Freeze-Thaw platform

The Single Use Support freeze-thaw platforms provide reliable end-to-end solutions, such as plate freezers for the controlled freeze/thaw processes of any drug substance - either for clinical phases or commercialized bulk production. 

Our new freeze-thaw units are fully scalable and compatible with all batch sizes and bags from all established manufacturers – you will only require one single system from the lab to blockbuster production.

Controlled Plate-Freezer_1

Product Overview

FTLA_Benchtop

RoSS.pFTU Lab Scale Benchtop | Plate Freezer

Plate freezer RoSS.pFTU Lab Scale Benchtop is the easy-to-implement platform system for labs to perform freezing of small volumes in 2D single-use bags for clinical studies, clinical trials and cell and gene therapies.

Down to -80°C/-112°F
Up to 10L
Controlled rate freezing & thawing
Laboratory freezer RoSS.PFTU Lab Scale

RoSS.pFTU Lab-Scale | Plate Freezer

1mL-10L: Laboratory freezer, compatible with single use bags of all sizes and manufacturers. Our lab freezer is the perfect solution for studies conducted in labs and, above all, if you want to start a controlled and scalable freezing process.

Down to -80°C / -112°F
Up to 10L
Controlled rate freezing & thawing
ross-pftu-mid-scale

RoSS.pFTU Mid-Scale | Plate Freezer

Up to 100L: Our mid scale freezer is a plate freezer and thaw unit designed for RoSS shells, to protect your preferred single-use bag during cryogenic applications. 

RoSS.pFTU mid scale is compatible with single-use bioprocess containers of all sizes and manufacturers and shows best product stability results for your biopharmaceuticals up to 100L. 

Down to -80°C / -112°F
Up to 100L
Controlled rate freezing & thawing
ross-pftu-large-scale

RoSS.pFTU Large-Scale | Plate Freezer

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.  

Down to -80°C / -112°F
Up to 400L
Controlled rate freezing & thawing
RoSS PFTU_Large Scale_Freeze-Thaw Platform_Hybrid

RoSS.pFTU Large-Scale Hybrid | Plate & Blast Freezer

Up to 400L Bags & 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. 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.

Controlled rate freezing & thawing
Up to 400L
Down to -80°C / -112°F
RoSS.PFTU XL_Large Volume Freeze-Thaw_Single Use Support

RoSS.pFTU XL | Freeze-Thaw

Up to 500L: Controlled freezing and thawing of thousand of liters in biopharmaceutical  manufacturing processes. Automated plate-based freeze-thaw unit for 500 liters per batch of any liquid substances including vaccines, media, buffer solutions or other drug substances.

Down to -80°C / -112°F
Up to 500L
Controlled rate freezing & thawing
BLST_Rendering

RoSS.BLST | Blast Freeze & Thaw

RoSS.BLST is a GMP-compliant blast system for freezing & thawing of drug substances down to -75°C, regardless of the choice of primary packaging.

Down to -75°C / -103°F
Up to +40°C / +104°F
Cryogenic Freezer RoSS LN2F

RoSS.LN2F | Cryogenic Freezer

Cryogenic controlled rate freezer for temperatures down to -180°C/ -292°F. An enclosed LN2 system and our innovative direct injection system ensure no direct exposure and no mechanical compressors are needed. This ensures a safe, low-maintenance and energy-saving handling.

Down to -170°C / -274°F
Increased Cell Viability
Down to < 250mL/ Bag
RoSS.FRDG-Rendering

RoSS.FRDG | Ultra Cold Storage Freezer

RoSS.FRDG is an ultra cold storage fridge for frozen drug substances in different sizes. The ultra cold freezer keeps the desired set point temperature down to -75°C. RoSS.FRDG offers highest storage density, is fully movable and can be modularly adapted to your individual needs.

ross-shak-shaker

ROSS.SHAK | Shaker

RoSS.SHAK is your reliable shaker to regain highest quality and homogeneity of your biopharmaceuticals.

RoSS.SHAK enables constant shaking of your protein to regain homogeneity and product quality after freezing. Shakes up to 70L per run in 3 pre-defined speeds.

RoSS.LODR open loading single-use shell

RoSS.LODR | Foldable gripper arm

RoSS.LODR is a mobile and foldable gripper arm that ensures ergonomic handling during loading or unloading activities. RoSS.LODR supports a safe working environment and can significantly reduce work related repetitive strain injuries.

Our customers trust in us:

Rentschler Biopharma SE

Lonza

SCHOTT Pharma

Whitepaper_Controlled_Scalable_Freezing_SEP22

Whitepaper Download

How controlled & scalable freezing becomes reality

Being able to control the freezing behavior of bulk drug substance is the ultimate goal in Biopharma manufacturing. It opens doors to process reproducibility, consistent quality of the final drug product by maintaining uniform conditions for the biopharmaceuticals during freezing, and consequently for frozen storage and shipment.

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Whats makes our Freeze-Thaw platform so special?

