ROSS.KSET | Protecting single-use bags up to 250mL

Scale-down to one single drop of drug substance!

RoSS.KSET offers the protection for drug substances with volumes less than 250 mL. The shell is robust, closed, safe and sterile – most suitable for cell and gene therapies or clinical studies.

Industry 4.0 biomanufacturing RoSS.KSET for CGT bag protection
speed

Fast lead times

Delivery within few weeks

worldwide

Worldwide shipping

We deliver all over the globe

customer-service

Personal customer service

Your satisfaction comes first

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.

100% 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:

  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 / -320°F.
RoSS.KSET CGT bag protection system in closeup view scaled

Facts about the RoSS.KSET:

  • 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.

RoSS.KSET rack to protect CGT single-use bags during shipping and handling
RoSS.KSET rack protecting CGT single-use bags for shipping by Single Use Support

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:

RoSS.KSET rack CGT single-use bag protection for shipping and handling drug substances

RoSS® Shell: Protecting single-use bags above 250mL

RoSS shell protecting single use bags open

RoSS® Shell | Protecting single-use bags

The safest transport solution for all available single-use bioprocess containers. Robust. Scalable. Single-use bag independent.

More solutions

RoSS shell protecting single use bags open

RoSS® Shell | Protecting single-use bags

The safest transport solution for all available single-use bioprocess containers. Robust. Scalable. Single-use bag independent.

Single-use bioprocess container by Single Use Support

IRIS Single-Use Bioprocess Container

Innovative. Robust. Individual. Single-Use. Make sure your supply chain is uninterrupted. Get your IRIS 2D single-use bioprocess container from Single Use Support in any size with the fastest possible delivery times. Store and ship anything from cell culture samples to large drug substance volumes reliably and on time.

Single Use Support shipper

RoSS.SHIP | Ship, Track & Trace

RoSS.SHIP secures the cold chain storage and shipping of bulk drug substance for almost one week. Highly robust, stackable, coolable and compact – Fort Knox for high-quality substances!

Single-use assemblies manifold

IRIS Manifold | Single-Use Assemblies

As an expert in single-use solutions, we have made it our goal to deliver vendor agnostic single-use assemblies manufactured at highest quality standards in ISO 7 cleanrooms and sterilized within shortest lead times. Prevent downtime and ensure an uninterrupted supply chain in compliance with GMP and regulatory requirements with our single-use manifold assemblies using silicone tubing and connectors of your choice.

Frozen RoSS bottle protecting single-use bottles

Bottle RoSS | Protecting Bottles

RoSS (Robust Storage and Shipping) can also be translated for PE rigid containers. With Bottle RoSS the tubings on bottles are protected at glass-like sub-zero temperatures with the help of a soft 3D foam which hardens at frozen state.

RoSS.FILL - single use filling system for drug substances

RoSS.FILL Bag | Single-use aseptic bag fill-filtration system

RoSS.FILL Bag is a flexible automated single-use aseptic bag filling machine for dispensing biopharmaceuticals into single-use bags. The fluid path is designed to be fully disposable and is able to accommodate a variety of sterile connection and disconnection options.

Laboratory freezer RoSS.PFTU Lab Scale

RoSS.pFTU Lab-Scale | Freeze-Thaw

1mL-5L: Laboratory freezer, compatible with single use bags of all sizes and manufacturers. Our lab freezer is the perfect solution for studies conducted in labs and, above all, if you want to start a controlled and scalable freezing process.

FAQ

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.

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.

More informations

Single-use tubing assembly service will convince you

How this service will convince you: Single-use tubing assemblies & Configurator

When it comes to highly valuable - and highly sensitive - drug substances, every drop counts and losing a batch due to cross contamination or issues in the cleanroom is just not an option. Reliability is key - learn why we are your solution!

PUPSIT - pre-use post sterilization integrity testing

PUPSIT - Benefits of single-use technology in pre-use post sterilization integrity testing

PUPSIT will contribute to simplifying not only integrity testing and validation but manufacturing processes in general, while keeping in line with current good manufacturing processes and any standards and guidelines defined by major authorities such as FDA and EMA. Read all about it!

Critical considerations of aseptic single use bag filling

5 critical considerations for aseptic bag filling

Aseptic bag filling is a process that is very important to the biopharma industry. This article will give you the basics of aseptic bag filling, highlight the most critical factors of the technique and discuss key considerations pertaining to the commercial use of aseptic bags.

Car t-cell therapy and it's great potential

CAR T-cell therapy - the process and side effects

Read more about CAR-T cell therapy, its history and hurdles. Learn also how Single Use Support can support this novel therapy with great potential!

Single-use systems triage, ultimately affecting patient

Single-use systems triage, ultimately affecting the patient

The current shortage of single-use consumables in the pharmaceutical industry has led some experts to go as far as calling it a “triage”: This only makes apparent the immensity and severity of the current challenges in the supply chain, which has far-reaching consequences if not addressed properly.

Send a Request