Low temperature bio decontamination units with vaporized hydrogen peroxide (H2O2)
With the FCDV bio decontamination unit you can bring inside the clean rooms all those products and instruments that cannot be thermally sterilized. Surface bio decontamination of the load is carried out with vaporized hydrogen peroxide - H2O2. This solution is becoming increasingly relevant as the regulators shift their focus away from traditional moist- and dry-heat sterilization processes to address all other bioburdedecn risks.
While bio decontamination process is usually a long and complex process, Fedegari focus in the active control for:
Process optimization: surface bio decontamination in 30 min. Fast bio decontamination with drasticaly reduced operational costs (use of non-proprietary consumables).
Reliability : Hydrogen peroxide vaporizer - totally engineered and manufactured by Fedegari - with control loop (PID based), provides superior reliability and repeatability for easier validation. Silicon self-retractable gaskets for 100% air tightness.
Flexibility: The unit can be used as a pass-through hatch aired with synchronized doors and pressure control.
Easy validation & integration: all the processes are managed by Thema4 process controller, pre-validated and standardized for all Fedegari machines. Total control and high reproducibility for easy validation.