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Case Study: Developing an Isolator Filling Line Using Quality Risk Management in Pharmaceuticals

Quality Risk Management in Pharmaceutical IndustryFollowing the patent of the “Espresso” innovative infusion device, the Italian Biochemical Institute (IBI) “Lorenzini” commissioned Comecer to construct a new isolated filling line. Particle Measuring System’s Contamination Control Advisory Team oversaw the development of the aseptic filling process and the environmental monitoring system of this project by applying proven quality risk management techniques. Using this case study we will  provide practical insights for Quality by Design principles.

Key Learning Points

  • Project Management Theory
  • Project milestone examples
  • Analyzing, reviewing, and improving processes
  • Process steps risk analysis and mitigation
  • Defining air and surface critical sampling points
  • Using risk management tools (FMEA, Fishbone, HACCP)
  • FAT/SAT and validation approach

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  • Speaker

  • Speaker

    Maurizio Della Pietra, MPhys

    Associated Product Line Manager for Life Science Services, Particle Measuring Systems

    Maurizio collaborates and consults with pharmaceutical companies and with developers of pharmaceutical equipment and isolation technologies for improving the sterility assurance on science-based strategies. He also is the EMEA Field Application Specialist for Data Management and Analysis. He has a strong background in QA processes, validation of equipment, utilities, facilities, computer systems, data and production processes and aseptic production processes and statistical analysis of them.

  • Moderator

    Daniele Pandolfi

    Global Product Line Manager, Aerosol, Particle Measuring Systems

    Daniele Pandolfi is the Global Product Line Manager, Aerosol in Particle Measuring Systems’ Life Science Division. He has over eleven years’ experience in particle counter instrumentation and cleanroom contamination control, focusing on strong customer relationships. He has helped many cleanroom users solve their cGMP issues. Mr. Pandolfi has been responsible for the EMEA Service Department, and a member of the Global Life Science organization in 2015.