RoSS.pFTU Large-Scale Hybrid

Freeze-Thaw | Bags and Bottles

The Hybrid Freeze and Thaw Platform freezes and thaws larger volumes of drug substances in both single-use bioprocess containers and bottles. All in one: plate-based freezing of single-use bags, protected in RoSS shells, and air flow freezing of bottles control cold chain management of valuable liquids in both primary packagings.

RoSS.pFTU large scale with its hybrid option is compatible with single-use bags and bottles from all manufacturers and of all sizes up to 400L and beyond.

RoSS PFTU_Large Scale_Freeze-Thaw Platform_Hybrid

Advantages of controlled plate-freezers

Dark blue spots indicate a higher cryoconcentration. 
Fast & controlled freezing with a plate freezer enables a homogeneous freezing result.

Advantages of controlled plate-freezers-Grafik

Description

Hybrid Freeze & Thaw platform system for freezing and thawing of larger volumes of drug substances in both, single-use bags and bottles.

  • Capacity 
    • Single-use bags: Up to 220 L and more, depending on bag type
    • Bottles: Up to 160 L and more, depending on bottle type
  • Freezing type
    • Plate-based freezing and thawing unit for single-use bags, protected in RoSS shells.
    • Freezing and thawing with air flow for bottles, protected in Bottle CCUs.
  • Usage for mid to large scale batch sizes. Scale-up for late phase studies or commercial production
  • Primary packaging independent: any bag vendor, any size. Bag or bottle.
  • Best product stability results for mABs and BDS
  • GMP-compliant, automated, at highest possible speed and accuracy
  • Freezes down to -90°C

Controlling freezing and thawing of bottles

The combination of the hybrid RoSS.pFTU Large Scale and the use of CCUs (cryo control units) for bottles enables homogeneity during freezing. CCUs are attached to single-use bags and bottles for cryogenic applications with airflow in air turbulence or blast freezers to control homogeneity and pressure at the last point of freeze.

cryoconcentration_bottles

Cryo Control Unit for Bottles

  • Insulation material made of styro foam
  • Vendor agnostic and applicable to all available types and sizes of bottles
  • Covers the bottle cap during freezing applications with air turbulence (blast freezing)
  • Avoids volcano cryoconcentration effect or bulging enabling homogeneous freezing results
Bottle_CCU (3)

Our customers trust in us:

Rentschler Biopharma SE

Lonza

SCHOTT Pharma

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RoSS.pFTU Large-Scale | Plate Freeze & Thaw

Up to 400L: Our large scale freezing platform system is a plate-based pharmaceutical freezer and thaw unit for any scale and batch size. Well-established RoSS.pFTU large scale is compatible with single-use bags of all sizes and manufacturers. The hybrid solution offers freeze-thaw capabilities for bags and bottles up to 400L in one platform.  

Data sheet

Datasheet RoSS.pFTU Hybrid Freezing for Bags & Bottles

Hybrid Freezing Brochure - Bags and Bottles

Filesize: 1.35 MB – Mime-Type: application/pdf

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Datasheet RoSS.pFTU Large Scale

Filesize: 1.78 MB – Mime-Type: application/pdf

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Whitepaper: How Controlled & Scalable Freezing Becomes Reality

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