The killing efficacy of ethylene oxide (EO) makes it the ideal method for sterilizing medical devices. However, it is also hazardous to health when it comes to direct contact with people.
In order to ensure safety of the personnel, system operators have an obligation to take appropriate technical and work organization measures (e.g., turn on warning lights, ventilation, interlocking mechanisms) if the EO concentration in working areas is too high. Therefore, continuous recording or measurement of the EO concentration in the operating areas of the EO sterilization system is not only critical, but also necessary to comply with the provisions for occupational safety.
RISK ACCEPTANCE CONCEPT
In order to ensure a safe operation, we recommend, based on TRGS 513, to comply with the following EO limits in working areas:
- Acceptance threshold: 0.2 mg/m3 (0.1 ppm)
- Tolerance threshold: 2.0 mg/m3 (1.0 ppm)
We at STERISYS offer you the necessary equipment, which allows you as the user to take and analyze the respective gas samples. Ethylene oxide is measured with an accuracy of 0.02 ppm. We also offer subsystems (e.g. warning lights, sirens) which automatically generate an alarm when the defined tolerance value is exceeded.
In addition, we will gladly assist you in the creation of a safety concept, which predefines the tolerance and acceptance values and security measures.
System features
We offer monitoring systems so that you are able to meet the increasing requirements for the control of EO concentration levels in working areas.
We provide you with assistance to develop the optimal safety concept.
When the EO limit is exceeded, safety mechanisms (e.g., fan) are automatically activated.
