Moist Heat Sterilization

Moist Heat Sterilization

Steam Sterilization

In addition to instructions for cleaning, manufacturers of reusable medical devices must provide complete written instructions for disinfection or sterilization following cleaning to ensure that the device can be used safely and for the purpose for which it is intended. Manufacturers are obligated under the Food and Drug Administration (FDA) labeling regulations (21 CFR 801) to have the suitability of these processes validated. 

LexaMed is an industry leader in designing and performing sterilization validations for reusable medical devices processed at health care facilities and has extensive experience in validating moist heat (gravity or prevacuum), ethylene oxide (EO), and dry heat sterilization modalities. Every device is different therefore each program begins with generation of a unique protocol by an experienced project manager followed by study execution by trained microbiologists using fully validated and calibrated sterilizers.  

The validation protocol and testing are developed and conducted in compliance with the following standards: