Single-use Filling & Filtration System

Aseptic Filling machine | Bulk drug dispensing system

RoSS.FILL is a fully automated single-use aseptic filling and filtration system for bags or bottles. The platform is fully scalable and enables maximum flexibility for both the aseptic filling and draining process. It is possible to fill unlimited volumes per batch with a speed of up to 300 liters per hour. 

The entire filling process is fully disposable, thus warranting an absolutely sterile fill process. For further productivity improvements check out our pinch valve innovation.

RoSS.FILL - single use filling system for drug substances
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Products

RoSS.FILL Benchtop_Rendering

RoSS.FILL Benchtop | High Accuracy aseptic fill-filtration system

RoSS.FILL Benchtop is a flexible lab-scale platform for dispensing therapies into single-use bags. The fluid path is designed to be fully disposable and can accommodate a variety of sterile connection and disconnection options.

RoSS.FILL - single use filling system for drug substances

RoSS.FILL Bag | Single-use aseptic bag fill-filtration system

RoSS.FILL Bag is a flexible automated single-use aseptic bag filling machine for dispensing biopharmaceuticals into single-use bags. The fluid path is designed to be fully disposable and is able to accommodate a variety of sterile connection and disconnection options.

RoSS.FILL CGT

RoSS.FILL CGT | Fill-Filtration | 10mL-1000mL

Fully automated platform system for aseptic filling of multiple small single use bags. Special designed for use in cell & gene therapies with batch sizes at low volumes. With its high filling accuracy, the platform provides filling for up to 36 bags with one rack - having the option to attach more racks.

RoSS Fill-Lab Scale_Fill & Filtraton Platform

RoSS.FILL Lab Scale | Fill-Filtration | 10mL-1000mL

Accuracy is key: Fully automated platform system for aseptic filling of up to 12 single-use bags in standard configuration and is extendable to higher bag quantities. Most suitable for filling small volumes in laboratories for cell & gene therapies or seed train intensification.

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RoSS.FILL Base | Fill-Filtration | up to 1000L

RoSS.FILL Base is a fully automated system for aseptic filling for large volume bulk drug substances. It is suitable for filling of up to 480L into 2D single-use bags or 1000L into 3D single use-bags.

Single use bottle filling machine RoSS.FILL bottle

RoSS.FILL Bottle | aseptic single-use bottle filling

The fully automated RoSS.FILL single-use bottle filling machine. The platform enables worry-free filling and filtration of your liquid drug and non-drug substances into bottles, within less than 1 hour/batch. With its high filling accuracy, the platform provides continuous filling for up to 6 racks at the same time as closed system, no limitations in volume. Contains 1 control unit + 1 bottle filling rack.

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RoSS.DRAI | Drain

Drain your single use bags at Fill & Finish site. This standalone draining rack enable controlled fluid flow while draining single-use bags. Connected peristaltic pumps enable lowest holdup volume. Multiple racks can be attached for simultaneous and continuous pooling thanks to inclination of all shelves. All disconnection types possible.

Our customers trust in us:

Fujifilm Diosynth

Moderna

AGC Biologics

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What makes the Fill & Filtration System so special?

Fully automated single-use filling & draining system

Fully automated single-use filling and draining system for single use bags or bottles. With a filling speed of up to 300 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 aseptic bag filling racks or aseptic single-use 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. Continuous filling thanks to seamless manifold changes and the option to attach a second filling rack to the control unit allows unlimited volumes per batch. The scalability is limitless.

Unrivalled throughput and speed

Up to 300 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 liquid drug substance in single-use bioprocess containers that are integrated in the protective RoSS® shell system. The liquid path is fully disposable, and can accommodate a multitude of sterile compound- and segregation options.

With a filling speed of up to 300 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?

Our single-use Filtration System

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.

Fluid management systems by Single Use Support

Fluid management systems by Single Use Support provide highly professional solutions for applications both on lab scale and bulk scale – from single-use aseptic bag filling machines for cell and gene therapy (CGT) as well as sterile filtration solutions, up to single-use bottle filling machines, single-use drain systems and bulk drug dispensing systems. 

Thus, our platform allows for the greatest flexibility and scalability.

RoSS.FILL scaling - aseptic single-use bag and bottle filling and draining system also for cgt

More solutions

Pharmaceutical freezer RoSS.pFTU large scale freeze thaw platform

Freeze & Thaw platform

The Single Use Support freeze-thaw platforms provide insular solutions for the freeze/thaw processes of each clinical phase. Our new freeze-thaw units are fully scalable and compatible with all batch sizes and bags from all established manufacturers – you will only require one single system from the lab to blockbuster production.

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MITS.2D | Integrity Testing System

Everything else is like “hoping that all goes well.”
With a patented system, MITS.2D tests single use bags with a capacity of up to 20 liters in less than 60 seconds to make sure they are 100% intact.

RoSS - single use bag protecting system

RoSS® Shell | Protecting single-use bags

The safest transport solution for all available single-use bioprocess containers. Robust. Scalable. Single-use bag independent.

Single-use assemblies manifold

IRIS Manifold | Single-Use Assemblies

As an expert in single-use solutions, we have made it our goal to deliver your custom single-use manifolds within 14 days. Prevent downtime and ensure an uninterrupted supply chain in compliance with GMP and regulatory requirements with our single-use systems using silicone tubing.

