology
Celsius® FFTp 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® FFTp with Safecore™ Technology benefit from:
- A flexible solution that can be used with horizonal plate freezers, working within existing infrastructure
- Proven performance down to -80°C
- Simplified operation, with an integrated line management system for secured tubing, pinch-clamp and connector stowage
- Pre-qualified shipping solutions for safe international transportation
Shippers
Celsius® FFTp Box Shipper
The Celsius® FFTp Box Shipper is a robust, qualified solution allowing safe shipment of frozen Celsius® FFTp to remote locations. Celsius® FFTp 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® FFTp to its destination site for thawing.
Celsius® FFTp Box Shipper is qualified according to the ASTM D4169 Assurance Level 1 and the ISTA 7D extreme summer temperature profiles.
Accessories
Celsius® FFTp 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 labeling space
Sterile, Pre-assembled and Ready-to-use
The Celsius® FFTp platform fits perfectly to the surface of the horizontal plate freezer, maximizing heat transfer for uniform, fast and reproducible freeze and thaw processes, alleviating concerns of cryoconcentration.
- Freezing containers require no tools to assemble
- Plates are transparent, making it easy to see and inspect the bag chamber
- Configurable with various connector/disconnector technologies
- Integrated line management system for secured tubing, pinch-clamp and connector stowage
Designed for Product Security and Process Flexibility
Celsius® FFTp freezing bags are qualified applying the most complex and innovative test regimes. Biological, chemical and physical tests combined with extensive extractable testing provide data representing the widest range of process fluids in a variety of processing conditions. Full compliance with ISO 11137 allows sterility assurance level validation of 10–6 over the entire shelf life of the product.
- Single supplier for bag, shell and shipper ensures accountability
- All materials characterized across a wide temperature range
- Shipping solutions qualified according to ASTM D4169 at Assurance Level 1 and ISTA 7D extreme summer/winter temperature profiles
- Safe, secure supply chain assures integrity of all materials, including resins, film, bags, filters and assemblies
