RoSS.KSET/ PROTECT

Hard, manipulation-safe shell – soft core!

 

The tested single use bag receives its 100% safe and compact shell.

Single use bags with a volume of 50 ml to 0.5 l are covered with a first 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. An innovative and intuitive sealing system is a further feature to warrant functionality and safety.

The RoSS.KSET unit is made of high-density stainless steel. The container can be locked and sealed, while an inspection window enables visibility of all product specific data. This guarantees absolute protection against manipulation and maximum transparency as well as intuitive handling at the same time.

Scale-down to one single drop of drug substance!
RoSS.KSET offers the protection for drug substances between 1 ml to 500 ml.
For anything above, RoSS can protect one or multiple small single use bags in one shell.

 

Advantages of the stainless steel construction:

  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 -200°C / -328°F.

 

Facts:

  • A container for all standard compact 2D single use bags (e.g. Origen, Miltenyi Biotec, ...) and all sizes
  • Robust and closed construction, construction, with temperature regulation, to secure the single use bag
  • Viewing window to read captions when container is closed/sealed
  • 3D foam offers extra space and protects the sensible connection of raw bag and tubing – complete immobilization < 0°C / 32°F
  • 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
  • Stainless steel container for consistent and quickest possible freezing and thawing
  • High density, which means compact measurements of the shipping unit
  • Ease of use during the recycling process – no composite materials
  • Serialized CGT.KSET available (specific RoSS.KSET for certain single use bags for segmented handling)
  • Robust locking-/opening mechanism with clear indicator
  • Open/locked clearly indicated
  • Easy to lock with thick gloves
  • Special lock to minimize risk of pinching and of damaging the single use bag

 

Like an amulet, RoSS.KSET carries its content softly covered and protected around the globe.

In case you are searching for a solution that carries one bigger or multiple smaller single use bags, check out RoSS as alternative option for CGT applications:

RoSS

We see issues with integrity of Single Use Systems in the biopharma world. Potentially, the MITS.2D technology is able to help address Endotoxin and Bioburden issues properly. Sterility is key for some applications very close to the patient in Fill and Finish facilities. Midterm, MITS.2D might be able to mitigate the risk of biocontamination in these process steps also.

FDA

FDA authority, USA

We were looking for a solid shipping solution for our single use bags. None of the available solutions to date offered reassuring solutions.
Thanks to a fortunate coincidence we got in touch with SUSupport. Not only have we found a more than solid 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.

Program Manager

Lonza AG, Basel

We were analyzing different solutions on the market for freezing and thawing our drug substances in single-use bags.
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.
Furthermore, it is a good starting point to expand to a whole end-to-end solution.

Program Manager

3S Bio
Download

Click here to download technical product datasheets, design videos, as well as a case studys and more.


Protective single use system for CAR-T and CGT: The RoSS.KSET

Single use bags have become a mainstay in the pharmaceutical logistics process, all the way from downstream to the fill & finish process. They are the ideal solution for small volumes required in the CAR-T and CGT approaches.

Advantages of single use bags in biopharma:

  • Industrial standard.
  • Compact and cost effective solution.
  • Available in various sizes and filling quantities.
  • Easy to dispose of after use.

Since single use bags are made of thin plastic they allow for ideal freezing results, yet, at the same time, they are sensible and require protection from external impact to reduce integrity issues, material loss and leakage or breakage.

Effective protection with a soft core and a tamperproof shell

Highly sensitive cell and gene material used for personalized therapies such as CAR-T and CGT requires sterile and safe handling. In order to protect the valuable goods throughout the logistics process, the single use bag is embedded in a soft core made of 3D foam, which is then encased by a compact and tamperproof, highly dense stainless-steel sleeve.

While the soft foam dampens external shocks, the stainless-steel shell adds an additional layer that is both impact-resistant and offers stability. For added functionality and safety, the RoSS.KSET is lockable, while product-specific data can be viewed through an inspection window, allowing for maximum transparency and easy handling.

Advantages of RoSS.KSET at a glance:

  • Compatible with bags from all established manufacturers, ranging from 1 ml to 500 ml in volume
  • Compatible with any L2 DEWAR/Shipper
  • Fully immobilizes bags and tubings at < 0°C / 32°F
  • Offers space for satellite samples, ID bags and vials
  • Expandable foam core adjusts to size fluctuations during freezing/thawing
  • Direct contact with the bag allows for consistent freezing with little to no cryoconcentation
  • Robust stainless steel sleeve withstands temperatures up to -200°C / -328°F
  • Highly dense and compact stainless-steel construction that can easily be handled with gloves
  • See-through window allows for inspection of closed KSET
  • Tamperproof sealing
  • No composites: User-friendly handling and easy recycling
  • Option of serialized CGT_KSET