Most sterilization in the medical device industry is accomplished by way of heat, usually in the form of steam. A significant alternative to heat-only processing methods is ethylene oxide (EtO) sterilization. As alluded to, this process is usually performed on heat- or moisture-sensitive items.
EtO sterilization uses both temperature (30°-70°C) and the presence of the EtO molecule in a very low humidity condition in a sealed vessel to provide sterility. EtO sterilization cycles are often very long, lasting 10+ hours. Ethylene oxide is very toxic to humans and it is also very flammable, meaning that EtO sterilization is very dangerous and requires equipment that is specially designed to address these aspects of the process.
Exact humidity is critical for the success of a sterilization cycle because it directly affects the efficacy and efficiency of the sterilization. Moisture must be distributed relative to air, sterilant gases, and stratification. Quite often, when conducting EtO sterilization, the principle limiting factor is moisture availability.1
For such a critical process, make sure you are using premium indicators for your sterilization monitoring program. Whether you need a PCD, spore strip or self-contained biological indicator (BI), Mesa is the ideal choice for a BI supplier and a sterility assurance partner.
Let’s talk biological indicators!
Talk with one of our experts to get your questions answered and see how we can help you solve your BI pain points.