Bıçakcılar medical equipment and disposable medical products are produced according to GMP, with latest technologies in state-of-the-art production facilities established on 26.500 m2 land with 30.900 m2 closed space.
Bio compatible raw materials used in production in conformity to USP and ISO 10993. In-house acceptance controls are also performed to meet the stringent demands of our quality system.
Raw material warehouses are temperature and humidity controlled areas meeting high industry standards.
QC laboratory has been accredited to perform physical, chemical, bio burden, sterility, stability, and EO residual testing, equipped with state-of-the-art technology and highly trained personnel.
In-house mould design and production capability add strength and flexibility both in product design and development stages.
Extrusion, injection and blow molding processes are performed in controlled environments. Product assembly and packaging are performed in class 100 000 clean rooms with a total area of 4.226 m2.
Automated urine bag production lines have capacity to meet worldwide demand.
Disposable medical devices to be terminally sterilized are packaged in clean rooms using fully automated equipment with validated processes and packaging materials.
In-house EO sterilization validation is performed in conformity to EN 550 Standard.
Finished products are stored in air-conditioned 3.500 m2 warehouses with around the clock humidity/temperature monitoring.
