Sanitary Process Solutions . Silicone Products

For steam sterilization of SPS silicone tubing, flush tube with water and sterilize while lumen is still wet. The presence of moisture during autoclaving is critical for proper sterilization. Use one of the following procedures when autoclaving.

Standard Gravity Autoclave (30 minutes 250 F(121°c) @ 15 psi (1.03 bar))

Wrap moist tubing in sterilization paper or muslin cloth and place in a clean, open tray. Autoclave at specified parameters.

High Speed Instrument Flash Autoclave
(10 minute 270°F(132°C) @ 30 psi (2.07 bar))
Place moist tubing on sterilization paper or muslin cloth and place in a clean, open tray. Autoclave at specified parameters.

Pre-Vacuum High Temperature Autoclave
(30 minutes 250°F(121 °C))
Wrap moist tubing in sterilization paper or muslin cloth and place in a clean, open tray . Autoclave at specified parameters.

SPS tubing can be gamma sterilized with 3.5 megarads of exposure cumulative. The tubing has shown minimal changes in physical properties during post exposure testing. Tensile strength remains relatively unchanged, while minimal increases in durometer and tensile modulus at ultimate elongation were measured. These changes are similar to post-cured elastomers.

Ethylene Oxide (ETO)
Exposure to Ethylene Oxide will not effect SPS tubing. This method should be tested to determine the time required for complete out-gassing of ETO and ETO by-products that could remain in tubing after contact.

SPS Silicone Tubing will not breakdown after repeated autoclaving and is the recommended method of sterilization. Steam In Place (SIP) sterilization should not be used unless the specification for the silicone hose meets the cleaning parameters and also confirmed by a factory representative. All tubing sterilization methods should be tested by the end user for their particular application and manufacturing requirements.