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Single Use Support GmbH, Austria

SUSupport closes the gap between downstream and the fill & finish process in the biopharma industry. On the basis of single-use bags, we offer biopharma companies access to a new and 100% secure logistics process for liquids. SUSupport is based in Kufstein, Austria.

VISION AND MISSION STATEMENT OF SINGLE USE SUPPORT GMBH 2018

It is and always has been one of humankind’s biggest endeavors to prolong life by staying healthy; to improve quality of life, reduce child mortality, and the number of terminal illnesses.
After many years of working in this industry with its unbelievable options, we started discovering weak points in the manufacturing and logistics processes.
On a regular basis, entire shipments of vital and high-quality substances become useless due to faulty containers, contamination, disruptions of the cold chain, or simply because of inappropriate handling.
It became even more frustrating for us to take this for granted. On the other hand, we knew that it would be a massive challenge to devise and implement an entire process for a globally organized industry, to make it ready for market and to protect our innovations by taking out patents – in short: To contribute our part in the quest for prolonging life.
We knew that we would only be able to achieve this if every single link in the new process chain would constitute an innovation in itself; together, these innovations would then create a real “game-changer” that would be impossible to ignore even by this powerful industry – because it builds upon existing and established technology, increases efficiency and reduces costs thanks to minimizing losses towards 0%.

MISSION Statement of SUSupport GMBH:

“We founded our company to increase patient safety by optimizing single-use technology in biopharma at the highest technological level.”

Yes, it is possible.

Through intense research and collaboration with this great industry and thanks to a highly motivated team, we were able to increase the industry’s quality standards as well as patient safety dramatically and traceably in an extremely short timeframe.

VISION of SUSupport GMBH:

“We are creating a globally active company that is a technology leader in the field of liquid logistics for pharmaceutical applications, pushing the quality of life and human health to an ever-higher level worldwide.”

Thanks to an increasing collaboration with the biopharma industry and institutions like the FDA every day brings us closer to reaching our vision.

BULK.STREAM®

By using the SUSupport technology, MORE high-quality substance can be shipped internationally in a FASTER and ABSOLUTELY SECURE manner, and at a LOWER loading volume.

“The next level of drug substance logistics.”

We close the gap between downstream and the fill & finish process in the biopharma industry.

On the basis of single use bags, we offer biopharma companies access to a new and almost 100% secure logistics process for liquids.

The technologies developed by us increase patient safety and minimize the risk of bio contamination and product loss towards 0%.

We are able to store and ship high-quality substances in a faster and more secure manner, and at a lower loading volume than to date. We build upon standards, eliminate material deficiencies, and minimize human errors.

We call this, our new development, BULK.STREAM®.

MITS.2D®

MITS.2D® is a patented technology that allows users of single use consumables to test their assemblies at the point of use. The technology is based on Helium as tracer gas. This gas is inert and does not have any negative impact on the product. Helium allows to detect leaks with a size of 2 microns and smaller.

Value of MITS.2D®

  • Indentifies single use
  • systems with a lack
  • of integrity
  • Fully automated point-of-use testing
  • In less than 2 minutes
  • Uses Helium as tracer gas
MITS.2D® is a patented technology that allows users ofsingle use consumables to test their assemblies at thepoint of use. The technology is based on Helium as tracergas. This gas is inert and does not have any negativeimpact on the product. Helium allows to detect leakswith a size of 2 microns and smaller.
RoSS®/ PROTECT

Tough protected & tamper evident!

The well tried-and-tested single use bag gets its 100% secure and compact shell.
In the first place, the single use bag will be covered by soft 3D foam, which provides a protective embedding as well as damping in case of vibrations.
Furthermore, the volume of the bag or of the liquid contained within can be expanded during the freezing process. This allows for a perfect adaption, which in turn maximizes the protective effect.
The frames of the RoSS® unit are made of heavy-duty plastic that withstands even the lowest temperatures and makes up the static frame of RoSS®. Apart from the guide rails for the stainless steel top and bottom, the frame contains ergonomically shaped grip plates for safe and intuitive handling.

The RoSS® top and bottom are made of high-quality stainless steel with the following three advantages:
1. Maximum durability and strength.
2. When in direct contact with the bag, these features offer the ideal basis for an effective initial and ongoing freezing process. Furthermore, they enable a consistent and gentle defrosting or thawing process.
3. Thanks to the right compounds, tolerances and material strengths of the stainless steel top and bottom, the RoSS® construction allows for only minimal vibration.
4. It also reduces the tension in the structure of the single use bag and offers shock absorbent protection.

