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Particle Measuring Systems
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Case Study: Developing an Isolator Filling Line using a Quality Risk Management Approach

Case Study: Developing an Isolator Filling Line Using a Quality Risk Management Approach 3/14/2019

Following 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 advisory team oversaw the development of the aseptic filling process and the environmental monitoring system of this project by applying proven 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

Watch Webinar Here

  • Speaker

    Sr. Daniele Pandolfi

    Gerente Global de Linha de Produtos, Software/Sistemas/Serviços, Particle Measuring Systems, Inc.

    Daniele Pandolfi é o Gerente Global de Linha de Produtos de Software/Sistemas/Serviços da Particle Monitoring Systems, Inc. Com mais de 11 anos de experiência em contador de partículas e controle de contaminação em salas limpas, ele se concentra em construir e manter relacionamentos fortes com os clientes. Ele ajudou muitos usuários de salas limpas a resolver seus problemas de cGMP.

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T. +1-303-443-7100
T. +1-800-238-1801
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Keep in touch! Receive industry news from us:

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  • Press Releases
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  • Trademarks & Patents

Particle Measuring Systems- SG

Corporate Headquarters
5475 Airport Blvd
Boulder, CO 80301

T. +1-303-443-7100
T. +1-800-238-1801
F. +1-303-449-6870
E. [email protected]

Keep in touch! Receive industry news from us:

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