Adriamed obtained the Declaration of Conformity to UNI EN ISO 11135 Standards for the process of Ethylene oxide sterilization.

This is another important objective on the path of continuous improvement undertaken by the organization, mainly aimed at demonstrating the efficiency and safety of the products and of the company processes with regard to applicable standards.

Certified quality for the ETO sterilization process.

Quality, safety and respect for the environment are the values Adriamed believes in.

A constant and knowledgeable commitment from the Company and its staff, who operate in full compliance with applicable regulations.

Adriamed has, certified since 1999, a quality system conforming with UNI EN ISO 9001 and UNI EN ISO 13485 standards.

The company quality management system is aimed at continuously improving processes; from planning and development of the product, to production, sale and after sales service, including Ethylene oxide sterilization services and micro-biological checks in the company laboratories.

The laboratory

The modern company laboratory is equipped for carrying out visual checks using optical microscopes, technological and biological trials.
All the equipment has been recently acquired and subjected to regular checks and calibration.
The laboratory thermostats ensure that the temperature set is maintained within acceptable ranges for carrying out trials, and for the maintenance of growth mediums and chemical/biological testers…

There are at the moment amongst the technological trials:

    • tests for air tightness on PVC bags for infusion solutions and blood bags (even subjected to the autoclave at 121°C);
    • pressure drop tests (holding) on sets and related components;
    • Stress-cracking tests on tubing with visual checks using optical microscopes;
    • seepage tests;
    • speed and stability of flow tests on elastomeric pumps at controlled temperatures

The biological trials are carried out on the biological indicators used during the process of sterilization.

Atrophaeus Bacillus spores are used (Bacillus subtilis var. niger) with pop. > 10 6 spores/unit (ATCC 9372), either in strip form or in self-contained phials, conforming with ISO 11138-1:2017 and ISO 11138-2:2017.

The sterility checks on the process biological indicators is necessary to guarantee a good outcome for the sterilization process, and to allow for the release of a sterile product.