RoSS.FILL Bag - aseptic bag filling machine

RoSS.FILL Bag is a flexible automated single-use aseptic bag filling machine for the allocation and distribution of bulk drug substance (DS) into single-use bags.

The system is highly precise, with highest accuracy, making RoSS.FILL bag an extremely reliable, user-friendly single-use aseptic bag filling machine.

Aseptic bag filling machine RoSS.FILL
capacity

Up to 400L+/Batch

highest-accuracy (1)

Highest Accuracy

fast-throughput

Fast Throughput

Our customers trust in us:

Rentschler Biopharma SE

Lonza

SCHOTT Pharma

Why is RoSS.FILL bag a reliable aseptic bag filling system?

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 sealer 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
RoSS.FILL Bag_Product Photo_Single Use Support-7

Advanced Sealer & Stepper Pinch Valve

3 functions in 1 device:  Fast filling with variable fluid control and simple aseptic decoupling

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

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 Perforation for Fast Disconnect:

  • Simple aseptic decoupling
  • No need for external tools
  • No risk of contamination
RoSS.FILL Bag_Product Photo_Single Use Support-16
Sealer Valve_3
filling-single-use-assembly-susupport

Fill Single-Use Assembly

Our Single-Use Assembly for individual fluid management processes provides fast and sterile fluid paths for substance transfers into bioprocess containers or bottles. The fully customizable and scalable configurations offer optimal filling characteristics for any volume and any final container. Sterilized tubesets manufactured from Single Use Support are optimized to sustain product safety throughout the entire fluid process in order to avoid  cross-contamination and product loss.

RoSS.LODR open loading single-use shell

RoSS.LODR | Foldable gripper arm

RoSS.LODR is a mobile and foldable gripper arm that ensures ergonomic handling during loading or unloading activities. RoSS.LODR supports a safe working environment and can significantly reduce work related repetitive strain injuries.

Data sheets

Datasheet RoSS.FILL Bag

Datasheet RoSS.FILL Bag

Filesize: 1.28 MB – Mime-Type: application/pdf

Whitepaper RoSS.FILL_Automated Aseptic Filling

Whitepaper: Automated Aseptic Filling

Filesize: 2.3 MB – Mime-Type: application/pdf

RoSS.FILL Scale Overview

Scale Overview RoSS.FILL

Filesize: 0.68 MB – Mime-Type: application/pdf

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RoSS.FILL Bottle | Single-use aseptic fill-filtration system for bottles

The fully automated RoSS.FILL single-use bottle filling machine. The platform enables worry-free filling and filtration of your liquid drug into bottles, within less than 1 hour/batch. With its high filling accuracy, the platform provides continuous filling for up to 6 racks at the same time as closed system, no limitations in volume. 

Cell and gene therapy filling machine with RoSS.FILL CGT system

RoSS.FILL CGT | Fill-Filtration | 1mL-1000mL

1mL-1000mL: Fully automated cell and gene filling machine system for aseptic filling of multiple small single use bags. Special designed for use in cell & gene therapies with batch sizes at low volumes. With its high filling accuracy, the platform provides filling from 36 up to 128+ bags with one or several racks.

ross-drai-drain-single-use-bags

RoSS.DRAI | Drain

Drain your single use bags at Fill & Finish site. This standalone draining rack enable controlled fluid flow while draining single-use bags. Connected peristaltic pumps enable lowest holdup volume. Multiple racks can be attached for simultaneous and continuous pooling thanks to inclination of all shelves. All disconnection types possible.

ross-liqu-smart-tote

RoSS.LIQU | 3D Bag Tote

RoSS.LIQU is a smart rigid tote to protect 3D single-use bags with large volumes of up to 1000L for shipping applications. This robust stainless steel transport container is re-usable and offers a sustainable solution for single-use bag shipments compared to plastic alternatives.

More information

Single-use Technology

Super-fast, Agile and Modular Single Use Filling System for the Biopharma Industry

The fill and drain process for biopharmaceutical products can be a massive challenge for the biopharma industry. Here, single use systems offer a multitude of advantages.

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Michael Eder

May 21, 2019

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Increasing Patient Safety: Risk assessment for small volume fluid management

Autologous therapies and other ATMPs with small volumes exhibit certain specific requirements. The scope of handling advanced therapies require special handling and care. When handling of small volumes is already automated in an early stage, it is a way more straightforward path to commercialization of the drug product. The benefit of a closed systems with automated solutions add value by offering a higher degree of sterility, safety, and process flexibility.

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December 4, 2023

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Aseptic bag filling – 5 critical considerations

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.

BRMO

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March 2, 2022

Fill & Filtration

Fluid management systems: 7 considerations to be made

What are the necessary considerations when implementing automated fluid management systems in biopharma? In this article, we will discuss seven of the most important ones.

michael-muehlegger

Michael Mühlegger

November 13, 2023

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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.