There is movement toward increased regulation around the validation of the parameters required for steam sterilization of reusable instruments and implants. To help our clients meet these tightening requirements we provide Steam Sterilization Cycle Validation (also known as Moist Heat Validation) for reusable products. Our Steam Sterilization Cycle Validations are typically performed at both 121°C Pre-Vac and 132°C Gravity, but we have the capability to run our Steam Sterilization Cycle Validation cycles as high as 135°C.
We have developed standard protocols that have withstood both customer and FDA scrutiny. We customize our protocols to meet the unique steam sterilization needs of your devices, and help you determine which products should be considered worse case. We have 5 autoclaves of varying sizes that we can utilize, so capacity and product size are never an issue.
In conjunction with our Cleaning Validation option, we can provide you everything you need when you are developing reusable product cleaning and steam sterilization parameters for your product Instructions for Use (IFU).