Designer Sterile Filtration in Aseptic Processing Using Single Use Technology


04th November 2020 | 10:00 am EST / 3:00PM GMT | Alan Kelly, Project Engineer at Sanofi |BOOK FREE SEAT FOR THIS WEBINAR

  • Review the new Revision Annex 1 with respect to Single Use Systems
  • Consider initial designs for Single Use Systems, including; design concepts/ location of bacterial retention filters inside or outside the Isolator or RABS/mock-ups
  • Look at the handling and set-up of Single Use Systems, as well as the sterilisation process and product filter preparation steps
  • Uncover the approach to qualification for Single Use Systems

 

Presented by Alan Kelly, Project Engineer at Sanofi

Alan Kelly is a Project Engineer who has been employed within the pharma/biopharma industry in Ireland for the past 25 years and is currently in his 18th year at Sanofi Waterford. Previous employers include Leo Pharma and Elan. During his current tenure at Sanofi Alan has held several engineering roles, including Project Lead on two high speed aseptic vial-filling isolator technology lines integrated with industrial scale freeze dryers and as Process Engineering Manager during start-up of fill finish. Alan has worked in the Technical Services Department at Sanofi responsible for technical expertise input into front-end studies for new aseptic filling lines with isolator technology. In his most recent role in MSAT, Alan is responsible for next generation product transfers to site, identifying innovative technology including: real time microbial monitoring, drone vial studies to assess aseptic filling line set-ups. Alan has successfully led cross functional teams in the qualification of high speed automatic visual inspection technology for cartridges and manual visual inspection of syringes. Alan has presented at international conferences including ISPE (Case study on VHP Cycle Development and Qualification of large scale aseptic Filling Isolator technology, European Compliance Agency (ECA) on “Case study on Manual Visual Inspection of syringes”, Alan is an active member of PDA Ireland Chapter and lead organizer for recent events including Annex 1 Conference (Revision of the EU GMP Guideline) May 2019 and Advances in Aseptic Processing with a focus on Media Fill simulations Oct 2018

 

Followed by an Industry Perspective and presented by Terri Love, Senior BioManufacturing at Merck

Terri Love is a Biomanufacturing Engineer within the Manufacturing and Sciences Technology team at Merck KGaA, based in Ireland. Following a BSc degree in Industrial Biochemistry from the University of Limerick, Terri worked for Lonza Biologics in the UK before returning to Ireland to work with Merck. Terri has been employed within the biopharma industry for the past 19 years, she is in her 15th year as a field-based Biomanufacturing Engineer at Merck in Ireland. During her time at Merck, Terri has been collaborating with Irish biopharma customers on their technology transfers, scale-up and implementation. An area of expertise for Terri is aseptic filtration, including the design and implementation of single-use final fill assemblies.

 

Terri has presented at international conferences. The presentation ‘Practical Implementation of Single Use Filtration Assemblies in the Final Filling Operation’ was given at the American Institute of Chemical Engineers (AIChE) conference in 2014, whilst the presentations ‘Adoption of single use final filtration assembly in a production facility’ and ‘Case Study: The Retrofit of an Existing Filling Line to Accommodate Single Use Filling Assemblies’ were given at the European Compliance Agency (ECA) meetings in 2014 and 2015.

Sponsored by Merck

 

Merck KGaA, Darmstadt, Germany is a leading science and technology company in healthcare, life science and performance materials. Our comprehensive life science portfolio supports customers during all stages of the drug manufacturing process. We offer a broad range of products and services including single-use manufacturing, filtration, chromatography and purification, virus reduction, pharma and biopharma raw materials, drug delivery compounds, and engineering and validation services.

Our final fill solutions integrate filters and single use components to provide sterility assurance while improving the efficiency and productivity of our customers’ processes. Our industry expertise and regulatory know-how help you get to clinic faster, allowing you to focus on what matters most — delivering safe, effective therapies sooner to the patients that need them most.


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