FHC – HEPA CART UNIT

ISO 5 CLASS (GRADE A – EU CGMP) CONTINUITY.
Applications Bio-pharmaceutical
Loads Powders, Heat sensitive, Syringes, Stoppers
Processes Contamination control
FHC_prodotto_fedegari

FHC HEPA Cart Unit is the best solution to assure safe storage and transport of aseptic products during manufacturing phase. For example, it allows a clean transfer of materials and/or tools between the washing area and the sterilization/decontamination stations.

According to the EU GMP requirements., this equipment can be defined as a protection device able to assure grade “A” continuity for the carried aseptic material passing through a grade “B” environment.

High-efficiency particulate arrestance (HEPA) H14 filters – with efficiency of 99,995% most penetrating particle size (MPPS) compliant to EN 1822 – guarantee ISO 5 class (Grade A – EU cGMP) continuity.

Fedegari HEPA Cart Unit is the cost-effective solution for sterile sites improvement and retrofitting. Avoid the installation of additional vertical unidirectional flow systems to cover material pathways within the aseptic area.

DESIGN & TECHNICAL FEATURES

  • Stainless steel AISI 304 body.
  • Doors with perfect dimensioning to close half of the loading side allowing an opening of 90°, 180° and 270° degrees.
  • This functional design guarantees ease of use for operators while loading and unloading the trolley.
  • 2 pivoting and 2 fixed castors.
  • Control board with ON/OFF switch and relevant lamp signal, fan alarm red light, display for air flow monitoring and alarms including HEPA filter differential pressure, air flow rate and air velocity.
  • FHC unit can be loaded with the same trays used on the internal trolleys of Fedegari autoclaves.
  • Self-adjusting airflow rate according to static pressure drop increase.

KEY BENEFITS

  • High efficiency/price ratio. Safety for material transfer ISO 5 class (Grade A – EU cGMP) continuity
  • Functional design: doors opening on 90°, 180° and 270° .

KEY BENEFITS

  • 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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