Oxyde d'éthylène (EO) Sterilization Glossary
Understanding the technical terminology is essential for maintaining compliance with FDA and ISO 11135 normes. Below is an alphabetical guide to terms frequently used in Oxyde d'éthylène (EO) stérilisation discussions among medical device manufacturers.
The process of removing gaz EO from a sterilized product by exposing it to air to reduce OE résiduelle levels.
The number and type of microorganisms present on a product prior to the EO sterilization process.
The sealed vacuum container where the processus de stérilisation takes place under controlled parameters.
A colorless gas used as a potent stérilisant 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 processus de stérilisation 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 cycle de stérilisation consistently achieves the desired sterility level.
Critical Technical Metrics: D-Value
Dans Technologie de stérilisation à l'oxyde d'éthylène, le Valeur 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 Stérilisateurs ETO série BCS are designed to meet all FDA sterilization et OIN 11135 requirements. Our equipment provides precise control over gas concentration, exposure time, et aeration, ensuring your products achieve the highest standards of safety and low OE résiduelle levels.
