RoSS® Shell | Protecting single-use bags

The safest transport solution for all available single-use bioprocess containers. Protect your bioprocess container and reduce product loss towards 0%. RoSS®: Robust Storage & Shipping 

 

RoSS shell with frozen IRIS Bag
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Bag Independent

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< 0.001 % Product Loss

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Best Freezing Results

Products

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RoSS® Shell | Protection of single-use bags

The RoSS® Shell is the solution for Robust Storage and Shipping of biopharmaceuticals. It is a robust case designed to protect 2D single-use bags of any size and vendor in any process step. The shell is optimized for transport, freeze and thaw steps, in which manufacturers see product loss of around 1.5% with traditional methods. In over 300,000 RoSS® Shells sold the product loss was <0.001%.

RoSS.KSET top view

ROSS.KSET | Protecting small single-use bags

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

For larger volumes, RoSS can protect one or multiple single-use bags in one shell.

Our customers trust in us:

Rentschler Biopharma SE

Lonza

SCHOTT Pharma

100% Protection

RoSS® stands for Robust Storage and Shipping. Our protective shell system is adapted from the oyster and has numerous advantages. 

Due to a smart combination of materials, the single-use biocontainer has a 100% protective shell. The shells protect bags of any size and from any manufacturer. As closed tamper-evident system RoSS is stackable to increase storage density. 

For particularly small volumes, such as in cell and gene therapy, RoSS.KSET is the perfect option.

Single Use Bag Independent

RoSS® shells are available for all established single-use bag manufacturers and filling volumes. Single-use bag vendor-agnostic RoSS® shells 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.

Facts about the RoSS® shell

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:

  1. No product loss due to maximum durability and strength
  2. Ideal characteristics for an effective freezing and defrosting or thawing process
  3. Available for every single-use bag

More details:

  • Unique functionality and patented system
  • Adjustable for all 2D single-use bioprocess container (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
  • Resisting vaporized hydrogen peroxide for decontamination without any long-term damage, visual changes or changes in the contact angle
  • Easy handling during the recycling process – no composite materials
  • Bag can be visually checked/inspected after filling and before dispensing
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Frozen IRIS Single-Use Bag in RoSS shell-6
RoSS with frozen IRIS Bag (9 von 10)

Ready for some sobering facts? Then just move the sliders in the direction of internal company key figures:

Volume Drug Substance/Product per year: liter Loss: % Cost per liter: $

Potential Savings with RoSS®

$

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

Temper Evidence Cable-5-min

Accessories of the RoSS® shell to improve drug substance handling

Various auxiliary tools help improve drug substance handling: RoSS Handle Closing Tool, Tamper-evidence seals, Cryo Control Units (CCU), Data Logger, Labels, etc

Data sheets

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

Datasheet RoSS® Shell

Datasheet RoSS Shell

Filesize: 0.64 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

Case-Study_Storage-Density

Case Study - RoSS Shell Storage Density

Filesize: 0.39 MB – Mime-Type: application/pdf

Instruction for Use_RoSS Shell_Single Use Support

Instruction for Use - RoSS® Shell

Filesize: 1.25 MB – Mime-Type: application/pdf

Sustainability_Infographic_Rev.1

Sustainability Overview - RoSS Shells

Filesize: 1.52 MB – Mime-Type: application/pdf

Does-RoSS-resist-vaporized-H2O2-peroxide

Study: Resistance of RoSS Shells against vaporized hydrogen peroxide (H2O2)

Filesize: 0.11 MB – Mime-Type: application/pdf

Datasheet_RoSS-Accessories

Datasheet RoSS Shell Accessories

Filesize: 1.25 MB – Mime-Type: application/pdf

Case_Study_RoSS-Bioburden

Case Study - Bioburden Testing of RoSS Shells

Filesize: 0.28 MB – Mime-Type: application/pdf

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More solutions

RoSS.KSET top view

ROSS.KSET | Protecting small single-use bags

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

For larger volumes, RoSS can protect one or multiple single-use bags in one shell.

IRIS Bag

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.

IRIS Single-Use Assmeblies_Production Kufstein-29

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.

Freeze-thaw technology for handlings mAbs on another quality level

Freeze & Thaw platform

The Single Use Support freeze-thaw platforms provide insular solutions for the freeze/thaw processes of each clinical phase. Our new freeze-thaw units are fully scalable and compatible with all batch sizes and bags from all established manufacturers – you will only require one single system from the lab to blockbuster production.

RoSS.FILL - single use filling system for drug substances

RoSS.FILL | Fill-Filtration

RoSS.FILL is a fully automated single-use bag filling system. This allows maximum flexibility and scalability of both the filling and draining process. It is possible to fill unlimited volumes per batch with a speed of up to 300 liters per hour. The entire filling process is fully disposable, thus warranting an absolutely sterile fill & drain process. For further productivity improvements check out our pinch valve innovation.

RoSS.FRDG-Rendering

RoSS.FRDG | Ultra Cold Storage Freezer

RoSS.FRDG is an ultra cold storage fridge for frozen drug substances in different sizes. The ultra cold freezer keeps the desired set point temperature down to -75°C. RoSS.FRDG offers highest storage density, is fully movable and can be modularly adapted to your individual needs.

Single Use Support shipper

RoSS.SHIP | Ship, Track & Trace

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

FAQ

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 our contact form.

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.

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 bioprocess container 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).

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.

More Information

Single-use Consumables

Case Study: Reducing product loss | Cost-efficiency

It is the key issue in the management of bulk medicines: How can product loss be avoided or at least reduced? This article explains everything about this topic!

Claus Exenberger - Single Use Support

Claus Exenberger

June 8, 2022

Single-use Consumables

Case Study: Reducing product loss | Hybrid for primary packaging

Harmonize the process for different types of single-use primary packaging. Protective shell solutions and hybrid systems optimize liquid transfer in Biopharma. 

Claus Exenberger - Single Use Support

Claus Exenberger

July 28, 2022

End-to-end Solution

Inline buffer dilution: an agile system for downstream processes

Inline buffer dilution (IBD) is a method for on demand buffer preparation from buffer concentrates at the point of use. This article will give an overview of the inline buffer dilution process and discuss its benefits over the traditional formulation of buffer solutions.

BRMO

Brian Moloney

February 2, 2022

Single-use Consumables

Case Study: Reducing product loss | Bag-independence

Learn about the benefits of supplier-agnostic solutions around single-use bioprocess containers that help minimize product loss.

Claus Exenberger - Single Use Support

Claus Exenberger

June 20, 2022

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