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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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 the following areas of bioprocessing applications throughout upstream and downstream bioprocessing and fill finish.
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?
Automated Filling Platform 1 | Automated Filling Platform 2 | RoSS.FILL Automated Filling, Filtration & Sealing | Comments | |
|---|---|---|---|---|
| Accuracy | ⁓ | × | ✅ | RoSS.FILL CGT achieving a weighing accuracy down to 1g |
| Speed | ✔ | ⁓ | ✅ | Parallel and sequential filling for highest throughput |
| Automation & Process Control | ⁓ | ⁓ | ✅ | Fully automated process control with user-friendly HMI, optional integration in MES and integrated dispensing and sealing of all primary packagings |
| Modularity & Scalability | × | × | ✅ | One Control Unit to attach different racks for simple scale-up and scale-out: |
| Operator Effort | ⁓ | ⁓ | ✅ | RoSS.FILL with cGMP-compliant process solutions for dispensing and sealing of primary packagings |
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 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.
Click here to download technical product data sheets and design videos.
Whitepaper: Automated Aseptic Filling
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Process Flexibility Guide - RoSS Fill
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Scale Overview RoSS.FILL
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Datasheet RoSS.FILL Bag
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Datasheet RoSS.FILL CGT
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Datasheet RoSS.DRAI
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Datasheet RoSS.FILL Bottle
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Datasheet RoSS.FILL Base
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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. All you need to fill well. The modular system RoSS.FILL allows great scalability & flexibility for filling single use bags and bottles, is independent on manifolds, tubings and connectors and decreases product loss and process contamination to the absolute minimum.
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.
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:
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.
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. 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.
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.
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.
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:
Both the terms aseptic and sterile refer to a germ-free state. However, the context the two words are used in are different:
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.
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.
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.
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.