More information

Benefits of single-use tubing assemblies manifold

All parts at a glance of Single-use tubing assemblies

Are you switching your operation to single-use tubing assemblies? In the following, we show you more about the separate components that single-use tubing assemblies and manifolds are made up of and their specific functions.

Critical considerations of aseptic single use bag filling

5 critical considerations for aseptic bag filling

Aseptic bag filling is a process that is very important to the biopharma industry. This article will give you the basics of aseptic bag filling, highlight the most critical factors of the technique and discuss key considerations pertaining to the commercial use of aseptic bags.

Silicone tubings manifolds

Single-Use Assembly Tubing: Medical Tubing Manufacturers

An overview of manufacturers and its brands of single-use tubings for biopharmaceutical fluid management.

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FAQ about single-use aseptic filling system

What is an aseptic filler?

Aseptic fillers are aseptic filling machines that are used in the pharma industry in order to maintain a sterile environment in the process of fluid management. They are made to prevent the processed drug products from being contaminated with germs while they fill them into sterilized containers before sealing these. 

With the aim to facilitate a secure, flexible and reliable filling process, Single Use Support has developed the RoSS.FILL platform, with single use filling machines both for lab and bulk scale production.

What is an aseptic bag?

An aseptic bag is a germ-free container that is used within the supply chain of several drug products. Sufficiently sealed, aseptic bags like Single Use Support’s IRIS Single-use bioprocess containers are designed to prevent the products that are stored within them from being contaminated.

Aseptic bags need to be sterilized before they can be used; the four main ways to do so are:

  • sterilization by heat
  • sterilization by radiation
  • mechanical sterilization
  • chemical sterilization

What are the requirements in the aseptic area?

The aseptic area requires maintaining a sterile environment for drug materials all the way from the manufacturing site to the place of application. This implies the necessity of specialized equipment that accompany this complex process as soon as the drug product is sterilized, including aseptic filling machines and tubing, sterile containers and a sterile filling environment. 

Additionally, the containers have to be sufficiently sealed in order not prevent contamination along the supply chain of the drug product.

What is the difference between aseptic and septic?

While describing something as septic implies that it is contaminated with germs and potentially harmful or – in the case of tissue – damaged, aseptic means the opposite, as a consequence of adding the prefix a. Aseptic is normally used to describe a process that is kept germ-free, and has a similar meaning as the word sterile; the latter, though, is most commonly used to describe a specific environment that is free of germs.

What is the difference between antiseptic and aseptic?

In the field of germ-free processes, there are various terms that seem similar but have a slightly different meaning to them. This also applies to the words aseptic and antiseptic; while antiseptic is used when talking about making an environment free of germs, aseptic refers to keeping it this way.

What is an aseptic filling machine?

An aseptic filling machine is part of the supply chain of various goods, including several drug products. It is designed to facilitate the filling of drug products into pre-sterilized containers, before these are sealed.

Considering the need for highest accuracy within this process, aseptic filling machines need to be extremely reliable; Single Use Support has therefore developed the RoSS.FILL platform with high quality aseptic filling machines for different fields of application.

How is aseptic packaging done?

Aseptic packaging is performed when a sterile product is transferred into an equally sterile container, before the latter is hermetically sealed. This happens in a sterile environment, as it is vital to prevent the processed drug product from being contaminated with germs.

The steps included in aseptic packaging are:

  • sterilization of the processed products
  • sterilization of the containers that the products are to be brought into
  • ensuring the included devices and other tools are sterile
  • maintaining a sterile environment before hermetically sealing the containers.

Is aseptic and sterile the same?

Both the terms aseptic and sterile refer to a germ-free state. However, the context the two words are used in are different:

  • aseptic: frequently used to describe processes that are performed under exclusion of germs in order to prevent involved individuals and components from contamination.
  • sterile: often used to refer to an environment that is kept or made germ-free; for instance, it can occur whilst describing ORs or surgical instruments.

What is aseptic filling in the pharma industry?

Aseptic filling in the (bio)pharma industry describes a process performed to prevent a drug product from contamination on its way from the manufacturer to its application. By the means of specialized filling systems, the products are filled in sterile containers without being exposed to germs like bacteria. Since the entire filling process is kept aseptic, final sterilization is not necessary.

What is sterile filling?

Sterile filling is a process carried out in a sterile environment, where a sterile drug product is transferred into equally sterile containers. The process is performed when contamination of drug products with germs is to be avoided, and involves dedicated filling solutions.

What is single use bag filtration?

Single use bag filtration is usually performed during the process of single use bag filling and is vital to guarantee product quality. It is carried out to remove impurities from the processed drug substances when they are filled into single use bags.

How does the liquid sampling system by Single Use Support work?

Single Use Support’s filling and draining system functions as a highly professional liquid sampling system for drug products – be it on lab scale or on bulk scale. It can either fill liquids in bags, bottles or vials at a high accuracy, with controlled pressure. Furthermore, an integrated sensor allows airless filling, optionally including the integrated filtration of your product.

The single-use bioprocess containers are well protected by the RoSS.SHELL system, allowing for plate freezing to be performed right after the filling process.

The liquid path of the biologics is fully disposable – from the sterile connectors to tubing –, which saves costs and resources.