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Sterility Test Isolator


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Sterility Test Isolator - 1

Sterility Test Isolator EN.1.4.1 SPA PROCESSES Sterilization Washing Chemical bio-decontamination Contamination control Dense-phase fluids plants FCTS- Fedegari Sterility Test Isolator with built-in Hydrogen Peroxide Vaporizer Innovation in a commodity market? When creativity is in your blood you cannot settle for basic innovation but you will explore new paths for revolutionary solutions. This was our goal when we started designing our first isolator. SPECIAL APPLICATIONS Rotating sterilizers Pharmaceutical closures processing COMPONENTS Pressure vessels Doors Piping Process controller Wireless sensors ACCESSORIES Un/loading conveyors Customized racks Process control Given Fedegari’s experience in different contamination control processes, our first priority was to assure the highest reliability of the process. We investigated various alternative solutions only to discover repeatability of performances – as it is normally expected in thermal sterilization – was a little more than a dream. System reliability Only experience – 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. 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. DOC. 337901.10/16.07.2014

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Sterility Test Isolator - 2

Sterility Test Isolator FCTS main features Leak testing Fedegari Autoclavi SpA SS 235 km 8 27100 Albuzzano (PV) T +39 0382 434111 F +39 0382 434150 E Gloves testing Decontamination Sterility test optimal conditions Germany Fedegari GmbH Lehrer-Götz-Weg, 11 81825 Munich T +49 89 42044920 F +49 89 42044918 E FHPV Singapore Fedegari Asia Pte. Ltd. 8, Boon Lay Way #03-16 - Tradehub 21 609964 Singapore T +65 6 3164761 F +65 6 8967365 E Switzerland Fedegari (SUISSE) SA Via alla Gerra, 11 6930 Bedano T +41 91 9352090 F +41 91 9352099...

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