All purchased products are subjected to thorough acceptance controls to confirm their compliance with requirements listed in the related technical specifications. The instruments used for control purposes are included in a calibration and periodic maintenance plan.
The first step in the production cycle is prosthesis cutting, performed with the aid of specific machines that allow constant monitoring of the process parameters, thereby guaranteeing consistent product quality.
Herniamesh® has a class ISO 7 contamination-controlled environment, appropriate to the packaging of medical devices requiring long-term sterilisation. In this room the product is washed and packaged in Tyvek bags or blister packs.
Periodic checks on air-particle contamination and bacterial contamination from washing water and work surfaces during the sterilisation process allow us to keep the product bio-burden well below the legal threshold.
The product takes on its final format, packaged in its sales carton. Labelling and transport documents make wide use of EN980 symbols, and multilingual translations are used whenever the information to be provided cannot adopt standard symbols.
Every stage of the production process is followed by quality controls on each item produced so as to identify any nonconforming products.
After sterilisation the product remains in quarantine pending its release for sale, this release being subject to confirmation of a successfully completed sterilisation cycle. If the biological and documentation checks prove positive, the product may be transferred to the finished products warehouse and sold.
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