Fully automated

Fully-automated freeze & thaw process, at highest possible speed and accuracy. CFR Part 11 and GMP-compliance as a further milestone for the biopharma manufacturers. Freeze/thaw recipe for lab scale also transferable for large scale.

Flexibility

Compatible with single use bags of all established manufacturers, sizes and capacities. Hybrid version of plate freezers to freeze & thaw vials, bottles and single use bags in one platform possible. Or blast freezing technologies for controlled rate cryogenic down to -170°C.

Unrestricted Scalability

The scalable solutions for plate-based freezing and thawing ranges from the RoSS.pFTU lab scale to RoSS.pFTU large scale. For ATMPs or cell culture inoculation using either multiple small bags or up to one 5L bag, there is RoSS.pFTU lab scale. Your way up to blockbuster commercial production is possible with RoSS.pFTU XL. From 10mL up to 50L bags and a batch size of up to 500L and more you can scale-up or down as required.

Safety

Taking the safe and controlled freezing of high-value biopharmaceuticals to a new level: A tamper-evident closed system with optimal freezing kinetics leads to proven product viability and a freezing process with best stability results for mABs, BDS, CGT, ADCs, viral vectors or any other vaccine.

Scalable freeze thaw system with RoSS.pFTU scalability

Freezing/Thawing with Static vs. Plate Freezer

We tried to visualize Cryoconcentration by using Naphthol Blue Black as color agent. An intense blue coloration shows a high concentration of dissolved solutions. The bags frozen in the plate freezer exhibit a homogenous tinge with a white line running through the center. The bag frozen in the static freezer exhibits higher concentration levels in the lower areas.

Uncontrolled "slow freezing"

Dark blue spots indicate a higher cryoconcentration

Blast freezer slow freezing

Controlled plate freezer “fast freezing”

A homogeneous freezing, no dark blue spots are visible.

Plate freezer biopharma fast freezing of drug substances by Single Use Support

Data sheets

Click here to download technical product data sheets, design videos, as well as a case studies and more.

Datasheet RoSS.pFTU LabScale

Datasheet RoSS.pFTU Lab Scale

Filesize: 0.73 MB – Mime-Type: application/pdf

Datasheet_pFTU_LargeScale

Datasheet RoSS.pFTU Large Scale

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

Datasheet RoSS.pFTU Hybrid Freezing for Bags & Bottles

Hybrid Freezing Brochure - Bags and Bottles

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

Whitepaper_Controlled_Scalable_Freezing

Whitepaper: How Controlled & Scalable Freezing Becomes Reality

Filesize: 1.96 MB – Mime-Type: application/pdf

Scalability Guide RoSS.pFTU

Freeze & Thaw Scalability Guide

Filesize: 0.83 MB – Mime-Type: application/pdf

Datasheet_pFTU_MidScale

Datasheet RoSS.pFTU Mid Scale

Filesize: 0.57 MB – Mime-Type: application/pdf

Datasheet_RoSS.pFTU XL

Datasheet RoSS.pFTU XL

Filesize: 0.58 MB – Mime-Type: application/pdf

Whitepaper: Scalable Freezing & Thawing of Pharmaceutical Bulk

Whitepaper: Scalable Freezing & Thawing of Pharmaceutical Bulk

Filesize: 1.13 MB – Mime-Type: application/pdf

App Note_Bestcellers-Controlled Filling Freezing of Cells

App Note: "Bestcellers": Controlled Filling & Freezing of Cells

Filesize: 2.39 MB – Mime-Type: application/pdf

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More solutions

Click here to download technical product data sheets, design videos, as well as a case studies and more.

RoSS.FILL - single use filling system for drug substances

RoSS.FILL | Fill-Filtration

RoSS.FILL is a fully automated single-use bag filling system. This allows maximum flexibility and scalability of both the filling and draining process. It is possible to fill unlimited volumes per batch with a speed of up to 300 liters per hour. The entire filling process is fully disposable, thus warranting an absolutely sterile fill & drain process. For further productivity improvements check out our pinch valve innovation.

Bulk.Stream RoSS shell

RoSS® Shell | Protecting single-use bags

The safest transport solution for all available single-use bioprocess containers. Robust. Scalable. Single-use bag independent.

Pharmaceutical freezers for safe storage

In biopharma and similar industries related to the healthcare sector there is a lot of talk about the process of freezing with a pharmaceutical freezer: This process brings medical grade drug substances into a frozen state to allow for protected, safe and reliable storage and shipping at low temperature.

It depends on the drug substance at what process steps and at what temperature it needs to be frozen in order not to get degraded. The most recent accomplishments in COVID-19 vaccine clinical trials and the raised discussions of required temperature for storage in vaccine refrigerators and vaccine freezers are solely about the vaccine storage temperature after fill & finish in final syringes and vials. There will still be need to fulfill CDC requirements for ultra cold freezing to -80°C in the bioprocess manufacturing process steps ahead until the vaccine is being filled into syringes and vials for global supply.

