Corporate

Manufacturing Facilities

At our 6,000 m² facility in the İzmir Buca Organized Industrial Zone, we carry out end-to-end production with our certified cleanroom levels and our own ETO sterilization unit.

TIO MEDIKAL was founded in 2011 with the goal of quality, competitive production of single-use surgical drapes and gowns. We carry out customer-focused production at our facilities, where modern production techniques are used and cleanliness and hygiene are given top priority.

Our high-technology facilities, spanning a 6,000 m² enclosed production area with more than 100 employees, hold EN 13795, ISO 13485 and CE certifications.

Founded
2011
Facility Size
6.000 m²
Employees
100+
Cleanroom Classes
Sınıf 10.000 · Sınıf 1 · Sınıf 2A
ISO 14644 Classification
ISO 8
Sterilization
EtO (Ethylene Oxide)
Sterilization Standard
EN ISO 11135
Certifications
EN 13795 · ISO 13485 · CE MDR

Our surgical sets and other medical products pass through certified cleanroom levels (Class 10,000, Class 1, Class 2A) and are sterilized in our own ETO sterilization room; the sterilization process is not dependent on any external party at any stage.

Most manufacturer websites state that they "manufacture to high standards" without specifying which cleanroom class or certification is behind that claim. We share this information not as a claim, but as the concrete data above.

ETO Sterilization Unit Technical Specifications

The outside of the vessel is covered with temperature-retaining insulation material and steel plates. An analysis certificate is issued for every gas mixture cylinder received; records are kept in accordance with our quality management system's document and record control procedure.

Device Model
ETO C 1445
Inner Vessel Material
316L Paslanmaz Çelik
Outer Body Material
304 Paslanmaz Çelik
Welding Material
316L Gıda Sınıfı Paslanmaz Çelik
Capacity
34 m³
Process Type
Negative-Pressure ETO Sterilization
Gas Mixture
%90 ETO · %10 CO₂
Gas Supplier
Koyuncu