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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.
Through H2O2 sensors and other devices, vapor concentration is directly monitored (over traditional estimated calculations) by process controller Thema4 and remains extremely constant (within ± 15 ppm) thus allowing process repeatability.
DESIGN AND TECHNICAL FEATURES
- AISI stainless steel chambers with bright annealed surface finishing (Ra ≤ 0.4 μm).
- Manufactured to the highest GMP quality standards.
- Doors are protected with a double gaskets system to ensure the highest level of safety for the operators.
- Integrated pressure decay leak test both for chambers and gauntlets Exhaust air from the isolator is filtered by a H14 HEPA filter before being expeled to outside environment.
- Customizable and modular unit manufactured according to customers’ needs.
KEY BENEFITS
- Operations guaranteed in a grade A environment.
- Avoid risk of material/operator cross contamination.
- Utilities savings compared to clean rooms.
- Integrated Hydrogen Peroxide Vaporizer (FHPV).
- Bespoke racking and storage to suit customer’s application.
COMPLIANT TO
- European directives: 2014/30/EU – electromagnetic compatibility (EMC), 2014/35/EU – Low tension equipment (LVD), 2006/95/EC – Safety of machinery (MD)
- European standards: EN 55011, EN IEC 61000-4-2, EN IEC 61000-4-4, EN IEC 60204-1
- FDA: compliance for non metallic component in contact with process fluids
- GMP
- GAMP5
- 21 CFR Part 210, 211 e 11
- UL 508A
- NFPA-79
- ASME BPE
Optional
- US electrical norms: NFPA 70 – National electrical code, UL 61010-1 – Safety requirement for electrical equipment for measurement, control and laboratory use – Part 1: general requirements.
Want to know more about our certifications? Please visit the dedicated section or do not hesitate to contact us.
RELATED PRODUCTS
Thema4
Thema4, developed to meet the most stringent requirements of thepharmaceutical industry, is installed on all Fedegari machines. It is able to integrate natively with SCADA and MES systems in use by the customer.
