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.
- 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° .
- 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
- 21 CFR Part 210, 211 e 11
- UL 508A
- ASME BPE
- 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.