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HomeWebinarsSolving problems in Fill & Finish: Single-Use Gloveless Isolator Assemblies and maintaining Annex 1 Compliance

Solving problems in Fill & Finish: Single-Use Gloveless Isolator Assemblies and maintaining Annex 1 Compliance



WEBINAR

In this webinar, you will learn:

  • The Benefits of Gloveless Isolator Technology
  • How Gloveless Isolator technology is optimized to asepteic filling processes
  • The role of Gloveless Isolator technology in maintaining Annex 1 Compliance
  • Current offerings and scope of our Mobius® FillReady Assemblies

Aseptic Final Filling is the last unit operation of critical drug product processing before medical treatments and therapies are given to patients. As such, maintaining sterility and quality in this step is paramount. As single-use systems are increasingly being adopted in all areas of bioprocessing, there is a focus on implementing new technologies that assure sterility and automation of assemblies handling critical drug product.

We will focus on a new platform of single-use filling technology that will help cusotmers meet regulatory expectations and reduce contamination risk. This solution will leverage novel automation automation that can help to reduce burdens on drug product processing offer an importnat opportunity for process risk mitigation and benefits in product yeild, sustainability, and operator safety.

Speaker List

Ram Sheth

Ram Sheth

Merck

Senior Strategic Product Manager, Fill & Finish

Ram Sheth has more than 8 years of experience in the bioprocessing industry managing large CapEx projects from design concept through development, testing, installation, and commissioning. He has also supported in design engineering and process improvement initiatives to improve operations across different business units. In his current role, he works directly with internal and external stakeholders to develop solutiosn that advance Single-Use (SU) technology in sterile fIltration and aseptic filling applications. Ram holds a B.S.E. in biomedical engineering from the University of Massachusetts Lowell and is currently purusing an MBA in Health Sector Strategy and Management from Boston Univeristy's Questrom School of Business.

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