How can a Microelectrodes test probe sold by ADInstrments be sterilized for human use?

The complete line of Microelectrodes products offered by ADInstruments can be sterilized with standard gas sterilization methods as long as the temperature is not allowed to exceed 140 °F (60 °C). An example Ethylene Oxide (EO) sterilization procedure is listed below:  

Preheat phase

Starting Temperature 110 ºF (43ºC) min.

Duration 30 minutes

 

Initial Vacuum

6.0 inHgA (20.3 kPa)

Rate: 3 minutes

 

Nitrogen Flush

2 cycles
Nitrogen Addition to: 28.0 ± 0.5 inHgA (94.8 ± 1.7 kPa)
Rate: 1.4 ± 0.5 inHgA/min. (4.7 ± 1.7 kPa/min.)
Evacuation: 6.0 ± 0.5 inHgA (20.3 ± 1.7 kPa)

Rate: 1.0 ± 0.5 inHgA/min. (3.4 ± 1.7 kPa)

 

Conditioning
Humidification: 1.5 ± 0.5 inHgA (5.1 ± 1.7 kPa)
Steam Conditioning: 10 min.
Humidity Dwell: 30 ± 5 min. at 7.5 ± 0.5 inHgA (25.4 ± 1.7 kPa)
Relative Humidity: 15-70%

 

Ethylene Oxide Concentration

500 ± 50 mg/L
Dwell Pressure: 16.5 ± 1.0 inHgA (55.8 ± 3.4 kPa)
Dwell Time: 2 hours
Temperature: 110-130 ºF (43-54 ºC)
Relative Humidity: 30-70% (35-44% nominal)

 

After Vacuum
Vacuum: 6.0 ± 0.5 inHgA (20.3 ± 1.7 kPa)
Rate: 1.0 ± 0.5 inHgA/min. (3.4 ± 1.7 kPa)
Vacuum Hold: 10 min.

 

Gas Wash A

4 cycles (minimum)
Release: 30.0 inHgA/min. (94.8 ± 1.7 kPa)
Rate: 1.4 ± 0.5 inHgA/min. (4.7 ± 1.7 kPa)

 

Vacuum

6.0 ± 0.5 inHgA (20.3 ± 1.7 kPa)
Rate: 1.0 ± 0.5 inHgA/min. (3.4 ± 1.7 kPa)

 

Release (Filtered Air)

28.0 ±0.5 inHgA (94.8 ± 1.7 kPa)
Rate: 2.0 ± 0.5 inHgA/min. (6.6 ± 1.7 kPa)

 

Aeration (Hot Cell)
Duration: At least 8 hours
Temperature: 110 ± 10 ºF (43 ºC)
 

For further technical assistance with this or any other issue, please contact ADInstruments Technical Support by clicking HERE.