Close-up left-side view of advanced sealing pinch valves on a Single Use Support aseptic filling platform.

SINGLE-USE FILLING SYSTEM

RoSS.FILL is a fully automated single-use aseptic filling and filtration system every primary packaging - no matter the type and size of bags & bottles. The platform is fully modular and adapable to different needs: It allows scale-up and scale-out to 1mL to 1000mL for small volumes and 1L to 1000L+ for large volumes. 

RoSS.FILL achieves process excellence in commercial GMP manufacturing in terms of scalability, flexibility, accuracy and speed.

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Download Success Story

Success Story RoSS.FILL: Aseptic Aliquoting in Bioprocessing Applications

A Success Story of the RoSS.FILL Automated Filling Solution that Connects Upstream, Downstream and Fill & Finish. The major technology gaps are filled by automated aseptic dispensing platforms that transfer drug substances from one process step to another, such as from downstream to fill & finish. But the proven record of aseptic filling with RoSS.FILL goes into more areas of application, including 

  • seed train intensification
  • bacterial fermentation
  • media perparation
  • fill finish of small volumes in single-use bags.

The high degree of process automation and cell viability promotes process efficiency at all scales and contributes to greater patient safety. Learn how Single Use Support’s RoSS.FILL offers maximum flexibility and scalability to these and more areas of bioprocessing applications.

  • Fully automated single-use fill & filtration system

    Fully automated single-use fill and filtration system for single use bags or bottles. With a filling speed of up to 250 liters per hour, the RoSS® units on the rack are filled in a GMP-compliant computerized system.

  • 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.

  • 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.

  • Unrivalled throughput and speed

    Up to 250 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 250 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 in filling and filtering drug substance is limitless.

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

Advantages of RoSS.FILL to other solutions in the industry

  • 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.

  • Close-up image of a sterile medical filter.

Downloads

Preview of Single Use Support's whitepaper about automated filling with RoSS.FILL
Whitepaper: RoSS.FILL - Automated aseptic filling
Preview of Single Use Support's whitepaper about automated filling with RoSS.FILL
Whitepaper: RoSS.FILL - Automated aseptic filling
 
Preview of datasheet for RoSS.FILL scale overview by Single Use Support
Guide: Scale overview RoSS.FILL
Preview of datasheet for RoSS.FILL scale overview by Single Use Support
Guide: Scale overview RoSS.FILL
 

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Frequently asked questions

What is an aseptic filler?

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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 filling machine?

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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.

What is single use bag filtration?

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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.

What is sterile filling?

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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 aseptic filling in the pharma industry?

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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 the difference between aseptic, septic and sterile?

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While describing something assepticimplies that it is contaminated with germs and potentially harmful or – in the case of tissue – damaged,asepticmeans the opposite, as a consequence of adding the prefixa.Asepticis normally used to describe a process that is kept germ-free, and has a similar meaning as the wordsterile; the latter, though, is most commonly used to describe a specific environment that is free of germs. Sterile, in contrast, refers to the absence of all microorganisms. Sterility is often achieved through sterilization with high-pressure steam, chemicals, or radiation. In this context.

What is the difference between antiseptic and aseptic?

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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 wordsasepticandantiseptic; whileantisepticis used when talking about making an environment free of germs,asepticrefers to keeping it this way.

What is an aseptic bag?

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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 undergo sterilization before they can be used; the four main ways to do so are:

  • Sterilization by heating
  • Sterilization by radiation
  • Mechanical sterilization
  • Chemical sterilization

What are the requirements in the aseptic area?

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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.

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

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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.

What is the difference between API and bulk drug?

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Bulk drugs, also known as active pharmaceutical ingredients (API), are ingredients of drug products that are inserted in order to have a biological impact on the person it is administered to.

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