RoSS.pFTU Lab Scale

Freeze-Thaw | 1mL - 5L

Our plate-based lab scale freezer is the perfect solution for clinical studies conducted in labs and, above all, if you want to start a controlled, cGMP-compliant and scalable freezing process. 

This laboratory freezer shows the best product stability results for Cell and Gene therapy or mAbs.  RoSS.pFTU lab scale is compatible with single-use bioprocess containers of all sizes and manufacturers. 

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Fast lead times

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Our customers trust in us:

3SBio Inc.

The combination of a bag agnostic robust secondary packaging (RoSS®) and the scalable plate based freeze/thaw technologies convinced us to select Single Use Support. It not only matches all our requirements, it is also safe, easy to navigate and flexible to single use bags from any supplier.

Lonza

Thanks to a fortunate coincidence, we got in touch with Single Use Support. Not only have we found a more than solid single-use solution for our main problem thanks to their product RoSS®, but we now have access to a clever and 100% safe drug substance logistics system.

Genezen

Having partners such as Single Use Support in place will be one of many essential components as we scale our operations to deliver high-quality programs and vector production services to our clients.

Freeze & Thaw for Cell and Gene Therapies

Compact freeze & thaw unit for small batches.

Monitored freezing and thawing of small batches – more important than ever in times of autologous and allogeneic cell therapies and gene therapies.

The RoSS.pFTU Lab Scale is the perfect solution for clinical trials and studies conducted in laboratories and, above all, if you want to start a controlled and scalable freezing process.

Another milestone towards more patient safety!

RoSS.pFTU Lab Scale Description

Plate-based Freeze & Thaw Unit for freezing and thawing of smaller volumes of drug substances protected by RoSS shells

  • Lab scale freezes drug substance volume from 1 mL up to 5 L per bag and more, depending on bag type
  • Setpoint freezing down to -80°C / -112°F
  • Upgrade optionally: Up to 3 RoSS shells of 5 L can be frozen in one freeze run.
  • Hybrid optionally: Both bags and bottles can be frozen in this lab scale unit.
  • Usage for stability studies in labs
  • Full automation and cGMP-compliance allowing a seamless transition to RoSS.pFTU large scale
  • Compatible with 2D single-use bags of all manufacturers and sizes
  • Protective RoSS shell and RoSS.KSET for single-use bags are recommended for freezing
  • Freezing at highest possible speed & accuracy

Freeze & Thaw System

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Freeze & Thaw platform

The Single Use Support freeze-thaw platforms provide insular solutions for the freeze/thaw processes of each clinical phase. 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.

Lab freezer for single-use technology

Biopharmaceutical manufacturers are increasingly utilizing single-use technologies for cold storage, shipping in the cryogenic temperature range and the transfer of biopharmaceutical substances and reagents under strict temperature control. The advantages speak for themselves:

By abandoning cost-intensive, outdated, and bulky lab equipment such as auto defrost solid door upright freezers, conventional manual defrost chest freezers, and ultra-low temperature freezers, manufacturers can save considerable amounts of USD and increase productivity considerably for each cu ft of plant space.

Single-use technologies, and single-use bioprocess containers in particular, require little storage space, which makes them a cost-effective solution. Additionally, bags of different sizes are freely available on the market and, where required, established and standardized quality tests are available to be conducted before filling and use.

Recently, the COVID-19 pandemic highlighted a weak point in the life science and biopharma business: refrigeration, freezing and cold temperature technology in general. With the need to manufacture massive amounts of vaccine vials with unprecedented storage requirements, the bottleneck of vaccine storage and transport emerged. This situation challenged innovative companies to develop benchtop solutions to overcome lab refrigerators and freezers.

But the advantages of single-use technology do not end with the storage: The entire handling of the logistics process for biopharmaceutical liquids is fool-proof, especially when compared to the utilization of stainless-steel tanks, Cryo vessels and other traditionell alternatives. With the use of single-use technologies, cleaning, storage as well as complicated logistics can practically be omitted.

