Sterilization Validation – Reuse Device

Testing Locations

• Salt Lake City, UT, USA
• Itasca, IL, USA
• Fairfield, NJ, USA (Formerly Gibraltar Laboratories)

Study Outline

Steam Sterilization Sterility Assurance Level testing: The testing validates the recommended gravity and/or prevacuum steam sterilization parameters for the medical device. Nelson Labs validates individual devices, implants, trays, kits, or other reusable devices. Typically, a Sterility Assurance Level (SAL) of 10⁶ is validated using the biological indicator overkill method. Along with the SAL validation it is recommended to perform dry time validation testing and internal temperature mapping may be appropriate. Dry time testing ensures that after the sterilization cycle, the packaging and the device(s) are not wet. Moisture may compromise the sterile properties of the packaged device. Temperature mapping profiles the temperature inside the containment device and demonstrates the heating properties of the device.

Nelson Labs validates individual devices, implants, trays, kits, reusable devices, or other devices processed at a health care facility.

If you have additional questions about Sterilization Validation – Reuse Device testing, or would like to consult with the experts at Nelson Labs, just send us a request or call us at +1 (801) 290-7500.