RoSS®/ PROTECT

The right material at the right place – what we can learn from oysters.

 

Tough protected & tamper evident!

The 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:

  1. Maximum durability and strength.
  2. 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 thaw process.
  3. 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:

  • Adjustable for all 2D single use bags (e.g. 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
  • 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 necessary freezer space capacity
  • Easy handling during the recycling process – no composite materials
  • bag can be visual 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

Volume Drug Substance/Product per year: liter
Loss: %
Cost per liter: $
Potential Savings with RoSS®
$

You want to get an exact calculation of how high the loss value you can avoid in your company by using RoSS®?

The RoSS® basis constitutes an industry standard for single use bags.

Thus, RoSS® stands for 100% compatibility – no system change required.

Flexibility – the RoSS® shell is available for all established single use bag manufacturers and filling quantities.

Safety – thanks to the use of clever materials the single use bag has a 100% protective shell.

RoSS® offers minimal storage volume and maximum strength.

Scalability – RoSS® is the basis for the highly effective BULK.STREAM

Recycling – even though it is designed for single use, RoSS® can be separated into its components quickly and easily.

RoSS® stands for a safety upgrade for the biopharma process chain.

?

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:

RoSS.FILL

Yes; it is one of the advantages of RoSS® as it provides space for tubings with a length of more than 50 m (20”)

The entire bag incl. all tubings and connectors is embedded in soft inlays that will harden in the freezing process and thus immobilize the entire system.

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.

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 (office@susupport.com)

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. Also see:

FREEZE-THAW PLATFORM

In any. In case of uncertainties, please contact Single Use Support GmbH.

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.

There is a variety of options to seal RoSS® tamper-evidently (labels, cable ties, …) in order to make any unwanted opening of RoSS® evident.

Generally, RoSS® is very robust and thus reusable – however, in order to guarantee highest possible protection, we advise against it.

Yes.

Yes, RoSS® is suitable for temperatures up to -200°C (-328°F).

We see issues with integrity of Single Use Systems in the biopharma world. Potentially, the MITS.2D technology is able to help address Endotoxin and Bioburden issues properly. Sterility is key for some applications very close to the patient in Fill and Finish facilities. Midterm, MITS.2D might be able to mitigate the risk of biocontamination in these process steps also.

FDA

FDA authority, USA

We were looking for a solid shipping solution for our single use bags. None of the available solutions to date offered reassuring solutions.
Thanks to a fortunate coincidence we got in touch with SUSupport. Not only have we found a more than solid 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.

Program Manager

Lonza AG, Basel
Download

Click here to download technical product datasheets, design videos, as well as a case studys and more.

RoSS® - Get your sample!

RoSS® isn't just a convincing evidence for securing your single use bag, the design of RoSS® does look good too - you have to hold a RoSS® in your hands! And why not especially for your purpose and the manufacturer of single use bags your are already using.

Simply fill in the form - and in just a few days you will hold a RoSS® in your hands!

Contact details


Your postal address

We will use this address only for sending your the RoSS sample.

Manufacturer

Bag size

You didn't found the right manufacturer? No problem tell us the name of your manufacturer here.

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.