エチレンオキサイド (EO) Sterilization Glossary
Understanding the technical terminology is essential for maintaining compliance with FDA and ISO 11135 標準. Below is an alphabetical guide to terms frequently used in エチレンオキサイド (EO) 殺菌 discussions among medical device manufacturers.
The process of removing ガス状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滅菌 process.
The sealed vacuum container where the 滅菌プロセス takes place under controlled parameters.
A colorless gas used as a potent 滅菌剤 due to its ability to penetrate packaging and reach complex device areas.
The movement of ガス状EO molecules from areas of high concentration to areas of low concentration within the load.
The measured ability of the 滅菌プロセス 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 滅菌サイクル consistently achieves the desired sterility level.
Critical Technical Metrics: D-Value
で エチレンオキサイド滅菌技術, the D値 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.
ボーコン: Your Expert in EO Sterilization Compliance
ボーコンの BCS シリーズ ETO 滅菌器 are designed to meet all FDA sterilization そして ISO 11135 requirements. Our equipment provides precise control over gas concentration, exposure time, そして aeration, ensuring your products achieve the highest standards of safety and low residual EO levels.
