The pass-through hatches of the FCDV and FCDM low temperature bio decontamination equipment is the latest development of all the process equipment manufactured by Fedegari.
These machines are designed for transferring non-autoclavable material into a clean room with a rapid and validatable surface bio-decontamination process.
This solution is becoming increasingly critical as the regulators shift their focus away from traditional moist- and dry-heat sterilization processes to address all other bio burden risks.
Fedegari has applied the QbD-concept to the development of this innovative project in order to meet the current approach required by the EMA and the FDA.
The decontamination and sporicidal action of vaporized H2O2 and peracetic acid are quite well understood and generally accepted by the regulatory bodies, process in general is not efficient, difficult to control and critical to validate.
Furthermore, when using COTS vaporizers, is virtually impossible to reproduce processes with tight tolerance. That’s why Fedegari FCDx equipment actively controls all the process-critical parameters such as relative humidity, temperature, airflow, etc.
H2O2 Vaporizer - FHPG
One of the most critical elements for guaranteeing high reproducibility of the processes is the vaporizer. In the FCDV machines this element has a proprietary design and is an integral part of process control.
Thanks to Fedegari proprietary design and control, concentration of H2O2 is adjusted within ± 15 ppm (typically ± 5 ppm) thus generating the obvious advantages during process development and validation.
A further considerable advantage is that the system does not require any proprietary consumable and this, in turn, drastically lowers operating costs.