Facts:
• Adjustable for all 2D single use bags (e.g. Thermofisher, Entegris, Sartorius, …)
• Robust, closed and tamper-evident construction
• 3D foam offers additional space and protection for the sensitive compound of the raw bag and tubing – complete immobilization <0 °C / <32 °F
• Space for sterile connectors and long hoses
• Space for satellite samples / ID bags
• Steel plates on the top and bottom for consistent and quickest possible freezing and defrosting times
• High density, which means a reduction of required freezer space capacity
• Easy handling during the recycling process – no composite materials
• Bag can be visually checked/inspected after filling and before dispensing

RoSS.FILL / FILL & DRAIN

RoSS.FILL is a flexible platform for the allocation and distribution of bulk drug substance in single use bags that are integrated in the RoSS system. The liquid path is fully disposable and can accommodate a multitude of sterile compound and segregation options.
With a filling speed of 200 litres per hour, the RoSS units on the rack are filled in fully automated manner. Single use bags of all established manufacturers and of different sizes and capacities are compatible. The scalability is limitless

Facts
• Fully automated filling and draining system for single use bags
• Filling of up to 200 litres of substance in less than 1 hour
• Accuracy of +/- 10ml for 10 litres with individual weighing cells
• Modular system with separate control unit and pumping station as well as storage rack made up of RoSS trays filled with singleuse bags
• Option to take samples
• Optional MES integration

FREEZE-THAW PLATFORM / FREEZE & THAW

It is no secret that SUSupport is continuously developing and expanding the Bulk.Stream®. This is why plate-based freezing and defrosting facilities for stability studies as well as for small to big batch sizes have been developed.

RoSS.pFTU blockbuster aspires to replace CryoVessels, which are used for very large batch sizes, in the single use variant. Its development is currently in its final stage.
Safety and constant freezing of high-quality substances in an even shorter timeframe will be pushed to a new level – a further milestone for the biopharma industry.
Find data sheets for all RoSS.pFTU sizes in the download area.

RoSS.pFTU
RoSS.pFTU lab scale

Compatible with single use bags of all sizes and manufacturers

RoSS.pFTU lab scale is the perfect solution for studies conducted in labs and, above all, if you want to start a controlled and scalable freezing process.

RoSS.pFTU small scale

Compatible with single use bags of all sizes and manufacturers

RoSS.pFTU small scale is a plate-based freeze-thaw unit for studies and small-scale batches.

RoSS.pFTU large scale

Compatible with single use bags of all sizes and manufacturers

RoSS.pFTU large scale is a plate-based freeze-thaw unit for any scale and batch sizes.

RoSS.pFTU blockbuster scale

Compatible with single use bags of all sizes and manufacturers

Blockbuster scale single use platform: for bulk drug substance of up to 300l in one fully disposable unit.

RoSS® Bag Shaker

Compatible with single use bags of all manufacturers and sizes

Re-homogenizing of protein solutions!
Based on a patent pending technology, RoSS® Bag Shaker is tailor-made to mix 2D bags efficiently.

 

Facts:
• Isolated shipping containers for passive cooling processes
• Validation based on ISTA / ASTM 4169
• Optional temperature- / GPS- / G-Force tracking
• Adjustable to all requirements and batch sizes
• Suitable for phase change materials and dry ice
• Single use or multi use

RoSS® Trolley

Compatible with RoSS®®

Stainless steel trolley for up to 22 RoSS® trays for handling and storage.

Simply ask for details.

RoSS.FILL Flex Rack

Compatible with RoSS.FILL

RoSS.FILL Flex Rack

Compatible with RoSS.FILL

The RoSS.FILL Flex Rack enables you to now also fill bottles with your RoSS.FILL, making the transition from bottles to single use bags easy.

  • Manifold gets placed on the system
  • Bottles get connected at point of use
  • 1 automatic valve/bottle, or one valve/weight cells (tbd)
  • 6 weight cells
  • GMP, cfrp11 compliant software control unit can be used with the bottle rack or the bag/shell rack
  • Flexible solution for single use bags (see RoSS.FILL) and bottles (with Flex Rack)
  • Same control unit (just switching rack)
  • Standard Siemens
  • DeltaV connection optional
RoSS.SHIP/ STORE & SHIP

Highly robust, stackable, coolable and compact – Fort Knox for high-quality substances!

RoSS.SHIP integrates 20 ROSS® trays and more in a compact volume. Most frozen substances can be stored and shipped in a protected manner and in compliance with international standards.
The statically highly solid RoSS.SHIP stainless steel container is designed for passive cooling with dry ice or “phase change materials” (PCM).

Optionally, the geographical location as well as the interior temperature of the RoSS-SHIP container can be tracked and monitored 24/7 via GPS or G-Force tracking.