Etilen Oksit (EO) Sterilization Glossary
Understanding the technical terminology is essential for maintaining compliance with FDA and ISO 11135 standartlar. Below is an alphabetical guide to terms frequently used in Etilen Oksit (EO) sterilizasyon discussions among medical device manufacturers.
The process of removing gaz EO from a sterilized product by exposing it to air to reduce residual EO levels.
The number and type of microorganisms present on a product prior to the EO sterilization process.
The sealed vacuum container where the sterilization process takes place under controlled parameters.
A colorless gas used as a potent kısırlaştırıcı due to its ability to penetrate packaging and reach complex device areas.
The movement of gaz EO molecules from areas of high concentration to areas of low concentration within the load.
The measured ability of the sterilization process 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 sterilizasyon döngüsü consistently achieves the desired sterility level.
Critical Technical Metrics: D-Value
In Etilen Oksit sterilizasyon teknolojisi, the D-value 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'lar BCS Serisi ETO Sterilizatörler are designed to meet all FDA sterilization Ve ISO 11135 requirements. Our equipment provides precise control over gas concentration, exposure time, Ve aeration, ensuring your products achieve the highest standards of safety and low residual EO levels.
