Single-Use Bag Filling - RoSS.FILL Base

Automated filling of bulk drug substance | up tp 480L / 1000L (2D/3D bags)

RoSS.FILL Base is a flexible platform for dispensing operations into single-use bags and bulk filtration that are supported by RoSS systems. The 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 one weighing scale allows to fill 2D single-use bags up to 480L and is therefore most suitable for commercial bulk filling use. The option to attach a 3D single-use bag of bulk makes it possible to fill one batch of up to 1000L.

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speed

Fast lead times

worldwide

Worldwide shipping

customer-service

Personal customer service

Our customers trust in us:

Fujifilm Diosynth

Moderna

AGC Biologics

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

  • Fully automated filling and filtration system for single-use bags
  • Suitable for 2D and 3D single-use bags
  • Integrated sealer valves for automated sealing
  • Scalability: Option to attach a second filling rack for continuous filling
  • Modular system with separate control unit and pumping station
  • Integration of bulk filtration and differential pressure measurement
  • Option to take samples
  • Optional MES integration to DeltaV or other
RoSS.FILL Scale Overview

Advanced Sealer & Stepper Pinch Valve

2 functions in 1 device: Variable fluid control for fast filling + simple aseptic decoupling

Automated Sealing Function:

  • Dropless disconnection by sealing
  • No need for cumbersome post processing of metal seals and giving the benefit of removing sharp edges
  • Fully aseptically closed – no risk of leakage
  • Simple Aseptic Decoupling: safer, automated disconnection
  • The fully tested sealed tubings withstand a temperature of up to -190°C


Automated Stepper Function:

  • Closed or open or anywhere in between
  • Run your pump at 100% speed - allow the stepper to control the fill rate
  • Unprecedented levels of control in your fill recipe
  • Fastest filling rate
  • Fill several bags in parallel
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Sealer Valve_3

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Up to 400L: Our large scale freezing platform system is a plate-based pharmaceutical freezer and thaw unit for any scale and batch size. Well-established RoSS.pFTU large scale is compatible with single-use bags of all sizes and manufacturers. The hybrid solution offers freeze-thaw capabilities for bags and bottles up to 400L in one platform.  

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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.

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RoSS® Shell | Protecting single-use bags

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

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Sterile bag filling - single-use handling in biopharma on another level

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Biotechs and CMOs alike are investing in novel bioprocessing approaches to meet the changing needs of a rapidly evolving market that requires bioprocessing approaches that will increase manufacturing supply chain flexibility and scalability. SUSupport can help – learn more!
 

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.

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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.