RoSS.FILL/ FILL & DRAIN

Fully automated drug substance filling & draining at small scale – goodbye, manual filling!

 

RoSS.FILL is a flexible platform for the allocation and distribution of a variety of products in the cell and gene therapy (CGT) in single use bags that are integrated in the RoSS System.

RoSS.FILL for CGT is the answer to the question how to fill many small single use bags within a short time, fully automated and at highest accuracy.

Scalability is limitless by reason of the flexible applicability of all different single use bag sizes and manufacturers. RoSS.FILL fills drug substance into single use bags with a filling volume of 10 ml to 20 l.

For example, up to 120 bags of 250ml can be filled in one batch run. With a filling speed per batch run of one hour, the single use bags on the rack are filled in a fully automated manner.

The liquid path is fully disposable and can accommodate a multitude of sterile compound- and segregation options. The fully closed system fulfills all GMP relevant requirements and offers a smooth process control.

Facts:

  • Fully automated filling and draining system for single use bags
  • Compatible with all single use bag sizes and manufacturers. I.e. filling of up to 120 bags per 250ml of substance in less than 1 hour – variable depending on bag size and individual preferences
  • Accuracy of +-5 ml for 500 ml with individual weighing cells
  • Less residual substances in the tubing spine
  • Modular system with separate control unit and pumping station as well as storage rack made up of RoSS trays filled with single use bags
  • Option to take samples
  • Bulk filtration included
  • Option to fill multiple bags per weighing cell
  • Optional MES integration

 

Fully automated, effective filling & draining process – what more could one wish for?

In case you are searching for scale-up solutions for bulk drug substance, check out RoSS.FILL for higher volumes:

BULK.STREAM

RoSS_FILL platform
flexibility for bottles and bags

One Control Unit - Several Options for BOTTLES and BAGS

 

NEW! The RoSS.FILL Flex Rack enables you to now also fill bottles with your RoSS.FILL, making the transition from bottles to single use bags easy.

  • Manifold gets placed on the system
  • Bottles get connected at point of use
  • 1 automatic valve/bottle, or one valve/weight cells (tbd)
  • 1 weight cells per modular RACK
  • GMP, cfrp11 compliant software control unit can be used with the bottle rack or the bag/shell rack
  • Flexible solution for single use bags (see RoSS.FILL) and bottles (with Flex Rack)
  • Same control unit (just switching rack)
  • Standard Siemens
  • DeltaV connection optional

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

We were analyzing different solutions on the market for freezing and thawing our drug substances in single-use bags.
The combination of a bag agnostic robust secondary packaging RoSS and the scalable plate based freeze/thaw technologies convinced us to select Single Use Support.
It not only matches all our requirements, it is also safe, easy to navigate and flexible to single-use bags from any supplier.
Furthermore, it is a good starting point to expand to a whole end-to-end solution.

Program Manager

3S Bio

RoSS.FILL Flex Rack
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The Single Use Filling System - RoSS.FiLL

When developing the BulkStreams, our focus was on developing a logistics process for single use bags.  Why? The single use bag has its established role in modern biopharma.
The entire “drug substance logistic” process can be managed with a single tool - the single use bag. It boasts a range of advantages, from compatibility in the handling process to a range of available volumes to extremely low storage capacity and immediate availability - to name just a few of the countless arguments in favor of the single use bag.

And this has driven us to develop a  100 % safe logistics process around the single use bag. Obviously, we have not forgotten about the fill & drain process either und have developed a fully automated single-use bag filling system, the RoSS.FILL, which allows for maximum flexibility and scalability of both the filling and draining process. Volumes of up to 200 L can be filled in less than an hour. Furthermore, the entire filling path is fully disposable, thus warranting an absolutely sterile fill & drain process.

And this is what makes our single use filling system truly stand out:

RoSS.FILL is the perfect single use filling system for all companies in the biopharmaceutical industry that are already using single use containers or are planning to do so. It is compatible with all single use bags from established manufacturers, which means that you can use any single use bag with our Bag filling System. You only need one system for filling and draining: RoSS.FILL.

All the advantages of our single use filling system at a glance:

• compatible with single use bags of all established manufacturers
• unrestricted scalability and flexibility
• 100% sterile filling and draining
• fully automated filling and draining of single use bags
• fast filling at a rate of up to 200 L per hour

Our single-use filling system is a modular system with separate control and pump units as well as a storage rack for RoSS trays containing single use bags.  The RoSS trays act as a protective shell for the single use bags throughout the entire process from downstream to fill & finish.

The single use bag is embedded in a 3D foam layer, which in turn is secured by a high-quality stainless steel shell. Thus, if the single use bag is contained in a RoSS® shell system, we expect external and mechanical impact to be eradicated as a reason for “loss of drug substance”.