RoSS® Shell

Protecting single-use bags

The RoSS® shell protects single-use bags during freezing, storage, handling, and transport ensuring secure bioprocess operations.

Image of RoSS shell, robust protection for single-use bags, on a transparent background.

Key features

Single-use bag independent

RoSS® shells are available for a wide range of single-use bag manufacturers and volumes.

Complete immobilization

3D foams cover the bag, tubings and connectors within the shell and immobilize + protect

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.

Robust construction

Robust and closed construction to secure the single-use bag during freezing, storage and transport

Optional add-ons

  • Space for satellite samples
  • Tamper-evident sealings
  • Partial-fill foams

Maximum protection for single-use systems across the process chain

RoSS® shell safeguards high-value drug substances and ensures reliable handling from freezing to transport.

  • Reduces risk of product loss throughout storage and logistics
  • Enhances safety when handling frozen or sensitive drug substances
  • Supports reliable and controlled bioprocess workflows
  • Improves process stability across manufacturing and transport steps
  • Enables secure handling of single-use bags across applications and scales
A top-view image of a frozen single-use bioprocess container protected by a RoSS Shell.

Robust material design for demanding conditions

The RoSS® shell combines a durable outer structure with stainless steel elements, supporting reliable handling, mechanical stability, and suitability for low-temperature applications.

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Downloads

Preview of datasheet for RoSS shell by Single Use Support

Datasheet

RoSS® shell - Datasheet

RoSS® shell - Datasheet
 
Preview of datasheet for RoSS shell robust protection for single-use bags by Single Use Support

Datasheet

RoSS® shell Accessories - Datasheet

RoSS® shell Accessories - Datasheet
 
Preview of Single Use Support's whitepaper about robust secondary packaging RoSS shell

Whitepaper

RoSS® shell: Advanced cold chain management - Whitepaper

RoSS® shell: Advanced cold chain management - Whitepaper
 
Recycling guide for RoSS shell - Single Use Support

Guide

RoSS® Shell Recycling - Guide

RoSS® Shell Recycling - Guide
 

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  • Frozen Storage and Shipping in biopharma with the RoSS® shell

    Frozen storage and shipping of drug substances is indispensable in the biopharma industry. Nevertheless, drug substances are precious and sensitive, not only requiring careful handling but also reliable protection throughout the entire logistics process. In order to allow for both, the liquid substances are frozen for shipping and storage in specialized containers that keep them safe in a temperature-controlled environment throughout the journey.  Single Use Support’s RoSS® Shell (robust shell system for frozen storage and shipping), composed of an outer sleeve of robust stainless-steel and an adaptive inner layer of 3D foam, contributes to a safe supply chain and timely deliveries of drug substances. It warrants the single-use bag’s intact arrival at its final destination, keeping its precious and perishable contents protected from biocontamination and other damages.  The highly flexible and scalable nature of the single-use components used for the construction of RoSS makes handling very easy and user-friendly, while acquisition and storage costs as well as space requirements can be reduced significantly. As a result, cold chain transportation processes based on advanced single-use technologies offer reliable, safe and controlled handling of biopharmaceutical liquids, which are not only highly valuable but also very sensitive. RoSS - Single Use Protecting System Flexible, versatile and user-friendly solution for frozen storage and shipment With the varying requirements of the biopharmaceutical industry, of labs and manufacturers in mind, RoSS has been designed to offer flexible, versatile and user-friendly protection for single-use bags of any size and brand. It is both bag-agnostic and scalable, protecting filled bags of any given manufacturer and volume. Furthermore, RoSS is extremely space-efficient, reducing costs for storage facilities and transportation services like shippers and other third-party logistics providers. Also, the storage and shipping solution allows for easy handling by staff, distributors, and warehousing teams for temperature-controlled storage. Read more about Storing and shipping frozen drug substance - why single-use systems are the optimal solution Protection of bulk drug substances in single-use bags The outer shell: Robust stainless steel Thanks to its thermal diffusivity, the stainless-steel used for the outer shell is not only acting as a protective buffer but also offers the best possible temperature transfer from freezer to bag to liquid. As a result of the direct contact between the plate freezer and the stainless steel plates covering the container, the substance contained in RoSS® is evenly frozen. The close contact between freezing plates and liquid substance significantly speeds up the process by facilitating a direct transfer of the cold. The interior: 3D foam for added protection during cold storage and shipping While the outer shell is made of robust stainless steel, specialized foam on the inside adds further stabilization. Single-use bag and content are shielded by a layer of soft 3D foam that adapts to the bag’s shape during the freezing process, eventually fully immobilizing it. The design leaves space for tubings to make handling a breeze. In short: Taking inspiration from an oyster, RoSS combines stainless steel on the outside and protective foam on the inside to make for the perfect robust and compact protection of your valuable goods during shipping and storage:  RoSS is independent from any single-use bag manufacturer, protecting what’s valuable in your single-use bag of choice.  RoSS is scalable to different volumes to cater for both lab and production environments. RoSS ist the scalable as flexible choice for frozen storage and shipping single-use bags (of different suppliers) in biopharma As an added benefit, there is no ambient air that requires cooling, as is the case when utilizing traditional freezers. The homogenous outcome when employing plate freezers not only maintains the substance’s original quality but also protects it from potential damages during shipping and thawing of drug substance.  The shell is tamper-proof so the bag contained within cannot be accessed during the entire controlled freezing and logistics process. RoSS® Shell | Protecting single-use bags Freeze-Thaw Platform for frozen storage and shipping of drug substances While RoSS shells are ideal when it comes to the overall protection of frozen drug substances, they form only one part of the state-of-the-art RoSS freeze thaw system, which in itself offers a number of benefits for pharmaceutical labs and production sites. As a main selling point, it helps to avoid human failure in the handling of drug substances as it offers a process that is fully controlled and monitored from beginning to end. In addition, it can be adapted and scaled to meet any requirements and needs, thanks to the utilization of single-use components. Like this, the RoSS freeze thaw platform furthermore significantly reduces the need for cleaning and sterilization  minimizes production costs maximizes production output is easy and simple to dispose of reduces power and water consumption minimum storage space optimized for frozen storage and cold chain shipping Simply put: Using RoSS means optimizing your process by significantly reducing risks and the potential for human error. Get your RoSS shell now!

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  • Biopharma packaging - requirements and solutions

