Celsius® FFT 12L (Opta®/Opta®)
Celsius® FFT (Flexible Freeze & Thaw) and Celsius® FFTp (Flexible Freeze & Thaw for Plate Freezer) 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 with the intent to leverage your existing freeze & thaw infrastructure.
Item no.: FZB129268
Celsius® FFT can be used with any type of conventional and blast freezers while Celsius® FFTp is specifically designed to be frozen in horizontal type plate freezers. Celsius® FFT | FFTp provides exceptional robustness and confidence when handling the frozen container. Celsius® FFT along with it's purpose-designed single-use shippers (Celsius® FFT Box Shipper) offers enhanced process capabilities to create a versatile approach to safeguarding your product in conventional manufacturing.
Maximum Product Security:
- Extensive functional qualification in real process conditions
- Confident handling protecting the complete assembly
- Pre-qualified shipper (ASTM D4169 AL1 mechanical and ISTA7D extreme summer thermal performances)
Simple, Easy to Use Solution:
- Closed system processing for successful aseptic processes
- Container design promotes easy handling for operator
- Shell design provides consistent heat transfer to each unit
Improved Process Efficiency:
- Stackable for efficient use of freezer space
- One-way logistics using single-use Celsius® FFT Box Shippers
- Single-use point accountability and process expertise (bag, shell & shipper from one supplier)
Create Process Flexibility:
- Replace bottles and carboys using existing freezers and thawing methods
- Configurable to fit process needs, Multi-fill with design into manifold
- Common film for efficient process development and samples in lab-scale Celsius® Paks
Celsius® FFT|FFTp provides single-use freeze & thaw solutions for every process step when frozen storage and frozen shipment are required. These containers are configured with the features needed to decouple downstream process steps and securely transport drug substances to drug product sites.
Celsius® FFT|FFTp PDS are qualified against extensive biological, chemical,physical, extractable and functional testing.
The performance and assurance of supply of our Celsius® products are based on the complete control of 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.
Application AreaFrozen Storage & Shipping
Cell Harvest & Downstream Processing Intermediates
Drug Substance Purification
Drug Product Formulation
Bulk drug substance freezing and thawing
- Process intermediates freezing and thawing
- Cell Harvest & Downstream Processing Intermediates
Biocompatibility (USP Class VI)USP and ISO 10993-5; USP
ExtractablesExtractable data readily available
Physico-chemical CompatibilityUSP and EP 3.1.7
Quality StandardsISO 9001 and ISO 13485 for medical devices
Inlet Line3/8" Opta® SFT male + 3/8" ID Clear C-Flex® 0.75m
Outlet Line3/8" Opta® SFT male + 3/8" ID Clear C-Flex® 0.75m
Sampling Lines1/8" ID Luer Female + luer lock plug + 1/8" ID Clear C-Flex® 0.5m
Dimensions69.8 × 53.4 × 13.1 cm
Designbag in shell
Temperature Range-70°C – +45°C (for use at lower temperatures contact Sartorius)
Materials of Construction
Film MaterialFilm S71: Ethylene-vinyl acetate (EVA)
Freezer TechnologyConventional and Blast Freezers
Working Volume3 L – 12L
The Celsius® FFT Box Shipper is a robust, qualified solution allowing safe shipment of frozen Celsius® FFT to remote locations. Celsius® FFT Box shipper is a single-use shipper refrigerated by dry-ice pellets which significantly simplifies biopharmaceuticals supply chain through one-way logistics and the transport of frozen Celsius® FFT to its destination site for thawing.