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.
|ISO-5 Laminar Airflow Workstation Integrated Cleanroom (Optional)|
|VENTILATION AND FILTRATION|
|Fresh Air and Pre-Filtration|
|Air Flow Technique|
|Air Cleanlines Class|
|Total Air Change Per Hour (ACH )|
|HEATING-COOLING SYSTEM (Optional)*|
|AUTOMATION CONTROL SYSTEM AND CONTROL PANEL|
|OPERATION, PERIODIC MAINTENANCE AND REPAIR|
|TEST AND CERTIFICATES|
|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|
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.