Modular Biosafety Room Units
Metisafe modular biosafety room units are designed for staff & environment protection featured over international guides’ criteria.
And also, those units protect the product/material according to EN 14644 standarts.
Modular units are suitable to work with toxic / carcinogenic materials and biological hazard grade 2+ microorganisms.
Units are composed of 'Entry / Air Lock Room(s)', 'Biological Safety Room' and 'Control Room' sections. Between the rooms and surroundings/unit the negative air directioning is available.
The room air pressures are arranged as decreasing in the direction of the entry room/airlock to biological safety room.
40x40cm Pass-Boxes are integrated for material transfers between room/outside.
Besides having negative air pressure the rooms have cleanliness class of ISO-7 (Class 10,000).
Fresh air passes through pre-filters & air conditioning and arrives to HEPA fan filter units.
HVAC, electricity, waste management, lighting, sealing, decontamination, automation control and alarm/warning systems are compliant with recommendations of Biosafety Level 3 (BSL-3) guidelines.
Air taken from the bottom suction culverts inside the rooms are thrown into the outer atmosphere with or without the air recirculation in reference to guideline recommendations.
Integated Class II biological safety cabinet (BSC) is available upon request. Air change per hour (ACH) and airflow rates are controlled by Metisafe automation system.
The negative pressure is kept and ballanced continously and particle leakage to surroundings is also prevented by additional negative plenum safety barrier.
Fast response air control valves and electronic control systems prevents the airflow direction form inside to outside while door openings.
STRUCTURAL FEATURES
Panel:
- Cleanroom panel with specially designed leakproof fasteners in steel structure
- 50mm thickness with heat and sound insulation with polystyrene material inside
- Panel connection with smooth surface continuity
- Radius monoblock corner panel suitable for cleanroom conditions with no protrusions and smooth surface continuity
- Removable and retained material property when reassembled
Surface Coating:
- Antibacterial hygienic epoxy coating with a minimum thickness of 1.5 mm with metallic ion additives that provides corrosion and chemical resistant layer formation
- Easy to clean smooth surface resistant to scratches, corrosion and chemicals
Ceiling:
- Self standing special ceiling system
Ground (Optional):
- Easy to clean homogeneous type PVC resistant to chemicals and abrasion
Door:
- Specially designed, easy to clean surface and hygienic coated impact resistant 70 Nm steel door
- Interlock door lock system with internal magnetic contact
- Dropdown seal system
- Adjustable Air Carrying Vent
- Hidden Type Hydraulic
- Ergonomic and Radius design stainless steel doorhandle
- Two way emergency exit button
- Fast closing, slow at last 15° and fixing at full open point movement mechanism
Window:
- Same thickness as the panel, >6 mm tempered glass
- Non-indentations panel and door glass combinations
CLEANROOM EQUIPMENT
Pass-Box:
- HEPA Filtration
- Interlock lid system
- Warning lights
- Rounded safe exterior corners
- Easy to clean inner surface with rounded corners
- Positive/Neutral/Negative pressurization options
ISO-5 Laminar Airflow Workstation Integrated Cleanroom (Optional):
- Homogeneous 0,45 m/s ± 20% air velocity integrated in the cleanroom
- Optimal airflow Dynamics with front air redirection plate and maximum protection
- Zero leakage negative plenum technology workplace
- Adustable light intensity and maximum comfort with low noise level
Bench :
- Shelf system that can be used as a storage area in the anteroom and a minimum 3 m2 workbench in the cleanroom
- Acrylic polymer-based non-porous composite
- Easy to clean, anti-bacterial and corrosion resistant surface with rounded edges
Lighting:
- Air leakproof type lighting luminaiers
- Adjustable lighting intensity option
