RoSS.FILL Bag is a flexible automated aseptic filling machine for the aliquotation and dispensing of bulk drug substance (BDS) into single-use bags. The system for aseptic filling and sterile filtration is highly precise, making RoSS.FILL Bag an extremely reliable, user-friendly single-use bag filling machine.
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Aseptic bag filling: Why to rely on RoSS.FILL Bag?
In terms of reliability, RoSS.FILL Bag is an aseptic bag filling system that stands out with several characteristics: Not only is the fluid path fully disposable, but it is ready to accomodate various sterile connection and disconnection options for single use aseptic filling.
In addition, the advanced sealing pinch valves, including an automated stepper, sealing and perforation fuction enable a fast and efficient filling process with an easy and dropless disconnection.
Features and benefits of our aseptic bag filling machine
- Volume: Up to 400 L per batch
- Scalability: Option to attach a second filling rack for higher batch volumes
- Fully automated filling and filtration system for single-use bags
- Accuracy of ±20g for 0.2 to 5.0kg & ±25g for 5.0 to 20kg
- Ease of use in operation / recipe driven processing
- Bag & Connector agnostic setup
- Modular system with separate control unit and pumping station as well as storage rack made up of RoSS trays
- Integration of bulk filtration and differential pressure measurement
- Option to take samples
- Optional MES integration to DeltaV or other
Advanced sealing pinch valves
Single Use Support‘s filling platforms are equipped with the next-gen, in-house developed pinch valves designed to accelerate the filling process and enable operator-free aseptic decoupling of single-use bags.
Sealing of the tubing:
- Heat-sealing for TPE tubing
- RF-sealing for PVC tubing
- Operator-free aseptic decoupling
- Fully aseptic closure – no risk of leakage
- No risk of contamination
Paralell filling:
- Due to the fully variable position of the valve multiple bags can be filled simultaneously
- Enables increased filling speed
- Pump can always be operated at the max. allowed speed
Tear-off feature:
- The perforation created during heating tear-off allows easy disconnection of the tubing by hand
- Easy separation of the bag from the rest of the manifold
- Eliminates the need for post-processing of metal seals and removal of sharp edges
- No external tools required
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RoSS.FILL Bag – the fully automated single-use bag filling & draining system
Why use aseptic filling at all?
Fluid transfer of biopharmaceuticals, particularly when small volumes are to be dispensed into a primary packaging, is typically done in biocabinets or isolators. Manual processing, as performed in isolators, is prone to error and contamination.
The FDA and Annex 1 of cGMP recommend automated equipment that supports a closed system for aseptic filling. With solutions such as RoSS.FILL Bag, aseptic filling and sterile filtration into primary packaging can be performed more efficiently and with reduced risk of contamination through effective sterilization methods.
RoSS.FILL Bag outperforms other aseptic filling platforms with its filling accuracy, its ease-of use and high throughput. It can be scaled down to smaller volumes and bags and up to fill bulk drug substances with changing the attached filling racks.
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FAQ on Single-use bag filling
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 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 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.
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, septic and sterile?
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.
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.