In this section, molds and technical drawings for all our products are prepared. This is where samples and production process starts. The molds made by Gerber Accumark are sent to the computer of the cutter machine over the network. Operator calls the mold number on the work order, with the screen attached to the machine and starts the cutting project. Product design, modeling and technical drawing files are created on AutoCAD. Sample and manufacturing processes are done according to this technical drawing.
We have the capacity to produce 17.500 units of gowns per day, which can respond to current customer demand, with our infrastructure consisting of production bands that bond the laminated garments together with ultrasonic welding, to produce the material especially eliminating the risk of liquid transition, at the same time capable of breathing in and out, providing a comfort to its users.
Sterile room conditions are provided with air-lock door systems in all entry and exit areas. The production is done in so called “clean rooms”, specified in accord with 100.000 standards in which criteria that might affect the product quality like temperature, humidity, positive pressure and particles are constantly monitored and recorded. Manufacturing is carried out in clean areas that are validated with GMP rules and ISO Class 8 which comply with EN ISO 14644-1 standards. In addition, the production processes and the products, are secured with relevant Medical Device Directives and the Quality Management Systems, which are documented with CE, ISO 9001, ISO 13485 and ISO 13795 + A1 certificates. A wide range of surgical drapes and sets are produced with automatic banding, folding and bonding machines and experienced production staff. The capacity of daily surgical kit production per shift is 15.000.
The sterilization process is made with 90% EO and 10% CO ₂ gas blend method complying the EN-ISO 11135-1 standard by our own two sterilization machines, one of them being a 12 m3 French brand Sterichem and the other 32 m3 Swiss brand Sterimed, with a total cycle capacity of 48 m3. Sterimed sterilization machine system has the latest technology parametric release. Due to our sensitivity for the environment, the ethylene oxide gas used isn’t emitted into the air but sent to the scrubber unit for purification. In this unit, the ethylene oxide gas is recycled to be used in the production of antifreeze solutions by turning into ethylene glycol.
All the raw and auxiliary materials layout and cutting processes are done automatically with the American technology Gerber branded automatic layout and cutter machine. Because the Cutter is operating within vacuum, it removes fabric particles that come as a byproduct of cutting which affect the product safety. In addition to that, with almost 99% of process efficiency of the cutter, the tolerances in the process and the environmental impact is minimized.
The products are manufactured by automatic packaging and labeling machines in an anti- bacterial and conditioned area. Formatting is done in our thermo forming packaging device (Multivac), which is periodically revalidated in regard to its standard of sealing and merging of material. In order to ensure the traceability, all products are labeled with the lot number. Prior to parceling, one more layer of protective bag is also used to ensure even in a possible breach of the container, the products sterility is not effected of it.