HIGHPOWER’s test methodology is based on methods outlined in AAMI TIR 12, ANSI / AAMI / ISO 14937, ANSI / AAMI ST81, and ANSI / AAMI ST79. Reusable medical devices require sterilization efficacy validation in order to assure proper and safe reprocessing by health care personnel.
Sterilization Efficacy testing is also sometimes referred to as ½ Cycle Testing, 100% Overkill Method Testing or Sterilization Validation Testing. All these terms mean the same thing in order to determine how effectively a sterilization process will sterilize the device(s) being tested.
The device being validated is run in a sterilization cycle using one half of the sterilization parameters that are normally used in a clinical environment. The test device also includes at least 106 spores of a highly resistant organism being placed in locations that would be the most difficult to sterilize. A full cycle would indicate a kill rate of at least 10-6 SAL (sterility assurance level).
Let us validate your products sterilization efficacy labeling claims. With over 25 years of experience validating reusable medical device sterilization processes and with every major FDA cleared sterilization process in-house (steam, ETO, hydrogen peroxide, peracetic acid, dry heat and chemical vapor), our scientists and technicians can assist device manufacturers in all of their sterilization efficacy validation needs.
HIGHPOWER Labs is ASP factory trained to perform STERRAD® functionality and efficacy validation testing. STERRAD® 100S, 200, NX and 100NX sterilization processes available for validation.
- Hydrogen Peroxide Sterilization Efficacy
- E.O. Gas Sterilization Efficacy
- Dry Heat Sterilization Efficacy (Convection and Forced Air)
- Chemical Vapor Sterilization Efficacy
- Chemical Immersion Sterilization Efficacy
- Steam Sterilization Efficacy (Gravity, Pre-vacuum and SFPP)
- Thermal Profile Studies
- Drying Time Studies
- Traditional Sterilizer Validations (AAMI ST-08, ST-55 and ST-50)
- Non-Traditional Sterilizer Validations (FDA Guidance on Premarket Notification [510(k)] Submissions for Sterilizers Intended for Use in Health Care Facilities)
We’re constantly adding new test to meet our customer’s expectations. If you don’t see your required sterilization efficacy test listed, please contact us at email@example.com with your inquiry.