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.
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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)
- Closed system processing for successful aseptic processes
- Container design promotes easy handling for operator
- Shell design provides consistent heat transfer to each unit
- 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)
- 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.