GMP Grade Modular Cleanroom

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.

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.

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.

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. 

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.