Product Description
Fedegari’s FMF Fan Filter Modules and FCP Downflow Booths provide controlled airflow solutions for critical cleanroom operations in pharmaceutical and biopharmaceutical manufacturing. Designed to support contamination control and safe powder handling, these systems deliver reliable airflow performance in regulated production environments.
FMF is a modular fan filter unit designed to generate vertical unidirectional airflow to ISO 5 cleanliness classification according to ISO 14644-1 (EU GMP Grade A), protecting critical areas within cleanroom environments. By maintaining higher pressure than the surrounding environment, the system helps prevent contamination from entering the controlled space.
FMF modules can be combined to create customised configurations, providing cost-effective protection for critical zones in pharmaceutical production facilities.
Design & Technical Features
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AISI 304 stainless steel casing
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Flexible installation options including suspended mounting, false ceiling grids or supporting legs
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Disposable synthetic fibre pre-filters (G3/G4 efficiency according to EN 779)
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H14 high-efficiency final filtration
The FCP Downflow Booth is a vertical unidirectional airflow unit delivering ISO 5 air cleanliness according to ISO 14644-1 (Grade A air supply with EU GMP Class C background). It is designed to safely contain pharmaceutical powders or chemicals during sampling and dispensing operations while protecting the operator, product and surrounding environment.
Engineering improvements including reduced HEPA filter pressure drop, increased prefilter capacity, high-efficiency fans and adjustable airflow control help reduce energy consumption and lower total cost of ownership by up to 40%.
Design & Technical Features
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Compact ceiling and rear plenum maximise workspace while minimising floor footprint
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Three-stage filtration system (G4, F9 and H14)
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Optional bag-in/bag-out pre-filter replacement
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Removable panels allow access to fans, cooling coil and fine dust filters for maintenance
- 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