Isolation chamber for biopharmaceutical applications FCIS

transfersteriledispensing

EQUIPPED WITH FHPV – FEDEGARI HYDROGEN PEROXIDE VAPORIZER. The FCIS pharmaceutical isolator have been designed primarily for: Pharmaceutical dispensing/handling of API and High Potent Ingredients. To assure sterile continuity after unloading sterile process machines. To guarantee aseptic filling during manufacturing phase. To achieve these goals, FCIS unit uses a barrier in order to separate the operator – working in C or D EU cGMP grade area (ISO7, ISO8 US cGMP) – from the working area – in A grade area EU cGMP (ISO5 US cGMP) – where all operations occur. The isolator meets all the requirements of the FDA, EMA, WHO and associated pharmacopoeia as well as all applicable EN standards and directives and international norms. Fedegari’s pharmaceutical isolator can be integrated with a side transfer hatch designed to introduce/remove all the containers and material necessary for the process. To avoid false positives, a Fedegari HPV peroxide vaporizer is provided, which can be used to launch a chemical decontamination cycle of the surfaces before starting to use FCIS. In this way we can guarantee that you are working in an aseptic environment. Fedegari has developed for the pharmaceutical isolators the same solution standardized for its bio-decontamination pass-boxes, since the performances and reliability of third party H2O2 vaporizers were not satisfactory. Moreover, the Fedegari Hydrogen Peroxide Vaporizer (FHPV) excludes the need of propietary consumables, reducing significantly operational costs.