Fedegari Training & Education team (represented by Serena Ambrosini and Maria Luisa Bernuzzi) was proud to work with Jim Agalloco, the internationally recognized expert on aseptic manufacturing, and Mesa Labs to share experiences about processes and applications.
The one-day training entitled “INSIGHTS IN CHEMICAL BIO-DECONTAMINATION: Design, applications and validation of H2O2 processes” was specially developed for the US FDA inspectors.
During the training, the FDA inspectors could learn more about process development and they had the opportunity to explore the technology of Fedegari systems and bio-decontamination units (FCDV). In addition, the team was able to better understand the use of biological indicators and Fedegari BI Evaluation Resistometer (BIER).
It was a great opportunity to exchange ideas and case studies between Fedegari, FDA and Mesa Labs.
Jim Agalloco is Fedegari long-term partner and senior advisor
The training program:
INSIGHTS IN CHEMICAL BIO-DECONTAMINATION:
Design, applications and validation of H2O2 processes
Vaporized H2O2 processes (J. Agalloco)
Process description and challenges
Biological Indicators (K. McCauley)
Process development and PQ (J. Agalloco)
Validation activities
BI Evaluation Resistometer (M. L. Bernuzzi)
Fedegari prototype
Fedegari system demonstration (S. Ambrosini)
Design features
Load and process examples
Process milestones (M. L. Bernuzzi)
Control, reproducibility, robustness, safety
