The well tried-and-tested single use bag gets its 100% secure and compact shell for upstream. The right material at the right place – what we can learn from oysters. Tough protected & tamper evident!
What makes RoSS® so special for biopharma logistics?
Scalability – RoSS® is the basis for the highly effective end-to-end process solutions BULK.STREAM & SEED.STREAM. RoSS® and RoSS.KSET offer minimal storage volume and maximum strength. The RoSS® basis constitutes an industry standard for single use bags.
Safety – thanks to the use of clever material setup the single use bag has a 100% protective shell. RoSS® stands for a safety upgrade for the biopharma process chain.
Single Use Bag Independent
RoSS® shells are available for all established single use bag manufacturers and filling volumes. Single-use-bag agnostic RoSS® fosters flexibility and 100% compatibility – no system change required.
High Storage Density
RoSS shells can be stacked one over another leading to huge savings in cold storage rooms and shipping costs and is easy to handle. RoSS® maximizes your storage density and minimizes your worries of requiring storage space.
How can RoSS® be 100% secure for single use bags?
The well tried-and-tested single use bag gets its 100% secure and compact shell.
In the first place, the single use bag will be covered by soft 3D foam, which provides a protective embedding as well as damping in case of vibrations.
Furthermore, the volume of the bag or of the liquid contained within can be expanded during the freezing process. This allows for a perfect adaption, which in turn maximizes the protective effect.
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.
The RoSS® top and bottom are made of high quality stainless steel with the following three advantages:
- Maximum durability and strength.
- When in direct contact with the bag, these features offer the ideal basis for an effective initial and ongoing freezing process. Furthermore, they enable a consistent and gentle defrosting or thawing process.
- Thanks to the right compounds, tolerances and material strengths of the stainless steel top and bottom, the RoSS® construction allows for only minimal vibration.
It also reduces the tension in the structure of the single use bag and offers shock absorbent protection.
Facts about the RoSS® shell:
- Adjustable for all 2D single use bags (e.g. PALL, Thermofisher, Entegris, Sartorius, …)
- Robust, closed and tamper-evident construction
- 3D foam offers additional space and protection for the sensitive compound of the raw bag and tubing – complete immobilization <0 °C / <32 °F
- Space for sterile connectors and long hoses
- Space for satellite samples / ID bags
- Steel plates on the top and bottom for consistent and quickest possible freezing and defrosting times
- High density, which means a reduction of required freezer space capacity
- Easy handling during the recycling process – no composite materials
- Bag can be visually checked/inspected after filling and before dispensing
Beneath its absolutely hard and robust shell, the oyster too embeds its pearl in a flexible and soft environment.
Any further questions about RoSS®? Click here for FAQs
RoSS.KSET / Protect
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.
How can RoSS.KSET protect small scale single use bags?
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 between 1 ml to 500 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 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.
Advantages of the stainless steel construction:
- 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 -200°C / -328°F.
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, 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:
Click here to download technical product data sheets, design videos, as well as a case studies and more.
CGT.RACK / protect & ship
How can CGT.RACK protect small scale single use bags?
Highly robust and compact – a CGT 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 CGT.RACK units.
CGT.RACK has been developed for the safe placement in shippers of all standard manufacturers (Cryoport, Savsu, …) and is able to withstand temperatures up to -200°C / -328°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® – Robust Storage & Shipping for all single use bags
What makes RoSS so special? How is the protection and immobilization of the bag secured? See some of many advantages of the protective shell, explained by Johannes Kirchmair, co-innovator of the RoSS shell system.
Instruction – Using RoSS® 1013 with PALL 5l Allegro™ bag
Do you already have the RoSS shell and unsure how to insert your PALL 5l Allegro single use bag into its dedicated protective container? Check out our instruction for use videos per bag manufacturer here.
Instruction – Using RoSS® 1040 with Millipore 20l Mobius® bag
Do you already have the RoSS shell and unsure how to insert your Merck/Millipore 20l Mobius single use bag into its dedicated protective container? Check out our instruction for use videos per bag manufacturer here.
CGT or CAR-T logistic solution – RoSS.KSET
The RoSS.KSET unit is made of high-density stainless steel. A container for all standard compact 2D single use bags and all sizes. Robust and closed construction, adjustable in temperature, to secure the single use bag.
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 bag 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 bag 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.
Can RoSS® be filled used with long tubings?
Yes, it is one of the advantages of RoSS® as it provides space for tubing with a length of more than 50 m (20”)
The entire bag incl. all tubing and connectors is embedded in soft inlays that will harden in the freezing process and thus immobilize the entire system.
Can a sample bag be placed in RoSS®?
