Optimising EtO sterilisation

Published: 30-Apr-2002


North American Sterilization & Packaging (NASP), of Franklin, New Jersey, US, has developed a new system of monitoring technologies for all types of ethylene oxide (EtO) sterilisation processes.

When medical devices are EtO sterilised, biological indicator spore strips are placed in the load prior to processing. Afterwards the indicators are retrieved and incubated for up to seven days. However, if the gas concentrations can be measured directly from headspace analysis, the product can be released without biological testing.

NASP is about to install mid-infrared spectrometers built especially for the EtO sterilisation industry by Spectros Instruments, of Massachusetts. The analysers will draw a gas stream directly from the steriliser headspace and provide accurate determination of the two critical gases: ethylene oxide and water vapour. Following completion of the cycle, product release is based entirely on the direct measurement of all physical process parameters and conformance of these parameters with validated specifications. This so-called parametric release technique reduces processing times. NASP has a client whose sterilisation time has been reduced from 11 to three days, it says.

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