The Ethylene Oxide sterilization Plant, built close to Midial’s production site in Trapani, has been born not only to meet the Company’s own internal demands but, has been planned to obtain maximum output and flexibility with the aim of being able to satisfy any requirements of our potential Clients.

The plant and the sterilization process are an integral part of the Company’s Quality system, certificated by the TUV of Monaco (cert. No. Q2971031125005).

The installation, built in two pre-conditioning tunnels, three autoclave to expose the sterilizing agent, three degassing tunnels (each one with a nominal volume of 51 m3), makes it possible for us to carry out several sterilization cycles completely independent for duration, temperature and humidity condition, ethylene oxide concentration and fluxing, according to the materials processed.

The customizing of the sterilization cycle, according to the physical and microbiological characteristics of the products, enables to optimise the outcome and the efficacy of the process

In addition the Company, through the chemical-biological laboratory equipped to perform all the analysis and controls connected to the sterilization process (bioburden assessment, sterility controls, ETO residue analysis, search for pyrogenic agents, offers a complete service for the drafting of sterilization protocols (in conformity to UNI EN 550 and ISO 11135 standards) and the possibility to carry out studies for the optimisation of the cycle.

All the areas, including the degassing tunnels, are installed and defined in conformity to UNI EN 550 and ISO 11135 standards. It’s possible to increase the fluxing, according to the client requirements, in order to obtain a much lower level of Ethylene oxide residue than the limits stated by UNI EN ISO 10993-7 and by Pharmacopoeia, with the scope to eliminate the quarantine time.

The plant and sterilization cycles are managed by sophisticated software, purposely validated for the recording of reference parameters. The software is programmed to memorize a variety of sterilization ‘recipes’, corresponding to each validated cycle, in order to reduce the chance to set wrong parameters by the operator.