QUALITY OF PRODUCTS
Our products are produced with the raw materials which are called non-woven and convenient to the quality standard of EN 13795, and they provide comfort to both users and patients and easy usage for healthy conditions. These fabrics have liquid-absorbent or liquid-repellent, breathable features and the medical bands and incision films used on the fabrics do not cause irritation on skin, therefore it takes the operation area under protection during the surgical procedures and avoid the passage of any liquid, blood and bacteria. In addition, by applying the experiments of SITOTOXITE (the experiment of death- toxic on the cell) and IRRITATION (the experiment of allergic reaction on skin) to the raw materials to be used in production by the Department of Pharmacology, biocompatibility is provided and thus it is proved that the raw materials to be used in our products will not cause any reaction on the skin. In the process of providing the raw material, the eligibility of the requirements of EN 10993 quality standards is controlled. We prefer the raw materials whose suppliers meet the quality standards so that we can keep the quality of products at the maximum level at the first stage of the production. Production process is completed according to the instructions and procedures required by the system. In our company, we have a clean-room that compensate the conditions of Class 100,000. Our clean-room also has a facility to manufacture according to conditions of Class 10,000. Our clean-room’s validation values are assessed according to quality standards of EN 14644-1, and the packaging phase of our products is realized in a clean-room under appropriate temperature with a packaging machine of which validation is completed and heat value of packaging is determined. After packaging of the product, labelling is also carried out in the clean-room conditions, and it is prepared in accordance with the graphics and symbols indicated in EN 980 Medical Devices Labelling. Packaging material used in our products complies with the EN 868-7 quality standards and provide the necessary conditions in terms of EO gas permeability. Sterility of our products is controlled through reports prepared after each charge. Our production facilities are also suitable for providing the changes required by the users besides the standard products. The folding pattern of single-use covers and the direction signs on them for folding
provide to cover at a time without ruining the sterilization, thus operation area is also isolated from the infections which can be caused by the environment. The single-use surgical clothes with sufficient protectiveness keep the surgeons and the operation team from the microorganisms caused by infection of the patient and meanwhile the breathable fabric provides comfort to the user. These features minimize the risk of infection for the patient compared with textile covers, and it provides security and comfort for the user, too. Besides, if the energy and labour force spent in order to provide reusing the textile covers and the risk of infection are considered, the single-use products that are manufactured fabrics is much more economical.
