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


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Anna Campanella (PhD)

Global Sterility Assurance & Advisor, Particle Measuring Systems

Anna Campanella (PhD) is the Global Sterility Assurance Advisor for Particle Measuring Systems. In this role, she uses her industry experience to collaborate and consult with pharmaceutical companies to develop and implement science-based strategies, principles of monitoring, and controlling and improving the chemical, physical, and microbiological state of various production processes. Anna has a diverse background in the Pharmaceutical field including a PhD in Molecular Medicine, expertise in QA&QC processes, validation of chemical and microbiological methods, validation of sterile production processes and experience in microbiological aspects of aseptic production processes.



Maurizio Della Pietra

Global Data Management Specialist and Process Advisor, Particle Measuring Systems

Maurizio Della Pietra is the Global Data Management Specialist and Process Advisor for Particle Measuring Systems. In this role, he collaborates and consults with pharmaceutical companies and with developers of pharmaceutical equipment and isolation technologies for improving the sterility assurance on science-based strategies. His expertise includes QA processes, validation of equipment, utilities, facilities, computer systems, aseptic production processes, and statistical analysis of aseptic production processes. He has earned a Master's Degree in Physics.


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 of the Global Life Science organization in 2015.