Yes, sample bags for various sizes, from small to several 100 ml, can easily be placed in RoSS®. This provides tamper-evident protection for the sample bag (or ID).
Upon request, RoSS® Systems are available for sample bags exclusively.
Can RoSS® be partially filled?
Yes, any partial filling volume is possible with the patented RoSS® technology. The most recent data sheet with all RoSS® versions and details regarding partial filling is available in the download area or via mail (firstname.lastname@example.org)
Which freezing technologies is RoSS® compatible with?
RoSS® is basically compatible with all standard freezing technologies, from static (lab) freezers to blast freezers and plate-based freeze-thaw units. For a scalable process and maximum product quality, we recommend the latter. Read more about Freeze-Thaw.
Which clean room categories can RoSS® be used in?
In any. In case of uncertainties, please contact Single Use Support GmbH.
Can RoSS® be opened and closed repeatedly?
We advise against it. Ideally, RoSS® is filled with the single use bag and arranged for the process before being closed and sealed. It should basically only be opened at the end of the process for disassembling and recycling the RoSS® components.
You can find further information regarding the recycling process in the download area.
Is the RoSS® Shell System tamper-proof?
There is a variety of options to seal RoSS® tamper-evidently (labels, cable ties, …) in order to make any unwanted opening of RoSS® evident.
Can a RoSS® unit be reused?
Generally, RoSS® is very robust and thus reusable – however, in order to guarantee the highest possible protection, we advise against it.
Do sterile connectors fit in RoSS®?
Yes. You can put a single use bag with long tubing and sterile connectors into our RoSS® shells. In this video we will explain how easy this works.
Is RoSS® suitable for N2 applications?
Yes, RoSS® is suitable for temperatures up to -200°C (-328°F).
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Click here to download technical product data sheets, design videos, as well as a case studies and more.
The single use bag Shell & Protection System: RoSS®
The single use bag is a tool that is indispensable in the “drug substance logistics” for the pharmaceutical industry. The reasons are simple: In biopharma, the entire process – from downstream to the fill & finish process – can be managed by using disposable bags. In fact, many biopharma processes are no longer imaginable without single use bags. Their compatibility, the various available sizes and capacities, small storing volume and immediate availability are powerful deciding factors.
Advantages of single use bags in biopharma:
- The single use bag is an industrial standard.
- Single use bags require hardly any storage space and are cost effective.
- Single use bags are available in various sizes and filling quantities.
- Thanks to the different connectors, the system compatibility of single use bags is multifaceted.
- Single use bag manufacturers can supply large quantities.
- Single use bags are easy to dispose of after use.
- Reduce the risk of loss of drug substance.
- Tamper-evident packaging to avoid unnoticed manipulation or contamination.
Why does a single use bag require a shell system?
Single use bags have many advantages – but also potential disadvantages. The bags, which are made of thin plastic, are filled with liquid. In order to safely transport the liquid and protect its “functionality”, it is frozen prior to being shipped and then thawed before draining. (This is called the “freeze-thaw process of drug substance” and/or “cold-chain logistics“.) During shipping, the single use bag and its content may be exposed to shocks and tremors that may impact both the bag and its content. With a frozen bag container system like the RoSS® Shell-System developed by Single Use Support Gmbh, integrity issues, material loss and leakage or breakage of single use bags can be more or less eliminated. In other words, the process called “loss of drug substance” can be minimized. As a load kit for single use bags, RoSS® considerably increases patient safety!
Why is it sensible to test single use bags prior to filling?
We assume that the bag is located in 100% safe and protected surroundings – in other words, in the RoSS® Shell-System. Shocks, warehousing and integrity issues can be ruled out as possible causes for “loss of drug product”. So why is it sensible to test single use bags prior to their filling with “drug substances”? Upon delivery, disposable bags can exhibit minor material deficiencies or faults that can hardly be detected and thus go unnoticed. Considering the value of the contents of a single use bag it is more than reasonable to test the bag with regards to its full functionality prior to filling. What is the content’s value? “Drug substances” usually require many years of development and come at a certain price.
A person or an institution on the other side of the world may be waiting desperately for exactly that substance for a certain treatment. Considering this urgency, one can understand the importance of ensuring the integrity of single use bags – even more so as it can be done in less than a minute thanks to the MITS.2D® System developed by Single Use Support GmbH. With its seemingly limitless flexibility, the single use bag is an almost invincible tool.
It does have its weaknesses – but those can be compensated easily. And just like this, a disposable bag turns into a pearl that is thoroughly protected by the oyster. With the right choice of ecosystem for the single use bag, “loss of drug substance” will slowly but surely become a thing of the past.
Process safety and the supply chain remain undisrupted, thus ensuring the patients’ safety.
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