RoSS.FILL
/ Fill & Drain

RoSS.FILL is a fully automated single-use bag filling & draining system. This allows maximum flexibility and scalability of both the filling and draining process. Volumes of up to 200 liter can be filled in less than an hour. The entire filling process is fully disposable, thus warranting an absolutely sterile fill & drain process.


What makes the Fill & Filtration system so special?

Fully automated

Fully automated filling and draining system for single use bags or bottles. With a filling speed of 200 liters per hour, the RoSS® units on the rack are filled in a GMP-compliant computerized system.

Unrestricted Flexibility

Not only the option to attach additional bag or bottle filling racks to enlarge the batch volume size, but also flexibility in consumables is limitless. RoSS.FILL allows users to attach different manifold systems, pump and sampling tubings, bulk filtration filters and bag.

Unrestricted Scalability

RoSS.FILL opens doors to unprecedented scalability in terms of both, number of bags and size of bags for both, small scale solutions like CGT.STREAM or SEED.STREAM and commercialized solution filling of 200 liters of substance per hour and more. The scalability is limitless.

Unrivalled throughput and speed

200 liters of bulk drug substance within 60 minutes helps the industry to skyrocket the efficiency and creates resources to improve the performance whilst reducing product loss through a closed and automated process system. On top of that, holdup volume is limited to only few ml due to the smart manifold design and construction of the platform.

How does RoSS.FILL work?

RoSS.FILL is a flexible platform for the allocation and distribution of bulk drug substance in single use bags that are integrated in the RoSS® system. The liquid path is fully disposable and can accommodate a multitude of sterile compound- and segregation options.

With a filling speed of 200 liters per hour, the RoSS® units on the rack are filled in a fully automated manner. Single use bags of all established manufacturers and of different sizes and capacities are compatible. The scalability is limitless.

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

Facts about the RoSS.FILL:

  • Fully automated filling and draining system for single use bags
  • Filling of up to 200 liters of substance in less than 1 hour
  • Accuracy of +-10 ml for 10 liters with individual weighing cells
  • Modular system with separate control unit and pumping station as well as storage rack made up of RoSS trays filled with single use bags
  • Bulk filtration included
  • Option to take samples
  • Optional MES integration

RoSS.FILL for CGT and Seed Train Intensification

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 of 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.

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.

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
RoSS.FILL advanced

RoSS.FILL Advanced

CU + Bag Filling Rack

  • Bag Filling Racks gets connected to the Control Unit
  • weight scale on every bag position
  • possibility to fill bags from 30ml to 20l with the same system
  • Filling of up to 60 bags/run
RoSS.FILL bottle

RoSS.FILL Bottle

CU + Multiple Bottle Racks

  • Multiple bottle fill racks can be connected to the Control Unit
  • weight scale on every RACK
  • possibility to fill 1 to 6 bottles per RACK (30ml to 10L)
  • Filling of up to 36 bottles/run
Fluid management for small single use bags in cell & gene therapies

RoSS.FILL CGT

CU + Filling rack for small bags

  • Control Unit to be connected to the bag filling rack containing
    3 weights standardized – extendable upon request.
  • Possibility to fill up to 36 single use bags ranging from 20ml to 500ml
  • Suitable for filling small single use bags for cell & gene therapies
  • Highest accuracy

CU + Valve Tower with Floor Scale

  • Bag Filling Rack gets connected to the Control Unit
  • One weight scale on the floor
  • Suitable for automated bulk filling for commercial use
  • Possibility to fill up to 12 single use bags and bottles
  • Scalable filling of few liters up to 400 liters/run or up to 1000 liters/run into large 3D bags

RoSS.FILL Lab Scale

CU + Integrated Scale

  • Control unit has integrated weighing scale for small volumes
  • Suitable for clinical studies and cell & gene therapies
  • small footprint, easy to install
  • possibility to fill one single use bag or bottle up to 2l

RoSS_FILL platform – flexibility for draining

One Control Unit – configurable to different racks for filling and draining single use bag.

CU + draining rack

  • Draining Racks gets connected to the Control Unit
  • Residual holdup volume in bags limited to the minimum
  • Possibility to drain bags from 30ml to 20l with the same system
  • Multiple racks can be attached allowing draining of up to 60 bags/run

Single Use Manifold Assemblies

Full Modularity: Get your customized manifold & tubing system based on different tubing modules and asceptic connectors directly from Single Use Support.

Whatever consumable for filling and filtration is needed,
RoSS.FILL is independent from any manifold, tubing, filter or connector and can attach all preferred systems on demand. The manifold configurability is applicable for both, Bag Filling Rack and Bottle Filling Rack.

RoSS.FILL in combination with the single use assemblies from SUSupport allow straightforward and customized manifold solutions within shortest lead time.

Single Use Support has the solution due to in-house production on demand. Your One-Stop-Shop for single use assemblies!

Flexibility is provided with

  • All manifold systems customizable
  • Different evacuating, pump, sampling and rack tubings available
  • Flexible for all available bulk filtration filters
  • Bag Manifold as you wish: Design, manufacturing and supply by SUSupport on request
  • Shortest delivery times of a few weeks only

RoSS.FILL – the fully automated single-use bag filling & draining system

RoSS FILL / Fill & Filter your Bulk Drug Substance

RoSS.FILL is a flexible platform for the allocation and distribution of bulk drug substance in single use bags that are integrated in the RoSS® system.

RoSS.FILL – flexible, fast, simple filling of bulk drug substances & biopharmaceuticals

RoSS.FILL - flexible, fast, simple filling of biopharmaceuticals

RoSS.FILL. All you need to fill well. The modular system RoSS.FILL allows great scalability & flexibility for filling single use bags, bottles and vials, is independent on manifolds, tubings and connectors and decreases product loss and process contamination to the absolute minimum.

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”.

Our Single Use Filtration System – RoSS.FiLL

Our single use filtration system now offers a new feature: An optional choice to integrate supplier-independent filters has been added to the RoSS.Fill platform in order to further enhance the speed and reliability of bulk drug substance production. In an environment as sterile, complex and fast-paced as the pharmaceutical industry, the advantages of single use filters are clear:

Easy handling combined with the omission of tedious cleaning and maintenance work should be enough to convince any player in the industry; add to that inexpensive hardware costs and it makes absolute sense to add filters as a new component in the range of sterile compound and segregation options to the fully automated platform. Whether you are looking to reduce bioburden during cell harvesting or want to influence viral vectors in terms of their effect, the RoSS.FiLL system now also offers you a filtration option, thus covering the entire biopharmaceutical logistics process. With sufficient filter surface area and a choice of pore sizes for different substances and volumes, the integrable filters are yet another key feature of our single use filtration system.

Filter for any need and individual requirements

We supply single use filters across all manufacturers and for different pore sizes to fit our bulk filtration system according to your individual needs and requirements. If required, single use microfilters are also available for different pore sizes.

The advantages of our single use filtration system at a glance

  • State-of-the-art single use filtration technology
  • Scalability and filter compatibility across all established manufacturers
  • Easy handling and filter replacement for daily use
  • No cleaning requirements
  • Required filters available for different pore sizes