RoSS® Shell | Protecting single-use bags
The safest transport solution for all available single-use bioprocess containers. Robust. Scalable. Single-use bag independent.
ROSS.KSET | Protection for small single-use bags CGT
Cell and Gene Therapy Packaging | Small volume bag protection
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.
100% Safe cell & gene single-use bag protection
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. 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 tamper-evidence sealed. This guarantees absolute protection against manipulation as well as intuitive handling at the same time.
Advantages of the stainless steel construction for cell and gene therapy packaging:
- Stainless steel offers maximum durability and extreme strength.
- 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.
- The stainless steel shell is safe up to temperatures of -196°C / -320°F.
CGT bag protection RoSS.KSET Facts:
- A 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 / 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
- 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 the RoSS shell as alternative option for CGT applications.
Our customers trust in us:
RoSS.KSET RACK | Protect & Ship
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.
In a first step, we developed a suitable RoSS.KSET based on standard single use bag sizes that, in a second step, can be manufactured according to required capacity needs of the RACK units.
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 / -320°F.
The main construction material is high-density stainless steel. It is compact, lockable, safe to freeze, sealable, and thus protected against manipulation.
Another step towards 0% product loss and thus 100% patient safety!
In case you are searching for racks for drug substance in RoSS shells, check out our RoSS Accessories that can be customized to your needs:
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.
RoSS® Shell: Protecting single-use bags above 250mL
Videos
Single use bag shell & protection system & RoSS = Dream Team
The 100% secure and compact shell for single-use bags. The bag will be covered by soft 3D foam, which provides a protective embedding as well as damping in case of vibrations. 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.
RoSS® // Robust Storage and Shipping for all single use bags
Liquid bulk drug substance is of utmost value after manufacturing from Biopharma industries. The single-use bag independent platform RoSS helps to avoid product loss through breakages through robust composition and makes it possible to introduce your flexible end-to-end solution in drug substance logistics. Bag independent. Robust. Scalable. Immobilized Bag.
Data sheets
Click here to download technical product data sheets, design videos, as well as a case studies and more.
More solutions
FAQ
How does a CCU (Cryo Control Unit) work?
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?
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 about RoSS.FILL.
What temperatures is the CGT bag protection system RoSS.KSET ready to be stored at?
The stainless steel shell is safe until temperatures as low as -190 °C.
How is the RoSS.KSET locked?
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.
