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. 

Product Overview_RoSS.KSET

Fast lead times

Delivery within few weeks

Worldwide shipping

We deliver all over the globe

Personal customer service

Your satisfaction comes first

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.

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:

  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 freezing single-use bags Cell Banking

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.

RoSS.KSET rack to protect CGT single-use bags during shipping and handling
Frozen IRIS Single-Use Bag in RoSS (4)

Our customers trust in us:

Rentschler Biopharma SE

Lonza

SCHOTT Pharma

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.KSET_Unfrozen (1 von 5)

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

Bulk.Stream RoSS shell

RoSS® Shell | Protecting single-use bags

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

Data sheets

Click here to download technical product data sheets, design videos, as well as a case studies and more.

Datasheet RoSS.KSET

Datasheet RoSS.KSET

Filesize: 0.35 MB – Mime-Type: application/pdf

Whitepaper_The One Shell to Advance Cold Chain Management

Whitepaper: Robust Storage & Shipping - The secondary packaging for every single-use bag

Filesize: 1.18 MB – Mime-Type: application/pdf

RoSS_Instruction-for-Use_KSET

Instruction for Use - RoSS.KSET & KSET.RACK

Filesize: 0.7 MB – Mime-Type: application/pdf

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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.

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Bottle RoSS | Protecting Bottles

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

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RoSS.pFTU Lab-Scale | Plate Freeze & Thaw

1mL-10L: 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

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.

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