April 12, 2019
You no longer want to be reliant on a single manufacturer when it comes to your single use bags? We tell you how you can become independentReading time: 3 minutes
Generally speaking, single use bags have become an indispensable solution for the biopharma logistics process. They offer one big advantage: They allow for an end-to-end handling of the entire process, from downstream to fill & finish.
Additionally, they require little storage space, are ideally suited for the freezing process and offer a high degree of safety while at the same time being affordable.
So it is no surprise that they have become an indispensable standard in the biopharma industry with different manufacturers offering them in a variety of sizes.
And this is where it starts getting tricky:
Depending on the phase you are currently in – from the lab to major manufacturer – you likely have to order bags of different sizes from a range of manufacturers. After all, the volume of drug substances produced is growing along with your business.
However, the individual single use bags are only compatible with logistics systems of the same manufacturer. As a consequence you not only require different bags for different phases, but you also require different compatible technologies. And that is pricey – both in terms of costs and resources.
We at Single Use Support have found the solution
For several years now we have been working on a logistics process that is completely independent of the bag brand and size as well as being almost 100 % safe and secure. We call this process the BULK.STREAM. Our Single-use technology allows you to freely choose your single use bags as it is compatible with all established brands – it is absolutely “bag-agnostic”.
This allows us to push scalability and efficiency to a new level.
You surely want to know which systems have been integrated into our BULK.STREAM? You can find them here at a glance:
- MITS.2D – a 100 % accurate integrity test for single use bags
- RoSS – a verified, maximum compact and 100 % secure shell for single use bags
- RoSS.FILL – a flexible platform to aliquote bulk drug substances
- FREEZE-THAW PLATFORM – a plate-based freeze and thaw unit for stability studies, compatible with small and large batch sizes
- RoSS.SHIP – a highly robust, stackable, coolable and compact container for the storage and shipping of single use bags
As you can see, we have considered every single step, all the way from Down.Stream to the fill & finish process. And as already mentioned, all of our systems are absolutely compatible with any single use bag – no matter its size or make, which means that you can combine different single use bags and different brands throughout all phases.
Let us take a detailed look at the separate systems:
Let us start with the MITS.2D test device, which tests single use bags for their integrity. After all, single use bags can be faulty, which can lead to a contamination of the drug substance.
The device can detect holes of a size as small as 2 microns, thus assuring that less substance is lost.
Moving on to RoSS – those are cassettes that protect the bag from external factors throughout the entire logistics process. Their inside is made of 3D foam that protects the bag from shocks.
The shell is made from a plastic frame that is combined with a stainless steel bottom and lid to further protect the single use bag from external impact. Stainless steel is ideally suited for the freezing process as it directly transfers the temperature to the bag, respectively the liquid.
RoSS.FILL is a single use filling system for bulk filling and draining, compatible with any single use bag. This compatibility with all bag manufacturers allows for infinite scalability and speeds up the process. The device fills your bags with a speed of up to 200 L per hour, allowing you to save time and money.
For the freeze/thaw process we have developed plate freezers – our so-called “Freeze/Thaw Platform”. The various models are suitable for small and large batch sizes, covering everything from lab processes to blockbuster production.
RoSS.pFTU “small scale” is our freeze/thaw unit for studies, small batch sizes and CTH tests. For medium-size and large batches we have developed RoSS.pFTU “large scale”, our standard freeze unit.
We also offer a solution for blockbuster volumes: RoSS.pFTU blockbuster scale is a freeze platform for bulk drug substance with a volume of up to 300 L per unit. This means that Cryovessel with all its disadvantages will soon be a thing of the past.
Last but not least, we have the RoSS.SHIP, our shipping and storage container for single use bags from any manufacturer. RoSS.SHIP is extremely compact and stores up to 20 RoSS trays. It is intended for passive freezing with dry ice or “phase-change materials” (PCM).
You can see that we have thought of everything. You do not have to weigh the pros and cons any longer. If you want to become “bag-agnostic”, we offer the perfect solution. Stop worrying about who to buy your bags from. Our solution works with all of them.
Watch this video to find out more about RoSS: