Ossido di etilene (EO) Sterilization Glossary
Understanding the technical terminology is essential for maintaining compliance with FDA and ISO 11135 standard. Below is an alphabetical guide to terms frequently used in Ossido di etilene (EO) sterilizzazione discussions among medical device manufacturers.
The process of removing gas OE from a sterilized product by exposing it to air to reduce OE residuo levels.
The number and type of microorganisms present on a product prior to the EO sterilization process.
The sealed vacuum container where the processo di sterilizzazione takes place under controlled parameters.
A colorless gas used as a potent sterilizzante due to its ability to penetrate packaging and reach complex device areas.
The movement of gas OE molecules from areas of high concentration to areas of low concentration within the load.
The measured ability of the processo di sterilizzazione to effectively kill specific microorganisms.
Preparing a product by exposing it to controlled humidity and temperature prior to EO gas injection.
The documented process of verifying that the ciclo di sterilizzazione consistently achieves the desired sterility level.
Critical Technical Metrics: D-Value
In Tecnologia di sterilizzazione con ossido di etilene, IL Valore D is one of the most vital metrics for quality control. It represents the specific time required to achieve a one-log (90%) reduction in the number of viable microorganisms at a set temperature and gas concentration.
BOCON: Your Expert in EO Sterilization Compliance
BOCON Sterilizzatori ETO serie BCS are designed to meet all FDA sterilization E ISO 11135 requirements. Our equipment provides precise control over gas concentration, exposure time, E aeration, ensuring your products achieve the highest standards of safety and low OE residuo levels.
