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