- Independently controllable, energy efficient 750-1200 Lux light intensity that is easy on the eyes
- Lamp change that can be made inside the room
VENTILATION AND FILTRATION
General Ventilation:
- Independent operation feature from central ventilation systems
- Negative plenum secondary air barrier surrounding
- Cleanroom pressure minimum +20Pa according to the environment outside the room
- Entrance pressure minimum +15Pa positive air pressure
Fresh Air and Pre-Filtration :
- EU5/EU7 inlet air intake to the cleanroom plenum after pre-filtration
HEPA Filtration:
- H14 Class HEPA Filter according to EN 1822 standard
- Air outlet speed can be adjusted in the range of 0.25-0.45 m/s homogeneous distributed
- Uniform air velocity: The difference between the velocity values measured throughout the filter surface is no more than ± 20%
Air Flow Technique:
- High Supply-Low Return air flow pattern, which is applied by giving the air taken from the places close to the floor into the rooms from the ceiling
- High efficiency particle sweeping performance
- Recovery time (room recovery) is maximum of 10 minutes
Air Cleanliness Class :
- Compliant with ISO 14644 standards
- Compliant with USP 797 pharmacy compounding guideline recommendations
- LAF Workstation and Pass-Box ISO 5 cleanliness class
- Buffer and anteroom are in ISO-7 cleanliness class
Total Air Change Per Hour(ACH ) :
- Cleanroom ≥30, Entrance ≥20, Pass-Box ≥1000, Section Under LAF ≥1000
HEATING-COOLING SYSTEM (Optional)
- Heating-cooling system with heat pump, DX gas expansion (R410 gas), new generation inverter PID controlled ,precision temperature adjustable
- The coefficient of performance control (COP) is 3.62. Possibility to adjust ± 1 C sensitivity between 19-24 C in Cleanroom, ±1 C sensitivity between 21-26 C in Entrance room.
- Homogeneous temperature distribution in the rooms
- Energy efficiency class A. The temperature difference between the coldest and the hottest zone is ±2°C at most. Cooling in case the outdoor temperature is +7°C and heating in case of -15°C
- Heating and cooling Powers vary between 7-17 kW/h depending on the cleanroom model.
AUTOMATION CONTROL SYSTEM AND CONTROL PANEL
- Whole system control from a single dashboard
- PLC control system with 7 inch touch screen; Continuous monitoring of temperature, pressure, air flow with the help of sensors
- Energy saving with daylight and night (Eco) modes
- Easy to use feature, possibility of accessing historical change graphs and records of temperature/humidity/pressure/air velocity values, making set settings of the system, entering alarm criteria.
- Control of the door air-lock system and recording of personnel entrances and exist, electronic and mechanical pressure detection and monitoring
- Remote control
- Independent adjustment and monitoring of cleanroom and entranceroom temperatures
OPERATION, PERIODIC MAINTENANCE AND REPAIR
- Suitable for 7/24 operation continuously
- Less thatn 2% failure rate in three years
- Minimum 5 years HEPA filter lifetime
- Minimum 10 year cleanroom performance protection warranty
- High energy saving
- Low noise level
- Pre-filter that can be changed and intervened from outside the unit, electronic control panel, heating-cooling outdoor unit
- Quick technical service with remote Access to the control panel
TEST AND CERTIFICATES
- CE
- ISO 9001-2015 Quality Management Certificate
- ISO 14644 Cleanroom Class Compliance
- EN61010 Electrical and Electronic Safety Compliance
- Accredited Testing Institution Validation Guarantee
- Separate DOP test output for all HEPA filters
- HEPA filter tightness tests, air velocity/flow/pressure/temperature/humidity tests, laminar air flow test, air orientation test, particle count, recovery time test, light intensity and noise measurements, electrical safety, alarm diagnostic tests
APPLICATION SPECIFIC TRANSMISSION MODULAR BIASAFETY MODELS
CLEAN ROOM CLASS LABORATORIES:
- Tuberculosis Laboratory
- Virology Laboratory
- BSL-3 Laboratory
- Mobile Laboratory
- Chemotherapy Unit
Metisafe_BSL-3_MCR-24