    Pharmaceutical packaging is becoming an increasingly important topic in the pharmaceutical industry, with the rise of biopharmaceuticals being a key driver of growth in this area. As the use of biopharmaceuticals continues to increase, so does the demand for specialized packaging solutions. The packaging and labeling of biologics and drug products presents unique challenges due to their complex and sensitive nature, requiring specialized packaging solutions for safe transport and storage in frozen state. In this article, we will explore the benefits of customized packaging solutions from contract packaging organizations, the use of single-use systems for biopharma packaging, and the trends and challenges in the field. We will also discuss the importance of sustainability in pharmaceutical packaging, the advantages of single-use systems in this regard, and how customized packaging solutions can meet specific requirements at all scales of biopharmaceutical processing.[[1]] Biopharmaceutical processing - learn more Special packaging requirements for Biologics Biologics are complex and sensitive to their environment and require advanced packaging to protect their therapeutic benefits. Compared to small molecule drugs, biologics have more intricate packaging needs, and the use of ordinary glass is not sufficient. Glass packaging vials, syringes, closures, or inserts may interact with the chemicals on the surface of the drug, causing contamination.[[2]] Safe transport of APIs (Active pharmaceutical ingredients) can be guaranteed at the correct freezing temperature. Packaging solutions must therefore meet the requirements for freeze-thaw conditions. Biologics are typically produced in large quantities and are transported in bulk to the fill & finish site. The drug delivery of these bulk drug substances requires specialized packaging that can maintain the appropriate temperature range during transit and the use of cold chain packaging is essential for maintaining the required temperature range during transport. Biopharma packaging solutions Packaging solutions for drug substances are mostly built in different layers. A distinction is made between primary and secondary packaging, but there is also tertiary packaging. While primary and secondary packaging complement each other to ensure the protection of the liquids, tertiary packaging is mostly used to stack the products efficiently and to load them safe and efficiently into transport facilities.  Biopharma packaging based on a Single Use Support case Up to 1000 liters of drug substance must be brought from A to B within the shortest possible time. How are the liquid substances packed appropriately?  Filling takes place automatically in the (primary packaging) single-use bags. The bags are protected by a (secondary packaging) shell in which the bags with the liquids can be frozen to the ideal temperatures and are thus optimally prepared for transport. Finally, the individual single-use shells are stowed in a (tertiary packaging) cold-chain shipping container, in which the temperature is kept constant during transport. The container can now go on its journey.  Biopharmaceutical packaging: Safety first In the production of pharmaceutical products, adherence to strict guidelines such as current Good Manufacturing Practices, requiring certifications from FDA (Food and Drug Administration), EMA (European Medicines Agency) or ASTM d4169 is crucial for ensuring the quality and safety of drug substances and medical devices. Similarly, the packaging of biologics must also be given strict attention by providers to ensure safe manufacturing process, storage and transport, as the risks of contamination or product loss can jeopardize its integrity and sterility. Automated process solutions can help prevent human errors in filling. Single-use bags provide optimal quality control and protection for high-value biologics and reduce the risk of contamination in comparison to reusable durable containers.[[3]] Efficient packaging reduces operating costs Efficient packaging solutions do not only reduce environmental impact, but they also decrease operating costs in the pharmaceutical healthcare industry and their supply chain. Efficient packaging is done space-saving to avoid empty spaces and automated to avoid errors and slow processing. When packaging is more efficient, there is less waste and fewer damaged products, leading to fewer product losses and cost savings for companies. Automation also plays a key role in reducing costs, as fully automated processes can help to minimize human errors and reduce the need for qualified personnel. Additionally, packaging that is designed to be space-efficient for storage and delivery systems can help to further reduce costs by maximizing storage density and minimizing shipping costs. As technology and eco-friendly packaging continue to advance, the cost of pharmaceutical packaging is expected to decrease, benefiting both manufacturers and consumers. If you want to learn more about drug substance shipping challenges and solutions, read the article about shipping of pharmaceutical liquids. Sustainability in biopharma packaging In the biopharma industry and life sciences, sustainability is becoming an increasingly important consideration in drug development, packaging design and packaging materials. One way this is being addressed is through the use of single-use bags and shells, which can be more environmentally friendly than multi-use options that require cleaning and sterilization. Single-use bags are a widely used primary packaging option for the safe storage and transport of frozen drug substances. Nevertheless, studies suggest that single-use technologies are more environment-friendly than stainless-steel systems.[[4]] With the focus on eco-friendly options increasing, the use of sustainable pharma packaging is set to become more widespread. Nevertheless, also the single-use RoSS® shell contributes to sustainable secondary packagings, since its few components are easy to recycle. When Single Use Support delivers its RoSS® shells to customers, the packaging materials used for outbound shipping are selected to fulfill sustainability criteria. The card boxes used are out of 80% recycled material and the standard pallet boxes to supply customers are highly suitable for recycling. The RoSS® shell itself can be easily recycled. Learn more about its recycling guide in our article: Mission completed – and now? How RoSS® Shell is to be recycled.[[4]] [[5]] Customized requirements: From lab scale to large scale Customized packaging solutions are necessary to meet the specific requirements of pharmaceutical manufacturing at all scales, from lab to large volumes of several thousand liters. For example, in the case of CAR-T cell therapy, small, safe packaging and high-quality solutions are required, while bulk drug substances need larger volume solutions. Single-use packaging offers an ideal solution to respond to these individual requirements. In the next paragraph, we will discuss how single-use packaging has become a state-of-the-art solution for the biopharmaceutical industry to meet customized packaging needs. Advantages of single-use systems for packaging of biopharmaceuticals Single-use systems have become increasingly popular for pharmaceutical companies and the packaging of biopharmaceuticals due to their numerous advantages. One major advantage is their scalability, which means that single-use systems can be used for both small-scale and large-scale productions. In addition, single-use systems are more sustainable than traditional multi-use systems, as they generate less waste and do not require the energy-intensive cleaning and sterilization processes that multi-use systems do.[[2]] Another significant benefit of single-use bioprocessing is the high level of safety, as disposable systems minimize the risk of product loss and contamination. References Global Biologics Market Outlook, https://www.expertmarketresearch.com/reports/biologics-market, Published The glass ceiling: The advantages of polymers over glass in biologic drug delivery, https://pharmaceuticalmanufacturer.media/pharmaceutical-industry-insights/the-glass-ceiling-the-advantages-of-polymers-over-glass-in-b/, Published 2016 Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics, https://www.fda.gov/media/70788/download, Published 1999 Streamlined life cycle assessment of single use technologies in biopharmaceutical manufacture, http://dx.doi.org/10.1016/j.nbt.2022.01.002, Published 2022-01-08 How is Sustainability Incorporated into Pharmaceutical Packaging?, https://www.news-medical.net/life-sciences/How-is-Sustainability-Incorporated-into-Pharmaceutical-Packaging.aspx, Published 2023

