FCIS – PHARMACEUTICAL ISOLATOR

Fedegari has decided to develop the FCIS pharmaceutical isolator to offer its customers a process machine capable of:

  • Ensure maximum safety in the handling and dosing phases of active ingredients and high potent substances.
  • To ensure continuity of sterility when unloading from a sterilizer.
  • To ensure aseptic filling in the production of sterile drugs.

The FCIS unit physically separates the operator – who works in a class C or D EU cGMP (ISO7, ISO8 US cGMP ) environment – from the work chamber that ensures a class A Eu cGMP (ISO5 US cGMP ) environment. The isolator complies with FDA , EMA and WHO standards and associated pharmacopeias as well as all applicable EN standards and directives.

The FCIS pharmaceutical isolator has a side door for the passage of material and to remove any waste after the process. To avoid false positives, a standard FHPV peroxide generator is supplied, thanks to which it is possible to launch a cycle of chemical decontamination of the work surfaces before starting to use FCIS. This allows you to be sure of working in an aseptic environment.

Fedegari has installed on FCIS the same solution that is provided in the FCDV decontamination pass-boxes because the reliability of third-party generators was judged insufficient. A further advantage of the Fedegari peroxide generator is that it does not require proprietary consumables, reducing the running costs of the machine.

Thanks to the presence of sensors in the chamber, the concentration of the hydrogen peroxide vapor are directly monitored in real-time by the Thema4 process controller (against the estimate that is generally carried out by others) and remain constant in the chamber, ensuring certainty of results and repeatability of the process.

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