Where the water volume as well as chemical detergents required when using stainless-steel solutions are significant and far from being sustainable, single-use technology is leading the way in terms of sustainability.

All these factors apply to established manufacturing as well as the production of small batches conducted in labs or for study purposes with conventional methods such as chromatography, countertop centrifuges, PCR, pipettes, and electrophoresis.

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The advantages of compact plate freezers over laboratory freezers

Humans are simple beings. So it seems just plausible to use a general purpose compressor fridge or laboratory freezer for freezing liquids such as culture media. But things are not always as simple as they may appear. While the use of laboratory refrigerators and low freezers may be logical, the outcome is far from the optimum and usually unsatisfactory. Traditional defrost freezers have disadvantages that can be clearly measured:

  • Unreliable thermostats, lack of digital controls, timers, microprocessor control, touchscreens
  • A lengthy freezing process for liquids
  • The formation of relatively big crystalline structures caused by the slow and not very homogenous freezing process, which are the cause of frictions that lead to the destruction of valuable proteins. Up to 20% of proteins can be destroyed like this. Effect: After thawing, the substance has lost a considerable amount of its original concentration, thus dropping in value.

At first it may feel unfamiliar to place a microplate or filled single-use bag in a compact plate freezer, which seems to resemble a toaster rather than a freezing device.

However, appearances do not matter as long as the outcome does not fail to convince:

  • The speed of the freezing process is multiplied: Thanks to the close contact of the freezing plates and the liquid there is no more need to freeze air used for isolation. The cold gets directly transferred, thus saving time and energy.
  • The shock-like freezing retains the quality of the substance, from small molecule drugs to enzymes and monoclonal antibodies. Due to direct contact with the freezing plates on both sides, the container is frozen consistently and evenly, as seen in the image. A condensed line is visible in the bag’s mirror axis, indicating a homogeneous freezing process.
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More solutions

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RoSS.pFTU Mid-Scale | Freeze-Thaw

Up to 70L: Our mid scale freezer is a plate-based Freeze/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 70L. 

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RoSS.pFTU Large-Scale | Freeze-Thaw

Up to 220L: Our large scale freezing platform system is a plate-based freeze-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 220L in one platform.  

RoSS_FRDG_Ultra Cold Storage

RoSS.FRDG | Ultra Cold Storage

RoSS.FRDG is a storage fridge for frozen drug substances in different sizes. It keeps the desired set point temperature down to -80°C. RoSS.FRDG is compatible with RoSS Shells, stackable itself, fully moveable and shippable. 

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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.

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RoSS.PADL | Homogenizing

RoSS.PADL is a scalable platform for cooling your single-use bag whilst gently massaging it to ensure there is a homogenous mixture of the solution. With the RoSS.PADL multiple cooling and massaging mechanisms can be placed side by side with one control system.

FAQ

What is a lab freezer?

Lab freezers are devices with the purpose to keep products at temperatures between 10 and -40 °C.

What is a medical freezer?

Medical freezers are specifically designed to store medical substances. Since these goods come with specific needs, the according devices have to meet several criteria that set them apart from ordinary household freezers.

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 temperature is a lab freezer?

While low temperature freezers can achieve cooling temperatures in a range between around -10 and -45 °C, ultra cold freezing requires lower temperatures, between -60 and -80 °C.

More information

freeze-thaw-platform-biopharma

Freeze-thaw platform revolutionizing the drug substance logistics process

With bulk drug substances playing an increasingly important role in the pharmaceutical and biopharmaceutical industry, the need for a reliable freeze/thaw process as well as safe shipping and storage is more important than ever.
 

single-use-technology

Single-use technology & the implementation in biopharma

Single-use technologies, which reduce the risk of cross-contamination of high-quality bulk drug substances, are becoming increasingly popular in the pharmaceutical industry. You can find out the reason for this in the blog post!
 

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