Gaseous ethylene oxide sterilization is a kind of chemical sterilization method. Because it has a strong sterilization effect on most microorganisms such as bacteria, viruses, and spores, the sterilization range is very wide. In addition, ethylene oxide has the characteristics of strong penetration, low sterilization temperature, and basically no damage to the product (compared to radiation sterilization), and has become one of the two mainstream sterilization methods for medical devices, especially disposable medical devices. First, it is widely used at home and abroad.

Since the sterilization process is a special process, process validation is an important part of sterility assurance. Custom Ethylene Oxide Treatment confirms that there are different methods such as half-cycle method and partial negative method. Each method has different emphases, but they all involve basic issues such as microbial challenge devices, ethylene oxide residues, and product family classification. This paper tries to start from these basic problems and briefly introduce related concepts and processing methods.

Ethylene oxide sterilization method and confirmation process

Pretreatment can be done in a sterilizer or in a separate room. However, in the standard, the following five characteristics are specified for the hardware conditions of the pretreatment chamber:

Equipped with a steam humidifier;

Have sufficient air circulation space;

Airflow detection equipment or alarm systems or indicators with monitoring circulatory system;

Configure the device for recording time;

Configure devices to monitor and control indoor temperature and humidity.

Sterilization cycle

Sterilization cycles are usually completed in a sterilizer. Some domestic manufacturers use semi-automatic sterilizers, which cannot output the monitoring data of pressure and ethylene oxide temperature during the sterilization process, and some of them are not even equipped with steam generators. A device like this does not meet the standard requirements. It is recommended that device manufacturers consider choosing a sterilizer that meets CE requirements when purchasing a sterilizer.