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