Single-Use Bag Filling - RoSS.FILL Base

RoSS.FILL Base is a flexible platform for bulk filtration and dispensing drug substances into single-use bags. The single-use fluid path is designed to be fully disposable and is able to accommodate a variety of sterile connection and disconnection options.

With RoSS.FILL Base the batch volume for filling is limitless: One rack with an accurate weighing scale allows to fill several 2D single-use bags up to 500L and is therefore most suitable for commercial bulk filling usage. The option to attach a 3D single-use bag makes it possible to fill one batch of up to 1000L.

RoSS.FILL Base_Product Photo-8
fast-throughput

Fast Throughput

highest-accuracy (1)

Highest Accuracy

capacity

Up to 500L+/Batch

Our customers trust in us:

Rentschler Biopharma SE

Lonza

SCHOTT Pharma

Features and Benefits of our aseptic bag filling machine for bulk drug substance

  • Fully automated filling and filtration system for any primary packaging, such as 2D and 3D single-use bags, drums, etc.
  • Integrated stepper valves for advanced fluid control
  • Scalability: Option to attach a second filling rack for continuous filling
  • Modular system with separate control unit and pumping station
  • Option to take samples
  • Optional MES integration to DeltaV or other
RoSS.FILL Scale Overview

Data sheets

Datasheet RoSS.FILL Base

Datasheet RoSS.FILL Base

Filesize: 0.67 MB – Mime-Type: application/pdf

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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 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 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 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 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.