Facilities and Equipment
IBG-NEVCELL, which is established on a total area of 655 m2 in the 3rd floor A block of the Izmir Biomedicine and Genome Center building; It consists of three parts: Clean Rooms (Production, Banking and Quality Control), R&D and Support-Office areas.
- 3 Class B Production Rooms
- 2 Class C Rooms
- 1 Class C Cryopreservation Room
- 2 Class D Quality Control Laboratories
- Class D receiving, storage and packing rooms
- 2 Pre-GMP Laboratories (Ar-Ge and Cell culture)
- Non-class archive , system management, offices and restrooms1 adet pre-GMP Hücre Kültürü Laboratuvarı
|

|
- IBG-NEVCELL GMP Facility; According to ISO 14644 standard, it monitors and records 24/7 parameters in the ambient air such as particle density, particle size, humidity and temperature. The system gives a visual-audible warning in any deviation in these parameters and notifies by e-mail. The online monitoring system creates a trend with the data it obtains and keeps logs.
- All devices and equipment used for the production and quality control tests in the facility; Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) and calibrations have been completed. Relevant parameters (temperature, humidity, CO2, O2) of critical devices are monitored 24/7 with regularly calibrated probes.
- The HVAC system filters 100% clean air from automation-controlled hygienic air handling units and sends it to the area, and the number of air cycles, humidity values and temperature parameters of the rooms can be controlled. Thanks to the HVAC system, it is ensured that the pressures are kept at standard values.
- Components that ensure the continuity of the system; IT Panels, Building Management System, Lighthouse Automation Monitoring System, fire detection-extinguishing system, fm200 gas extinguishing system, security cameras are monitored 24/7 by authorized technical personnel.
-