• An image of an open RoSS.KSET protecting a single-use bag, on a transparent background.

Protection for small single-use bags | ROSS.KSET

Protection for small single-use bags | ROSS.KSET

RoSS.KSET offers protection for small single-use bags. Most suitable for small batch sizes. Smart protection for single-use bags with volumes less than 250 mL in cell and gene therapy or clinical studies. 

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Bag independent
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<0.001% product loss
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Best freezing result

Overview of RoSS.KSETs

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100% safe single-use bag protection for small batches

The equivalent of RoSS for small scales – hard, manipulation-safe shell!

Scale down to one single drop of drug substance! RoSS.KSET offers the protection for drug substances less than 250 mL. For anything above, RoSS can protect one or multiple small single use bags in one shell.

In RoSS.KSET, single use bags are covered with one layer of soft 3D foam. This offers protection and dampens shocks. Furthermore it allows for an expansion of the liquid volume and the bag in the freezing process and immobilizes the frozen bag in the hardened foam.

The RoSS.KSET unit is made of high-density stainless steel. The container can be locked and tamper-evidence sealed. This guarantees absolute protection against manipulation as well as intuitive handling at the same time.

  • Close-up of a small frozen single-use bag enclosed in a RoSS.KSET, displayed on a white background.

  • Advantages of the stainless steel construction for cell and gene therapy packaging

    1. Stainless steel offers maximum durability and extreme strength.
    2. When in direct extensive contact with the bag, it is the ideal basis to keep the freezing process effective from the beginning all the way to the end and allows for a gentle thawing process.
    3. The stainless steel shell is safe up to temperatures of -196°C.

  • CGT bag protection RoSS.KSET Facts

    • Stainless steel container for all standard compact 2D single-use bags (e.g. Origen, Miltenyi Biotec, …) and all sizes
    • Robust and closed construction with temperature regulation, to secure the single-use bag
    • 3D foam offers extra space and protects the sensible connection of raw bag and tubing – complete immobilization < 0°C
    • Space for satellite samples/ID bags/vials
    • Sealable locking system protects against manipulation
    • Suitable for cells (Apheresis), viruses and DP bags
    • L2 DEWAR/Shipper compatible
    • Ease of use during the recycling process – no composite materials
    • Robust locking-/opening mechanism with clear indicator
    • Easy to lock with thick gloves

  • Image of a RoSS.KSET and RoSS.KSET rack to protect small scale single use bags during transport or storage.
  • Protective RoSS.KSET rack for safe shipment of small-scale single-use bags.

  • How can RoSS.KSET RACK protect small scale single use bags?

    Highly robust and compact – a CGT (cell & gene therapy) vault for standard shipper systems.

    The Rack for RoSS.KSETs has been developed for the safe placement of all standard manufacturers (Cryoport, Savsu, …) in shippers for transport or storage and is able to withstand temperatures up to -196°C.

    The main construction material is high-density stainless steel. It is compact, lockable, safe to freeze, sealable, and thus protected against manipulation.

  • Protection for small single-use bags in CGT

    For cell and gene therapy packaging, maintaining the product’s qualities is key. Therefore, the biopharma industry relies on dedicated CGT bag protection systems.

    Since single-use systems play an increasingly important role in the supply chain of several biologics, it is only logical that cell and gene single-use bag protection is a topic stakeholders have to be concerned with – in various fields, such as stem cell therapy or CAR-T therapy bag protection.

    In order to provide manufacturers not only with CAR-T therapy single-use bag protection, but with a highly flexible protection system, the RoSS.KSET was designed to be implemented in the supply chain of various types of CGT, combining extensive protection with great user-friendliness.

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  • Close-up image of an operator placing RoSS.KSETs into a RoSS.pFTU Lab-Scale solution to freeze small volumes of drug substances.

Downloads

Preview of instruction for use for RoSS.KSET robust protection for small single-use bags by Single Use Support
Datasheet: RoSS.KSET
Preview of instruction for use for RoSS.KSET robust protection for small single-use bags by Single Use Support
Datasheet: RoSS.KSET
 
Preview of Single Use Support's whitepaper about robust secondary packaging RoSS shell
Whitepaper: RoSS shell - Advanced cold chain management
Preview of Single Use Support's whitepaper about robust secondary packaging RoSS shell
Whitepaper: RoSS shell - Advanced cold chain management
 
Preview of datasheet for RoSS.KSET robust protection for small single-use bags by Single Use Support
Instruction for use: RoSS.KSET
Preview of datasheet for RoSS.KSET robust protection for small single-use bags by Single Use Support
Instruction for use: RoSS.KSET
 

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FAQ

How does a CCU (Cryo Control Unit) work?

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We developed a system called Cryo Control Unit (CCU) which is an insolation material styro foam piece that covers the shoulders of the single-use bioprocess container and the shell. CCU is meant for enabling the use of RoSS®shells in standard lab freezers or in blast freezers.

Should I fill the biocontainer inside the shell or outside the shell?

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Yes, both options are possible. Either fill the bag and place it in the RoSS®System or place the empty bag in the system and fill it with a fully automated filling system, compact and with little air. Learn more aboutRoSS.FILL.

What temperatures is the CGT bag protection system RoSS.KSET ready to be stored at?

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The stainless steel shell is safe until temperatures as low as -190 °C.

How is the RoSS.KSET locked?

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RoSS.KSET shell for small volume bag protection has a sealable locking system minimizing the danger of pinching and of damaging the single-use bag; it is also easy to be locked with thick gloves.

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