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Celsius® S<sup>3</sup> Benchtop System with US Computer

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® CFT systems (Celsius® FT33 | 66 | 100). This tool allows generation of consistent samples library useful for evaluating stability, storage and shipping conditions and formulations.

Item no.:  FTH-CS00000-0001

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® CFT systems (Celsius® FT33 | 66 | 100). 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 a 100 L production system with a minimal amount of product. Using the same freeze & thaw path length 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® CFT technology for future scale-up (Celsius® FT33 | 66 | 100)
  • 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

Brochure

Celsius CFT The controlled-rate F&T Platform Technology
en 2.5 MB

Datasheet

Celsius S3 System
en 623.7 kB

Flyer

Celsius CFT: safeguarding your drug substances in controlled-rate FT manufacturing
en 379.2 kB
Have you ever thought about freezing?
en 988.7 kB

Publication

Bulk Freeze-Thawing of Macromolecules in BioProcess technical
en 1.2 MB
Large Freezing of Biologics - BioProcess Technical
en 419.2 kB
Safe Freeze-Thaw of protein drug products: a QbD approach
en 4.3 MB

Accessories Information

  • Software
    Cryopilot® 5

Applications

  • Area of Application
    Frozen Storage & Shipping
  • Process Step
    • Cell Harvest & Downstream Processing Intermediates
    • Drug Substance Purification
    • Drug Product Formulation
    • Lab-scale Freeze & Thaw

Dimensions

  • Dimensions
    188 × 76 × 71 cm

Features

  • Languages
    English
  • Load Capacity
    10× Lab-scale Celsius®-Pak
  • Use with
    30 mL & 100 mL Celsius®-Pak

Materials of Construction

  • Materials of Construction
    302/304 Stainless Steel, 6061-T6 aluminum, 5052 aluminum, transparent PVC cover

Power Requirements

  • Power Requirements
    Cryomixer Jr.: USA: 110 V, 60 Hz, 5 A, 1 Phase; Temperature control unit: USA: 230 V, 50 Hz, 16 A breaker minimum, 1 Phase

Product Information

  • Primary Product Type
    Freeze & Thaw Systems

Specifications

  • Additional Product Specifications
    Control unit: Laptop computer
  • Condition of Use
    5–35°C | Relative Humidity <80%
  • Temperature Range
    -70°C – +40°C

Volumes

  • Working Volume
    20 mL – 1 L

Weights

  • Weight
    135 kg
Lab-scale Celsius®-Pak
Lab-scale Celsius®-Pak

Celsius® Lab-scale implements small-scale single-use Celsius® solutions to support production-scale freezing and thawing operations with the Celsius® technology. Scalability is a feature unique to Celsius®. Lab-scale Celsius®-Paks together with the process development tool called Celsius® S3 Benchtop System allow you to characterize the freeze & thaw processes on your biopharmaceutical product in the lab before scaling-up to the production system.

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