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

micheal-eder

Michael Eder

May 21, 2019

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

On the one hand, the use of single use systems dramatically reduces the risk of contamination of valuable liquids, while on the other hand costs are being reduced as single use bags require less storage capacity, are available for a range of filling quantities, and they are cheap.

Nevertheless, the handling of valuable drug substances in single use bags requires appropriate technology. Especially in terms of filling drug substance a sterile process without loss of drug substance is imperative.

At Single Use Support we have studied and analyzed the entire drug substance logistics process, and have developed a fill and drain system that automatically fills single use bags – not only fast but also with a 100% reliability rate.

RoSS.FILL – infinite scalability and reliability

Our RoSS.FILL facility consists of a modular system with a separate control unit and pumping station as well as a storage rack for RoSS®-trays. The rack offers space for up to 20 trays. The single use bags, which are embedded in the RoSS® shell system, are filled with a speed of up to 300 liters per hour. Of course the entire process is fully automated.

The RoSS® shell systems developed by us are 100% reliable and compact trays for single use bags. They are constructed of 3D foam that is protected by a stainless steel sleeve. They offer optimum protection against external impact and eliminate any loss of drug substance caused by shocks, damages during storage or mechanical impact.

RoSS protecting single-use bags

The filling facility is compatible with single use bags of any size and from all established manufacturers, which in turn means unlimited scalability. The system fills and drains bags with an accuracy of +/- 10 ml for 10 liters in separate weighing cells.

RoSS.FILL Bag_Product Photo_Single Use Support-15

In order to guarantee a fully sterile fill and drain process, the liquid pathway of our single use filling system can be disposed of. Furthermore, a combination between a variety of sterile connector and disconnector options is also possible.

RoSS.FILL Bag_Product Photo_Single Use Support-16

RoSS.FILL is not only able to fill your bags; it can also drain single use bags embedded in the RoSS® System. Up to 300 liters of liquid can be moved in only one hour.

You might also be interested in this post: How to avoid mistakes during the filling process for cell and gene therapies

eBook: Filling Gaps in Managing Large Volumes of Biologics

Aseptic aliquotation and cryopreservation of drug substances are crucial process steps in bioprocessing. Even though they’re not in the spotlight of biomanufacturing. In drug development and drug delivery, biologics must be transferred at numerous occasions. Along the journey of monoclonal antibodies, vaccines and more, the drug substance passes lots of process steps where liquid transfer is required. This is relevant for the transitions between upstream processing, downstream processing and fill & finish, but also within these manufacturing milestones. The market of fluid & cold chain management has great growth potential and is on its way to professionalization and industrialization. To meet the challenges of manufacturing drug substances, Single Use Support helps manufacturers and CDMOs to advance their fluid & cold chain management process to achieve a secure and efficient process for liquids on the basis of single-use bags.

RoSS.FILL – all facts at a glance:

  • Single use bags are filled and drained automatically
  • Fast filling with a speed of up to 300 liters of drug substance in less than an hour
  • RoSS.FILL fills your bags with an accuracy of +/- 10 ml per 10 l
  • Modular system with separate control unit and pumping station as well as a storage rack for RoSS trays filled with single use bags
  • Sample taking is possible
  • Optional integration in MES
  • RoSS.Fill is compatible with single use bags of all established manufacturers and any size
  • Unrestricted scalability and flexibility
  • 100% sterile filling and draining of single use bags

As you can see, our innovative single use system not only helps you save time. With our technology we also push safety to the next level by guaranteeing a maximum level of sterility, thus preventing the loss of valuable drug substance as far as possible.
In addition, RoSS.FILL is flexible and agile. You can use the filling facility with single use bags of any established manufacturer.

In case you are still using bottles but wanting to change over to single use technology, RoSS.FILL is your ideal solution. If combined with the RoSS.FILL Flex Rack, the system can also fill bottles. A later change to single use bags is possible without problems. All you need from now on is one single technology!

micheal-eder

Michael Eder

Senior Marketing Manager

Michael Eder, MA, is Senior Marketing Manager at Single Use Support. He is expert in pharma and health communication with his 10+ years experience in pharma. After completing his master's degree in International Healthcare Management at MCI The Entrepreneurial school in Innsbruck, he has gained experience in the pharmaceutical field manufacturing and commercialization of OTC and RX drugs. Michael creates articles about Freeze Thaw applications and Platform solutions from Single Use Support and is the author of current news with Single Use Support worldwide. 

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