GMP Grade Modular Cleanroom

 

Metisafe® has standardized products that can bring the ambient air quality to the highest level thanks to the modular cleanroom units designed as the device developed specifically for the application. Metisafe, which can offer practical and economical solutions in a wide spectrum with a device installation approach and advanced production technology instead of traditional construction and ventilation techniques, is also ahead of its competitors in the energy class. Metisafe Cleanroom Units with maximum product protection feature are suitable for working with materials that are not toxic or aerosol hazard. Depending on usage capacity, application and quality class, there are over 100 modular cleanroom models and more than 30 GMP /GLP compliant model among them.  In addition to the cell culture laboratory, PCR laboratory, GMO analysis laboratory, stem cell unit, total parenteral nutrition (TPN) unit, neutropenic patient isolation room, operating room, intensive care units, there are production and maintenance applications of microelectronic, glass-optical devices in the industrial area.

Hard-Wall Metisafe® modular Cleanroom Units, which have the highest level of product protection, consist of ‘cleanroom’, ‘entrance room’ and ‘control unit’ sections. There is a Pass-Box used for material entry and exit between the outdoor/entrance room and the cleanroom. Both sections are positive air pressure and the cleaning class is ISO-7 (Class 10.000).  Fresh air taken from outside the unit reaches the HEPA Fan Filter Units inside the rooms after pre-filters and air-conditioning. The air taken from the vents inside the unit is recirculated in the hygienic plenum. With the electronic control system, there is no air flow direction from outside to inside during door opening and a clean environment is constantly maintained. There are three different models of Metisafe® Hard-Wall systems with varying usage areas.

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 
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 Cleanlines 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
  • 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
  • Separate DOP test output for all HEPA filters. ISO 9001-2015 Quality Management Certificate, CE, ISO 14644 Cleanroom Class Compliance, EN61010 Electrical and Electronic Safety Compliance, Accredited Testing Organization Validation Guarantee ( if installation is made by Metis certified technical personnel)
APPLICATION SPECIFIC METISAFE CONCEPT CLEANROOM MODELS
ASEPTIC SOLUTION / PARMACY COMPOUNDING
TPN Cleanroom Unit

TPN cleanroom units, in which intravenous feding solutions are prepared for patients who cannot be fed orally for prematüre babies, are low-scale drug production facilities in a way. Metisafe® Total Parenteral Nutrition Preparation TPN-Temioda Unit is a fully steel structurec unit that Works like a device. Metisafe® TPN cleanroom unit has a laminar flow filling zone integrated into the room, which provides primary protection in ISO-5 cleanliness class according to ISO 14644-1 and USP 797 standards and guidlines. It also includes the work area that provides secondary protection in ISO 7 cleanliness class, the dynamic Pass-Box and the entrance that contains the antre room requirements. Metisafe® TPN cleanroom units can operate independently of the building’s central ventilation system and have advanced technology automation control. There are Metisafe® TPN cleanroom models produced in three different standard sizes. Metisafe TPN units, which can easily pass cleanroom validation tests, have a validation guarantee for up to 10 years or when disassembled and reinstalled.

LABORATORIES IN THE CLEANROOM CLASS
PCR Laboratory

False-positive or false-negative results are frequently encountered in laboratories where molecular DNA/RNA amplification methods are applied for research or diagnostic purposes. Although these negativities can be caused by personnel, materials or methods, the air cleanliness of the facility and the correct air directions are also highly effective. The sterile/nonpyrogenic material used in PCR reactions where sensitive techniques are applied in in-vitro conditions may be contaminated with DNA or RNA destructive particles or microorganisms originating from the ambient air. In order to reduce this false negative result or test sensitivity, the pre-PCR stage must be protected with primary and secondary HEPA filtered air barriers. The most important reason for false-positive results in the PCR method is that the target nucleic acid gene regions, which were previously copied and amplified, reach the test tube by air (PCR Carry-Over). To minimize this risk, there are air-directed and leakproof ready-to-use standard laboratories by Metisafe®.  These facilities can be used for research purposes as well as units that are suitable for legislation and licensing with their design and production features.

 

GDO Analysis Laboratory

In addition to the PCR laboratory, there is a sample processing and containment booth in the GMO Analysis facilities. The fresh air taken from the outside of the unit is reached  through the hygienic air ducts to the HEPA fan units inside the rooms after pre-filters and air-conditioning. The air taken from the vents in the analysis room is discharged to the outside atmosphere without being recirculated. There is a Pass-Box used for material transfer between rooms.

All tests related to validation required by EN 14644 standards can be made ex-factory. In cases where conventional techniques such as electrophoresis are applied, entrance and exit to the analysis room can be made via the optional air-lock unit with an air shower.

EUKARYOTIC CELL CULTURE FACILITIES
Cell Culture Laboratory

Since the cells used in primary or secondary cell cultures do not have any defense mechanism, they need optimal cleaning and use. The sterile/pyrogen conditions of the materials used in these methods, which provide cell proliferation in in-vitro conditions, must be maintained when they come into contact with air. There are standard cell culture laboratory models available by Metisafe® that are GMP or GLP compliant, air pressure oriented and leakproof ready to use. 

Stem Cell Facilities

In addition to the cell culture laboratory, stem cell facilities require different application-specific cleanrooms and equipment. These facilities often require GMP compliance. Nowadays, due to the rapid development of stem cells, post-installation revisions are frequently encountered due to reasons such as transfection and viral vector use. Thanks to Metisafe’s modular units operating independently of the building, these revisions have convenience and cost advantages compared to those working with central systems.