Sterility Testing Isolator With Hydrogen Peroxide Vapor (FCTS)

Source: Fedegari Group


This innovative design provides real time biocide concentration control (over traditional estimated calculations) and is  managed by the very same Thema4 which is today’s reference standard for all contamination control machines where process failure is not an option.

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Only experience in sterility testing isolators – practical field experience – provides the highest degree of reliability because the single subsystems and solutions in general have already been tested under real operating conditions. In Fedegari when we design a new machine our assembly procedure is unique in that we use several in-house engineered solutions which have already been used in other machines before, thus reducing to a minimum the new developments which have to be validated by the time. Unhappy with the performances and the reliability of third-party H2O2 – vaporizers, we have installed the same solutions that we have standardized for our bio-decontamination machines that does not require any proprietary consumables. This innovative design provides real time biocide concentration control (over traditional estimated calculations) and is managed by the very same Thema4 which is today’s reference standard for all contamination control machines where process failure is not an alternative. Through the H2O2 sensors and other devices, Thema4 assures that vapor concentration remains extremely stable (within ± 15 ppm) thus making process repeatability the obvious consequence.

  • Feedback control for superior process repeatability even if load patterns change
  • Fixed concentration profile with no impact of H2O2 degradation on the process
  • Drastically reduced validation time for cycle and load
  • Material routing optimization
  • Gloves and leak testing totally managed by Thema4 process controller
  • Silicon self-retractable gaskets for 100% air tightness on all doors
  • Significantly reduced operational costs with non-proprietary consumables
  • Thema4: easy integration with other Fedegari machines and customers' SCADA systems
  • Cost-effectiveness: time and cost-savings on training and maintenance due to standardization of components, procedures and process controller
  • Custom designed racking and storage
  • Controlled means for loading and removing the processed loads and waste materials

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