ETO Sterlizer Automation for CE mark / USFDA

For ETO sterilizer automation, we have developed a special software complying with European Standard EN-550 and ISO-11135, a guideline for the sterilization of medical devices (validation and routine control) using ethylene oxide, to get CE marking for their healthcare disposable products.

For sterilizer automation, our software in featured with excellent data reporting system. The data records are in encrypted format and are password protected. For each and every sterilization process cycle conducted by our automation software, the system gives graphical as well as numerical records at selectable time interval with all the important sterilization process information including process parameters like pressure/vacuum, temperatures, relative humidity and time.

It also involves all the related important process details like name of the client, equipment identification no., cycle number or load no., product name, batch no., load size, operator code, Gas cylinder no., gas concentration mg/liter and other related important process information.

These sterilization process records are self explanatory, very easy to understand and are very useful for the users (production and quality people) as well as for the external regulatory auditors. The data records are formatted in such a way that they can become useful for the parametric release of the products once sterilized.

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