Celsius® S3 Benchtop System EU

The Celsius^® S³ Benchtop System is the only lab-scale freeze & thaw system for single-use bags that is scalable to our production-scale Celsius^® platforms (FFT, FFTp and CFT). This system is a tool to execute freeze & thaw process development and stability studies using a minimal amount of product.

Scalability

Using the same freeze & thaw critical process parameters and materials of construction as seen in all Celsius^® Paks, the Celsius^® S³ Benchtop System ensures unmatched scalability across systems of all scales.

Ease of Use

The CryoPilot Control Unit provides automated operation and data collection. The Celsius^® S³ Benchtop System freezes and thaws 1 to 10 product samples per run. Lab-scale Celsius^® Pak PDS are available in 30mL and 100mL nominal fill volumes with various filling port and thermowell configurations.

Improved Process Validation

The Celsius^® S³ Benchtop System offers excellent batch-to-batch reproducibility as well as consistent product stability after freezing, thawing, and storing. The Celsius^® S³ Benchtop System allows for documented and reproducible freeze & thaw processes, thus facilitating validation of your freeze & thaw operations.

Celsius^® S³ Benchtop System Applications:

• Process development studies to understand decoupling (hold) steps during downstream processing, e.g., frozen storage of process intermediates or drug substances. Explore the Celsius^® technology for future scale-up. (FFT, FFTp and CFT)
• Scale-down storage and transportation studies (using minimal volumes as low as 20mL) for understanding extended drug substance storage and shipping in terms of time and temperature
• Formulation development of freeze & thaw compatible formulations for drug substances
• Stability Studies in accordance with industry guidelines, conducted in freezing and thawing conditions as well as in a container closure system that is the same as or simulates the packaging proposed for freezing, storage, shipping, and thawing at production-scale