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Celsius<sup>®</sup> S<sup>3</sup> System

The Celsius® S3 Benchtop System is the only laboratory instrument available on the market to evaluate freeze & thaw processes of new drug candidates in single-use bags with full scalability to production-scale Celsius® platforms (FFT, FFTp and CFT). This tool allows generation of consistent samples library useful for evaluating stability, storage and shipping conditions and formulations.

Item no.:  FTH-CS00000-0002

Availability:  On Request

   

The Celsius® S3 Benchtop System is the only lab-scale freeze & thaw system in 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

The Celsius® S3 Benchtop System models production system with a minimal amount of product. Using the same freeze & thaw critical process parameters and identical materials of construction in all Celsius® Pak, the Celsius® S3 Benchtop System ensures unmatched scalability between all scale systems.

Ease of Use

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

Improved Process Validation

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

Celsius® S3 Benchtop System Applications:

  • Process development studies to understand decoupling (hold) steps during downstream processing, i.e., frozen storage of process intermediates, frozen storage of drug substances. Investigate the Celsius® technology for future scale-up. (FFT, FFTp and CFT)
  • Scale-down storage and transportation studies (using minimal volumes as low as 20 mL) for understanding extended drug substance storage (time and temperature) and shipping
  • Formulation development of freeze & thaw compatible formulations for drug substance
  • Stability Studies in accordance to 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

Application Note

Modelling Celsius® FFT | FFTp Freeze & Thaw Temperature Profiles in the Celsius® S3 Benchtop System
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Brochure

Celsius® CFT - The Controlled-Rate Freeze & Thaw Platform Technology
en 2.7 MB

Flyer

Celsius® CFT: Safeguarding Your Drug Substances in Controlled-rate Freeze & Thaw Manufacturing
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Have you ever thought about freezing?
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Publication

Evaluating Freeze-Thaw Processes in Biopharmaceutical Development
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Large-Scale Freezing of Biologics - A Practitioner’s Review, Part 2: Practical Advice
en 293.8 kB
Safe Freeze-Thaw of protein drug products: a QbD approach
en 4.3 MB

 

  • Application Area
    Frozen Storage & Shipping
  • Languages
    English
  • Load Capacity
    10× Lab-scale Celsius® Pak
  • Materials of Construction
    302/304 Stainless Steel, 6061-T6 aluminum, 5052 aluminum, transparent PVC cover
  • Software
    Cryopilot® 5
  • Temperature Range
    -60°C – +40°C
  • Working Volume
    20 mL – 1 L

 

  • Power Requirements
    Cryomixer Jr.: EU: 230 V, 50 Hz, 5 A, 1 Phase; Temperature control unit: EU: 230 V, 50 Hz, 16 A breaker minimum, 1 Phase
  • Process Step
    • Cell Harvest & Downstream Processing Intermediates
    • Drug Substance Purification
    • Drug Product Formulation
    • Lab-scale Freeze & Thaw

 

  • Additional Product Specifications
    Control unit: Laptop computer

 

  • Dimensions
    188 × 76 × 71 cm

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