However, the medial anxiety about freezing biopharmaceuticals to ultra low sub-zero temperatures in the -60°C and -80°C temperature range has only shown that established technologies do not fulfill high performance industry requirements and are not well-trusted yet. To date, the methods employed in research often involve traditional auto defrost and countertop laboratory freezers and cooling systems that usually are, however, not the most efficient ones.

Freezer for biopharma - freeze-thaw platform

Countless academic research labs utilize dated refrigerator/freezer combinations for flammables and freestanding chest freezers as lab freezers, often without digital temperature display or temperature alarms, and still require manual defrost. Medical-grade refrigerators (e. g. blood bank refrigerators) and medical freezers are usually equipped with thermostats that are calibrated with NIST conforming thermometers and with automatic defrost. 

The utilization of static glass door refrigerators and standard solid door compressor laboratory refrigerators is responsible for up to 56 % of viral potency product loss in biopharmaceutical manufacturing.​ This almost incredible percentage is the result of a slow and inefficient procedure that leads to decreased temperature uniformity and inhomogeneous results.

In highly complex and technically progressive environments brimming with microprocessors and data loggers, with a focus on speed and quality, traditional pharmaceutical refrigerators and freezing processes are, generally speaking, no longer appropriate. They prove to be more and more inefficient as they only slowly drain the heat from the product, thus lacking appropriate temperature control and leading to an inconsistently frozen substance. What is needed are efficient systems based on elaborate, cutting-edge procedures that are tailored to push productivity by freezing biopharmaceutical substances evenly and without any product loss - ultra cold freezer.

Plate freezer large scale

What is required of cutting-edge pharma freezer systems today?

Sophisticated and intelligent freezing system will have to cover three main aspects in order to meet the basic requirements of today’s biopharmaceutical industry:

  1. Preserving the quality of any frozen substance
  2. Facilitating organized and easy storage of drug substances 
  3. Scalability: The client needs to be able to scale both volume and quantity.

These three parameters have to be considered in order for a platform to be relevant for drug substance logistics in labs and manufacturing, both for small batches and bulk production.

Plate freezer for the pharmaceutical industry

RoSS.pFTU: Time-saving freeze-thaw platform based on plate freezers

With RoSS.pFTU, Single Use Support has developed a freeze-thaw platform that addresses the needs of the industry and provides solutions. The system designed by Single Use Support allows for a blast-like freezing where the substance contained in RoSS® is evenly frozen thanks to the direct contact between the plate freezer and the stainless steel plates covering the container: The close contact between freezing plates and liquid substance significantly speeds up the process as it facilitates a direct transfer of the cold. Additionally, there is no ambient air that requires cooling, as is the case with traditional freezers. The homogenous outcome of this plate freezing technology not only maintains the substance’s original quality but also protects it from potential damages during shipping and thawing.

In addition to affording fast and homogeneous results, Single Use Support’s freeze-thaw platform offers additional benefits that merit its use in the biopharma and similar industries:

  • Minimized production costs
  • Maximized production output
  • Easy and simple disposal
  • Reduced power and water consumption

FAQ

What is the difference between a blast freezer and a plate freezer?

While blast freezers use cold air that is blasted on products that are yet to be frozen, plate freezers work via direct contact between the cooled plates and the products.

What is plate freezing application of refrigeration?

The fields of application of plate freezers are manifold, since they are able to deliver a very consistent and fast freezing process. Therefore, they are, for instance, an essential tool in biopharma industry, where the quality of highly delicate products needs to be maintained when bringing them to ultra-low temperatures.

What is a pharmaceutical-grade freezer?

A pharmaceutical-grade freezer is a freezer that is designed to freeze and store pharmaceutical substances – for instance vaccines – in a secure and efficient manner. In order to be able to cope with the high fragility of these products, there are several aspects in which they differ from ordinary kitchen freezers.

How cold are medical freezers?

Medical freezers are designed to maintain set temperatures within a range of usually between -40 and 86 °C, in some cases down to -150 °C.

Latest Insights about Freeze & Thaw

Freeze & Thaw

Shedding light on optimal freezing results for drug substance

How x-ray views from frozen single use bags affirm plate-based freezers as spearheaded freezing technology in Biopharma

johannes-kirchmaier

Johannes Kirchmair

May 12, 2021

Freeze & Thaw

Plate freezing: best approach for freezing biopharmaceuticals

Plate freezing is a process where a product’s temperature is reduced by the means of contact with cold surfaces. Thus, a defining step in the freeze-thaw process for conservation, with several advantages for biopharma.

Alexander Fuchs | Single Use Support

Alexander Fuchs

May 18, 2022

Freeze & Thaw

Advancements in Small Volumes Drug Freezing Techniques

Freezing small volumes extends beyond laboratory settings to include commercialized manufacturing processes for small batches in biomanufacturing, like cell banking, gene therapies utilizing viral vectors, lipid nanoparticles, and fill & finish procedures.

Alexander Fuchs | Single Use Support

Alexander Fuchs

November 20, 2023

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