CLEANROOM SOLUTIONS

ISO 5 CLASS (GRADE A – EU CGMP) CONTINUITY.
Applications Bio-pharmaceutical
Loads Powders, Biohazard
Processes Contamination control, Isolation
FMF_prodotto_fedegari

Fedegari Group has engineered a set of products specially designed for clean room applications and aseptic manufacturing:

FMF – UNIDIRECTIONAL FLOW FAN FILTERS MODULES

FMF is a modular unit which creates a vertical unidirectional airflow in Class ISO 5 according to ISO 14644-1 (“Grade A” EU GMP), protecting the critical area. The airflow maintains the clean room under a higher pressure than the surrounding environment, thus avoiding any contamination risk.

FMF modules can be combined together to create a tailor-made solution to assure the most cost-effective protection to critical areas inside pharmaceutical production sites.

DESIGN & TECHNICAL FEATURES

  • AISI 304 stainless steel casing.
  • Suitable for different assembling solutions (suspended, fitted on false ceiling grids or on supporting legs).
  • G3/G4 efficiency disposable synthetic fibre pre-filters (according to EN 779) and H14 efficiency filters.

FCP – CAPPA DOWN CROSS

FCP – Down Flow Booth is a unidirectional vertical airflow unit, ISO 5 air cleanliness classification according to ISO 14644-1 (Grade A air supply and Class C according to EU GMP) designed to contain any kind of pharmaceutical powders or chemicals during sampling and dispensing operation. FCP has been designed according to the ISPE Good Practice Guide: “Assessing the Particulate Containment Performance of Pharmaceutical Equipment”.

The booth design adresses operation of sampling and dispensing and assures total protection of the operator, of the environment and of the product.

Fedegari has redesigned the workstation to reduce the electric power required to run the process by:

  • lowering by 50% HEPA filters’ pressure drop.
  • Resizing prefilter area: 50% extra capacity.
  • Installing more efficient fans.
  • Installing individual adjustable airflows.

Thanks to this design and engineering improvement, FCP Down Flow Booth has lowered its total cost of ownership by 40%.

DESIGN & TECHNICAL FEATURES

  • Compact ceiling and rear plenum optimize usable work area while minimizing floor space.
  • Three-stage filtration, G4, F9 and H14 can be accommodated (Bag-in, Bag- out pre-filter replacement upon request).
  • Removable bulkhead panels enable access to fans, cooling coil and fine dust filter for maintenace.

KEY BENEFITS

  • Grade A air supply.
  • FMF modular units: customizable shape to assure safety on critical areas.
  • Integrable systems to satisfy all needs related to clean rooms operations.
  • FCP new design & engineering: -40% of total cost of ownership.
  • Safety & contamination control: operator, product & environment.

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.

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