To overcome the risk of contamination is one of the biggest challenges in the field of biopharma – after all, the contamination of valuable drug substance results in the loss of the entire amount of liquid, which not only entails financial losses but also reduced patient safety.
At Single Use Support we have been dealing with this challenge and looking for a way to eliminate any inherent problems.
We started with the single use bag, which is an established industry standard in the biopharma field – and considering all the advantages single use bags offer, this should come as no surprise:
According to an article by drug development the single use technology is regarded as one of the leading development areas in the global biopharma industry. An increasing number of bioprocess companies are making use of what SUT has to offer, not least because SUTs can be facilitated for any kind of biopharmaceutics.
As is the case with anything in life, the single use bag does not only have advantages. Among the disadvantages are material deficiencies and processing errors, and stability poses another challenge. It is our aim to eliminate these disadvantages – after all, each chain is only as strong as its weakest part.
Based on this theory we are developing single use technologies that support the single use bag, minimize the risk of bio-contamination and prevent the “loss of drug substance”.
Starting from the single use bag we have developed a system to protect said single use bag during the entire logistics process both from external impact and manipulation in order to make sure it arrives at its destination unharmed.
Our RoSS Single Use Shell Systems can be compared to an oyster. A hard shell covers the precious pearl nestled within. In our case the pearl is biopharmaceutical liquid that is stored in a single use bag, while the shell is our RoSS Shell that protects the single use bag all the way from the downstream to fill and finish.
A hard shell is required in order to reliably protect the single use bag from harm and to make it tamper-proof, which is why we have decided to use stainless steel for the outer shell of our single use system.
We have chosen the material for its extreme robustness but also for its thermal diffusivity, which is conducive in the freeze & thaw process. Stainless steel not only keeps the initial but – if required – the entire freezing process effective.
A hard shell is not enough to guarantee maximum protection. In order for the single use bag to be 100% protected it has to be embedded in a soft shroud. This is why the interior of our Single Use Protection Systems is made up of a layer of adjustable high-quality 3D foam.
This is a material that can perfectly adjust to the shape and consistency of the liquid contained within the single use bag; it can expand during the freezing process along with its contents. In addition, the soft foam layer dampens any external shocks and vibrations.
And there is another advantage: Our shell systems are constructed in the most compact way possible, which means that they require no unnecessary space – neither during storage nor shipping.
You surely want to know which single use bags our technology can be used with. Good news: Our Single Use Shell Systems as well as all our other products are absolutely compatible with single use bags of all sizes and from any established manufacturer.
Of course we have not stopped with the RoSS Protection System. By constantly improving our BULK.STREAM we can now close the gap between Down.Stream and the Fill & Finish process with our innovative solutions.
On the basis of single use bags we offer the biopharma industry a 100% reliable logistics process for liquids, including specifically designed technologies for Single Use Bag Testing, Fill & Drain, Freeze & Thaw as well as Store & Ship, and a range of accessories. You can watch the entire end-to-end process in the following video: