Designer Sterile Filtration in Aseptic Processing Using Single Use Technology

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Presented by

Alan Kelly, Project Engineer at Sanofi and Terri Love, Senior BioManufacturing at Merck

About this talk

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, identifying innovative technology including: real time microbial monitoring, drone vial studies to assess aseptic filling line set-ups and multi-purpose PAT technology for detection of trace silicone oil, leak detection and primary/secondary drying functionality for freeze dryers. 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 organiser 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

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