Sterility Test Isolator: Fedegari innovates in a commodity market

3 April 2016

While other manufacturers claim a know-how difficult to be recognized on-site and turn their production facilities into assembling shops, Fedegari is still investing in developing in-house innovative solutions thus retaining a truly all-around know-how for guaranteeing the highest performances money can buy today.


With this perspective Fedegari introduces the new FCTS series of GMP Sterility Test Isolators with built-in H2O2 vaporizer designed and manufactured in-house. The isolator offers different modularity options and can be integrated with a chemical bio-decontamination chamber (transfer hatch). The new FCTS series is equipped with the innovative PID-based hydrogen peroxide vaporizer and gloves and leak testing totally managed by Thema4 process controller.


PID-based hydrogen peroxide (H2O2) generator  – How does it work?

Most of the H2O2 vaporizers available on the market control the biocide concentration inside the chamber by weight/volume rate per time unit. Once the concentration is detected it is recorded. The decontamination cycle can be accepted if there is a coincidence with the values identified during the qualification activities and cycle development. Fedegari new generator can be controlled according to the instantaneous concentration of the biocide in the vapour phase. A PID control loop has been implemented and the concentration can be controlled in a very narrow range. This development can guarantee robustness and a better decontamination process design according to different loads.

The hydrogen peroxide dosage is defined by the process controller Thema4. The process just starts if there is enough H2O2 liquid inside the buffer tank. An H2O2 level sensor fixed on the buffer tank, restores the liquid H2O2 level from the customer H2O2 tank. The fluid metering system checks the amount of H2O2 in the chamber and controls the specific amount of liquid biocide to be delivered to the vaporizer unit.

Process control

Given Fedegari’s experience in different contamination control processes, the first priority when developing the sterility test isolator was to assure the highest reliability of the process. Our team investigated various alternative solutions and discover that repeatability of performances – as it is normally expected in thermal sterilization – was a little more than a dream.


System reliability

Only practical field experience provides the highest degree of reliability. Our single subsystems and solutions have usually been tested under real operating conditions, so when we design a new machine we use these several in-house engineered solutions which have already been tested and used in other machines before. This way, Fedegari reduces new developments which in turn require less new validations.

Unsatisfied with the performance and reliability of third-party hydrogen peroxide (H2O2) vaporizers, we have equipped our sterility test isolators with the same solutions we have developed in-house for our bio-decontamination units: an H2O2 vaporizer that does not require any proprietary consumables. This revolutionary equipment provides real time biocide concentration control (over traditional estimated calculations) and is totally managed by Thema4 which is today’s reference standard for all contamination control machines where process failure is not an option. Through the H2O2 sensors and other devices, Thema4 assures that vapor concentration remains extremely stable (within ± 15 ppm) thus making process repeatability the predictable consequence.


Efficient bio-decontamination

The unit transfer hatch is equipped with a magnetic-driven fan in the ceiling. This innovative design for homogenizing the H2O2- air mixture allows a uniform distribution of the vapor and avoids any possible leak. Moreover, an UDAF that creates a piston effect, guarantees the correct biocide distribution.


Design Features

Compliant to cGMP guidelines, the working chamber has non-directional BA surface finishing (Ra ≤ 0.4 μm). Air-tightness is 100% guaranteed by ultra-safe doors. Two sensors monitor the amount of H2O2 in a fixed sampling point of the chamber. The first H2O2 sensor (150-1500 ppm) measures the concentration to control the process. The second H2O2 sensor (0-300 ppm) is installed for safety (TLV<1ppm). The isolator can be equipped with sterility test suits from different manufacturers and rtp port 1ppm.




· Control loop for superior process repeatability even with different load patterns

· Fixed concentration profile with no impact of H2O2 degradation on the process

· Drastically reduced validation time for cycle and load

· Gloves and leak testing totally managed by Thema4 process controller

· Silicon inflatable gaskets for 100% air-tightness on all doors

· Reduced operational costs with non-proprietary consumables

· Thema4: easy integration with other Fedegari machines and customers’ SCADA systems

· Cost-eff ectiveness: 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