What are the Sterilization guidelines for Millar Mikro-Tip / VENTRI-CATH Catheters?

Note: Sterilization of catheters is OPTIONAL

CAUTION: DO NOT sterilize by autoclaving, radiation (gamma or e-beam), plasma, peroxide or
formaldehyde vapor solutions.

Catheters must be completely cleaned and dried before sterilization. Aerate at room temperature or in
a heated aeration cabinet. (max. 145 ºF, 63 ºC) Catheters may be sterilized in the white plastic
shipping tray. The foam dome and connector caps must be removed and placed alongside the catheter
inside the pouch during sterilization. The caps should be saved and reused each time the catheter is
cleaned.

The tray, with lid, should be placed in a breathable polyethylene pouch (e.g., 3M™ Steri-Lok™).

CAUTION: The catheter should be completely dry before sterilization.

Ethylene Oxide Sterilization Cycle Parameters

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)

CAUTION: The Mikro-Tip transducer should not be used earlier than 5 days after sterilization.

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This information is valid for the following catheter models:

Small Animal (Rats / Mice)

Mikro-Tip:
  • Single Pressure - SPR-1000, SPR-320, SPR-407, SPR-513, SPR-671, SPR-882, 
  • Multiple Pressure - SPR-721
  • Pressure-Volume - PVR-1030, PVR-1035, PVR-1045, SPR-838, SPR-839, SPR-864, SPR-869, SPR-878, SPR-901
Large Animal (Rabbit/Dog/Pig/Sheep/Cow/Horse)

Mikro-Tip:
  • Single Pressure - MPR-500, SPR-249A, SPR-330A, SPR-340, SPR-340S, SPR-350, SPR-350S, SPR-370, SPR-370S, SPR-524, SPR-595
  • Implantable - SPR-407I, SPR-671I
Non Mikro-Tip:
  • Pressure-Volume - SPR-877, SPR-889, SPR-894, SPR-923-1, SPR-923-2, SPR-923-3
Ventri-Cath:
  • Pressure-Volume - SPR-562-1, VENTRI-CATH-507, VENTRI-CATH-507S, VENTRI-CATH-510, VENTRI-CATH-510S, VENTRI-CATH-512, VENTRI-CATH-512S, VENTRI-CATH-512, VENTRI-CATH-512S