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  • Case Study: Reducing product loss | Cost-efficiency

    Biopharmaceutical companies have largely accepted a certain level of product loss when managing drug substances in single-use systems - unaware that solutions exist to streamline process steps and dramatically diminish product loss . The breaking of single-use bags in turn means loss of very valuable drug substances.  A global biotechnology company produces different drug substances of highly valuables monoclonal antibodies (mABs). The company experienced a product loss rate between 0.5% and 5% due to the sensitivity of single-use bioprocess containers at sub-zero temperatures. Therefore, the goal was to reduce the current product loss below 0.5%. This case study discloses how the implementation of RoSS® technologies from Single Use Support had an impact on the product loss during trials of hundreds of single-use bags.  You will be surprised of the cost savings due to reduced product loss.

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FAQ about the RoSS® shell

Can a sample bag be placed in the RoSS® shell?

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Yes, sample bags of various sizes, from small to several 100 ml, can easily be placed a RoSS® shell. This provides tamper-evident protection for the sample bag. Upon request, RoSS® shell systems are available for sample bags exclusively. Learn more here.

For which applications can I use the RoSS® shell?

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For literally every drug substance in a 2D single-use bag. The robust design helps minimize product loss caused by single-use bag breakages. The RoSS® shell is primarily used for high-value products, such as mAbs, HPAPI such as novel ADCs, mRNA, pDNA, viral vectors and cell-based applications.

Can RoSS® be partially filled?

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Yes, any partial filling volume is possible with the patented RoSS® shell technology. Please read here about partial fill foams or contact our experts with regards to partial filling.

Which freezing technologies are compatible with the RoSS® shell?

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The RoSS® shell can be used with a wide range of freezing technologies, including blast freezers, and plate-based freeze-thaw systems, as well as static laboratory freezers for storage.

For scalable manufacturing and consistent product quality, plate-based freezing offers significant advantages through improved temperature control and process standardization. Learn more about our Freeze-Thaw solutions.

When using shells for blast freezing consider a cryo control unit (CCU) as one accessory.

In which clean room categories can the RoSS® shell be used?

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In all. In case of uncertainties, please contact us.

Is the RoSS® shell tamper-proof?

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There is a variety of options to make the RoSS® shell tamper-evident.

Please read more here about label, cable ties and other types of tamper-evident options or contact our experts.

Can the RoSS® shell be reused?

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In order to guarantee the highest possible protection of drug substances, we advise not to reuse the RoSS® shell. Read more about this in our Recycling Guide.

Do sterile connectors fit in the RoSS® shell?

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Yes. In general, you can put a single-use bioprocess container with long tubing and sterile connectors into our RoSS® shells. Ask our experts if you have big sterile connectors attached.

How does the Cryo Control Unit (CCU) support freezing applications?

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The Cryo Control Unit (CCU) extends the compatibility of RoSS® shell systems with standard laboratory freezers and blast freezers. The insulated cover is designed to protect the shoulder area of the contained single-use bag, supporting controlled freezing conditions and greater flexibility across different freezing environments. Learn more about the CCU here..