Fedegari receives FDA inspectors for a training on chemical bio-decontamination

10 April 2018

Fedegari US Tech Center provided training on chemical bio-decontaminations for  FDA inspectors

It was a great pleasure to receive the FDA (Food and Drugs Administration) inspectors for a Seminar on chemical bio-decontamination with hydrogen peroxide last March at Fedegari Tech Center, Sellersville, PA (USA).

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_giuseppe fedegari

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

 

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FDA_fedegari_training_sterilization_decontamination_pharma_sterile_aseptic_processing

FDA_fedegari_training_sterilization_decontamination_pharma_sterile_aseptic_processing

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